From: Hammersla, Ann (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=87FB28AA23744COB855EF0683AC2E8B4-HAMMERSLAA]
Sent: 4/16/2018 12:11:27 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Bruff, Susan (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=d3bdf8cac94049dcab28d2eb5fad5137-bruffs]
Subject: RE: Exec Sec FYI: KE! and patent reporting
Mark and Susan: Is this ExSec request for the University of Pennsylvania and Juxtapid? Or is this for another KEI request?
Ann
From: Rohrbaugh, Mark (NIH/OD) [E]
Sent: Friday, April 13, 2018 10:38 AM
To: Bruff, Susan (NIH/OD) [E] <bruffs@od.nih.gov>; Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov> Subject: Exec Sec FYI: KE] and patent reporting
| know you have seen this correspondence but just wanted to share what | received from the ExSec record and assignment.
Work Folder Information
Work Folder: WF 371552
Process: FY]
Program Analyst: Crone, Colleen (NIH/OD) [E]
Due Date:
WF Subject: OS forwards for direct reply letter from James Love from Knowledge Ecology International (KEI) requesting investigation of and remedy to non-disclosure of NIH funding for 5 patents.
IC: od_osp
From: Love, James
To: Azar, Alex
Remarks: Assigned to OTT to create a draft direct reply to James Love on behalf of the Secretary for OD clearance. Please forward draft to Exec. Sec. to obtain clearances before mailing out. DUE: 04/17/18 COB. Also forwarded as FYI to NINDS, OIR, OM, OMA, OGC, OCPL, OLPA, and OSP.
REL0000023656
From: Hammersla, Ann (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=87FB28AA23744COB855EF0683AC2E8B4-HAMMERSLAA]
Sent: 4/10/2018 10:43:43 AM
To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Berkson, Laura (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=adb561ab47e54fdc94e2a54682514434-berksonld]
cc: Bulls, Michelle G. (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=b366f1a4382d44c1bde626e7730c3dd4-bullsmg]; Jackson, Stephanie (NIH/OD) [C] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=813a0dc9ddbc4fa2be8ca6ea23d081ca-jacksonsg]; Jorgenson, Lyric (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=3bbde7d361374981a4d336b6eeb17521-jorgensonla]; Mullman, Lauren (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=084e30198ca04156b3c91537del4adb3-mullmanl]
Subject: RE: Exondys 51 patents
Also — this request was sent to the Secretary. While OPERA is looking into the request, we have not heard whether the Secretary has delegated a response to NIH. The requestors, in addition to asking HHS to take title, has requested a meeting with the Secretary.
Ann
From: Rohrbaugh, Mark (NIH/OD) [E]
Sent: Monday, April 09, 2018 6:17 PM
To: Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov>; Berkson, Laura (NIH/OD) [E] <laura.berkson@nih.gov> Ce: Bulls, Michelle G. (NIH/OD) [E] <michelle.bulls@nih.gov>; Jackson, Stephanie (NIH/OD) [C] <stephanie.jackson3@nih.gov>; Jorgenson, Lyric (NIH/OD) [E] <lyric.jorgenson@nih.gov>; Mullman, Lauren (NIH/OD) [E] <lauren.mullman@nih.gov>
Subject: RE: Exondys 51 patents
Thank you. | was talking to Laura. b5 | These
eee ee ee ee ee eee ee ee eee nett 4
comments are useful background if he chooses to go into more detail.
From: Hammersla, Ann (NIH/OD) [E]
Sent: Monday, April 09, 2018 4:08 PM
To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Berkson, Laura (NIH/OD) [E] <laura.berkson@nih.gov> Cc: Bulls, Michelle G. (NIH/OD) [E] <michelle.bulls@nih.gov>; Jackson, Stephanie (NIH/OD) [C] <stephanie.jackson3@nih.gov>; Jorgenson, Lyric (NIH/OD) [E] <lyric.jorgenson@nih.gov>; Mullman, Lauren (NIH/OD) [E]
<lauren.mullman@nih.gov> Subject: FW: Exondys 51 patents
All: Thank you Mark for your offer to help. The following is OPERA’s information for the steps of review and options available.
RELO000023657
From: Hammersla, Ann (NIH/OD) [E]
Sent: Monday, April 09, 2018 11:04 AM
To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Berkson, Laura (NIH/OD) [E] <laura.berkson@nih.gov> Cc: Jorgenson, Lyric (NIH/OD) [E] <lyric.jorgenson@nih.gov>; Mullman, Lauren (NIH/OD) [E] <lauren.mullman@nih.gov> Subject: RE: Exondys 51 patents
Mark: A little more information may be helpful. | have drafted and it is being reviewed. When ok’d | will send to you for your review.
Ann
From: Rohrbaugh, Mark (NIH/OD) [E]
Sent: Friday, April 06, 2018 3:51 PM
To: Berkson, Laura (NIH/OD) [E] <laura.berkson@nih.gov>; Hammersla, Ann (NIH/OD) [E] <hammersiaa@mail.nih.gov> Cc: Jorgenson, Lyric (NIH/OD) [E] <lyric.jorgenson@nih.gov>; Mullman, Lauren (NIH/OD) [E] <lauren.mullman@nih.gov> Subject: RE: Exondys 51 patents
oy O1
Ann: can we work on this together? Not sure if you to say more about OER’s steps and processes.
From: Berkson, Laura (NIH/OD) [E] Sent: Friday, April 06, 2018 3:07 PM To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>
Cc: Jorgenson, Lyric (NIH/OD) [E] <lyric.jorgenson@nih.gov>; Mullman, Lauren (NIH/OD) [E] <lauren.mullman@nih.gov> Subject: RE: Exondys 51 patents
Hi Mark,
RELO000023657
Thanks for flagging this. Dr. Collins is testifying in front of the House Appropriations L-HHS Subcommittee on Wednesday, April 11 and we want to make sure he is prepared in case this comes up. Can you help pull together some talking points? We would need something by Monday afternoon. im hoping we can pull from previous march-in bullets. NINDS pulled together some background bullets (see below}, but | think we need something that would be responsive to a question. I've taken a first stab at drafting a mock question and left a spot for aresponse. Feel free to make edits to that or the NINDS background.
Happy to chat if that would be helpful.
From: Rohrbaugh, Mark (NIH/OD) [E]
Sent: Wednesday, April 04, 2018 5:19 PM
To: Wolinetz, Carrie (NIH/OD) [E] <carrie.wolinetz@nih.gov>; Jorgenson, Lyric (NIH/OD) [E] <lyric.jorgenson@nih.gov>; Baker, Rebecca (NIH/OD) [E] <rebecca.baker@nih.gov>; Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>; Berkson,
Laura (NIH/OD) [E] <laura.berkson@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov> Subject: FW: Exondys 51 patents
KEI, Health GAP, Patients for Affordable Drugs, People of Faith for Access to Medicines, Social Security Works, and Universities Allied for Essential Inventions sent Ann Hammersla a copy of a letter they plan to send to Secy Azar
RELO000023657
tomorrow (cc’ing Daniel Levinson HHS OIG) asserting that inventors/institutions failed to disclose NIH funding on 5 relevant patents on Serapta’s Exondys 51 (eteplirsen), a treatment for DMD, “which provides the government with an opportunity to take title to patents, and to use the ownership of the patents as leverage to lower the price.” KEI also suggests that “the NIH and the U.S. Department of Defense review 91 other patents
assigned to Sarepta which do not disclose federal research funding.” He asks for a meeting with the HHS.
From: Hammersla, Ann (NIH/OD) [E]
Sent: Wednesday, April 04, 2018 3:40 PM
To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV> Subject: FW: Exondys 51 patents
FYI
From: James Love <james.love@keionline.org>
Sent: Wednesday, April 04, 2018 1:08 PM
To: Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov>
Ce: Andrew S. Goldman <andrew.goldman@keionline.org>; Kim Treanor <kim.treanor@keionline.org> Subject: Exondys 51 patents
Dear Ann Hammersla,
| am attaching two PDF files that we are sending tomorrow, regarding the patents on Exondys 51, so you have a heads up.
Jamie
James Love. Knowledge Ecology International http://www.keionline.org/donate. html KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile: +41.76.413.6584, twitter.com/jamie_ love
RELO000023657
From: Joe Allen [jallen@allen-assoc.com]
Sent: 4/5/2017 2:10:34 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=O0D/cn=ROHRBAUM]; Hammersla, Ann (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=Recipients/cn=hammerslaa]
Subject: Rep. Doggett's press release on letter to Pres Trump on using march in rights to control drug prices
FYI:
(https://doggett.house.gov/media-center/press-releases/congressional-democrats-trump-we-re-calling-your- hand-lower-prescription)
Congressional Democrats to Trump: “We’re Calling Your Hand -- Lower Prescription Drug Prices”
April 4, 2017
Washington, D.C.—Today, 51 members of Congress, led by U.S. Congressman Lloyd Doggett (D-TX), urged President Donald Trump to fulfill his oft-repeated promise to lower prescription drug prices. Rep. Doggett and his colleagues asked President Trump to protect public access to drugs developed with public dollars. Rep. Doggett, a senior member of the Ways and Means Committee and a leader of the House Prescription Drug Task Force, said:
“Today, we are calling Trump’s hand on his promises to lower prescription drug prices. To date he has failed completely to fulfill his commitment. So far his only related legislative action was to endorse a $28.5 billion tax windfall for brand name drug makers, while seeking nothing in return for consumers. He can act immediately to discourage many drug makers from charging the public sky-high prices on drugs developed with public dollars.
“When taxpayers finance pharmaceutical research, they have earned the right to obtain affordable access to that medication. And that is not happening now. Instead, taxpayers are hit twice for too many drugs—once when they pay for drug research and again when the pharmaceutical company engages in price gouging. When drug makers are granted unrestricted, government-approved monopolies and exploit them to set monopoly prices, a diagnosis of a dread disease can become a prognosis for financial ruin.”
The letter explains that federal agencies, like the National Institutes of Health (NIH), can foster competition by requiring companies holding patents for publicly-funded inventions to license the patent to third parties. This authority was created by the Bayh-Dole Act, a 1980 statute, and can be used when “action is necessary to alleviate health and safety needs which are not being reasonably satisfied” or when the benefits of the taxpayer- funded drug are not “available to the public on reasonable terms.” This effort is supported by Public Citizen, Doctors for America, Consumers Union, and Knowledge Ecology International. The Prescription Drug Task Force aims to advance legislative and administrative solutions to lower the cost of prescription medications for American families.
REL0000023662
Joseph P. Allen President
Allen and Associates 60704 Rt. 26, South Bethesda, OH 43719
(ey b6
www.allen-assoc.com
REL0000023662
From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM]
Sent: 8/27/2019 1:59:17 PM
To: Berkley, Dale (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=5ee461c29f5045a49fOadf82caaa2f31-berkleyd]; Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]
cc: Goldstein, Bruce (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=cb67e8fe5aa2452a8a7f200e5fb4335b-goldsteb]; Pazman, Cecilia (NIH/NHLBI) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=bf35741501e247d887acd224eaf9d679-pazmance]
Subject: Re: Emailing: KEl Comments NIH License to MTTI Described in 84 FR 39001_.pdf, NIHtoKE! re MTTI 25Aug2019.docx
Ok, Ill simplify.
From: "Berkley, Dale (NIH/OD) [E]" <berkleyd@od.nih.gov>
Date: Monday, August 26, 2019 at 16:23:16
To: "Shmilovich, Michael (NIH/NHLBI) [E]" <michael.shmilovich@nih.gov>, "Rohrbaugh, Mark (NIH/OD) [E]" <rohrbaum@od.nih.gov>
Ce: "Goldstein, Bruce (NIH/OD) [E]" <goldsteb@mail.nih.gov>, "Pazman, Cecilia (NIH/NHLBI) [E]" <pazmance(@nhibi.nih.gov>
Subject: RE: Emailing: KE] Comments NIH License to MTTI Described in 84 FR 39001_.pdf, NIHtoKEI re MTTI 25Aug2019.docx
----- Original Message-----
From: Shmilovich, Michael (NIH/NHLBJ) [E] <michael.shmilovich@nih.gov>
Sent: Monday, August 26, 2019 4:03 PM
To: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov> Ce: Goldstein, Bruce (NIH/OD) [E] <goldsteb@mail.nih.gov>; Pazman, Cecilia (NIH/NHLBD [E] <pazmance@pnhlbi.nih.gov>
Subject: RE: Emailing: KE] Comments NIH License to MTTI Described in 84 FR 39001_.pdf, NIHtoK EI re MTTI 25Aug2019.docx
Importance: High
Their listed of comments were essentially the same as before.
From: Berkley, Dale (NIH/OD) [E]
Sent: Monday, August 26, 2019 15:57
To: Shmilovich, Michael (NIH/NHLBI) [E] <michael.shmilovich@nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>
Ce: Goldstein, Bruce (NIH/OD) [E] <goldsteb@mail-nih.gov>; Pazman, Cecilia (NIH/NHLBD [E] <pazmance@nhlbi.nih.gov>
Subject: RE: Emailing: KEI Comments NIH License to MTTI Described in 84 FR 39001_.pdf, NIHtoK EI re MTTI 25Aug2019.docx
REL0000023665
Misha:
I don't see any objections or even any questions from KEI in their August 23 letter that you attached. Have I missed any?
[fon ee eee eee ee RR em
Best, Dale
Dale D. Berkley, Ph.D., J.D.
Office of the General Counsel, PHD, NIH Branch Bldg. 31, Rm. 47 Bethesda, MD 20892
301-496-6043
301-402-2528(Fax)
This message is intended for the exclusive use of the recipient(s) named above. It may contain information that is PROTECTED or PRIVILEGED, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information.
From: Shmilovich, Michael (NIH/NHLBJ [E] <michael.shmilovich@nih.gov>
Sent: Sunday, August 25, 2019 7:47 PM
To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>; Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov> Ce: Goldstein, Bruce (NIH/OD) [E] <goldsteb@mail.nih.gov>; Pazman, Cecilia (NIH/NHLBD [E] <pazmance@nhlbi-nih.gov>
Subject: Emailing: KEI Comments NIH License to MTTI Described in 84 FR 39001 _.pdf, NIHtoKEI re MTTI 25Aug2019.docx
Dale and Mark -- a pdf with KEI's comments (received Aug 23) and a word doc with my response enclosed. Please have a look at both and let me know if you have any comments or edits to the response.
Thanks again!
Regards,
Michael A. Shmilovich, Esq., CLP
Office of Technology Transfer and Development 31 Center Drive Room 4A29, MSC2479 Bethesda, MD 20892-2479
0. 301.435.5019
shmilovm@mail.nih.gov
This message may contain privileged and confidential information intended only for the use of the individual(s) or entity named above. If you are not the intended recipient, you are hereby notified that any use, dissemination, distribution, or copying of this message or its content is strictly prohibited. If you have received this message in error, please notify sender immediately and destroy the message without making a copy. Thank you.
“Always be yourself....unless you can be a pyrate... then; obviously, be a pyrate”
‘Your message is ready to be sent with the following file or link attachments:
KEI Comments NIH License to MTTI Described in 84 FR 39001_.pdf NIHtoKEI re MTTI 25Aug2019.docx
REL0000023665
Note: To protect against computer viruses, e-mail programs may prevent sending or receiving certain types of file attachments. Check your e-mail security settings to determine how attachments are handled.
REL0000023665
From: Berkley, Dale (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=5EE461C29F5045A49FOADF82CAAA2F31-BERKLEYD]
Sent: 8/27/2019 2:29:01 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]
Subject: RE: Questions Regarding NIH's Prospective Grant of an Exclusive Patent License: Development and
Commercialization of CD19/CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies
Ok thanks.
Dale D. Berkley, Ph.D., J.D.
Office of the General Counsel, PHD, NIH Branch
Bldg. 31, Rm. 47
Bethesda, MD 20892
301-496-6043
301-402-2528(Fax)
This message is intended for the exclusive use of the recipient(s) named above. It may contain information that is PROTECTED or PRIVILEGED, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information.
From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>
Sent: Tuesday, August 27, 2019 10:28 AM
To: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>
Subject: Re: Questions Regarding NIH's Prospective Grant of an Exclusive Patent License: Development and Commercialization of CD19/CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies
| saw your response to Misha and will work with jim in a similar vein
Sent from my iPhone
On Aug 27, 2019, at 10:22 AM, Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov> wrote:
Parente tere imei momen nrment er mI mee eile EINE IESE IEEE Riese eee SIE Ie RIE EaCE IEEE Era aa eteSiatmatamiassmtaaiarmiaimemimimies a
More and more questions. | b5
Sent from my iPhone
Begin forwarded message:
From: "Knabb, Jim (NIH/NCI) [E]" <jim.knabb@nih.gov>
Date: August 27, 2019 at 8:57:25 AM EDT
To: "Rohrbaugh, Mark (NIH/OD) [E]" <rohrbaum @od.nih.gov>
Subject: FW: Questions Regarding NIH's Prospective Grant of an Exclusive Patent License: Development and Commercialization of CD19/CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies
Hi Mark,
| hope you are doing well. | see that you’re out of the office, | hope you’re enjoying a vacation.
Could we work together to craft a response to KEI regarding their comments below? My
understanding from Richard isi_ b5
i i inert rrr terete seem emimemre reeeee teers tense AMAT RAY MET RAT RRR APT LETT APTA ATTY RPT PR YP i i i i i
i b5
REL0000023667
Thanks, Jim
From: kathryn ardizzone <kathryn.ardizzone@keionline.org>
Sent: Friday, August 23, 2019 4:57 PM
To: Knabb, Jim (NIH/NCI) [E] <jim.knabb@nih.gov>
Cc: James Love <james.love@keionline.org>
Subject: Questions Regarding NIH's Prospective Grant of an Exclusive Patent License: Development and Commercialization of CD19/CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies
Dear Dr. Knabb:
We are writing to request information about the proposed exclusive license in CAR therapies targeting certain B-cell cancers, which was noticed at 84 FR 43148, to Lyell Immunopharma, Inc. (“Lyell”), located in South San Francisco, CA.
1. According to the notice, there are two inventions covered by the proposed license, described at OTT Ref. Nos. E-016-2015 and E-017-2017.
a. What clinical trials are associated with the subject inventions? We are aware of only one trial, NCT01593696, which is associated with E-016-2015.
b. Can you please confirm that this trial is associated with the licensed technology?
c. How much will the NIH contribute to the cost of NCT01593696? A research on the NIH RePORTER database for NCT01593696 for all fiscal years returned zero results.
d. Are there any other clinical trials are associated with these technologies? If so, what NIH grant numbers, if any, associated with each trial, and how much did each trial cost?
2; Please confirm the stages of research and development that has been completed or started for each invention.
>. What is the NIH’s rationale for concluding that an exclusive, rather than a non-exclusive, or a partially-exclusive license is a necessary incentive under 35 U.S.C. § 209?
a. Did the NIH estimate the amount of investment required to bring the technology to practical application?
b. Did the NIH consider the incentives from the Orphan Drug Act regulatory exclusivity for rare diseases or FDA rules on exclusive rights to rely on regulatory test data as inadequate to protect the private investment in the technology?
4. What is the period of exclusivity for the proposed exclusive license? a. NIH’s model exclusive license, located at https://www.ott.nih.gov/resources#MLA, does include duration as a standard term. As a general matter, does the NIH negotiate the period of exclusivity for proposed licenses?
b. If the NIH does not negotiate duration as a term of its licenses, why not? How is this consistent with 35 U.S.C. § 209?
REL0000023667
c. CAR technologies are promising new cancer treatments, yet costs hundreds of thousands of dollars, straining hospital budgets and threatening patient access. From the industry perspective, they can be highly lucrative technologies. Has the NIH undertaken an economic analysis to determine if a shorter exclusivity period such as a five or 10 year term would be a sufficient incentive under 35 U.S.C. § 209 for the licensed technologies?
=A The proposed territorial application of the license is “worldwide.” NIH’s licensing page, https://www.ott.nih.gov/licensing, states that “[w]here appropriate, licenses can be granted on a worldwide basis.”"(Emphasis added). Determining the territorial application of a
license on a case-by-case basis would comport with 35 U.S.C. § 209. Yet, KEI rarely encounters a licensing notice where the proposed field of use is
not worldwide.
a. Did the NIH consider any of the benefits of licensing the technology
on an exclusive basis in some but not all countries?
6. What are the proposed royalties and other terms of financial compensation for this proposed exclusive license?
a. What licensing guidelines, if any, does the NIH Office of Technology Transfer use to determine royalty rates for its licenses?
b. What are the average royalty rates for licenses in NIH-owned CAR
therapies, as well as the average royalty rates for NIH license for cancer therapeutics.
re How has the NIH, through the proposed license, sought to give effect to the policy objective in the “United States Public Health Service Technology Transfer Policy Manual, Chapter No. 300, PHS Licensing Policy,” which states the following: “PHS seeks to promote commercial development of inventions in a way that provides broad accessibility for developing countries”? How has the NIH contemplated how its licensing decisions affect access to CAR therapies in developing countries?
a. If the license is worldwide, how will the NIH ensure access in countries with lower incomes, given the lack of access to other CAR T treatments in developing countries?
8. Has the NIH sought the advice of the Attorney General under 40 U.S.C. § 559?
Thank you in advance for your consideration of these questions. Sincerely,
Kathryn Ardizzone, Esq.
Counsel
Knowledge Ecology International
1621 Connecticut Avenue NW, Suite 500 Washington, DC 20009
kathryn.ardizzone@keionline.org (202) 332-2670
REL0000023667
From: Buchbinder, Barry (NIH/NIAID) [E] [/O=NIH/OU=NIHEXCHANGE/CN=NIAID/CN=BBUCHBINDER]
Sent: 3/16/2017 2:28:50 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=O0D/cn=ROHRBAUM] Subject: FW: ACTION - Fwd: Anyone have objection from KEl in 2017
Mark,
As an excuse to write you .... :-)
KEI lists their activities on their home page (<http:/Awww.keionline.org/>, scroll down). A quick look (“quick” => | might have missed something) found nothing in 2017 stood out as relevant. Note that Zika is listed <http://keionline.org/zika>, so it seems to be pretty up to date.
Hope you're having fun!
- Barry Ee: ‘NIAID/NIH = 240-627-3678 / Fax: 240-827-3717 }
tps ned .nih.gov/search/View Details aspx?NiHiD=00 10146018
‘aD16 « o8.2844 |
« The information in this e-mail and any of its attachments is confidential and may contain sensitive information. « it should not be used by anyone who is not an intended recipient. > If you have received this e-mail in error, please inform the sender and delete it from your mailbox or any other storage devices. = NIAID shall not accept liability for any statements made that are sender's own and nol expressly made on behalf of the NIAID by one cf its representatives.
From: Buchbinder, Barry (NIH/NIAID) [E]
Sent: Thursday, March 16, 2017 10:00 AM
To: Salata, Carol (NIH/NIAID) [E] <CSalata@niaid.nih.gov>; Castiblanco, Diana (NIH/NIAID) [C] <diana.castiblanco@nih.gov>; Contreras, Vince (NIH/NIAID) [E] <vince.contreras@nih.gov>; Petrik, Amy (NIH/NIAID) [E] <petrika@niaid.nih.gov>
Subject: RE: ACTION - Fwd: Anyone have objection from KEI in 2017
Carol, I'm not aware of any objections. All:
To save you looking for who this is (like | had to), KEI = Knowledge Ecology International (<http://Awww.keionline.org/>; <https://en.wikipedia.org/wiki/Knowledge Ecology International>), Jamie Love's group.
In case you want to look at it, the objection and related items seem to be here <http://keionline.org/zika>. Also, KEI lists their activities on their home page (scroll down) — nothing in 2017 stood out as relevant. Best,
- Barry TTIPO:NIAID: NIH 8 | 240- 627-3678 { Fax: 240-627-3117 /
& ar information in e-mail and any “ofits ean ents is confidential and may contain sensitive information. - It should not be used by anyone who is not an intended recipient. « if you have received this e-mail in error, please inform the sender and delete it from your mailbox or any other storage devices. » NIAID shail not accept liability for any statements made that are sender's own and not expressly made on behalf of the NIAID by one of its represeniatives.
From: Salata, Carol (NIH/NIAID) [E]
Sent: Thursday, March 16, 2017 6:57 AM
To: Buchbinder, Barry (NIH/NIAID) [E] <BBuchbinder@niaid.nih.gov>; Castiblanco, Diana (NIH/NIAID) [C] <diana.castiblanco@nih.gov>; Contreras, Vince (NIH/NIAID) [E] <vince.contreras@nih.gov>; Petrik, Amy (NIH/NIAID) [E]
<petrika@niaid.nih.gov> Subject: FW: ACTION - Fwd: Anyone have objection from KEI in 2017
Please let me know of any objections you are aware of. Thanks, Carol
RELO000023668
From: Feliccia, Vincent (NIH/NIAID) [E]
Sent: Wednesday, March 15, 2017 6:44 PM
To: Salata, Carol (NIH/NIAID) [E] <CSalata@niaid.nih.gov>; Green, Wade (NIH/NIAID) [E] <wade.green@nih.gov> Subject: FW: ACTION - Fwd: Anyone have objection from KEI in 2017
RE: Any Objections from KE! in 2017?
Hi Carol and Wade,
Please confirm with your Teams that we have not received any objections fram KElin 2047. Thanks,
Vince
aie 8 fs Se os oie Os oie a oe
Vincent L. Feliccia, Ph.D., J.D.
Branch Chief
Vaccine Design, Allergic and Infectious Diseases Branch (VDAID)
Technology Transfer and Intellectual Property Office (TTIPO}
National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH} 5601 Fishers Lane, Suite 6D
MSC 9804
Bethesda, Maryland 20892-9804 [Courler: Rockville, Maryland 20852-9804]
Office: (240) 627-3687 Mobile: (240) 620-2647 Fax: (240) 627-3117
vieliccla@niaid.nih.gav
The information in this e-mail and any of its attachments is confidential and may contain sensitive information. it should not be used by anyone who is not the original intended recipient. [f you have received this e-mail in error please inform the sender and delete it from your mailbox or any other storage devices. National Institute of Allergy and Infectious Diseases shall not accept liability for any statements made that are sender's own and not expressly made on behalf of the NIAID by one of its representatives.
From: Mowatt, Michael (NIH/NIAID) [E]
Sent: Monday, March 13, 2017 8:05 PM
To: Feliccia, Vincent (NIH/NIAID) [E] <VFeliccia@niaid.nih.gov>; Sayyid, Fatima (NIH/NIAID) [E] <fatima.sayyid@nih.gov>; Williams, Richard (NIH/NIAID) [E] <RWILLIAMS @niaid.nih.gov>
Ce: Frisbie, Suzanne (NIH/NIAID) [E] <frisbies@otd.nci.nih.gov>; Ranjan, Mukul (NIH/NIAID) [E]
<MRanjan@niaid.nih.gov> Subject: ACTION - Fwd: Anyone have objection from KE! in 2017
Branch chiefs,
Please let me know what we've got on this.
RELO000023668
To my knowledge none. Thx,
Mike
Begin forwarded message:
From: "Rohrbaugh, Mark (NIH/OD) [E]" <RohrBauM@OD.NIH.GOV> Date: March 13, 2017 at 5:00:29 PM EDT
To: NIH TDC Long <niaaatdcl-l@mail.nih.gov>
Subject: Anyone have objection from KEI in 2017
From FR notice of intent to grant?
Thx Mark
Sent from my iPhone
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From: Joe Allen [jallen@allen-assoc.com]
Sent: 3/16/2017 7:19:53 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM]
Subject: HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in lonis Pharmaceuticals’ Spinraza
FYI
Sent from my iPhone
See link below for press release that KEI posted this morning. The Inspector General’s Office has declined to investigate the federal funding issue for Spinraza.
http://keionline.org/node/2744
REL0000023670
From: Robert Hardy [RHardy@COGR.edu]
Sent: 3/17/2017 7:24:44 PM To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM] Subject: FW: HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in lonis
Pharmaceuticals’ Spinraza Attachments: 18Jan2017-OlG-investigation-Request-Nusinersen-Patents. pdf
Mark,
Good to see you at AUTM. Hope you got back OK.
Here FY! is the response by the HHS OIG to the KE! request, as well as the original letter from KEI.
From: Susalka, Stephen [mailto:SSusalka@autm.net]
Sent: Friday, March 17, 2017 11:55 AM
To: Robert Hardy; Joe Allen; Willey, Teri
Cc: Fred Reinhart; Michael Waring; Ashley Stevens (astevens@fipglic.com)
Subject: RE: HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in Ionis Pharmaceuticals’ Spinraza
Dear Bob,
| attached the official letter they sent to HHS to this email and their website has the following information:
HAS Of ice of Inspector General Declines to Investiqate Fallure to MAO WTC OF TS OOCTOP Generar WOCHMNeS LO MIVeESUCaLe Fanure ry «a rtaral Cane ‘ 7 ig’
The Depariment of Health and Human Services Office of Inspector General (O1G) informed KEI that it would not move forward with an investigation into whether Isis Pharmaceuticals, now known as lonis Pharmaceuticals, failed to report federal funding in patents on Spinraza.
in a letter dated March 13, 2017, Matthew Charette, the Special Agent in Charge of the Investigations Branch of O1G, explained that OIG counsel believes that OlG has limited authority, and that the obligation fo “monitor]] Invention reporting and remedyi] noncompliance” “rests with NIH's Office of ees for Extramural Research Administration (OPERA)."
On January 18, 2077, SE a 2e-padge i {3 containing evidence that the patents on Spinraza benefited frorn federal grants. KEI did not just ask OIG to iP veetguta Isis' alleged failure to report this funding, in violation of the Bayh-Dole Act and federal requiations, but also urged the OIG “to investigate whether the National institutes of Health failed to conduct proper oversight in administering its grants” and to "recommend appropriate action to remedy the situation in line with the statute and prior decisions with regard to failure to disclose a subject invention.”
Spinraza is used to treat Spinal Muscular Atrophy (SMA), a debilitating illness that largely affects very young children. Biogen, which collaborates with lonis, sells Spinraza for a price of $750,00 for the first year of four injections, and $375,000 for every year thereafter. As explained in KE!'s original letter fo OIG, lonis worked with researchers at Cold Spring Harbor Laboratories who received federal funding for their work on a treatment for SMA. We also noted that failure
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to disclose federal funding affects the ability of the government to use march-in rights or its royalty-free rights in patents under the Bayh-Dole Act.
and transcribed below.
The letter from is avaiable @s @ or
Sincerely, Steve
Stephen J. Susalka, Ph.D., CLP
Chief Executive Officer
Association of University Technology Managers (AUTM) Advancing Discoveries for a Better World
(336) 546-7977
Ssusalka@autm.net
From: Robert Hardy [mailto:RHardy@COGR.edu] Sent: Friday, March 17, 2017 11:51 AM
To: Joe Allen <jallen@allen-assoc.com>; Willey, Teri <twilley@cshl.edu> Cc: Fred Reinhart <fred@research.umass.edu>; Michael Waring <mwaring@umich.edu>; Susalka, Stephen <SSusalka@autm.net>; Ashley Stevens (astevens@fipgiic.com) <astevens@fipgilc.com>
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Subject: RE: HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in lonis Pharmaceuticals’ Spinraza
Can someone please send me the text of the KEI press release?
Thanks. KEL denies me access ta their website.
From: Joe Allen [mailto:jallen@allen-assoc.com]
Sent: Thursday, March 16, 2017 3:26 PM
To: Willey, Teri
Cc: Fred Reinhart; Michael Waring; Susalka, Stephen; Ashley Stevens (astevens@fipgllc.com); Robert Hardy Subject: Re: HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in Ionis Pharmaceuticals’ Spinraza
This keeps Jamie's perfect streak (for having every petition denied) intact. He's the Cal Ripken for that category Sent from my iPhone On Mar 16, 2017, at 3:15 PM, Willey, Teri <twilley@cshl.edu> wrote:
And we are continuing to diligently bring all our reporting into compliance. No rest for the wicked.
From: Frederick Reinhart [mailto:fred@research.umass.edu]
Sent: Thursday, March 16, 2017 3:14 PM To: Joe Allen
Subject: Re: HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in Ionis Pharmaceuticals’ Spinraza
Ditto. No doubt they will continue to press the issue. Sent from my iPhone On Mar 16, 2017, at 2:54 PM, Joe Allen <jallen@allen-assoc.com> wrote: Best news of the day! Sent from my iPhone On Mar 16, 2017, at 2:02 PM, Willey, Teri <twilley@cshl.edu> wrote: Sharing some positive news See link below for press release that KEI posted this morning. The Inspector General’s Office has declined to investigate the federal
funding issue for Spinraza.
http://keionline.org/node/2744
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RNOWLEDGE ECOLOGY INTERNATIONAL
1622 Connecticut Ave NW Suite 500 Washington, D.C. 20009 +1 (202) 332-2670
January 18, 2017
The Honorable Daniel R. Levinson
U.S. Department of Health & Human Services Office of Inspector General
330 Independence Avenue, SW
Washington, DC 20201
via email: Dan.Levinson@oig.hhs.gov
Dear Inspector General Levinson:
RE: Allegation of Isis Pharmaceuticals Failure to Satisfy Disclosure Requirements for a Subject Invention Under the Bayh-Dole Act, 35 U.S.C. §§ 200 et seq.
This letter requests that you investigate substantial evidence that Isis Pharmaceuticals (now known as lonis Pharmaceuticals) and Cold Spring Harbor Laboratory failed to satisfy disclosure requirements under the Bayh-Dole Act, 35 U.S.C. §§ 200 et seg., and Federal regulations, 37 C.F.R. §§ 401.3(a) & 401.14, with regard to federally-funded subject inventions related to the composition and methods of use of nusinersen, an antisense oligonucleotide (ASO), for the treatment of spinal muscular atrophy (SMA), embodied in U.S. Patent Nos. 8,361,977 (hereinafter the “977 patent”) and 8,980,853 (hereinafter the “853 patent’).
We have a high degree of confidence that both the ’977 patent and the ’853 patent are subject inventions under the Bayh-Dole Act, in that they were “conceived or first actually reduced to practice in the performance of work under a funding agreement.” 35 U.S.C. § 201(e).
Specifically, we present evidence that both inventions benefitted from the grant of funds from the National Institutes of Health (NIH) to support the research of Dr. Adrian R. Krainer at Cold Spring Harbor Laboratory, which was then used to file patents that have been assigned to Isis.
KEI Nusinersen Patent Complaint, Page 1 of 22
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In addition, the National Institutes of Health (NIH) gave several grants to Isis, and those grants appear to have directly contributed to the reduction to practice of the patented inventions assigned to Isis.
Table of Contents
I. About Us 2
lil. Spinal Muscular Atrophy (SMA) and Nusinersen (Spinraza) 3
i.A. Spinal Muscular Atrophy Incidence, Presentation, and Genetics 3
Table II.1: Classifications of Spinal Muscular Atrophy (SMA) 3
ll.B. Nusinersen (Spinraza) Mechanism of Action and Efficacy 4
lil. The Bayh-Dole Act and Disclosure of Subject Inventions 5 IV. The Nusinersen Patent Landscape and Failure to Disclose Government Rights in a
Subject Invention 9
Table IV.1: Key United States Patents in Nusinersen 9
IV.A. The University of Massachusetts Patents 10
IV.B. The ’977 and ’853 Patents: Failure to Disclose Government Rights in the Patents 11
Figure IV.1: Timeline of Publications, Collaborations, and Patent Filings/Grants 14
IV.B.1 Federal grants to ISIS Pharmaceuticals 16
V. Remedies 17
VI. Concluding Comments 17
Appendix |: Information on Misc Grants 19
1. Adrian R. Krainer/Cold Spring Harbor Laboratory Grant No. GM42699 19
2. Isis Pharmaceuticals’ Grants from REPORTER query 20
3. Selected DoD Army and DARPA SBIR and STTR grants 22
I. About Us
Knowledge Ecology International (KEI) is a 501(c)(3) non-profit non-governmental organization based in Washington, D.C., that advocates for access to affordable medicines, with a focus on human rights and social justice.
KEI has conducted oversight of federal intellectual property policy as it relates to federally-funded inventions. Over the years, we have filed petitions and comments with
various federal agencies, including the National Institutes of Health, in regards to the grant of intellectual property licenses and the use of federal authorities to end monopolies under the
KEI Nusinersen Patent Complaint, Page 2 of 22
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Bayh-Dole Act. See, for example, our recent work on the exclusive licensing of federally owned inventions by the National Institutes of Health, hite://keionline. org/nih-licenses . See also our petition to the National Institutes of Health and the U.S. Army to use march-in rights (35 U.S.C. § 203) or the government’s royalty-free license in the patents (35 U.S.C. § 202(c)(4)) on the prostate cancer drug Xtandi as a mechanism to lower the excessive price of the drug in the United States, hite://kelionline.org/xtandi .
ll. Spinal Muscular Atrophy (SMA) and Nusinersen (Spinraza)
[1.A. Spinal Muscular Atrophy Incidence, Presentation, and Genetics
Spinal Muscular Atrophy (SMA) is a genetic neuromuscular disease that affects the nervous system, in particular control of muscle movement.' The disease results in muscle weakness and wasting, difficulty breathing, and paralysis.
SMA is the primary genetic cause of infant death.” Current estimates for incidence range from 1 in 6,000 to 1 in 10,000 live births. Approximately 1 in 40 to 1 in 60 people carry the gene that contributes to the disorder. Because SMA is
recessive, both parents must carry the gene in order for the disease to present.
Clinicians classify SMA “into four phenotypes on the basis of age of onset and motor function achieved.”°
The following table from D’Amico et al. shows the classifications:
Table Il.1: Classifications of Spinal Muscular Atrophy (SMA)
Po Age of Onset | Highest function achieved Type | (Werdnig-Hoffmann disease) 0-6 months Type Il (intermediate) 7-18 months /Sitnever stand /Sitnever stand stand
Type Ill (mild, Kugelberg-W elander > 18 months Stand and Walk during disease) in adulthood adulthood
Type IV (adult) 2°-3° decade | Walk unaided
1 This section draws upon Adele D'AMico et al., Spinal Muscular Atrophy, 6 Orphanet J. Rare Diseases 71 (2011), unless otherwise stated.
2 Cure SMA, About SMA, http://www.curesma.org/sma/about-sma/.
3 D'Amico, Spinal Muscular Atrophy.
KEI Nusinersen Patent Complaint, Page 3 of 22
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The most common form of SMA is Type |, causing severe symptoms and death, as D’Amico et al. write:
SMA type 1 (Werdnig-Hoffmann disease) is the most severe and common type, which accounts for about 50% of patients diagnosed with SMA. Classically infants with SMA type | have onset of clinical signs before 6 months of age, never acquire the ability to sit unsupported and, if no intervention is provided, generally do not survive beyond the first 2 years. These patients have profound hypotonia, symmetrical flaccid paralysis, and often no head control. Spontaneous motility is generally poor and antigravity movements of limbs are not typically observed. In the most severe forms decreased intrauterine movements suggest prenatal onset of the disease and present with severe weakness and joint contractures at birth and has been labeled SMN 0. Some of these children may show also congenital bone fractures and extremely thin ribs. (Citations excluded.)
Everyone has two SMN genes, SMN1 and SMN2, to produce the SMN protein. In individuals with SMA, the SMN1 gene is defective and cannot be used to produce SMN protein. They must therefore rely solely on SMN2 gene to make the SMN protein. However, the SMN2 gene is not as efficient at making full length SMN protein and does not produce enough of the functional protein to make up for the loss of SMN1. This affects several cellular processes in motor neurons resulting in their degeneration, causing the muscles under their control begin to atrophy.’
[!.B. Nusinersen (Spinraza) Mechanism of Action and Efficacy
Nusinersen, marketed by Biogen under license from lonis Pharmaceuticals as Spinraza, is the first treatment for pediatric and adult SMA approved for sale in the United States by the Food and Drug Administration. °
The FDA approved nusinersen as a New Drug Application under Priority Review. In addition, the FDA granted nusinersen Orphan Designation, which enabled Biogen to claim the 50-percent orphan drug tax credit on qualifying clinical trials, and affords Biogen seven years of marketing exclusivity from the date of approval of the NDA.°
4 Saif Anmad et al., Molecular Mechanisms of Neurodegenerationin Spinal Muscular Atrophy, 10 J. Experimental Neurosci. 39 (2016).
5 Biogen, U.S. FDA Approves Biogen’s SPINRAZA™ (nusinersen), The First Treatment for Spinal Muscular Atrophy, Dec. 23, 2016,
nite. /media blocen cam/oress-reléase/neurodeqenérative-diseases/us-fda-anproves-bingens-soinraza-nusi
eived orphan designation on April 18, 2011. See the FDA database of Orphan Drug Designations and Approvals, at
tatetersbentbadcessonsanscsnsastanbecssssrecacotatnanetouevcasseansnssenatetaterencelnduncnensnceerenasnsaeepssuecccesesesepucnecusnasseaseenldieneconccedbecancecsessnerasezercsnsanavensensnsnenscnecsscnentecctseceressussetiesshudacasesateentnenefbessascvaenenenensnenseat
KEI Nusinersen Patent Complaint, Page 4 of 22
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The high price of nusinersen — $750,000 for the first year of treatment and $375,000 for every year thereafter — generated significant controversy, as reported in FiercePharma: “Regardless of how fair or reasonable Spinraza’s sticker might be in the ultra-orphan context, however, the outsize price tag was guaranteed to raise eyebrows, given the close scrutiny drug prices currently face.”’
As mentioned in the previous section, patients with SMA have a defective SMN1 gene, which leaves their body with an insufficient amount of the SMN protein and causes the death of motor neurons and muscular degeneration. Nusinersen acts on SMN2 unspliced mRNA transcripts and helps it make full length functional SMN protein, thus compensating for the malfunctioning SMN1 gene.
FDA approval of nusinersen was based on the interim results of a phase 3 double blind randomized clinical trial, ENDEAR (NCT02865109), and phase 3 open-label clinical trial, SHINE (NCT02594124).
ENDEAR enrolled 121 infants less than 7 months of age, and 82 were eligible for analysis at the time. According to the FDA label, the primary endpoint measured was “improvement in motor milestones according to Section 2 of the Hammersmith Infant Neurologic Exam (HINE).” The analysis demonstrated “statistically significant improvements in motor milestones, and the drug was generally well-tolerated, with a favorable safety profile and no significant adverse events.”®
The SHINE study, conducted in patients 30 days to 15 years, supported the ENDEAR results, such that, according to the FDA label, “some patients achieved milestones such as ability to sit unassisted, stand, or walk when they would otherwise be unexpected to do so, maintained milestones at ages when they would be expected to be lost, and survived to ages unexpected considering the number of SMN2 gene copies of patients enrolled in the studies.”
phase III studies cited in the FDA label for nusinersen were conducted after the FDA granted orphan designation, making them eligable for the orphan drug tax credit.
’ Tracy Staton, Biogen’s $375K Spinraza Price Puts a Sovaldi-Style Spotlight on Rare Disease Meds, FiercePharma, Jan. 3, 2017,
nite /Avwwiiercepharmna com/oharma/biogens-375k-spinraza-price- se-meds.
§ Carolina Henriques, Regulatory Applications for SMA Therapy Nusinersen Accepted in US and EU, SMA News Today, Nov. 1, 2016,
nites -//smanewstoda ycom/20 16/11/0 t/regquiatory-applications-sma-iherap
uts-a-sovaldi-style-spotlicht-rare-disea
~Tusinersen-emepied-us-fda-eu-
erra.
KEI Nusinersen Patent Complaint, Page 5 of 22
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lll. The Bayh-Dole Act and Disclosure of Subject Inventions
The Bayh-Dole Act and Federal regulations and guidelines make clear several obligations for contractors in the disclosure of government rights in subject inventions, including: (1) a requirement to disclose that federal funding contributed to an invention; (2) NIH contractual requirements for disclosure; and (3) required language to be inserted in patent applications and the patents, stating the role of federal funding and the government's rights.
First, contractors are required to disclose subject inventions discovered with federal funding in a timely manner and with sufficient detail to describe the invention.
Under 35 U.S.C. § 202(c)(1), any contractor that receives funding from the federal government is required to “disclose each subject invention to the Federal agency within a reasonable time after it becomes known to contractor personnel responsible for the administration of patent matters.”®
Under 37 C.F.R. § 401.3(a), each federal funding agreement shall contain the “standard patent rights clause” found at 37 C.F.R. § 401.14(a), barring specific circumstances and exceptions. '° Subsection (c)(1) of the patent rights clause outlines the disclosure requirements, including a two month time limit on the disclosure of patents and a requirement that the disclosure have sufficient detail:"
Fe R. .§ 4 401. 14(ayen)
c) Invention Decoses Election of Title and Filing of Patent Application by Contracto
on The contractor will disclose each Subject invention to the Federal Agency within
identify ihe contract under which the invention was ede and the inventor(s). It shall be sufficiently complete in technical detail to convey a clear understanding to the extent known at the time of the disclosure, of the nature, purpose, operation, and the physical, chemical, biological or electrical characteristics of the invention. The disclosure shall ace : identify any publication, on sale or public use of the invention and whether a manuscript describing the invention has been submitted for publication and, if so, whether it has been ped for publication at me time of Bese in adanon, ae disclosure to the agen
° The statute defines a “subject invention” at 35 U.S.C. § 201(e) as “any invention of the contractor conceived or first actually reduced to practice in the performance of work under a funding agreement,” and defines a contractor at 35 U.S.C. § 201(c) as “any person, small business firm, or nonprofit organization that is party to a funding agreement.”
10 The exceptions do not contain reference to the disclosure requirements.
Italics in original.
KEI Nusinersen Patent Complaint, Page 6 of 22
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Second, in implementing this regulation, the National Institutes of Health requires contractors to disclose subject inventions via iEdison, an online electronic system for reporting inventions and patents discovered under federal grants, and via HHS Form 568, entitled, “Final Invention Statement and Certification (For Grant or Award),” available at:
nites: //orants nih cov/arants/hhsS68 odf .
The NIH specifies the required information on an FAQ related to the use of iEdison, and also notes that contractors should disclose the subject invention even if they have, in the past, failed to report the invention within the two month period:
hedison fags cirevillgaccessed Jan. 6, 2017).
KEI Nusinersen Patent Complaint, Page 7 of 22
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ys report 4 the invention, even if it is late. ‘The invention report date soul Be the date nventor notifi ed me awardee | institution of the a invention. Provide an | explanation
On February 17, 2016, NIH issued a notice entitled “Reminder: All Subject Inventions Must Be Reported on the HHS 568 - Final Invention Statement and Certification (For Grant or Award) and in iEdison.” The notice explained that failure to disclose the subject invention via both iEdison and Form 568 could result in the loss of rights in the invention. '° As explained below in section V on remedies, this notice is consistent with precedent related to failure to disclose.
Finally, under 35 U.S.C. § 202(c)(6) and 37 C.F.R. § 1.77(b)(3), contractors are required to state within the patent application that the federal government contributed funding to support the discovery of the invention and that the government retains certain rights:
Government support and oe
13 National Institutes of Health, Reminder: All Subject Inventions Must Be Reported on the HHS 568 - Final Invention pevroele Wu pain (For Grant or Award) and in iEdison, NOT-OD-16-066 (Feb. 17, 2016), j fnotice-Ties/NOFOD- 16-066 him
KEI Nusinersen Patent Complaint, Page 8 of 22
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opment.
The Manual of Patent Examining Procedure contains the following recommended language:
“This invention was made with government support under (identify the contract) awarded by (identify the Federal agency). The government has certain rights in the invention.” *
IV. The Nusinersen Patent Landscape and Failure to Disclose Government Rights in a Subject Invention
This section will outline the patent landscape for nusinersen and explain the failure of Isis Pharmaceuticals to disclose federal funding in the work that contributed to the ’977 and ’853
patents, in violation of 35 U.S.C. § 202(c)(1).
lonis claimed five United States patents as the “key ... patents protecting nusinersen” in its 2015 Securities and Exchange Commission 10-K filing."
Table IV.1: Key United States Patents in Nusinersen
Priority {Filing Expiration Original Patent No. | Title Date Date Date Assignee
ALTERATION OF
CELLULAR
BEHAVIOR BY Isis
MODULATION OF Oct. 7, Mar. 26, Pharmaceuticals, 6,210,892 |MRNA PROCESSING /|1998 1999 2018 Inc.
MPEP (9th ed. Rev. 07.2015, Nov. 2015), § 310.
8 flonis Pharm., Inc., Annual Report (Form 10-K), (Feb. 25, 2016). The Food and Drug Administration (FDA) approved nusinersen for the treatment of spinal muscular atrophy based upon New Drug Application No. 209531 on December 23, 2016. Drugs@FDA Database. Due to the recent approval date, the patents for nusinersen are not yet listed in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book.
KEI Nusinersen Patent Complaint, Page 9 of 22
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SPINAL MUSCULAR
ATROPHY (SMA)
TREATMENT VIA
TARGETING OF
SMN2 SPLICE SITE
INHIBITORY Dec. 3, Dec. 5, University of 7,838,657 |SEQUENCES 2004 2005 2027 Massachusetts
SPINAL MUSCULAR
ATROPHY (SMA)
TREATMENT VIA
TARGETING OF
SMN2 SPLICE SITE
INHIBITORY Dec. 3, Aug. 21, University of 8,110,560 |SEQUENCES 2004 2009 2025 Massachusetts
COMPOSITIONS AND
METHODS FOR Isis
MODULATION OF June 23, |June 23, Pharmaceuticals, 8,361,977 |SMN2 SPLICING 2005 2006 2030 Inc.
COMPOSITIONS AND
METHODS FOR Isis
MODULATION OF Pharmaceuticals,
SMN2 SPLICING INA |June 17, |June 17, Inc.; Cold Spring 8,980,853 |SUBJECT 2009 2010 2030 Harbor Laboratory
We will not address the 892 patent, which is set to expire next year, nor will we address a European patent that is identical to the 977 patent (European Patent No. 1910395).
IV.A. The University of Massachusetts Patents
The patents owned by the University of Massachusetts describe the composition (U.S. Patent No. 7,838,657) and the method of use (8,110,560) of “oligonucleotide reagents (e.g., oligoribonucleotides) that effectively target the SMN2 ISS-N1 site in the SMN2 pre-mRNA, thereby modulating the splicing of SMN2 pre-mRNA to include exon 7 in the processed transcript.”
The laboratory of Dr. Ravindra N. Singh invented the ‘657 and ’560 patents in the course of research on the “molecular basis of Spinal Muscular Atrophy.””®°
KEI Nusinersen Patent Complaint, Page 10 of 22
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The patents list Dr. Ravindra N. Singh, Dr. Natalia N. Singh, Dr. Nirmal K. Singh, and Dr. Elliot J. Androphy as inventors.
Both patents acknowledge federal funding from the National Institutes of Health in support of the work described in the patent, and also acknowledge the government’s retained rights:
Funding for the work described herein was at least in part provided by the federal government (N.I.H. grant RO1 NS40275). The government may, therefore, have certain rights in the invention.
The NIH awarded grant RO1 NS40275 to Dr. Elliot J. Androphy, who at the time of the discovery of the invention directed the joint M.D./Ph.D. program at the University of Massachusetts Medical School."”
The University of Massachusetts licensed the patents to Isis Pharmaceuticals on January 14, 2010."
KEI has requested additional information on the research and resulting intellectual property from the University of Massachusetts through a request under the Massachusetts Public Records Law, Mass. Gen. Laws ch. 66, §10 (2017).
IV.B. The ’977 and ’853 Patents: Failure to Disclose Government Rights in the Patents
The ’977 and ’853 Patents are, respectively, a compound patent and method of use patent for nusinersen as a treatment for SMA. We believe that Isis Pharmaceuticals and Cold Spring Harbor Laboratory failed to disclose that the inventions in the patents are subject inventions under the Bayh-Dole Act, as required by 35 U.S.C. § 202(c)(1).
The ’977 patent is assigned to Isis Pharmaceuticals, and was invented by employees of Isis and Cold Spring Harbor Laboratory, a nonprofit research laboratory located on Long Island in New York. The inventor Brenda F. Baker was at the time of the patent application filing date employed by Isis, while Adrian R. Krainer was a Professor at Cold Spring Harbor Laboratory, and Yimin Hua was a Postdoctoral Fellow and later a Research Investigator at Cold Spring Harbor Laboratory. Before joining Cold Spring Harbor Laboratory in July 2004, Yimin Hua was a postdoctoral fellow at Tufts and the University of Massachusetts, studying SMA/SMN. '°
1? See the NIH REPORTER database for additional information on the UMass grants: nitos:/projectreportemin gov/Reporter Vewsh cim?si= 12ZEBCDOF4888C 403 7 S98BS90 1 CAAIADLACEECE
*® UMass Agreement No: UMMS 05-19-03, nites /Amansec cov/Archives/ecqaridata/S 74) 15/00008 74015 1400009S/ex10 Lhim
9 https://wwwiinkedin.com/in/yimin-hua-6b58956
KE] Nusinersen Patent Complaint, Page 11 of 22
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The ’853 patent is assigned to both Isis and Cold Spring, and lists amongst its inventors employees of Isis, Genzyme, and Cold Spring Harbor:”°
e C. Frank Bennett — Isis Senior Vice President for Research
e Gene Hung — Isis
e Frank Rigo — Isis
e Adrian R. Krainer — Professor, Cold Spring Harbor Lab
e Yimin Hua — Postdoctoral Fellow and Research Investigator, Cold Spring Harbor Lab e Marco A. Passini — Researcher, Genzyme
@ Lamya Shihabuddin — Senior Director, Genzyme
e Seng H. Cheng — Group Vice President, Genetic Diseases Science, Genzyme
e Katherine W. Klinger — Senior Vice President, Genetics and Genomics, Genzyme
A news story published in October 2016 in Nature Biotechnology describes how the collaboration between Isis and Dr. Krainer of Cold Spring Harbor came about:
“The one-nucleotide change that causes SMN2 to skip an exon prevents a splicing activator from binding. Krainer began experimenting with a peptide designed to trigger the splicing of SMN2 exon 7 and its inclusion in the SMN2 pre-mRNA, thus creating a full-length, stable SMN2 protein. He linked an antisense molecule to the peptide just to direct it to the correct region on SMN2, but to Krainer’s surprise the antisense alone was able to correct the splicing defect, although not as potently. “An important and lucky observation,” says Krainer. “We didn’t expect it, and we didn’t initially understand it.” Upon publication of the finding, lonis contacted Krainer and began collaborating with him (Nat. Struct. Biol. 10, 120-125, 2003).
“lonis brought its antisense technology to the table. The company’s 2'-O-meth oxyethyl (2'MOE) phosphorothioate chemistry, with sulfur substituting for one of the non-bridging oxygen atoms in the phosphate backbone, and chemical modification of the sugar at the 2' position, helps resist nuclease degradation and enhances cell penetration. It thus was an excellent in vivo splicing modifier. Krainer and Isis screened over 500 different antisense molecules against various sites on SMN2 exon 7 and its adjacent introns. The best at splicing exon 7 into the SMN2 pre-mRNA was nusinersen, an 18-nucleotide antisense oligo that blocks the intronic binding site of a splicing repressor. Because nusinersen binds a unique sequence, it shouldn’t have off-target effects, says Krainer, and because the target is on an intron that’s spliced out of the protein, the drug comes off and doesn’t interfere with SMN2 translation. Blocking this single site is enough for the drug to achieve up to
20 All employments listed below indicate employmentat the time that the patent application for the '853 patent was filed.
KEI Nusinersen Patent Complaint, Page 12 of 22
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90% exon 7 inclusion in SMN2 transgenic mice (Am. J. Hum. Gen. 82, 834-848, 2008). Human trials began in 2011.”*"
Dr. Krainer published his initial findings (the first finding described above in the Nature Biotechnology story, that we should target SMN2 to treat SMA) in 2003 in Nature Structural Biology with Dr. Luca Cartegni, then a Post-Doc at Cold Spring Harbor:
e Luca Cartegni and Adrian R. Krainer, Correction of Disease-Associated Exon Skipping by Synthetic Exon-Specific Activators, 10 Nature Structural Biology 120-125 (2003).
In the acknowledgements section, Dr. Cartegni and Dr. Krainer acknowledged support from the National Institutes of Health, without providing a particular grant number. Cartegni and Krainer, 125.
In 2008, Dr. Krainer and members of his lab co-authored a paper with C. Frank Bennett and Timothy A. Vickers of Isis Pharmaceuticals identifying the sequence for nusinersen:
e Yimin Hua, Timothy A. Vickers, Hazeem L. Okunola, C. Frank Bennett & Adrian R. Krainer, Antisense Masking of an hnRNP A1/A2 Intronic Splicing Silence Corrects SMN2 Splicing in Transgenic Mice, 82 Am. J. Human Genetics 834-848 (2008).
The acknowledgements in this paper also cited NIH funding, this time providing a particular grant number:
"We thank Chaolin Zhang for help with hnRNP A1 PWM analysis and Xavier Roca and Michelle Hastings for useful comments on the manuscript. We also thank A. Burghes for helpful discussions. Y.H. and A.R.K. gratefully acknowledge support for this work from the SMA Foundation, the Muscular Dystrophy Association, the Louis Morin Charitable Trust, and National Institutes of Health grant GM42699. T.A.V. and C.F.B. are employees of Isis Pharmaceutical, the owner of the antisense oligonucleotide chemistry used in this report, and materially benefit either directly or indirectly through stock options. Y.H. and A.R.K., along with their employer, Cold Spring Harbor Laboratory, could materially benefit if a therapeutic for SMA results from this work. A.R.K. serves on the scientific advisory board of two nonprofit SMA foundations.” *”
The NIH RePORTER database shows that Dr. Krainer has received funding from the NIH under grant number GM42699 since at least 1993 (the earliest date in the database). Between 2006 and 2007 (the year in which the paper was submitted to the journal), Dr. Krainer received $1,175,935 in funding under the grant. Over the course of the past 23 years,
21 Ken Garber, Big Win Possible for lonis/Biogen Antisense Drug in Muscular Atrophy, 34 Nature Biotech. 1002, 100 (2016) (emphasis added). 2 Hua et al., 846 (emphasis added).
KEI Nusinersen Patent Complaint, Page 13 of 22
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Dr. Krainer has received $11,701,483 in funding under this grant. See Appendix | for additional information on Dr. Krainer’s grants.
We have a high degree of confidence that the Krainer grants contributed directly to the reduction of practice of nusinersen as a treatment for SMA because of the federal funding acknowledged in the paper and the overlap between the findings described in the paper and the patent.
Figure IV.1: Timeline of Publications , Collaborations, and Patent Filings/Grants
200: isis and Dr. Adan R. Krainer at Gaki
Spring Marber Laboratory begin ta collaborate Jkune 23, 2008: Filing date Jan. 29, 2043 and Mar. 17, after fir. Krainer publishes. @ paper on targeting of for 877 and ‘853 pate ‘i 2078 USPTO grants the the SMN2 gene for the treatment of SMA. Ee ‘O?? and ‘853 patents.
dune 23, 2005: Priority date 2007-2008: Oe. Kreiner and isis subst for S77 and 853 oaterts. and publish an article armouncing the diacovery of nusinersen as a treatment
for SMA in the American Journal of Human Ganetics.
The above timeline of events shows that Isis and Dr. Krainer started their collaboration shortly after Dr. Krainer published his 2003 paper, which benefitted from public funding. The research that led to the discovery of nusinersen as a treatment for SMA, then, was conducted between 2003 and 2005 — the priority date listed on both the 977 and ’853 patents. Shortly after the patent filing date of June 23, 2006, Isis and Dr. Krainer likely began work on drafting their paper, which was submitted in 2007 and accepted for publication in 2008. The paper, as stated previously, acknowledged that NIH funding contributed to the research to discover that nusinersen could be used as a treatment for SMA.
Dr. Krainer and colleagues identified the antisense oligonucleotide (ASO) that would best correct SMN2 splicing in their 2008 American Journal of Human Genetics publication:
“After elucidating the exact position and mechanism of the intron 7 ISS, we optimized the most potent ASOs that target this silencer and used them to try to rescue SMN2 splicing in mice harboring a human SMN2 transgene. First, we synthesized 38 ASOs of different lengths and examined their effects on splicing of transcripts of the endogenous SMN2 gene in HEK293 cells.””°
3 Yimin Hua, Timothy A. Vickers, HazeemL. Okunola, C. Frank Bennett & Adrian R. Krainer, Antisense Masking of an hnRNP A1/A2 Intronic Splicing Silence Corrects SMN2 Splicing in Transgenic Mice, 82 Am. J. Human Genetics 834, 842-3 (2008).
KE]! Nusinersen Patent Complaint, Page 14 of 22
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They found that ASO 10-27 and 09-23 were the best candidates for further testing in transgenic mice. Ultimately, the ASO 10-27 sequence was chosen for nusinersen.
ASO 10-27 is the same as the gene sequence for nusinersen as listed in the 977 and ’853 patents.
The ’853 patent claims the following:
1. Amethod comprising administering by a bolus injection into the intrathecal space of a subject with infantile-onset type | spinal muscular atrophy (SMA) an antisense compound comprising an antisense oligonucleotide consisting of 18 linked nucleosides, wherein the oligonucleotide has a nucleobase sequence consisting of the nucleobase sequence SEQ ID NO: 1, wherein each internucleoside linkage of the oligonucleotide is a phosphorothioate linkage, wherein each nucleoside of the oligonucleotide is a 2-MOE nucleoside, and wherein the administering of the antisense compound ameliorates at least one symptom of SMA in the subject.
2. The method of claim 1, wherein the antisense compound is administered at a dose from 0.5 to 10 milligrams of antisense compound per kilogram of body
weight of the subject.
3. The method of claim 1, wherein inclusion of exon 7 of SMN2 mRNA in a motoneuron in the subject is increased.
4. The method of claim 1, wherein a 5 mg to 20 mg dose of antisense is administered.
SEQ ID NO: 1, as described in claim 1, is the following: TCACTTTCATAATGCTGG.
The 2008 collaborative paper published by Cold Spring Harbor and Isis, which benefitted from federal funding, also identifies sequence number 1 in Table 1, as ASO 10-27:
KEI Nusinersen Patent Complaint, Page 15 of 22
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Sicvoeaik tn Intven 7°
R-25 SUALTITESTAATECIGGCA- 6 ta SS
8-36 THCATAARATOR-3° 3 ha 26
Wei Be ibe 2 Yi-2R —-4§- TECACTITEATAATOCTG-3° 1 to 28 ER-BS SUAPICACT TIA ESA T-3° 15 ty 2S 16-23S S-TRCALTITICATA AI -3 48 te 88 E3-27 SU-TCALTYICATAST-3° 43 te 27 2-26 5) LACT ILATAARR TF 1é te 26 I-24 SULTYLST AAT OES G-3° 16 ty 24 4-33 8 -TERLATAATALTOGL- 3° a ba 23
RA-7E SUTRCATAATECIOGUA-3° 6 ta 82
OY-24 5" TEATSATORTGHIAR-2 ¥ ta SE
2-25 S_ATIWACTTICAT- 2 18 te 29 Ly=28 0S -TREACTITCATA-3° 1¥ to 28 16-27 a TEACTTICATAS-3° 18 te 27 18-26 5 CUCTTIATAA E23" 18 te 26 4-25 S-SETITES TART G-3" 14 te 25 ER-Za SCP TTCATAATOC-2 1S te 24 22-23 5°. TRRATAARRT-3 LF te 23
The ’853 patent makes the link explicit by citing the 2008 paper.
The ’977 patent also relied on the research from the Cold Spring Harbor/Isis collaboration, similarly identifying the sequence in the first claim of the ’853 patent.
IV.B.1 Federal grants to ISIS Pharmaceuticals
Isis has also received federal funding for its work on antisense-based drugs, which may have contributed to the research on the development of nusinersen.™ For example, project number 1R43GM058974-01 describes the development of antisense oligonucleotides, with the following proposed commercial applications:
“Therapeutic antisense oligonucleotides are potentially a multibillion-dollar industry. Commercialization of antisense oligonucleotides against viral, cellular and cancer targets is limited by the pharmacokinetic and pharmcodynamic properties of existing first generation 2'-deoxy phosphorothioate drugs. RNA modifications which enhance target affinity and biostability can lead to antisense drugs of (i) shorter length (which translates to improved absorption and lower production cost), and (ii) less frequent dosing, and (iii) higher target specificity, and hence less toxicity.””°
Overall, the NIH has provided Isis with at least $17,509,977 in total funding since 1993. Between 2003 and 2006, the period that nusinersen was in development, Isis received $10,821,633 in grants from DHHS, not including grants received from the US Army and
4 See Appendix | for additional information on the Isis grants. 25
nites -//orojectreportemih covioroiect info description cim?aid=27o2e6568icce=32525007 dddparam=addval Je=gcddsub=Scr=2hSesh=adefaulthcs=ASCanball=
KEI Nusinersen Patent Complaint, Page 16 of 22
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DARPA. In general, however, the NIH funding to Cold Spring Harbor Laboratory is the most direct and compelling evidence regarding the federal funding of the inventions.
V. Remedies
In addition to investigating the above evidence related to the possibility that Isis failed to disclose subject inventions, the Office of the Inspector General should explore relevant remedies to rectify the alleged failure to disclose the subject inventions in the 977 and ’853 patents.
In particular, failure to disclose subject inventions pursuant to 35 U.S.C. § 202(c)(1) permits
the Federal Government to “receive title to any subject invention not disclosed to it within such time” (emphasis added).
in the past, the Federal Government has utilized its authority to claim title in subject inventions that have not been properly disclosed, as in the case of Campbell Plastics Engineering & Mfg., Inc. v. Brownlee, 389 F.3d 1243 (Fed. Cir. 2004) (finding that federal government claim of title in invention was legitimate under federal acquisition regulations and supported by the Bayh Dole Act where disclosure submissions were “piecemeal” and violated the contractual agreement with the government); see a/so Central Admixture Pharmacy Services, Inc. v. Advanced Cardiac Solutions, P.C., 482 F.3d 1347, 1352-53 (Fed. Cir. 2007) (“Critically, Campbell Plastics holds that a Bayh—Dole violation grants the government discretionary authority to take title. ... When a violation occurs, the government can choose to take action; thus, title to the patent may be voidable.”).
In Campbell Plastics, the court found that the contract was clear and unambiguous, but moreover the government's claim to title was “buttressed by the policy considerations behind the Bayh Dole Act.” /d. at 1248. These include, specifically under 35 U.S.C. § 200, the need “to ensure that the Government obtains sufficient rights in federally supported inventions to meet the needs of the Government and protect the public against nonuse or unreasonable use of inventions.”
VI. Concluding Comments
On behalf of patients, taxpayers, employers and everyone who pays for health care, we ask your office to investigate whether Isis and/or Cold Spring Harbor failed to comply with the provisions of the Bayh-Dole Act requiring the disclosure of federal funding in patents related
to nusinersen.
We also ask your office to investigate whether the National Institutes of Health failed to conduct proper oversight in administering its grants.
KEI Nusinersen Patent Complaint, Page 17 of 22
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Finally, we ask you to recommend appropriate action to remedy the situation in line with the statute and prior decisions with regard to failure to disclose a subject invention.
The failure to disclose federal funding in nusinersen is significant because it affects the disposition of the federal government's rights to end the patent monopoly and authorize generic manufacture under the march-in provisions and government royalty-free right in the Bayh-Dole Act.
KEI and other public interest groups have asked the government to use those rights to lower the excessive price of pharmaceuticals in the past. (See hitto://keionline org/xtandi). We intend to ask the NIH to initiate a march-in case for the federally-funded patents on nusinersen over the excessive price ($750,000 in the first year and $375,000 per year thereafter for maintenance doses), and also to ask Medicare or other federal agencies to use their royalty free rights in the drug to authorize the manufacture and sale of generic versions of the drug at reasonable prices. We believe the Trump administration will take a different view than the Obama Administration on the issue of charging excessive prices on federally funded medical inventions.
We recognize that nusinersen benefits from non-patent exclusivities, including Orphan Drug exclusivity and exclusive rights in test data. However, Congress is likely to consider exceptions to such exclusivity in the coming years, and in any event, the patent term exceeds any non-patent exclusivities. Resolving access to the federally-funded inventions via march-in or the royalty free right provides the federal government with much greater leverage to lower the price of this treatment for a very severe disease.
We would like to meet with you and your staff to discuss how we can assist you in moving forward with an investigation.
Sincerely Yours,
James Love, Director Knowledge Ecology International
Andrew Goldman, Legal Counsel Knowledge Ecology International
Zack Struver, Research Associate Knowledge Ecology International
Diane Singhroy, Scientific Advisor Knowledge Ecology International
CC: Gary Cantrell, Deputy Inspector General for Investigations, Gary.Cantrell@oig.hhs.gov
KEI Nusinersen Patent Complaint, Page 18 of 22
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Appendix I: Information on Misc Grants
1. Adrian R. Krainer/Cold Spring Harbor Laboratory Grant No. GM42699
For additional information, see the following query results from the NIH REPORTER database: https //oroiectreporier nih.gov/Reporter Viewsh. .cim?si= 1 2E BC DOS4889C4 Dr 7S598RBR961 CA ASADIAZFFCEBSCIBE
Dr. Krainer’s grants for the project entitled “Biochemistry of Pre-mRNA Splicing” are administered by the National Institute of General Medical Sciences (NIGMS).
KEI Nusinersen Patent Complaint, Page 19 of 22
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2. Isis Pharmaceuticals’ Grants from RePORTER query
For additional information, see the following query results from the NIH REPORTER database:
ASADTAZFECEBSOIBE
Isis Pharmaceuticals’ grants are administered by various components of the National Institutes of Health, or the CDC, under several different grant numbers.
Project Title IC
ANTISENSE INHIBITORS OF HERPES SIMPLEX VIRUS
REPLICATION NIAID OLIGONUCLEOTIDES AS INHIBITORS OF
PAPILLOMAVIRUSES NCI
Project Number
-2R44A1030331-02
-2R44CA052391-02
Contact PI / Project Leader
“ANDERSON, KEVIN P
‘COWSERT, LEX
» 1993 |
FY Total.
$193,250 -
$118,544
ANTISENSE INHIBITORS OF -HERPES SIMPLEX VIRUS
REPLICATION NIAID S' CAP--A NOVEL TARGET
FOR ANTISENSE » TECHNOLOGY NIAID
-SYNTHETIC MRNA CLEAVING
AGENTS NIGMS |
-OLIGONUCLEOTIDES AS INHIBITORS OF -PAPILLOMAVIRUSES NCI
-3' CAP--A NOVEL TARGET »-FOR ANTISENSE / TECHNOLOGY NIAID
5R44A1030331-03
-2R44A1030333-02A1
5R44CA052391-03
: 5R44A1030333-03
ANDERSON, KEVIN P
BAKER, BRENDAF
“COWSERT, LEX M
BAKER, BRENDA F
1994
1994
$223,920 : _$100 900) $246,302 |
$253,349 |
“OLIGONUCLEOTIDES AS INHIBITORS OF »PAPILLOMAVIRUSES NCI
ANTISENSE INHIBITION OF -MULTIDRUG RESISTANCE IN
CANCER NCI “SYNTHESIS AND SELECTION
OF PLA2 INHIBITORS NIAMS
UTILITY OF CARBOCYCLIC ‘'NUCLEOSIDES FOR ANTISENSE THERAPY NCI
5R44CA052391-04
:1R41CA068790-01
, 1R43CA074636-01
‘COWSERT, LEX M
: DEAN, NICHOLAS M
1R43AR043034-01A1 WYATT, JACQUELINE R
GRIFFEY, RICHARD H ©
» 1995
» 1995 ©
1995 |
$127,758 |
$99,865 |
$99,732.
1997 $100,000.
KEI Nusinersen Patent Complaint, Page 20 of 22
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TARGETING AN ESSENTIAL -METHYLASE IN PATHOGENIC ‘BACTERIA
TARGETING RHO--A “TRANSCRIPTION TERMINATION FACTOR
1R41A1041775-01A1
1R43A1043102-01
BLYN, LAWRENCE B
BLYN, LAWRENCE B
1998
$99,939
$100,000.
UTILITY OF CARBOCYCLIC _NUCLEOSIDES FOR “ANTISENSE THERAPY
L11/23S RRNA INTERACTION--ANTIMICROBI ‘AL DRUG DEVELOPMENT
NCI
-1R43A1045210-01
3R43CA074636-01S1 |
GRIFFEY, RICHARD H
BLYN, LAWRENCE B
1998
$90,000
$100,000.
DISRUPTION OF -EUBACTERIAL 4.5S RNA -P48 ‘COMPLEX
“TARGETING 4.55 RNA “ANTIMICROBIAL DRUG _ DISCOVERY
ANTISENSE THERAPY USING ‘NOVEL RNA MIMETICS
OLIGONUCLEOTIDES FOR _ DIRECTED GENE KNOCKOUT
-ORAL ANTISENSE THERAPY »-FOR CANCER
‘ANOVELANTICANCER
“STRATEGY
‘COMBINATORIAL CARBOHYDRATE LIBRARIES FOR DRUG DISCOVERY
ANTIMICROBIAL AGENTS ‘DIRECTED AGAINST L11/23S />RRNA
“ANTIMICROBIAL AGENTS ‘DIRECTED AGAINST L11/23S -RRNA
“AUTOMATED SIMULTANEOUS | DETECTION OF BIOTERRORISM AGENTS
NCI
NIAID
NIAID
-1R41A1044515-01
-41R41A1050406-01 -2R44A1045210-02A1 /5R44A1045210-03
-1R01C1000099-01
JAMES, THOMAS L
-MANOHARAN, -1R43GM058974-01 = MUTHIAH ‘MANOHARAN, -1R43GM060087-01 = MUTHIAH -MANOHARAN, -1R41CA083543-01 — MUTHIAH
~ SAMPATH, -4R43CA083601-01A1 |
RANGARAJAN
GRIFFEY, RICHARD H “SWAYZE, ERIC E
“SWAYZE, ERIC E
-ECKER, DAVID J
“AUTOMATED SIMULTANEOUS ‘DETECTION OF ‘BIOTERRORISM AGENTS
‘SINGLE WELL MPCR DONOR SCREEN TO ID BLOOD PATHOGENS
CID
5R01C/000099-02
1R43HLO76946-01
2001
2004
$100,000 - $140,000
$224,700
$100,000
$100,000.
$265,000.
$375,000 |
$2,313,198
$94,040
KE]! Nusinersen Patent Complaint, Page 21 of 22
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PATHOGEN DIAGNOSTIC ‘_PRODUCTS--BIODEFENSE DEVELOPMENTS NIAID -1UC1A1067232-01 BLYN, LAWRENCE B
“AUTOMATED SIMULTANEOUS ‘DETECTION OF _BIOTERRORISM AGENTS CID —_- 5RO1C1000099-03 = ECKER, DAVID J
2005
2005
$4,649,863
$1,036,103
»CHEMICAL MODIFICATION TO IMPROVE SIRNA
_PHARMACOKINETICS IN | | “ANIMALS NIGMS 1R43GM076793-01 SWAYZE, ERICE 2006 = $99,187, IDENTIFICATION OF AN : 2 2 INHIBITOR OF MICRORNA-122 | 2 2 IN LIVER NIAID 1R43A1072802-01 FREIER,SUSANM. 2007 $299,390 CHEMICAL MODIFICATIONS | | ‘TO IMPROVE RNAIDRUGS —NIGMS.__2R44GM076793-02 SWAYZE, ERIC E 2007 $482,643. IDENTIFICATION OF AN
INHIBITOR OF MICRORNA-122 : : IN LIVER NIAID 5R43A1072802-02 FREIER,SUSANM. 2008S $132,885. ‘CHEMICAL MODIFICATIONS : | 2 bee ‘TO IMPROVE RNAIDRUGS NIGMS 5R44GM076793-03 SWAYZE, ERIC E 2008 $464,156. ‘ASSESSING THE SAFETY OF _ - a CELL SUBSTRATES AND 'SAMPATH, VACCINE COMPONENTS NIAID NO1AI40100-5-0-1 RANGARAJAN 2009 $621,848. ‘CHEMICAL MODIFICATIONS : 2 | : ‘TO IMPROVE RNAIDRUGS —- NIGMS 5R44GM076793-04 SWAYZE, ERIC E 2009 «=: $463,365.
“ASSESSING THE SAFETY OF CELL SUBSTRATES AND -SAMPATH, “VACCINE COMPONENTS NIAID = N01A140100-6-0-1 » RANGARAJAN
3. Selected DoD Army and DARPA SBIR and STTR grants
$500,000 -
Grant title ‘Agency Type Year Amount CERoC ei - aioe oe : ha laitten Engineered Microbes DoD, Army SBIR 2005 = $119,663 TIGER Biosensor for Broad Viral Detection and Genetically : Engineered Microbes DoD, Army SBIR 2007 == $728,422 Chee ee Gory ee Come a Sb i
KEI Nusinersen Patent Complaint, Page 22 of 22
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From: Hammersla, Ann (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/CN=RECIPIENTS/CN=HAMMERSLAA] Sent: 3/14/2017 3:39:41 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM]
Subject: RE: Anyone have objection from KEI in 2017
KEI has made public statements that it is objecting to all grants of exclusive licenses and that it does not have enough information to analyze whether NIH is making a good decision re the license and royalties
weeee Original Message-----
From: Rohrbaugh, Mark (NIH/OD) [E]
Sent: Tuesday, March 14, 2017 11:22 AM
To: Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov> Subject: Re: Anyone have objection from KEI in 2017
I was asking in general about IRP notices of intent to grant. KEI objected to nearly every notice of exclusive licenses from the IRP last year, and asked for our justification under the statutory criteria for granting the exclusive.
Sent from my iPhone
On Mar 14, 2017, at 10:29 AM, Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov> wrote:
I am not familiar with this FR notice. I will check. When was the FR notice? Ann
VVVVV
v
----- Original Message-----
From: Rohrbaugh, Mark (NIH/OD) [E]
Sent: Monday, March 13, 2017 5:00 PM
To: NIH TDC Long <niaaatdcl-1@mail.nih.gov> Subject: Anyone have objection from KEI in 2017
From FR notice of intent to grant?
Thx Mark
VVVVVVVVVVV
Sent from my iPhone
REL0000023673
From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM]
Sent: 8/25/2019 11:46:33 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Berkley, Dale (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=5ee461c29f5045a49fOadf82caaa2f31-berkleyd]
cc: Goldstein, Bruce (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=cb67e8fe5aa2452a8a7f200e5fb4335b-goldsteb]; Pazman, Cecilia (NIH/NHLBI) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=bf35741501e247d887acd224eaf9d679-pazmance]
Subject: Emailing: KEl Comments NIH License to MTTI Described in 84 FR 39001_.pdf, NIHtoKEI re MTT! 25Aug2019.docx
Attachments: KEI Comments NIH License to MTTI Described in 84 FR 39001_.pdf; NIHtoKE! re MTTI 25Aug2019.docx
Dale and Mark -- a pdf with KEI's comments (received Aug 23) and a word doc with my response enclosed. Please have a look at both and let me know if you have any comments or edits to the response.
Thanks again!
Regards,
Michael A. Shmilovich, Esq., CLP
office of Technology Transfer and Development 31 Center Drive Room 4A29, MSC2479
Bethesda, MD 20892-2479
o. 301.435.5019
shmi lovm@mail.nih. gov
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REL0000023675
KNOWLEDGE ECOLOGY INTERNATIONAL
1621 Connecticut Avenue NW Suite 500 Washington, DC 20009 www.keionline.org August 23, 2019
Michael Shmilovich, Esq.
Senior Licensing and Patent Manager National Heart, Lung, and Blood Institute 31 Center Drive
Bethesda, MD 20892
Re: Prospective Grant of Exclusive Patent License: Radiotherapeutic against Cancers that Overexpress Integrin avB3, 84 FR 39001
Dear Mr. Shmilovich:
Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) are writing to comment on the prospective grant of an exclusive patent license in “a radiotherapeutic against cancers that overexpress integrin av63” to Molecular Targeting Technologies, Inc. (MTTI), as referenced in the notice located at 84 FR 39001.
The 84 FR 39001 notice is the third time since 2018 that the NIH has published a notice concerning an exclusive license with MTTI in the same patent family, but it adds a new field of use.
The previous exclusive license and a proposed amendment between the NIH and MTTI for Lutetium-177 technologies were:
e The prospective license noticed on July 27, 2018 (83 FR 35663), which described a prospective exclusive license to MTTI in “Radiotherapeutics Against Somatostatin-Receptor Expressing Neuroendocrine Tumors,” and
e A prospective amendment to the 2018 license noticed on June 17, 2019 (84 FR 28063), for “Lutetium-177 Radiotherapeutics Against Somatostatin-Receptor Expressing Neuroendocrine Tumors.”
REL0000023675.0001
KEI filed comments in both of these cases, and copies of those comments are available here: httos //www. Keionline ora/nih-licenses. The July 2, 2019 comments were filed jointly with the Union for Affordable Cancer Treatment (UACT), and three individuals in their personal capacity, James Love, Manon Ress and Luis Gil Abinader. We ask that the comments regarding the earlier licenses be included in the record for this license, by reference, and also that the suggestions for safeguards in that license that were set forth in the July 2, 2019 comments be considered here for the new license (see below).
The Subject Invention and Patent Estate Thank you for answering several of our questions about this new license.
Per your answers, it is our understanding that the original licensing opportunity was published in 2015 and updated in 2016, as “early stage.”
Long Acting Therapeutic Conjugates with Evans Blue
The licensing opportunity notice describes the patent estate as “a platform technology that pertains to the advantages of conjugating therapeutics to Evans Blue thus providing long lasting pharmacokinetic profiles by complexing with albumin.”
You have described this as a new license that expands the field of use for the same patent estate identified in 84 FR 28063. In your August 23, 2019 email, you compare the new license to the previous MTTI/lu-177 license and its proposed amendment as follows:
The fields of use and cancer targets are different. The targeting moiety in the previous field of use licensed to the company is tetraazacyclododecanetetraacetic acid-octreotide (TATE) which binds to somatostatin receptor present on neuroendocrine tumors. The targeting moiety in the instant contemplated field is the RGD peptide arginylglycylaspartic acid which binds to integrin avB3 that is overexpressed on a variety of different cancers; however, the present field of use would be limited to only glioblastoma multiforme and small cell lung cancers.
In the event that the NIH decides to grant this exclusive license, we ask that safeguards be
placed on the license to protect the public from (a) unreasonable pricing, (b) excessive terms of exclusivity, (c) to address access in developing countries, and (d) to enhance transparency. Our specific suggestions for safeguards are listed below, following further discussion of the licensee.
MTTI
Molecular Targeting Technologies, Inc. (MTTI) appears to be a small privately held firm with few employees of its own, that has considerable success in obtaining NIH grants, either directly or
Page 2 of 7
REL0000023675.0001
indirectly through non-profit institutions. According to the NIH REPORTER database, MTTI has received funding from the FDA and/or the NIH every year since 1998.
Table 1: NIH RePORTER figures for MTTI grant funding by fiscal year
Fiscal Year Projects Total Funding 1995 1 $98,500 1998 1 $100,000 1999 1 $134,600 2000 1 $100,000 2001 1 $372,700 2002 2 $727,300 2003 2 $513,688 2004 1 $335,239 2005 1 $418,825 2006 2 $891,387 2007 3 $1,853,974 2008 3 $1,732,733 2009 6 $1,891,013 2010 2 $572,812 2011 1 $414,018 2012 3 $1,457,619 2013 2 $1,078,417 2014 2 $1,055,660 2015 1 $224,819 2017 2 $514,163 2018 2 $279,610 2019 2 $608,921 Total 42 $15,375,998
MTTI has also benefited from NIH grants to other institutions. For example, MTTI has received NIH funds through grants to Thomas Jefferson University and other research institutions.
Of the eight projects, seven report funding from the NIH. The only project without NIH funding reports funding from the government of Taiwan.
NAME: Rabies mAb NAME: ZAPS SN-38 IP: MTTI licensed from the Thomas Jefferson University | INDICATION: Cancer North China Pharmaceutical Company (NCPC) is STAGE OF DEVELOPMENT: Phase | clinical planned
initiating the phase III clinical trial in China in 2018. by Taivex Pharmaceutical in 2019. PARTNER : MTTI sublicensed the product to North PARTNER: National Health Research Institutes (NHRI, China Pharmaceutical Company in exchange for future | Taiwan) for preclinical studies.
Page 3 of 7
REL0000023675.0001
royalty stream. NCPC is responsible for all clinical development costs.
IP: MTTI licensed from the Thomas Jefferson University FUNDING: $425,000 from USDA (2006); $918,000 from NIH (2007).
OWNERSHIP: MTTI shares co-exclusive rights in China with Johnson & Johnson (previously Crucell).
Liaw
F CORIO OTS! en ey ose
NAME: 177Lu-DOTA-EB-TATE
(EBTATE) INDICATION: Neuroendocrine Neoplasms (NEN) PROOF OF CONCEPT: Extensive preclinical and two Phase | studies (50 patients) performed by NIH and Peking Union Medical College Hospital (China) PRINCIPAL COLLABORATORS: NIH & Memorial Sloan Kettering Medical Center
OWNERSHIP: MTTI awarded world-wide-exclusive rights by NIH.
callin stine/M
NAME: 1311 SapC-DOPS
INDICATION: Glioblastoma (Brain Cancer)
STAGE OF DEVELOPMENT: Preclinical. Seeking partner.
PRINCIPAL COLLABORATOR: University of Cincinnati IP: Pending
FUNDING: Obtained funding from NCI.
OWNERSHIP: MTTI is establishing an option
NAME: LeishCure
INDICATION: Cutaneous Leishmaniasis (CL)
STAGE OF DEVELOPMENT: Preclinical. Seeking partner.
PRINCIPAL COLLABORATOR: University of Notre Dame (UND)
IP: Multiple approved and pending patents on Zn-DPA: US7,179,616; 8,389,223 and 9,211,349.
FUNDING: Obtained funding from NIAID. OWNERSHIP: MTTIVUND
btte Aww miarcet om
IP: MTTI/NHRI US Patent 9,388,193B2 July 12, 2016 OWNERSHIP: MTTI/NHRI sublicensed ZAPS technology to Taivex Pharmaceutical
nlarget. com/mms/pdfs/pipeline/Asset'e20 %
NAME: AMISCAN
The company has completed a Phase II study funded by NHLBI to assess the ability of 99mTcglucarate to detect cardiac ischemia in chest pain patients.
bitp Ave miarget eom/mmo/pdisipipeling/AMISCANIa p20 18March pdt
NAME: TDURA
CLASS: Imaging Agent
INDICATIONSancer, injury due to drug toxicity, atherosclerotic plaque and acute myocardial infarction STAGE OF DEVELOPMENT: Ready for Phase 0/1 development in 2018. Seeking partner.
PRINCIPAL COLLABORATOR: University of Antwerp MICA (Molecular Imaging Center Antwerp)
IP: US 7,877,783 B2, US 8,778,303B2, Chinese patent CN102014970B, European approved 2017. These patents are secure through 2029 in US, EU and China. MTTI obtained an exclusive license from the
Medical College of Wisconsin.
FUNDING: Obtained ~$1 million non-dilutive grants from NIH & EU.
OWNERSHIP: MTTI
tte Avan miarget oe
NAME: CypH
CLASS: Diagnostic Spray for Guided Surgery INDICATION: Ovarian cancer surgery
STAGE OF DEVELOPMENT: Preclinical. Seeking partner.
PRINCIPAL COLLABORATOR: Cornell Medical College
IP: Pending patents owned by Methodist Hospital, Houston, Texas
FUNDING: Secured funding from NCI OWNERSHIP: MTTI is establishing an option agreement with Methodist Hospital
Page 4 of 7
REL0000023675.0001
Further issues Related to the License
Ownership. When the public grants a monopoly on a taxpayer-funded invention, there should be much greater transparency in the process. This transparency should extend to the ownership of the entity seeking an exclusive license. In the United States, publicly-traded companies are required to disclose major shareholders. We ask that the NIH obtain and provide to the public information about who owns any privately-held companies seeking exclusive licenses from the NIH. Related to this issue is the question of foreign ownership. A company can be incorporated in the United States, but have foreign ownership. In our experience, the NIH does not identify or at least does not disclose the ownership of privately-held companies seeking exclusive licenses on taxpayer-funded inventions.
Government role in funding future development. If there is any expectation that the NIH will provide future funding to further develop the technology, that information should be disclosed to the public, and taken into account in negotiating the term of exclusivity in the license. If the U.S. government will be funding any human subject clinical trials relevant to the new license, the period of exclusivity should be reduced to reflect the need for a smaller incentive.
Terms of the proposed license. In recent years, the NIH has refused to describe the term of exclusivity or the royalty rate for a proposed license. Both the royalty rate and the number of years of exclusivity are quite important in evaluating if the NIH is protecting the public interest. We note that in 2018, the NIH reported a mere $118 million in royalty payments for all licenses (httes /www. ott nih gov/reporisstais/ott-statistics). For the license at hand, we requested the expected royalty rate and statistical data on past licenses for cancer diagnostics and cancer therapeutics, and the NIH declined to provide such information (which we assume the NIH has readily available. The NIH also declined to specifically confirm the expected term of exclusivity, although there was a strong suggestion that the NIH always grants life-of-patent licenses, despite the statutory requirement to limit the scope of each individual license to that which is reasonably necessary to induce investments.
Expected Development Costs. The NIH needs to have an estimate of the expected costs of bringing a technology to practical application, in order to assist in the evaluation of the number of years of exclusivity and other elements of the scope of rights granted.
You have been very helpful in answering several questions about the technology to be licensed. The NIH needs to be more open about the terms of the license, beyond the field of use, and the
rationale for the scope of exclusive rights.
In addition to any of the points discussed above, we ask that going forward the NIH provide the following information to the public so that comments on the license can be better informed:
Page 5 of 7
REL0000023675.0001
(1) The specific countries where exclusive rights will be licensed;
(2) An estimate of the public expenditures on research and development associated with the inventions to be licensed;
(3) The proposed term of exclusivity for the license;
(4) The proposed royalty;
(5) The expected cost of bringing the invention to practical application;
(6) The measures proposed to ensure the inventions will be made available to the public on reasonable terms;
(7) The measures proposed to ensure access to the inventions in developing countries;
(8) The anticipated non-patent exclusive rights or other incentives associated with the development of the inventions, such as the Orphan Drug Act exclusivity or the Priority Review Voucher; and
(9) The economic analysis, if any, that was used to determine that exclusive rights were necessary, and if so, how the scope of rights, including the term of the exclusive rights, was limited to that which is a reasonably necessary incentive in order to bring the invention to practical application.
Proposals for Additional Safeguards
. Price discrimination. Any drug or other medical technology using the patented invention should be available in the United States at a price that does not exceed the median price in the seven largest economies by GDP that have at least 50 percent of the GNI per capita as the United States, using the World Bank Atlas method. This is a modest safeguard.
Low and middle income countries. The exclusive license should not extend to countries with a per capita income less than 30 percent of the United States, in order to ensure that the patents do not lead to restricted and unequal access in developing countries. If the NIH rejects this suggestion, it needs to provide something that will give effect to the policy objective in the “United States Public Health Service Technology Transfer Policy Manual, Chapter No. 300, PHS Licensing Policy,” which states the following: “PHS seeks to promote commercial development of inventions in a way that provides broad accessibility for developing countries.”
. Global registration and affordability. The license should require Molecular Targeting Technologies, Inc, to disclose the steps it will take to enable the timely registration and availability of the drug or other medical technology at an affordable price in the United States and in every country with a demonstrated need, according to the Centers for Disease Control and Prevention (CDC) and/or the World Health Organization (WHO), either by supplying a country directly at an affordable, publicly disclosed price and with sufficient quantities, or by providing technology transfer and rights to all intellectual property necessary for third parties to do so.
Page 6 of 7
REL0000023675.0001
4, Medicines Patent Pool. The NIH should retain a right to grant the WHO, the Medicines Patent Pool or other governments the rights to use the patent rights to procure the drug or other medical technology from competitive suppliers, including technology transfer, in developing countries, upon a finding by HHS or the WHO that people in these markets do not have sufficient access to the drug or other medical technology.
5. Years of exclusivity. We propose the license reduce the years of exclusivity when revenues are large. The NIH has many options, including by providing an option for non-exclusive licensing, such as was done in the ddl case. We propose that the exclusivity of the license be reduced when the global cumulative sales from products or services using the inventions exceed certain benchmarks. For example, the period of exclusivity in the license could be reduced by one year for every $500 million in global cumulative revenue after the first one billion in global sales. This request is consistent with the statutory requirements of 35 U.S.C. § 209, which requires that “the proposed scope of exclusivity is not greater than reasonably necessary to provide the incentive for bringing the invention to practical application.”
6. Transparency of R&D outlays. The licensee should be required to file an annual report to the NIH, available to the public, on the research and development (R&D) costs associated with the development of any product or service that uses the inventions, including reporting separately and individually the outlays on each clinical trial. We will note that this is not a request to see a company business plan or license application. We are asking that going forward the company be required to report on actual R&D outlays to develop the subject inventions. Reporting on actual R&D outlays is important for determining if the NIH is meeting the requirements of 35 U.S.C. § 209, that “the proposed scope of exclusivity is not greater than reasonably necessary to provide the incentive for bringing the invention to practical application.” Specifically, having data on actual R&D outlays on each clinical trial used to obtain FDA approval provides evidence that is highly relevant to estimating the risk adjusted costs of bringing NIH licensed inventions to practical application.
Sincerely,
Knowledge Ecology International Union for Affordable Cancer Treatment
Page 7 of 7
REL0000023675.0001
Office of Technology Transfer and Development 31 Center Drive Room 4A29, MSC2479
National Heart, Lung, Bethesda, MD 20892-2479
: F Michael Shmilovich, Esq, CLP and
lood uystitute shmilovm@mail.nih.gov
August 25, 2019 James Packard Love Luis Gil Abinader
Dr. Manon Anne Ress
INRE: Prospective Grant of Exclusive Patent License: Radiotherapeutic against Cancers that overexpress Integrin avB3 84 FR 39001 (to Molecular Targeting Technologies, Inc. (MTTI)).
Dear Messrs. Love, Abinader and Dr. Ress:
Sincerely,
Michael A. Shmilovich, Esq., CLP
REL0000023675.0002
From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM]
Sent: 8/23/2019 10:16:56 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Pazman, Cecilia (NIH/NHLBI) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=bf35741501e247d887acd224eaf9d679-pazmance]; Berkley, Dale (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=5ee461c29f5045a49fOadf82caaa2f31-berkleyd]; Goldstein, Bruce (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=cb67e8fe5aa2452a8a7f200e5fb4335b-goldsteb]
Subject: Fwd: Prospective Grant of Exclusive Patent License: Radiotherapeutic against Cancers that Overexpress Integrin avB3, 84 FR 39001
Attachments: KEI Comments, NIH License to MTTI, Described in 84 FR 39001 .pdf
ed. It appears to only be comments that includes their standard boiler
"
From: "James Love" <james.love@keionline.o
Date: Friday, August 23, 2019 at 16:16:14
To: "Shmilovich, Michael (NIH/NHLBI) [E]" <michael.shmilovich@nih.gov>
Ce: "Kathryn Ardizzone" <kathryn.ardizzone@keionline.org>, "Manon Ress" <MANON.RESS@cancerunion.org>, "Luis Gil Abinader" <luis.gil.abinader@keionline.org>, "Claire Cassedy" <claire.cassedy@kecionline.org>
Subject: Re: Prospective Grant of Exclusive Patent License: Radiotherapeutic against Cancers that Overexpress Integrin avB3, 84 FR 39001
Michael Shmilovich, Esq.
Senior Licensing and Patent Manager National Heart, Lung, and Blood Institute 31 Center Drive
Bethesda, MD 20892
Comments from KEI and UACT are attached.
James Love. Knowledge Ecology International U.S. Mobile +1.202.361.3040 USS. office phone +1.202.332.2670
http://www.keionline.org twitter.com/jamie love
REL0000023677
KNOWLEDGE ECOLOGY INTERNATIONAL
1621 Connecticut Avenue NW Suite 500 Washington, DC 20009 www.keionline.org August 23, 2019
Michael Shmilovich, Esq.
Senior Licensing and Patent Manager National Heart, Lung, and Blood Institute 31 Center Drive
Bethesda, MD 20892
Re: Prospective Grant of Exclusive Patent License: Radiotherapeutic against Cancers that Overexpress Integrin avB3, 84 FR 39001
Dear Mr. Shmilovich:
Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) are writing to comment on the prospective grant of an exclusive patent license in “a radiotherapeutic against cancers that overexpress integrin av63” to Molecular Targeting Technologies, Inc. (MTTI), as referenced in the notice located at 84 FR 39001.
The 84 FR 39001 notice is the third time since 2018 that the NIH has published a notice concerning an exclusive license with MTTI in the same patent family, but it adds a new field of use.
The previous exclusive license and a proposed amendment between the NIH and MTTI for Lutetium-177 technologies were:
e The prospective license noticed on July 27, 2018 (83 FR 35663), which described a prospective exclusive license to MTTI in “Radiotherapeutics Against Somatostatin-Receptor Expressing Neuroendocrine Tumors,” and
e A prospective amendment to the 2018 license noticed on June 17, 2019 (84 FR 28063), for “Lutetium-177 Radiotherapeutics Against Somatostatin-Receptor Expressing Neuroendocrine Tumors.”
REL0000023677.0001
KEI filed comments in both of these cases, and copies of those comments are available here: https www. keionline oramih-licenses. The July 2, 2019 comments were filed jointly with the Union for Affordable Cancer Treatment (UACT), and three individuals in their personal capacity, James Love, Manon Ress and Luis Gil Abinader. We ask that the comments regarding the earlier licenses be included in the record for this license, by reference, and also that the suggestions for safeguards in that license that were set forth in the July 2, 2019 comments be considered here for the new license (see below).
The Subject Invention and Patent Estate Thank you for answering several of our questions about this new license.
Per your answers, it is our understanding that the original licensing opportunity was published in 2015 and updated in 2016, as “early stage.”
Long Acting Therapeutic Conjugates with Evans Blue
The licensing opportunity notice describes the patent estate as “a platform technology that pertains to the advantages of conjugating therapeutics to Evans Blue thus providing long lasting pharmacokinetic profiles by complexing with albumin.”
You have described this as a new license that expands the field of use for the same patent estate identified in 84 FR 28063. In your August 23, 2019 email, you compare the new license to the previous MTTI/lu-177 license and its proposed amendment as follows:
The fields of use and cancer targets are different. The targeting moiety in the previous field of use licensed to the company is tetraazacyclododecanetetraacetic acid-octreotide (TATE) which binds to somatostatin receptor present on neuroendocrine tumors. The targeting moiety in the instant contemplated field is the RGD peptide arginylglycylaspartic acid which binds to integrin avB3 that is overexpressed on a variety of different cancers; however, the present field of use would be limited to only glioblastoma multiforme and small cell lung cancers.
In the event that the NIH decides to grant this exclusive license, we ask that safeguards be
placed on the license to protect the public from (a) unreasonable pricing, (b) excessive terms of exclusivity, (c) to address access in developing countries, and (d) to enhance transparency. Our specific suggestions for safeguards are listed below, following further discussion of the licensee.
MTTI
Molecular Targeting Technologies, Inc. (MTTI) appears to be a small privately held firm with few employees of its own, that has considerable success in obtaining NIH grants, either directly or
Page 2 of 7
REL0000023677.0001
indirectly through non-profit institutions. According to the NIH REPORTER database, MTTI has received funding from the FDA and/or the NIH every year since 1998.
Table 1: NIH RePORTER figures for MTTI grant funding by fiscal year
Fiscal Year Projects Total Funding 1995 1 $98,500 1998 1 $100,000 1999 1 $134,600 2000 1 $100,000 2001 1 $372,700 2002 2 $727,300 2003 2 $513,688 2004 1 $335,239 2005 1 $418,825 2006 2 $891,387 2007 3 $1,853,974 2008 3 $1,732,733 2009 6 $1,891,013 2010 2 $572,812 2011 1 $414,018 2012 3 $1,457,619 2013 2 $1,078,417 2014 2 $1,055,660 2015 1 $224,819 2017 2 $514,163 2018 2 $279,610 2019 2 $608,921 Total 42 $15,375,998
MTTI has also benefited from NIH grants to other institutions. For example, MTTI has received NIH funds through grants to Thomas Jefferson University and other research institutions.
Of the eight projects, seven report funding from the NIH. The only project without NIH funding reports funding from the government of Taiwan.
NAME: Rabies mAb NAME: ZAPS SN-38 IP: MTTI licensed from the Thomas Jefferson University | INDICATION: Cancer North China Pharmaceutical Company (NCPC) is STAGE OF DEVELOPMENT: Phase | clinical planned
initiating the phase III clinical trial in China in 2018. by Taivex Pharmaceutical in 2019. PARTNER : MTTI sublicensed the product to North PARTNER: National Health Research Institutes (NHRI, China Pharmaceutical Company in exchange for future | Taiwan) for preclinical studies.
Page 3 of 7
REL0000023677.0001
royalty stream. NCPC is responsible for all clinical development costs.
IP: MTTI licensed from the Thomas Jefferson University FUNDING: $425,000 from USDA (2006); $918,000 from NIH (2007).
OWNERSHIP: MTTI shares co-exclusive rights in China with Johnson & Johnson (previously Crucell).
f
CGR OTS men ey ose
FAR ASAY
NAME: 177Lu-DOTA-EB-TATE
(EBTATE) INDICATION: Neuroendocrine Neoplasms (NEN) PROOF OF CONCEPT: Extensive preclinical and two Phase | studies (50 patients) performed by NIH and Peking Union Medical College Hospital (China) PRINCIPAL COLLABORATORS: NIH & Memorial Sloan Kettering Medical Center
OWNERSHIP: MTTI awarded world-wide-exclusive rights by NIH.
callin stine/M
NAME: 1311 SapC-DOPS
INDICATION: Glioblastoma (Brain Cancer)
STAGE OF DEVELOPMENT: Preclinical. Seeking partner.
PRINCIPAL COLLABORATOR: University of Cincinnati IP: Pending
FUNDING: Obtained funding from NCI.
OWNERSHIP: MTTI is establishing an option
NAME: LeishCure
INDICATION: Cutaneous Leishmaniasis (CL)
STAGE OF DEVELOPMENT: Preclinical. Seeking partner.
PRINCIPAL COLLABORATOR: University of Notre Dame (UND)
IP: Multiple approved and pending patents on Zn-DPA: US7,179,616; 8,389,223 and 9,211,349.
FUNDING: Obtained funding from NIAID. OWNERSHIP: MTTIVUND
bitte Aas miaroet oe
IP: MTTI/NHRI US Patent 9,388,193B2 July 12, 2016 OWNERSHIP: MTTI/NHRI sublicensed ZAPS technology to Taivex Pharmaceutical
hitec/Awww miargel com/mmS/pdts/mipeline/Assethc20 2%
3 Roe LIOR
NAME: AMISCAN
The company has completed a Phase II study funded by NHLBI to assess the ability of 99mTcglucarate to detect cardiac ischemia in chest pain patients.
http Ave miarget eom/mmo/pdisipipeling/AMISCANIa n2018March pdt
NAME: TDURA
CLASS: Imaging Agent
INDICATIONSancer, injury due to drug toxicity, atherosclerotic plaque and acute myocardial infarction STAGE OF DEVELOPMENT: Ready for Phase 0/1 development in 2018. Seeking partner.
PRINCIPAL COLLABORATOR: University of Antwerp MICA (Molecular Imaging Center Antwerp)
IP: US 7,877,783 B2, US 8,778,303B2, Chinese patent CN102014970B, European approved 2017. These patents are secure through 2029 in US, EU and China. MTTI obtained an exclusive license from the
Medical College of Wisconsin.
FUNDING: Obtained ~$1 million non-dilutive grants from NIH & EU.
OWNERSHIP: MTTI
AI88 9, A Parcs
NAME: CypH
CLASS: Diagnostic Spray for Guided Surgery INDICATION: Ovarian cancer surgery
STAGE OF DEVELOPMENT: Preclinical. Seeking partner.
PRINCIPAL COLLABORATOR: Cornell Medical College
IP: Pending patents owned by Methodist Hospital, Houston, Texas
FUNDING: Secured funding from NCI OWNERSHIP: MTTI is establishing an option agreement with Methodist Hospital
bite /Avwaw miarget com/muinS/ndis/s)
Page 4 of 7
REL0000023677.0001
Further issues Related to the License
Ownership. When the public grants a monopoly on a taxpayer-funded invention, there should be much greater transparency in the process. This transparency should extend to the ownership of the entity seeking an exclusive license. In the United States, publicly-traded companies are required to disclose major shareholders. We ask that the NIH obtain and provide to the public information about who owns any privately-held companies seeking exclusive licenses from the NIH. Related to this issue is the question of foreign ownership. A company can be incorporated in the United States, but have foreign ownership. In our experience, the NIH does not identify or at least does not disclose the ownership of privately-held companies seeking exclusive licenses on taxpayer-funded inventions.
Government role in funding future development. If there is any expectation that the NIH will provide future funding to further develop the technology, that information should be disclosed to the public, and taken into account in negotiating the term of exclusivity in the license. If the U.S. government will be funding any human subject clinical trials relevant to the new license, the period of exclusivity should be reduced to reflect the need for a smaller incentive.
Terms of the proposed license. In recent years, the NIH has refused to describe the term of exclusivity or the royalty rate for a proposed license. Both the royalty rate and the number of years of exclusivity are quite important in evaluating if the NIH is protecting the public interest. We note that in 2018, the NIH reported a mere $118 million in royalty payments for all licenses (httes /www_ ott nih gov/reportsstais/ott-statistics). For the license at hand, we requested the expected royalty rate and statistical data on past licenses for cancer diagnostics and cancer therapeutics, and the NIH declined to provide such information (which we assume the NIH has readily available. The NIH also declined to specifically confirm the expected term of exclusivity, although there was a strong suggestion that the NIH always grants life-of-patent licenses, despite the statutory requirement to limit the scope of each individual license to that which is reasonably necessary to induce investments.
Expected Development Costs. The NIH needs to have an estimate of the expected costs of bringing a technology to practical application, in order to assist in the evaluation of the number of years of exclusivity and other elements of the scope of rights granted.
You have been very helpful in answering several questions about the technology to be licensed. The NIH needs to be more open about the terms of the license, beyond the field of use, and the
rationale for the scope of exclusive rights.
In addition to any of the points discussed above, we ask that going forward the NIH provide the following information to the public so that comments on the license can be better informed:
Page 5 of 7
REL0000023677.0001
(1) The specific countries where exclusive rights will be licensed;
(2) An estimate of the public expenditures on research and development associated with the inventions to be licensed;
(3) The proposed term of exclusivity for the license;
(4) The proposed royalty;
(5) The expected cost of bringing the invention to practical application;
(6) The measures proposed to ensure the inventions will be made available to the public on reasonable terms;
(7) The measures proposed to ensure access to the inventions in developing countries;
(8) The anticipated non-patent exclusive rights or other incentives associated with the development of the inventions, such as the Orphan Drug Act exclusivity or the Priority Review Voucher; and
(9) The economic analysis, if any, that was used to determine that exclusive rights were necessary, and if so, how the scope of rights, including the term of the exclusive rights, was limited to that which is a reasonably necessary incentive in order to bring the invention to practical application.
Proposals for Additional Safeguards
. Price discrimination. Any drug or other medical technology using the patented invention should be available in the United States at a price that does not exceed the median price in the seven largest economies by GDP that have at least 50 percent of the GNI per capita as the United States, using the World Bank Atlas method. This is a modest safeguard.
Low and middle income countries. The exclusive license should not extend to countries with a per capita income less than 30 percent of the United States, in order to ensure that the patents do not lead to restricted and unequal access in developing countries. If the NIH rejects this suggestion, it needs to provide something that will give effect to the policy objective in the “United States Public Health Service Technology Transfer Policy Manual, Chapter No. 300, PHS Licensing Policy,” which states the following: “PHS seeks to promote commercial development of inventions in a way that provides broad accessibility for developing countries.”
. Global registration and affordability. The license should require Molecular Targeting Technologies, Inc, to disclose the steps it will take to enable the timely registration and availability of the drug or other medical technology at an affordable price in the United States and in every country with a demonstrated need, according to the Centers for Disease Control and Prevention (CDC) and/or the World Health Organization (WHO), either by supplying a country directly at an affordable, publicly disclosed price and with sufficient quantities, or by providing technology transfer and rights to all intellectual property necessary for third parties to do so.
Page 6 of 7
REL0000023677.0001
4, Medicines Patent Pool. The NIH should retain a right to grant the WHO, the Medicines Patent Pool or other governments the rights to use the patent rights to procure the drug or other medical technology from competitive suppliers, including technology transfer, in developing countries, upon a finding by HHS or the WHO that people in these markets do not have sufficient access to the drug or other medical technology.
5. Years of exclusivity. We propose the license reduce the years of exclusivity when revenues are large. The NIH has many options, including by providing an option for non-exclusive licensing, such as was done in the ddl case. We propose that the exclusivity of the license be reduced when the global cumulative sales from products or services using the inventions exceed certain benchmarks. For example, the period of exclusivity in the license could be reduced by one year for every $500 million in global cumulative revenue after the first one billion in global sales. This request is consistent with the statutory requirements of 35 U.S.C. § 209, which requires that “the proposed scope of exclusivity is not greater than reasonably necessary to provide the incentive for bringing the invention to practical application.”
6. Transparency of R&D outlays. The licensee should be required to file an annual report to the NIH, available to the public, on the research and development (R&D) costs associated with the development of any product or service that uses the inventions, including reporting separately and individually the outlays on each clinical trial. We will note that this is not a request to see a company business plan or license application. We are asking that going forward the company be required to report on actual R&D outlays to develop the subject inventions. Reporting on actual R&D outlays is important for determining if the NIH is meeting the requirements of 35 U.S.C. § 209, that “the proposed scope of exclusivity is not greater than reasonably necessary to provide the incentive for bringing the invention to practical application.” Specifically, having data on actual R&D outlays on each clinical trial used to obtain FDA approval provides evidence that is highly relevant to estimating the risk adjusted costs of bringing NIH licensed inventions to practical application.
Sincerely,
Knowledge Ecology International Union for Affordable Cancer Treatment
Page 7 of 7
REL0000023677.0001
From: Rodriguez, Richard (NIH/NCI) [E] [/O=NIH/OU=NIHEXCHANGE/CN=OD/CN=RODRIQUR]
Sent: 3/14/2017 6:37:01 PM To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM] Subject: RE: Anyone have objection from KEI in 2017
No I haven't. I thought they had just stopped when I hadn't heard any TTMs mentioning them.
----- Original Message-----
From: Rohrbaugh, Mark (NIH/OD) [E]
Sent: Tuesday, March 14, 2017 1:36 PM
To: Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov> Subject: Re: Anyone have objection from KEI in 2017
I asked your folks here at AUTM and I hear back from Dave and Jim. No one seems to have gotten the exclusive license objections from KEI in 2017 that they were getting last year. Have you heard anything different?
Sent from my iPhone
> On Mar 14, 2017, at 12:17 PM, Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov> wrote:
>
> Hi Mark,
>
> I'm not sure what you are specifically asking for here but you might get a more complete response if
you also send this to the ELCG email group. I'm not sure everyone doing licensing is on the NIH Long list.
>
> Richard
>
> ooeeoe Original Message-----
> From: Rohrbaugh, Mark (NIH/OD) [E]
> Sent: Monday, March 13, 2017 5:00 PM
> To: NIH TDC Long <niaaatdcl-1@mail.nih.gov> > Subject: Anyone have objection from KEI in 2017 >
> From FR notice of intent to grant?
>
> Thx
> Mark
>
> Sent from my iPhone
REL0000023678
From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM]
Sent: 8/23/2019 1:07:02 PM
To: Berkley, Dale (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=5ee461c29f5045a49fOadf82caaa2f31-berkleyd]; Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]
Subject: RE: Additional questions about the technology in the proposed exclusive license described in the 84 FR 39001 Notice
Dale — can’t explain in a sentence. |’ll try to come up with a response and send your way to look through.
From: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>
Sent: Friday, August 23, 2019 9:00 AM
To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @oad.nih.gov>; Shmilovich, Michael (NIH/NHLBI) [E] <michael.shmilovich@nih.gov>
Subject: FW: Additional questions about the technology in the proposed exclusive license described in the 84 FR 39001 Notice
response.
Dale D. Berkley, Ph.D., J.D.
Office of the General Counsel, PHD, NIH Branch
Bldg. 31, Rm. 47
Bethesda, MD 20892
301-496-6043
301-402-2528 (Fax)
This message 1s intended for the exclusive use of the reciptent(s) named above. It may contain information that is PROTECTED or PRIVILEGED, and it should not be disseminated, distributed, or copied to persons not authorized to recerve such information.
From: Shmilovich, Michael (NIH/NHLBI) [E] <michael.shmilovich@ nih.gov>
Sent: Friday, August 23, 2019 8:27 AM
To: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>
Subject: Fwd: Additional questions about the technology in the proposed exclusive license described in the 84 FR 39001 Notice
Date: Friday, August 23, 2019 at 06:35:50
To: "Shmilovich, Michael (NIH/NHLBI) [E]" <michael.shmilovich@nih.gov>, "Shmilovich, Michael (NIH/NHLBIP [E]" <michael.shmilovich@nih.gov>
Ce: "James Love" <james.love@kcionline.org>
Subject: Additional questions about the technology in the proposed exclusive license described in the 84 FR 39001 Notice
Dear Mr. Shmilovich:
In light of the upcoming deadline to submit comments, please respond to the following questions as soon as practicable.
REL0000023680
1. What is the relationship between the subject technology and the technology covered by the recent past licenses to MTTI (described in 83 FR 35663 and 84 FR 28063)?
2. KEI understands that the 84 FR 28063 license amended the license that resulted from 83 FR 35663. Please confirm that the license in the instant notice would be an additional, separate license and not an amendment.
3. What is the relationship between the intellectual property in the present license notice and the previous license/amendment to MTTI?
4. What is the relationship between the field of use of the license and the previous license/amendment to MTTI. For example, the previous licenses pertained to a
radiotherapeutic against neuroendocrine tumors that express somatostatin receptor. Radionuclide therapies directed against tumors that express somatostatin receptors (SSTRs) have proven effective for the treatment of advanced, low- to intermediate-grade neuroendocrine tumors.” The current notice pertains to radiotherapeutic against cancers that overexpress integrin avB3, including small cell lung cancers. Neuroendocrine tumors may include small cell lung cancers. Are the small cell lung cancers that would be targeted by the subject technology neuroendocrine tumors? Does the new field of use expand or does it modify the previous fields of use to MTTI?
5. Has the NIH, NHLBI, or any institute of the NIH ever published, online, a licensing opportunity notice for the subject invention? If so, where is it located?
6. What are the clinical trial numbers that pertain to the instant technology? How much did the trials cost?
7. Has the NIH sought the advice of the Attorney General under 40 U.S.C. § 559? If not, has it considered the potential anti-competitive effect of the license?
8. What is the NIH's rationale for giving additional IP rights to a company that is already obligated to commercialize the technology under the previous licensing agreement?
9. How and why has the NIH determined that the prospective license would comply with Section 209 of the Bayh Dole Act?
Thank you,
Kathryn Ardizzone, Esq.
Counsel
Knowledge Ecology International
1621 Connecticut Avenue NW, Suite 500 Washington, DC 20009 kathryn.ardizzone(@keionline.org
(202) 332-2670
REL0000023680
From: Sent: To: cc:
Subject:
Hi Mark,
Baden, Elizabeth (NIH/OD) [E] [/O=NIH/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=BADENEM]
3/14/2017 4:13:02 PM
Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=O0D/cn=ROHRBAUM] Baden, Elizabeth (NIH/OD) [E] [/O=NIH/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=Badenem]
RE: edits to the Drug Pricing BRAIN brief
Thanks se much for the quick feedback. I've incorporated the relevant info in the BRAIN record. | have one more
question.
Best, Elizabeth
From: Rohrbaugh, Mark (NIH/OD) [E] Sent: Monday, March 13, 2017 6:46 PM To: Baden, Elizabeth (NIH/OD) [E] <badenem@od.nih.gov> Subject: Re: edits to the Drug Pricing BRAIN brief
The quick feedback | have gotten is that KEI has not filed objections in at least 2 notices this CY
Sent from my iPhone
Hi Mark,
Jen for the information below. |
“and also rearranged the key points! L
stasevsenvnertesstavnenssestsDWasuevacevetsenenenenererdekevueaces
if you have a chance, please look at the attached version. My changes are tracked. If this look ok to you, then | can make the changes in BRAIN.
Thanks! Elizabeth
From: Rohrbaugh, Mark (NIH/OD) [E] Sent: Monday, March 13, 2017 6:02 AM
To: Volkov, Marina (NIH/OD) [E] <r Ce: Baden, Elizabeth (NIH/OD) [E] <badenem @
od nih.gzov>
Subject: Re: edits to the Drug Pricing BRAIN brief
REL0000023683
KEI said last year it would appeal to the new HHS Sec'y on Xtandi, and they continue to object to proposed exclusive licensing of specific technologies when public notice is made in FR. Pricing and exclusivity is a current public issue with the Army's proposed Zika vaccine and NIAID is likely to get the same heat when they get to a point of licensing theirs.
With drug pricing issues continuing to fester and comments from the administration about addressing the high price of drugs, we are likely to see more pressure at least from advocacy groups on this issue.
Sent from my iPhone
On Mar 12, 2017, at 8:49 PM, Volkov, Marina (NIH/OD) [E] <mvelkev@od.nih.gov> wrote:
Hi Mark,
Dr. Tabak has made the following comment on the Drug Pricing BRAIN brief:
Any chance you can make these changes tomorrow (Monday)? Dr. Collins will be starting his study of the briefs on Monday, so we need to wrap everything up by then.
Thanks,
Marina
<Drug Pricing v2.docx>
REL0000023683
From: Berkley, Dale (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=5EE461C29F5045A49FOADF82CAAA2F31-BERKLEYD]
Sent: 8/23/2019 2:39:30 PM
To: Shmilovich, Michael (NIH/NHLBI) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=7dfe19bfd1d443ceb700b9f22d159a90-shmilovm]; Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]
Subject: RE: Additional questions about the technology in the proposed exclusive license described in the 84 FR 39001 Notice
See my proposed changes in red below.
Dale D. Berkley, Ph.D., J.D.
Office of the General Counsel, PHD, NIH Branch
Bldg. 31, Rm. 47
Bethesda, MD 20892
301-496-6043
301-402-2528(Fax)
‘This message is intended for the exclusive use of the recipsent(s) named above. It may contain information that is PROTECTED or PRIVILEGED, and st should not be disseminated, distributed, or copied to persons not authorized to recetve such information.
From: Shmilovich, Michael (NIH/NHLBI) [E] <michael.shmilovich@nih.gov>
Sent: Friday, August 23, 2019 9:31 AM
To: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov> Subject: RE: Additional questions about the technology in the proposed exclusive license described in the 84 FR 39001 Notice
Dale —please comment. My responses are in blue
From: "kathryn ardizzone" <kathryn.ardizzone@keionline.org>
Date: Friday, August 23, 2019 at 06:35:50
To: "Shmilovich, Michael (NIH/NHLBI) [E]" <michael.shmilovich@nih.gov>, "Shmilovich, Michael
Ce: "James Love" <james.love@keionline.org>
Subject: Additional questions about the technology in the proposed exclusive license described in the 84 FR 39001 Notice
Dear Mr. Shmilovich:
In light of the upcoming deadline to submit comments, please respond to the following questions as soon as practicable.
1. What is the relationship between the subject technology and the technology covered by the recent past licenses to MTTI (described in 83 FR 35663 and 84 FR 28063)?
2. KEI understands that the 84 FR 28063 license amended the license that resulted from 83 FR 35663. Please confirm that the license in the instant notice would be an additional, separate license and not an amendment.
REL0000023684
3. What is the relationship between the intellectual property in the present license notice and the previous license/amendment to MTTI?
4. What is the relationship between the field of use of the license and the previous license/amendment to MTTI. For example, the previous licenses pertained to a
radiotherapeutic against neuroendocrine tumors that express somatostatin receptor. Radionuclide therapies directed against tumors that express somatostatin receptors (SSTRs) have proven effective for the treatment of advanced, low- to intermediate-grade neuroendocrine tumors." The current notice pertains to radiotherapeutic against cancers that overexpress integrin avB3, including small cell lung cancers. Neuroendocrine tumors may include small cell lung cancers. Are the small cell lung cancers that would be targeted by the subject technology neuroendocrine tumors? Does the new field of use expand or does it modify the previous fields of use to MTTI?
5. Has the NIH, NHLBI, or any institute of the NIH ever published, online, a licensing opportunity notice for the subject invention? If so, where is it located? https: Sao ea fateniartee aac rep epee
November 16, 204 7} bttps//www.ott.nih govtechnology/e-143-20 15
6. What are the clinical trial numbers that pertain to the instant technology? How much did the trials
7. Has the NIH sought the advice of the Attorney General under 40 U.S.C. § 559? If not, has it considered the potential anti-competitive effect of the license?
rai ag ofan imme cnet toch ai hae cate cmd ast cinema ced an atm Pea alata nena bee along ah dacesbaeh detec ieee tanec ata tate neo amet atmentLeaacidaduiateter asec
8. What is the NIH's rationale for giving additional IP rights to a company that is already obligated to commercialize the technology under the previous licensing agreement?
Mosca a'cia eac ia ean em lence ov aba nn cdi eco shes bach usc ace nee tat ease onetime Geena dees em ecanccinced amanda ean ee cclomaanimint nimi imieaeibinmemiacesminaimrataimimine
9. How and why has the NIH determined that the prospective license would comply with Section 209 of the Bayh Dole Act?
REL0000023684
Thank you,
Kathryn Ardizzone, Esq.
Counsel
Knowledge Ecology International
1621 Connecticut Avenue NW, Suite 500 Washington, DC 20009
kathryn. ardizzone@
S < a. cS) Pe = o ° en]
(202) 332-2670
REL0000023684
From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM]
Sent: 8/23/2019 3:11:19 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Berkley, Dale (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=5ee461c29f5045a49fOadf82caaa2f31-berkleyd]
Subject: RE: Other response to KEI
Mark- lets discuss when you return. As of this morning I received not less than 4 emails from Kathryn and James Love with questions, many of which were technical and straight forward that I felt comfortable answering. I'1]1 forward those to you.
w---- Original Message-----
From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>
Sent: Friday, August 23, 2019 11:08 AM
To: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>; Shmilovich, Michael (NIH/NHLBI) [E] <michael.shmi lovich@nih. gov>
Subject: Other response to KEI
where are we with the other response I was going to send. If we agree on language I can send it this morning. b5 iNo response needed now
Sent from my iPhone
RELO000023686
From: Hammersia, Ann (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=87FB28AA23744COB855EF0683AC2E8B4-HAMMERSLAA] Sent: 3/14/2018 7:53:27 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum] Subject: FW: Request for Investigation Re Failure to Disclose Federal Funding in Patent No. 7,964,580
Attachments: HHS-Azar-KEl-Patent-7964580-SOF-14March2018.pdf
Mark: | have not read through completely and as far as | know this has not be assigned to Dr. Collins.
Ann
From: Andrew Goldman [mailto:andrew.goldman@keionline.org]
Sent: Tuesday, March 13, 2018 1:05 PM
To: secretary@hhs.gov
Cc: Levinson, Dan R (OIG/IO) <dan.levinson@oig.hhs.gov>; Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov> Subject: Request for Investigation Re Failure to Disclose Federal Funding in Patent No. 7,964,580
Dear Secretary Azar:
Attached, please find a copy of a request that you initiate an investigation into the failure to disclose federal funding leading to the development of Patent No. 7,964,580, held by Gilead. This patent is the first patent listed for Gilead's
sofosbuvir and its other sofusbuvir-based treatments for the hepatitis C virus.
As we describe in further detail in the letter, the failure to disclose is a violation of the law under the Bayh-Dole Act and permits the government to receive title to the invention. If a violation is found, we urge you to seek this remedy.
We request a meeting to discuss this matter with you at your earliest convenience.
Sincerely,
Andrew S. Goldman
Counsel, Policy and Legal Affairs Knowledge Ecology International andrew. goldman
RELO000023687
From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM]
Sent: 8/23/2019 12:22:32 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]
cc: Pazman, Cecilia (NIH/NHLBI) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=bf35741501e247d887acd224eaf9d679-pazmance]
Subject: Fwd: Additional questions about the technology in the proposed exclusive license described in the 84 FR 39001 Notice
Date: Friday, August 23, 2019 at 06:35:50 To: "Shmilovich, Michael (NIH/NHLBI) [E]" <michael.shmilovich@nih.gov>, "Shmilovich, Michael
(NIH/NHLBJ) [E]" <michael.shmilovich@nih.gov>
Ce: "James Love" <james.love@kcionline.org>
Subject: Additional questions about the technology in the proposed exclusive license described in the 84 FR 39001 Notice
Dear Mr. Shmilovich:
In light of the upcoming deadline to submit comments, please respond to the following questions as soon as practicable.
1. What is the relationship between the subject technology and the technology covered by the recent past licenses to MTTI (described in 83 FR 35663 and 84 FR 28063)?
2. KEI understands that the 84 FR 28063 license amended the license that resulted from 83 FR 35663. Please confirm that the license in the instant notice would be an additional, separate license and not an amendment.
3. What is the relationship between the intellectual property in the present license notice and the previous license/amendment to MTTI?
4. What is the relationship between the field of use of the license and the previous license/amendment to MTTI. For example, the previous licenses pertained to a
radiotherapeutic against neuroendocrine tumors that express somatostatin receptor. Radionuclide therapies directed against tumors that express somatostatin receptors (SSTRs) have proven effective for the treatment of advanced, low- to intermediate-grade neuroendocrine tumors.” The current notice pertains to radiotherapeutic against cancers that overexpress integrin avB3, including small cell lung cancers. Neuroendocrine tumors may include smail cell lung cancers. Are the small cell lung cancers that would be targeted by the subject technology neuroendocrine tumors? Does the new field of use expand or does it modify the previous fields of use to MTTI?
5. Has the NIH, NHLBI, or any institute of the NIH ever published, online, a licensing opportunity notice for the subject invention? If so, where is it located?
6. What are the clinical trial numbers that pertain to the instant technology? How much did the trials cost?
REL0000023689
7. Has the NIH sought the advice of the Attorney General under 40 U.S.C. § 559? If not, has it considered the potential anti-competitive effect of the license?
8. What is the NIH’s rationale for giving additional IP rights to a company that is already obligated to commercialize the technology under the previous licensing agreement?
9. How and why has the NIH determined that the prospective license would comply with Section 209 of the Bayh Dole Act?
Thank you,
Kathryn Ardizzone, Esq.
Counsel
Knowledge Ecology International
1621 Connecticut Avenue NW, Suite 500 Washington, DC 20009
kathryn.ardizzone@keionline.org (202) 332-2670
REL0000023689
From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM] Sent: 8/23/2019 3:20:04 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]
Subject: FW: 84 FR 39001
.. These...
From: Shmilovich, Michael (NIH/NHLBI) [E] Sent: Friday, August 23, 2019 9:45 AM
To: James Love <james.love@keionline.org> Subject: RE: 84 FR 39001
| do not have information regarding their investors and that information is confidential.
From: James Love <james.love@keionline.org>
Sent: Friday, August 23, 2019 8:38 AM
To: Shmilovich, Michael (NIH/NHLBI) [E] <michael.shmilovich@nih.gov> Subject: Re: 84 FR 39001
Thank you. So the three different licenses all involve Lu-177, but are different also, in ways the require the separate licenses.
| noticed the lead researcher is from China, was is the founder of Molecular Targeting Technologies, Inc. (MTTI), and that there have been trials in China. Do you know who the investors are in MTTI? For example, is this a company with Chinese investors?
Jamie
On Fri, Aug 23, 2019 at 8:25 AM Shmilovich, Michael (NIH/NHLBI) [E] <michael.shmilovich@nih.gov> wrote: Not related. Different tumor, different targeting molecule.
From: "James Love" <james.love@keionline.org>
Date: Thursday, August 22, 2019 at 16:27:42
To: "kathryn ardizzone" <kathryn.ardizzone@keionline.org>
Ce: "Shmilovich, Michael (NIH/NHLBI) [E]" <michael.shmilovich@nih.gov> Subject: Re: 84 FR 39001
Dear Michael, is this trial related to the technology in the proposed license?
hitps://clinicaltrials.gov/ct2/show/record/NCT 03478358?term=eb-tate&rank=2
On Wed, Aug 21, 2019 at 5:15 PM James Love <james.love@keionline.org> wrote:
: In terms of the royalty data, if the technology is expected to be used for a therapeutic use, the statistical data __ on licenses should be for licenses involving therapeutics for cancer.
REL0000023691
From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM]
Sent: 8/23/2019 3:21:09 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]
Subject: FW: 84 FR 39001
From: Shmilovich, Michael (NIH/NHLBI) [E] Sent: Friday, August 23, 2019 9:44 AM
To: James Love <james.love@keionline.org> Subject: RE: 84 FR 39001
| don’t have access to that information, you are free to contact the company if they are willing to divulge that
information.
From: James Love <james.love@keionline.org> Sent: Friday, August 23, 2019 9:35 AM
To: Shmilovich, Michael (NIH/NHLBI) [E] <michael.shmilovich@nih.gov>
Subject: Re: 84 FR 39001
As far as we can tell, the NIH is funding every single one of MTTI's pipeline products. Is there an account of how much money the NIH is providing for each of these projects? And more importantly for this license, how
much the NIH conducted or funded trials cost?
Jamie
NAME: Rabies mAb
IP: MTTI licensed from the Thomas Jefferson University
North China Pharmaceutical Company (NCPC) is initiating the phase III clinical trial in China in 2018.
PARTNER : MTTI sublicensed the product to North China Pharmaceutical Company in exchange for
future royalty stream. NCPC is responsible for all clinical development costs.
IP: MTTI licensed from the Thomas Jefferson University
FUNDING: $425,000 from USDA (2006); $918,000 from NIH (2007). OWNERSHIP: MTTI shares co-exclusive rights in China with Johnson & Johnson (previously Crucell) http://www.mtarget.com/mm5/pdfs/pipeline/Asset%20Rabies%20mAb.pdf
NAME: 177Lu-DOTA-EB-TATE (EBTATE)
INDICATION: Neuroendocrine Neoplasms (NEN)
PROOF OF CONCEPT: Extensive preclinical and two Phase | studies (50 patients) performed by
NIH and Peking Union Medical College Hospital (China).
PRINCIPAL COLLABORATORS: NIH & Memorial Sloan Kettering Medical Center
NAME: ZAPS SN-38
INDICATION: Cancer
STAGE OF DEVELOPMENT: Phase | clinical planned by Taivex Pharmaceutical in 2019.
PARTNER: National Health Research Institutes (NHRI, Taiwan) f preclinical studies.
IP: MTTI/NHRI US Patent 9,388,193B2 July 12, 2016 OWNERSHIP: MTTI/NHRI sublicensed ZAPS technology to Taiv Pharmaceutical http://www.mtarget.com/mm5/pdfs/pipeline/Asset%20ZAPS%20- %20SN%2038.pdf
NAME: AMISCAN
The company has completed a phase || study funded by NHLBI t assess the ability of 99mTcglucarate to detect cardiac ischemia it pain patients.
http:/Awww.mtarget.com/mm5/pdfs/pipeline/AMISCANjan2018Mal
NAME: TDURA
CLASS: Imaging Agent
INDICATION: cancer, injury due to drug toxicity, atherosclerotic ¢ and acute myocardial infarction
REL0000023692
OWNERSHIP: MTTI awarded world-wide-exclusive rights by NIH. STAGE OF DEVELOPMENT: Ready for Phase 0/1 development
htto://www.mtarget.com/mm5/pdfs/pipeline/MTTI%20Asset™20EBTATE.pdf | 2018. Seeking partner. PRINCIPAL COLLABORATOR: University of Antwerp MICA (Mol
: Imaging Center Antwerp) NAME: 1311 SapC-DOPS
. IP: US 7,877,783 B2, US 8,778,303B2, Ch tent INDICATION: glioblastoma (brain cancer) res : ee ee
. ee : CN102014970B, European approved 2017. These STAGE OF DEVELOPMENT: Preclinical. Seeking partner. patents are secure through 2029 in US, EU and China. MTTI obt PRINCIPAL COLLABORATOR: University of Cincinnati
IP: pending an exclusive license from the i : ‘ ; Medical College of Wisconsin. co eING: Dae meraing rary Ne . ; ; . FUNDING: Obtained ~$1 million non-dilutive grants from NIH & E OWNERSHIP: MTTI is establishing an option agreement with University of | QyNERSHIP: MTT! Cincinnat :
http:/Avww.mt t.com/mm5/pdfs/pipeline/TDURA. pdf hitp://www.mtarget.com/mm35/pdfs/pipeline/Glioblastoma.pdf B a B
NAME: LeishCure INDICATION: Cutaneous Leishmaniasis (CL) aes : : STAGE OF DEVELOPMENT: Preclinical. Seeking partner. CLASS: Diagnostic Spray for Guided Surgery
NAME: CypH
PRINCIPAL COLLABORATOR: University of Notre Dame (UND) INDICATION: Ovarian cancer surgery
. : : 7 : STAGE OF DEVELOPMENT: Preclinical. Seeking partner. ea ere econ PRINCIPAL COLLABORATOR: Cornell Medical College
FUNDING: Obtained funding from NIAID. ge. Jeeps il # ee Hospital, Houston, Texa OWNERSHIP: MTTVUND : Secured funding from
http://Awww.mtarget.com/mm5/pdfs/pipeline/Asset%20LeishCure.pdf tb alia MTT! is establishing an option agreement with Me
http:/Avwww.mtarget.com/mm95/pdfs/pipeline/Asset?o20CypH pdf
REL0000023692
From: Joe Allen [jallen@allen-assoc.com]
Sent: 3/13/2018 3:07:56 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Hammersla, Ann (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=87fb28aa23744cOb855ef0683ac2e8b4-hammersiaa]
Subject: KEI using King language, misrepresentation of march in rights in letter to USTR on compulsory licenses
Of course, Bayh-Dole has never been used as implied in the highlighted paragraph below, but why let facts get in the way of a good story:
(htt
KEI testimony at March 8, 2018 USTR Special 301 hearing, focusing on US compulsory licensing of patents
s://www.keionline.org/27147)
Posted on March 8, 2018 by James Love
On March 8, 2018, USTR and the interagency committee on the Special 301 held a hearing. KEI was one of the groups testifying. More on this process here: https://keionline.org/ustr/special301
I began our oral testimony discussing President Trump’s promise, during the election, to negotiate lower prices on drugs for Medicare, noting that many of the comments by PhRMA and other drug company lobby groups would create norms that would make it impossible for President Trump to deliver on even a small fraction of his promised savings.
I then read the following comments about compulsory licensing.
(more on compulsory licensing here: https://keionline.org.cl)
Compulsory licensing
PhRMA and other groups lobbying on behalf of big drug companies frequently target the use of compulsory licensing as a “harmful IP-related trade barrier”.
KEI sees compulsory licenses as an important and underutilized tool to address excessive pricing and restrictive licensing practices.
I would like to take a minute to provide some context for this proceeding.
First, the United States has at least 15 separate statutes that are used to permit non-voluntary use of patents, not counting our various exceptions to patent rights for research or uses by medical professionals.
Second, the United States is by far, and I mean by far, the most frequent user of compulsory licenses. USTR
itself overturned an injunction on the importation of iPhones and iPads that infringed on patents owned by Samsung, on August 3, 2013.[1]
RELO000023693
Under the Supreme Court eBay Doctrine regarding the enforcement on injunctions, courts routinely permit infringement of patents, when royalties are paid to the patent holder. For another example involving Apple: in 2017, Apple successfully asked a judge for permission to use, without a voluntary license but subject to an ongoing royalty, U.S. Patent No. 5,781,752, titled “Table based data speculation circuit for parallel processing computer.[2]
The compulsory licenses under the eBay doctrine are fairly common, about one a month for a while, but now less frequent as parties tend to grant voluntary licenses, when it is perceived to be hard to enforce an injunction, and they cover a wide range of technologies.
In the area of medical technologies, the most common compulsory licenses ordered by the courts are for medical devices and diagnostics, of which there are many, on everything from contact lenses to artificial heart valves to diagnostic technologies. Often the companies requesting such compulsory license are innovators themselves.
For example, in 2008, Abbott used the eBay doctrine to obtain a license to HCV Genotyping testing patents. Similar compulsory licensing efforts were successful in several high income countries, including Germany, where Roche was requesting the compulsory license, and in Australia and the UK, to mention a few other countries.
The United States has also used the threat of compulsory licensing to force more liberal licensing or price discounts, in cases where the federal government was a funder of research, including the patents on reverse genetics needed to manufacture vaccines for the Avian flu, the stem cell patents held by WARF, the Abbott patents on ritonavir, and the Fabry patents now held by Sanofi, to mention a few cases under the Bayh-Dole Act. In 2016, 51 members of Congress asked the federal government to make more frequent use of this Act.[3]
Recently 18 members of Congress asked the federal government to use 28 USC 1498 to grant compulsory licenses on patents on HCV drugs, and the Senate Armed Services Committee in 2017 adopted a directive to the Department of Defense to use compulsory licenses when prices on Army-funded drugs like Xtandi are more expensive in the United States than in other high income countries.
Many persons, including President Trump, have called for changes in the law to allow Medicare to negotiate drug prices. If Medicare negotiates drug prices, it will involve a threat, by the United States, to withhold reimbursement, narrow formularies or increase co-payments. All of these measures hurt patients. We want the Congress to give the government more robust authority to use compulsory licensing, in order to protect patients, effectively putting the monopoly at risk rather than the patient, when there are disputes over prices.
KE] and others are planning to asking the Trump administration to use, under existing statutes, either or both 35 USC 203 and/or 28 USC 1498, to end monopolies, on at least three drugs, this calendar year. In every case there are very significant abuses of patent rights, and negative consequences for patients.
Finally, we want to call attention to the growing patent thickets for two new important technologies, CRISPR and CAR T. If we don’t have to ability to use compulsory licenses to force more liberal licensing of technologies, it will harm innovation and make us defenseless from abusive pricing.
[1] Michael Froman’s decision in the Apple/Samsung ITC patent dispute and the USTR trade agenda, August 6, 2013, https://www.keionline.org/22282.
[2] Wisconsin Alumni Research Foundation v. Apple, Inc., Case: 3:14-cv-00062-wmce, (W.D. Wis., June 6, 2017).
RELO000023693
[3] 2016: 51 members of Congress have asked the NIH to use March-In rights to rein in high drug prices, January 11, 2016. https:/(Awww.keionline.org/22983
Annex. US statutes that are used for compulsory licensing (non- voluntary use) of patents.
35 U.S.C. 203 - MARCH-IN RIGHTS (Bayh-Dole Act)
35 U.S.C. 271(e)(6)(B) — INFRINGEMENT OF PATENT (biologic products where patents are not timely
disclosed) 35 U.S.C. 283 — INJUNCTION (under eBay doctrine)
28 USC 1498 — Patent and copyright cases (use by or for government)
30 U.S.C. 937 - CONTRACTS AND GRANTS (Black Lung disease)
42 USC Sec 2183 — Nonmilitary utilization (patents on atomic energy)
42 U.S.C. 7608 - MANDATORY LICENSING (Clean Air Act)
42 U.S.C. 16192 - NEXT GENERATION LIGHTING INITIATIVE
42 U.S.C. 17231 —- ENERGY STORAGE COMPETITIVENESS
19 U.S.C. 1337 - UNFAIR PRACTICES IN IMPORT TRADE (United States International Trade Commission) Sherman Antitrust Act, 15 USC 1-7
15 U.S. Code § 1 — Trusts, etc., in restraint of trade illegal; penalty
15 U.S. Code § 2 — Monopolizing trade a felony; penalty
Wilson Tariff Act, 15 USC 8-11 15 U.S. Code § 8 — Trusts in restraint of import trade illegal; penalty
Clayton Act, 15 USC 12-27
15 U.S.C. 45 - UNFAIR METHODS OF COMPETITION UNLAWFUL; PREVENTION BY COMMISSION (Federal Trade Commission)
=
James Love
James Love is the Director of Knowledge Ecology International. Previously, he was an economist for the Center for Study of Responsive Law where he also directed the Consumer Project on Technology and the Taxpayer Assets Project, Senior Economist for the Frank Russell Corporation, and held lecturer positions at Rutgers and Princeton Universities. His KEI webpage is https://keionline.org/jamie.
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Innogenetics v. Abbott — 2008 compulsory license granted for HCV genotyping kits under eBay v. MercExchange
Chile Ministry of Health Takes Next Step Toward Compulsory License on HCV Drugs, Announces Public Health Justifications
Joseph P. Allen President
Allen and Associates 60704 Rt. 26, South Bethesda, OH 43719 (W) 740-484-1814
(c) 304-280-2259 www.allen-assoc.com
RELO000023693
From: Baden, Elizabeth (NIH/OD) [E] [/O=NIH/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=BADENEM]
Sent: 3/13/2017 8:17:12 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM]; Volkov, Marina (NIH/OD) [E] [/O=NIH/OU=Nihexchange/cn=nimh/cn=mvolkov]
Subject: RE: edits to the Drug Pricing BRAIN brief
Attachments: Drug Pricing_v2.docx
Hi Mark,
loge sta teri Sesvcires eter leivenen arora Sreney Sears vesevenrerarmraralmlinenis lnemimscieieleraimbevai mtnimemsmetmest inner eeat
if you have a chance, please look at the attached version. My changes are tracked. If this look ok to you, then | can make the changes in BRAIN.
Thanks! Elizabeth
From: Rohrbaugh, Mark (NIH/OD) [E]
Sent: Monday, March 13, 2017 6:02 AM
To: Volkov, Marina (NIH/OD) [E] <mvolkov@od.nih.gov> Cc: Baden, Elizabeth (NIH/OD) [E] <badenem @od.nih.gov> Subject: Re: edits to the Drug Pricing BRAIN brief
KEI said last year it would appeal to the new HHS Sec'y on Xtandi, and they continue to object to proposed exclusive licensing of specific technologies when public notice is made in FR. Pricing and exclusivity is a current public issue with the Army's proposed Zika vaccine and NIAID is likely to get the same heat when they get to a point of licensing theirs.
With drug pricing issues continuing to fester and comments from the administration about addressing the high price of drugs, we are likely to see more pressure at least from advocacy groups on this issue.
pietmreiereimsmimsmemimeeresscmrmemememememime Nem nmemnmememememememememimimememsmemierenrmre nee ete ERI RR RRR aan memimsmimemimemsmrmememimel
Sent from my iPhone
On Mar 12, 2017, at 8:49 PM, Volkov, Marina (NIH/OD) [E] <mvyoikev@od.nih.gov> wrote:
‘A * 2B
Hi Mark,
Dr. Tabak has made the following comment on the Drug Pricing BRAIN brief:
Any chance you can make these changes tomorrow (Monday)? Dr. Collins will be starting his study of the briefs on Monday, so we need to wrap everything up by then.
RELO000023698
Thanks,
Marina
RELO000023698
Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe
Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe
Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe
Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe
Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe
Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe
Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe
Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe
From: Rogers, Karen (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=B23EF4CA2FA14A6EB174EE611953A396-ROGERSK]
Sent: 2/28/2018 10:14:43 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]
cc: Gottesman, Michael (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group {(FYDIBOHF23SPDLT)/cn=Recipients/cn=918c2344931542a592d00dbe83d3d5a3-gottesmm]
Subject: FW: ES - WF 370674 - FYI (CC)
Hi Mark ~ Since you mentioned this in our meeting this morning, | wanted to make sure that you were aware of this DORMS notice. Looks like it has been assigned to NCI to respond. Regards, Karen
Naren L. Rogers
Acting Director
Office of Technology Transfer National institutes of Health
6017 Executive Boulevard, Suite 325 Rockville, MD 20852
&-Mail: RogersK@nih.gov
Phone: 301-435-4359
Fax: 301-402-8878
SENSITIVE/CONFIDENTIAL INFORMATION
The attached information may be confidential. It is intended only for the addressee(s) identified above. If you are not the addressee(s), or an employee or agent of the addressee(s), please note that any dissemination, distribution, or copying of this communication is strictly prohibited. If you have received this e-mail in error, please destroy the document and notify the sender of the error. Thank you.
From: EDRMS_NO_REPLY@mail.nih.gov [mailto:EDRMS_NO_REPLY@mail.nih.gov]
Sent: Wednesday, February 28, 2018 3:29 PM
To: Rogers, Karen (NIH/OD) [E] <rogersk@od.nih.gov>; White, Tracy (NIH/OD) [E] <whitever@od.nih.gov>; White, Tracy (NIH/OD) [E] <whitever@od.nih.gov>
Subject: ES - WE 370674 - FYI (CC)
To whom it may concern:
Message from the Director's Document and Records Management System (DDRMS)
You have received a task notification requiring your attention.
Please do not reply to this email, this is an automated message.
If you have concerns please contact the NIH Help Desk at (301) 496-4357.
Work Folder Information Work Folder: WF 370674
REL0000023704
Process: FYI
Program Analyst: Cramer, Lindsay (NIH/OD) [E]
Due Date:
WE Subject: Mr. Andrew Goldman writes to Dr. David Lambertson (NCI) and Dr. Collins to provide Knowledge Ecology International’s (KEI) appeal of the NIH/NCI decision to proceed with the anti-CD30 license to Kite Pharma. This email is in response to Dr. Lambertson’s February 26 email responding to KEI’s February 14 email requesting information on the formal appeal procedures.
IC: od_ott
From: Goldman, Andrew
To: Lambertson, DavidCollins, Francis
Remarks: FYI to OER, OIR, OTT, and OGC. Assigned to NCI for any necessary action. Thank you! -Lindsay
Additional instructions are included on the task form, click the link to open the Task
REL0000023704
From: Berkley, Dale (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=5EE461C29F5045A49FOADF82CAAA2F31-BERKLEYD]
Sent: 2/27/2018 9:12:51 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]
cc: Jambou, Robert (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ff42a9fa39824980aa9e36af49e56chc-jambour]; Jorgenson, Lyric (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=3bbde7d361374981a4d336b6eeb17521-jorgensonla]
Subject: RE: FOIA Request -- Can you help?
Best, Dale
From: Rohrbaugh, Mark (NIH/OD) [E]
Sent: Tuesday, February 27, 2018 2:00 PM
To: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>
Cc: Jambou, Robert (NIH/OD) [E] <jambour@od.nih.gov>; Jorgenson, Lyric (NIH/OD) [E] <lyric.jorgenson@nih.gov> Subject: RE: FOIA Request -- Can you help?
See below.
THanks, Mark
From: Jambou, Robert (NIH/OD) [E]
Sent: Tuesday, February 27, 2018 1:45 PM
To: Rohrbaugh, Mark (NIH/OD) [E] <rehrbaum@oc.nib.gov>; Jorgenson, Lyric (NIH/OD) [E] <ivric.jorgenson@inih.eov> Subject: RE: FOIA Request -- Can you help?
OK thank you Mark.
Thanks se much!
REL0000023705
Bob J.
From: Rohrbaugh, Mark (NIH/OD) [E]
Sent: Tuesday, February 27, 2018 1:37 PM
To: Jorgenson, Lyric (NIH/OD) [E] <iyric.jorgenson@nih.gov>; Jambou, Robert (NIH/OD) [E] <jambour@eod.nih.gov> Subject: RE: FOIA Request -- Can you help?
From: Jorgenson, Lyric (NIH/OD) [E]
Sent: Tuesday, February 27, 2018 1:32 PM
To: Jambou, Robert (NIH/OD) [E] <jambour@od.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <rehrbaum@od nih.goy> Subject: RE: FOIA Request -- Can you help?
I’m meeting with CW in an hour. I'll make sure to bring it up with her as well. Mark — do you have a recommendation?
From: Jambou, Robert (NIH/OD) [E]
Sent: Tuesday, February 27, 2018 1:28 PM
To: Rohrbaugh, Mark (NIH/OD) [E] <rehrbaum @od.-nib.gov> Ce: Jorgenson, Lyric (NIH/OD) [E] <iyric.jorgenson@nih.gov> Subject: FOIA Request -- Can you help?
Hi Mark & Lyric,
We have received a FOIA request from Andrew S. Goldman of Knowledge Ecology International (KEI -- see items attached “Request for documents for OSP request” and therein “Request 47590.pdf”). The formal request consists of four aggregated requests.
The instructions from the FOIA office per Roger Bordine =
Any guidance you can provide on how to proceed with this request would be greatly appreciated. Thanks...
Bob J.
REL0000023705
From: Jambou, Robert (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=FF42A9FA39824980AA9E36AF49ES6CBC-JAMBOUR]
Sent: 2/27/2018 6:27:30 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]
cc: Jorgenson, Lyric (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=3bbde7d361374981a4d336b6eeb17521-jorgensonla]
Subject: FOIA Request -- Can you help?
Attachments: Request for documents for OSP request
Hi Mark & Lyric, We have received a FOIA request from Andrew S. Goldman of Knowledge Ecology International (KEI -- see items
attached “Request for documents for OSP request” and therein “Request 47590.pdf”). The formal request consists of four aggregated requests.
Any guidance you can provide on how to proceed with this request would be greatly appreciated. Thanks...
Bob J.
REL0000023706
From: Sullivan, Nicholle (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=49A1E4D7663F48A39B2D953804DDBFB8-SULLIVANN] Sent: 2/26/2018 8:37:30 PM
To: Jambou, Robert (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=ff42a9fa39824980aa9e36af49e56cbc-jambour] Subject: Request for documents for OSP request
Attachments: NIH FOIA Request for Direct - Goldman (OSP) - (Aggregate 4 requests into 1 request).pdf; Request 47590. pdf
Flag: Follow up Hi Bob,
We received the attached FOIA Requests for any and all documents seeking antitrust advice under 40 USC section 559 for specified date ranges: 1) January 1, 2000 to the present; 2) the year 1979; 3) the year 1984 and 4) the year 1994from the period of January 1, 1979 to December 31, 1979. 40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice from the Attorney General prior to the disposal of property, including patents, to private interests.
The requester is specifically interested in any documents which discuss the obligations of NIH, including any of its institutes and centers, with regard to seeking antitrust advice in the context of licensing federally-owned and/or federally-funded inventions.
The FOIA requests will be aggregated into one OSP request per the attached email. Please conduct a search for responsive records and if you could, please give me an idea of how the search is going.
Thanks so much, Nicholle
Nicholle Sullivan, J.D.
Lead Government Information Specialist
Freedom of Information and Privacy Act Branch OM/OD/NHLBI 6705 Rockledge Dr., Suite 6054
Bethesda, MD 20892-7957
301-496-9737 (office)
240-507-9935 (direct line)
301-402-3604 (fax)
sullivann@mail.nih.gov
REL0000023706.0001
From: Bordine, Roger (NIH/OD) [E
To: NHLBI FOIA REQUEST (NIH/NHLBI) Ce: Manheim, Marianne (NIH/NHLBD [E]; NIH FOIA Subject: NIH FOIA Request for Direct - Goldman (OSP) - (Aggregate 4 requests into 1 request) Date: Thursday, February 22, 2018 12:21:00 PM Attachments: 2369 _001.pdf image001.png
paves ayaa eee oS EUR
Good Afternoon,
Please see the attached request for direct response regarding a copy of records related to the NIH’s obligation to seek anti-trust advice from the Attorney General regarding federally owned or funded inventions.
Thank you.
Roger Bordine
Program Assistant
Freedom of Information Office National Institutes of Health Building 31, Room 5B35
31 Center Drive
Bethesda, MD 20892
Phone: 301-496-5633 Fax: 301-402-4541
Roger bordine@niki gov
REL0000023706.0001.0001
Freedom OF Information Act Tracking System (FOJA) Page 1 of 1
Goldman
DATE: 2/22/2018
TO: Marianne Manheim NHLBI FOIA Coordinator Building Rockledge 1, Rm. 6182 6705 Rockledge Drive Bethesda, MD 20892
FROM: NIH FOIA Office, OD/OCPL SUBJECT: FOIA Log No. 2018/052
The attached FOIA request is forwarded to you for the following action:
FOR DIRECT REPLY. Enter the case into the FOIA Tracking System. Upon completion, please complete the Close-Out, and if there is an invoice, please send a copy of the invoice with the final letter to the NIH FOIA Office.
If you forward this request to a program office within your IC, keep a copy of this request in your FOIA Case file. As the IC FOIA Coordinator, you are responsible for the collection of records and follow-up until the request is closed.
Please contact the NIH FOIA Office on 301-496-5633 or at nin
Bria nibdey if you have any questions.
COMMENTS: See Email (OSP)
https://foia.od.nih.gov/Requests/CoverMemo.aspx 2/22/2018 REL0000023706.0001.0001.0001
Bordine, Roger (NIH/OD) [E]
From: Andrew Goldman <andrew.goldman@keionline.org>
Sent: Wednesday, February 21, 2018 1:05 PM
Tao: NIH FOIA
Subject: Re: FOIA Request Re: NIH Seeking Antitrust Advice Under 40 US.C. § 559 Attachments: KE|_FOIA21Feb2018_NIH_40_USC_559.pdf; KEI_FOIA21Feb2018_NIH_40_USC_559 2. pdf.
KEI FOIA21Feb2018_NIH_40_USC_559 3 pdf; KEL FOIA2 1Feb2018_ NIH_40_ USC 559 _4 pdf
Dear Sir or Madam:
Yesterday | sent four related FOIA requests, but | unfortunately attached the incorrect requests. if you could please replace those requests with the corrected versions attached, | would appreciate it.
Best, Andy
Andrew 5. Goldman Counsel, Policy and Legal Affairs Knowledge Ecology International
ance ns PELASG KEE tel.: +1,202.332 2670 www. Ke re
On Tue, Feb 20, 2018 at 12:51 PM, Andrew Goldman <andrew.goldman@keion! Dear Sir or Madam:
ire.ore> wrote:
Please find attached four related Freedom of Information Act requests from Knowledge Ecology International regarding the NIH's obligations to seek antitrust advice under 40 USC § 559. The first is for the period January 1, 2000 to the present; the second is for the year of 1979; the third is for the year of 1984; and the fourth is for the year of 1994.
Thank you in advance for your attention to this request.
Sincerely,
Andrew $. Goldman
Counsel, Policy and Legal Affairs Knowledge Ecology international tel.: wiv keto
REL0000023706.0001.0001.0001
FROM: Andrew S. Goldman
clo Knowledge Ecology International 1621 Connecticut Ave NW Suite 500 Washington, DC 20009 andrew.goldman@keionline.org
TO: FOIA Officer
FOIA Information Office
NIH Building 31, Room 5B35 31 Center Drive, MSC 2107 Bethesda, MD 20892-2107 a nihfoia@mail.nih.gov Al A D
DATE: February 21, 2018
RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40 U.S.C. § 559
Dear FOIA Officer:
Under the Freedom of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR Part 5), Knowledge Ecology International (KEI) requests any and all documents, from the period of January 1, 1979 to December 31, 1979, related to 40 U.S.C. § 559.
40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice from the Attorney General prior to the disposal of property, including patents, to private interests.
We are specifically interested in any documents which discuss the obligations of NIH, including any of its institutes and centers, with regard to seeking antitrust advice in the context of licensing federally-owned and/or federally-funded inventions.
Request for Full Waiver of Fees
Knowledge Ecology International (KEI) requests a full waiver of fees under the Freedom of Information Act and under 45 CFR Part 5.54.
KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable access to affordable medicines.
Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit public interest groups, such as KEI, that seek to disseminate information that is in the public interest:
REL0000023706.0001.0001.0001
“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies from using high fees to discourage certain types of requesters and requests,’ in a clear reference to requests from journalists, scholars and, most importantly for our purpogées, nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86, 94 (D.C. Cir. 1986) (citations omitted).
Disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the Government.
1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or activities of the government.”
Disclosure of the requested records would shed light on the operations and activities of the federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations federal agencies have in seeking antitrust advice in the context of licensing federally-owned patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).
2. § 5.54(b)(2): Disclosure of the requested information would be likely to contribute significantly fo public understanding of those operations or activities.
This factor is satisfied because the following criteria are met.
2.4. § 5.54(b)(2)(i): Disclosure of the requested records must be meaningfully informative about government operations or activities.
Disclosure of the requested records would be meaningfully informative about government operations and activities because it would reveal information that is not yet in the public domain. In particular it would provide information regarding whether the National Institutes of Health is abiding by the law when licensing medical technologies that have received federal funding. This information would be helpful in informing policy discussions regarding the public interest and the disposal of federal property.
As mentioned previously, the information is not publicly available and our attempt to seek that information from the NIH was denied.
“Legislative history suggests that information has more of this potential [to contribute to public understanding] to the degree that the information is new and supports public oversight of agency operations, including the effect of agency policy on public health.” McClellan Ecological Seepage Situation v. Carlucci , 835 F.2d 1282, 1286 (9th. Cir. 1987) (citations omitted).
REL0000023706.0001.0001.0001
2.1. § 5.54(b)(2){ii): The disclosure must contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester.
The subject of the request concerns government operations and activities related to the antitrust ramifications of the licensing of federally-owned and federally-funded patents, including on medical technologies, and is intertwined with policy discussions affecting the prices of prescription drugs in the United States.
There is a broad audience of persons interested in the subject, including, inter alia, advocates for affordable access to medicines; doctors, nurses, and other medical providers; patients and caretakers; policy experts; and people who purchase insurance or other forms of medical care. Disclosure would contribute to the understanding of that broad audience of persons because it would provide context for the policies, positions, and decisions of the National Institutes of Health related to federal R&D funding and its approach to drug pricing issues.
KEI is an NGO that works on drug pricing and access to medicines, and has expertise in public health, drug pricing, and access to medicines.
KEI has the ability and intention to effectively convey the information contained in the requested records to the public. KE] operates a website (https://keionline.org) which hosts an extensive archive that is regularly consulted by advocates, academics, and the press. KEI will review the requested records and produce a clear and concise analysis of those records. KEI will use social media and listservs to distribute that analysis to the broad audience of persons interested in the subject of the request.
KEI regularly publishes and analyzes records requested under the FOIA on its website, including recently on various government operations and activities at parts of DHHS:
* 28 February 2017, “CDC FOIA shows US, WHO opposed request to discuss UNSG's High-Level Panel on Access to Medicines Report at EB,” https://keionline.org/node/2727 * 18 October 2016, “Kite Pharma Uses CRADAs to Conduct Important Clinical Research on New Cancer Treatments,” https://keionline.org/node/2640
@ 19 September 2016, “500+ Pages of Documents on NFL Attempts fo Influence NIH Funding of Concussion Studies,” https://keionline.org/node/2630
e 16 September 2016, “NIH Waivers for U.S. Manufacturing Requirements for Federally-Funded Drugs,” https://keionline.org/node/2629 Additionally, KEI works closely with journalists to provide analysis for documents requested by KEI under the FOIA.
KEI does not merely distribute documents to journalists, but provides in-depth analysis that later becomes the basis for stories:
REL0000023706.0001.0001.0001
# 3 March 2017, Vidya Krishnan, “U.S. nixed India’s plea on reforms in medicine,” The Hindu, http:/Avww.thehindu.com/news/national/us-nixed-indias-plea-on-reforms-in-medici ne/article17403526.ece
# 31 December 2016, Dan Vergano, “If Taxpayers Invent A Drug, Should The Government Just Give It Away?,” Buzzfeed News, hitps:/Awww.buzzfeed.com/danvergano/nih-drug-giveaway
e® 20 December 2016, “Front page New York Times story explores Kite Pharma's profitable relationship with NIH regarding expensive cancer drug,” https://keionline.org/node/2703
3. § 5.54(b) (3): The disclosure must not be primarily in the commercial interest of the requester.
Knowledge Ecology International is a non-profit 501(c)(3) organization that does not have any commercial, trade, or profit interest in disclosure of the requested records.
Other
We request the identification of any withheld records with specificity, including descriptions of the withheld material in detail, the specific statutory exemption or basis for denial, the reasons that the statutory exemption or denial applies in this instance, and the interests that would be
foreseeably harmed by disclosure of the record.
We look forward to your acknowledgement of this request within 10 working days and your final determination within 20 working days. 5 U.S.C. § 552(a)(6)(A)(i). Please inform us of any unusual circumstances that would require you to extend the 20-day statutory time limit, “setting forth the unusual circumstances for such extension and the date on which a determination is expected to be dispatched.” 5 U.S.C. § 552(a)(6)(B)(i).
If possible, please conduct all correspondence by email and disclose all records via electronic copy. Please contact me if you have any questions about our request for records or if you require additional information in support of our request for a fee waiver. Thank you in advance for your assistance.
Sincerely,
Andrew S. Goldman, Esq. Counsel, Policy and Legai Affairs Knowledge Ecology International +1.202.332.2670
REL0000023706.0001.0001.0001
andrew.goldman@keionline.org
REL0000023706.0001.0001.0001
FROM: Andrew S. Goldman
clo Knowledge Ecology International 1621 Connecticut Ave NW Suite 500 Washington, DC 20009 andrew.goldman@keionline.org
TO: FOIA Officer
FOIA Information Office
NIH Building 31, Room 5B35 31 Center Drive, MSC 2107 Bethesda, MD 20892-2107 nihfoia@mail.nih.gov
DATE: February 21, 2018
RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40 U.S.C. § 559
Dear FOIA Officer:
Under the Freedom of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR Part 5), Knowledge Ecology International (KE!) requests any and all documents, from the period of January 1, 1984 to December 31, 1984, related to 40 U.S.C. § 559.
40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice from the Attorney General prior to the disposal of property, including patents, to private interests.
We are specifically interested in any documents which discuss the obligations of NIH, including any of its institutes and centers, with regard to seeking antitrust advice in the context of licensing federally-owned and/or federally-funded inventions.
Request for Full Waiver of Fees
Knowledge Ecology International (KE!) requests a full waiver of fees under the Freedom of information Act and under 45 CFR Part 5.54.
KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable access to affordable medicines.
Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit public interest groups, such as KEI, that seek to disseminate information that is in the public interest:
REL0000023706.0001.0001.0001
“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies from using high fees to discourage certain types of requesters and requests,’ in a clear reference to requests from journalists, scholars and, most importantly for our purposes, nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86, 94 (D.C. Cir. 1986) (citations omitted).
Disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the Government.
1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or activities of the government.”
Disclosure of the requested records would shed light on the operations and activities of the federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations federal agencies have in seeking antitrust advice in the context of licensing federally-owned patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).
2. § 5.54(b)(2): Disclosure of the requested information would be likely to contribute significantly to public understanding of those operations or activities.
This factor is satisfied because the following criteria are met.
2.1. § 5.54(b)(2)(i): Disclosure of the requested records must be meaningfully informative about government operations or activities.
Disclosure of the requested records would be meaningfully informative about government operations and activities because it would reveal information that is not yet in the public domain. In particular it would provide information regarding whether the National Institutes of Health is abiding by the law when licensing medical technologies that have received federal funding. This information would be helpful in informing policy discussions regarding the public interest and the disposal of federal property.
As mentioned previously, the information is not publicly available and our attempt to seek that information from the NIH was denied.
“Legislative history suggests that information has more of this potential [to contribute to public understanding] to the degree that the information is new and supports public oversight of agency operations, including the effect of agency policy on public health.” McClellan Ecological Seepage Situation v. Carlucci , 835 F.2d 1282, 1286 (9th. Cir. 1987) (citations omitted).
REL0000023706.0001.0001.0001
2.1. § 5.54(b)(2)(ii): The disclosure must contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester.
The subject of the request concerns government operations and activities related to the antitrust ramifications of the licensing of federally-owned and federally-funded patents, including on medical technologies, and is intertwined with policy discussions affecting the prices of prescription drugs in the United States.
There is a broad audience of persons interested in the subject, including, inter alia, advocates for affordable access to medicines; doctors, nurses, and other medical providers; patients and caretakers; policy experts; and people who purchase insurance or other forms of medical care. Disclosure would contribute to the understanding of that broad audience of persons because it would provide context for the policies, positions, and decisions of the National Institutes of Health related to federal R&D funding and its approach to drug pricing issues.
KEI is an NGO that works on drug pricing and access to medicines, and has expertise in public health, drug pricing, and access to medicines.
KEI has the ability and intention to effectively convey the information contained in the requested records to the public. KEI operates a website (https://keionline.org) which hosts an extensive archive that is regularly consulted by advocates, academics, and the press. KEI will review the requested records and produce a clear and concise analysis of those records. KEI will use social media and listservs to distribute that analysis to the broad audience of persons interested in the subject of the request.
KEI regularly publishes and analyzes records requested under the FOIA on its website, including recently on various government operations and activities at parts of DHHS:
* 28 February 2017, “CDC FOIA shows US, WHO opposed request to discuss UNSG's High-Level Panel on Access to Medicines Report at EB,” https://keionline.org/node/2727 # 18 October 2016, “Kite Pharma Uses CRADAs to Conduct Important Clinical Research on New Cancer Treatments,” https://keionline.org/node/2640
# 19 September 2016, “500+ Pages of Documents on NFL Attempts to Influence NIH Funding of Concussion Studies,” https://keionline.org/node/2630
* 16 September 2016, “NIH Waivers for U.S. Manufacturing Requirements for Federally-Funded Drugs,” https://keionline.org/node/2629 Additionally, KE] works closely with journalists to provide analysis for documents requested by KEI under the FOIA.
KE! does not merely distribute documents to journalists, but provides in-depth analysis that later becomes the basis for stories:
REL0000023706.0001.0001.0001
@ 3 March 2017, Vidya Krishnan, “U.S. nixed India’s plea on reforms in medicine,” The Hindu, http:/Awww.thehindu.com/news/national/us-nixed-indias-plea-on-reforms-in-medici ne/article17403526.ece
@ 31 December 2016, Dan Vergano, “If Taxpayers Invent A Drug, Should The Government Just Give It Away?,” Buzzfeed News, https:/Awww.buzzfeed.com/danvergano/nih-drug-giveaway
# 20 December 2016, “Front page New York Times story explores Kite Pharma's profitable relationship with NIH regarding expensive cancer drug,” https://keionline.org/node/2703
3. § 5.54(b)(3): The disclosure must not be primarily in the commercial interest of the requester,
Knowledge Ecology International is a non-profit 501(c)(3) organization that does not have any commercial, trade, or profit interest in disclosure of the requested records.
Other
We request the identification of any withheld records with specificity, including descriptions of the withheld material in detail, the specific statutory exemption or basis for denial, the reasons that the statutory exemption or denial applies in this instance, and the interests that would be
foreseeably harmed by disclosure of the record.
We look forward to your acknowledgement of this request within 10 working days and your final determination within 20 working days. 5 U.S.C. § 552(a)(6)(A)(i). Please inform us of any unusual circumstances that would require you to extend the 20-day statutory time limit, “setting forth the unusual circumstances for such extension and the date on which a determination is expected to be dispatched.” 5 U.S.C. § 552(a)(6)(B)(i).
If possible, please conduct all correspondence by email and disclose all records via electronic copy. Please contact me if you have any questions about our request for.records or if you require additional information in support of our request for a fee waiver. Thank you in advance for your assistance.
Sincerely,
Andrew S. Goldman, Esq. Counsel, Policy and Legal Affairs Knowledge Ecology International +1,202.332,.2670
REL0000023706.0001.0001.0001
andrew.goldman@keionline.org
REL0000023706.0001.0001.0001
FROM: Andrew S. Goldman
c/o Knowledge Ecology International 1621 Connecticut Ave NW Suite 500 Washington, DC 20009 andrew.goldman@keionline.org
TO: FOIA Officer
FOIA Information Office
NIH Building 31, Room 5B35 31 Center Drive, MSC 2107 Bethesda, MD 20892-2107 nihfoia@mail.nih.gov
DATE: February 21, 2018
Fel 4 Josh
i
RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40
U.S.C. § 559
Dear FOIA Officer:
Under the Freedom of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR Part 5), Knowledge Ecology International (KE!) requests any and all documents, from the period
of January 1, 1994 to December 31, 1994, related to 40 U.S.C. § 559.
40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice from the Attorney General prior to the disposal of property, including patents, to private
interests.
We are specifically interested in any documents which discuss the obligations of NIH, including any of its institutes and centers, with regard to seeking antitrust advice in the context of
licensing federally-owned and/or federally-funded inventions.
Request for Full Waiver of Fees
Knowledge Ecology International (KE!) requests a full waiver of fees under the Freedom of
Information Act and under 45 CFR Part 5.54.
KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable
access to affordable medicines.
Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit public interest groups, such as KEI, that seek to disseminate information that is in the public
interest:
REL0000023706.0001.0001.0001
“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies from using high fees to discourage certain types of requesters and requests,’ in a clear reference to requests from journalists, scholars and, most importantly for our purposes, nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86, 94 (D.C. Cir. 1986) (citations omitted).
Disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the Government.
1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or activities of the government.”
Disclosure of the requested records would shed light on the operations and activities of the federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations federal agencies have in seeking antitrust advice in the context of licensing federally-owned patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).
2. § 5.54(b)(2): Disclosure of the requested information would be likely to contribute significantly to public understanding of those operations or activities.
This factor is satisfied because the following criteria are met.
2.1. § 5.54(b)(2)(i): Disclosure of the requested records must be meaningfully informative about government operations or activities.
Disclosure of the requested records would be meaningfully informative about government operations and activities because it would reveal information that is not yet in the public domain. In particular it would provide information regarding whether the National Institutes of Health is abiding by the law when licensing medical technologies that have received federal funding. This information would be helpful in informing policy discussions regarding the public interest and the disposal of federal property.
As mentioned previously, the information is not publicly available and our attempt to seek that information from the NIH was denied.
“Legislative history suggests that information has more of this potential [to contribute to public understanding] to the degree that the information is new and supports public oversight of agency operations, including the effect of agency policy on public health.” McClellan Ecological Seepage Situation v. Carlucci , 835 F.2d 1282, 1286 (Sth. Cir. 1987) (citations omitted).
REL0000023706.0001.0001.0001
2.1. § §.54(b)(2) (ii): The disclosure must contribute to fhe understanding of a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester.
The subject of the request concerns government operations and activities related to the antitrust ramifications of the licensing of federally-owned and federally-funded patents, including on medical technologies, and is intertwined with policy discussions affecting the prices of prescription drugs in the United States.
There is a broad audience of persons interested in the subject, including, inter alia, advocates for affordable access to medicines; doctors, nurses, and other medical providers: patients and caretakers; policy experts; and peaple who purchase insurance or other forms of medical care. Disclosure would contribute to the understanding of that broad audience of persons because it would provide context for the policies, positions, and decisions of the National Institutes of Health related to federal R&D funding and its approach to drug pricing issues.
KEI is an NGO that works on drug pricing and access to medicines, and has expertise in public health, drug pricing, and access to medicines.
KEI has the ability and intention to effectively convey the information contained in the requested records to the public. KE! operates a website (httos://keionline.org) which hosts an extensive archive that is regularly consulted by advocates, academics, and the press. KE] will review the requested records and produce a clear and concise analysis of those records. KEI will use social media and listservs to distribute that analysis to the broad audience of persons interested in the subject of the request.
KEI regularly publishes and analyzes records requested under the FOIA on its website, including recently on various government operations and activities at parts of DHHS:
# 28 February 2017, “CDC FOIA shows US, WHO opposed request to discuss UNSG's High-Level Panel on Access to Medicines Report at EB,” https://keionline.org/node/2727 # 18 October 2016, “Kite Pharma Uses CRADAs to Conduct Important Clinical Research on New Cancer Treatments,” https://keionline.org/node/2640
e 19 September 2016, “500+ Pages of Documents on NFL Attempts to Influence NIH Funding of Concussion Studies,” https://keionline.org/node/2630
@ 16 September 2016, “NIH Waivers for U.S. Manufacturing Requirements for Federally-Funded Drugs,” https://keionline.org/node/2629 Additionally, KEI works closely with journalists to provide analysis for documents requested by KEI under the FOIA.
KEI does not merely distribute documents to journalists, but provides in-depth analysis that later becomes the basis for stories:
REL0000023706.0001.0001.0001
* 3 March 2017, Vidya Krishnan, “U.S. nixed India’s plea on reforms in medicine,” The Hindu, http:/Avwww.thehindu.com/news/national/us-nixed-indias-plea-on-reforms-in-medici ne/article17403526.ece
# 31 December 2016, Dan Vergano, “If Taxpayers Invent A Drug, Should The Government Just Give It Away?,” Buzzfeed News, hitps:/Awww.buzzfeed.com/danvergano/nih-drug-giveaway
* 20 December 2016, “Front page New York Times story explores Kite Pharma's profitable relationship with NIH regarding expensive cancer drug,” https://keionline.org/node/2703
3. § 5.54(b)(3): The disclosure must not be primarily in the commercial interest of the requester.
Knowledge Ecology International is a non-profit 501(c)(3) organization that does not have any commercial, trade, or profit interest in disclosure of the requested records.
Other
We request the identification of any withheld records with specificity, including descriptions of the withheld material in detail, the specific statutory exemption or basis for denial, the reasons that the statutory exemption or denial applies in this instance, and the interests that would be
foreseeably harmed by disclosure of the record.
We look forward to your acknowledgement of this request within 10 working days and your final determination within 20 working days. 5 U.S.C. § 552(a)(6)(A){i). Please inform us of any unusual circumstances that would require you to extend the 20-day statutory time limit, “setting forth the unusual circumstances for such extension and the date on which a determination is expected to be dispatched.” 5 U.S.C. § 552(a)(6)(B)(i).
If possible, please conduct all correspondence by email and disclose all records via electronic copy. Please contact me if you have any questions about our request for records or if you require additional information in support of our request for a fee waiver. Thank you in advance for your assistance.
Sincerely,
Andrew S. Goldman, Esq. Counsel, Policy and Legal Affairs Knowledge Ecology International +4.202.332.2670
REL0000023706.0001.0001.0001
andrew.goldman@keionline.org
REL0000023706.0001.0001.0001
FROM: Andrew S. Goldman
clo Knowledge Ecology International 1621 Connecticut Ave NW Suite 500 Washington, DC 20009 andrew.goldman@keionline.org
TO: FOIA Officer
FOIA Information Office
NIH Building 31, Room 5B35 31 Center Drive, MSC 2107 Bethesda, MD 20892-2107 nihfoia@mail.nih.gov
DATE: February 21, 2018
RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40 U.S.C. § 559
Dear FOIA Officer:
Under the Freedom of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR Part 5), Knowledge Ecology International (KEI) requests any and all documents, from the period of January 71, 2000 to the present, related to 40 U.S.C. § 559.
40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice from the Attorney General prior to the disposal of property, including patents, to private interests.
We are specifically interested in any documents which discuss the obligations of NIH, including any of its institutes and centers, with regard to seeking antitrust advice in the context of licensing federally-owned and/or federally-funded inventions.
Request for Full Waiver of Fees
Knowledge Ecology International (KE!) requests a full waiver of fees under the Freedom of information Act and under 45 CFR Part 5.54.
KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable access to affordable medicines.
Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit public interest groups, such as KEI, that seek to disseminate information that is in the public interest:
REL0000023706.0001.0001.0001
“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies from using high fees to discourage certain types of requesters and requests,’ in a clear reference to requests from journalists, scholars and, most importantly for our purposes, nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86, 94 (D.C. Cir. 1986) (citations omitted).
Disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the Government.
1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or activities of the government.”
Disclosure of the requested records would shed light on the operations and activities of the federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations federal agencies have in seeking antitrust advice in the context of licensing federally-owned patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).
2. § §.54(b)(2): Disclosure of the requested information would be likely to contribute significantly to public understanding of those operations or activities.
This factor is satisfied because the following criteria are met.
2.1. § 5.54(b)(2)(i): Disclosure of the requested records must be meaningfully informative about government operations or activities.
Disclosure of the requested records would be meaningfully informative about government operations and activities because it would reveal information that is not yet in the public domain. In particular it would provide information regarding whether the National Institutes of Health is abiding by the law when licensing medical technologies that have received federal funding. This information would be helpful in informing policy discussions regarding the public interest and the disposal of federal property.
As mentioned previously, the information is not publicly available and our attempt to seek that information from the NIH was denied.
“Legislative history suggests that information has more of this potential [to contribute to public understanding] to the degree that the information is new and supports public oversight of agency operations, including the effect of agency policy on public health.” McClellan Ecological Seepage Situation v. Carlucci , 835 F.2d 1282, 1286 (9th. Cir. 1987) (citations omitted).
REL0000023706.0001.0001.0001
2.1. § 5.54(b)(2) (i): The disclosure must contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed fo the individual understanding of the requester.
The subject of the request concerns government operations and activities related to the antitrust ramifications of the licensing of federally-owned and federally-funded patents, including on medical technologies, and is intertwined with policy discussions affecting the prices of prescription drugs in the United States.
There is a broad audience of persons interested in the subject, including, inter alia, advocates for affordable access to medicines; doctors, nurses, and other medical providers; patients and caretakers; policy experts; and people who purchase insurance or other forms of medical care. Disclosure would contribute to the understanding of that broad audience of persons because it would provide context for the policies, positions, and decisions of the National Institutes of Health related to federal R&D funding and its approach to drug pricing issues.
KEI is an NGO that works on drug pricing and access to medicines, and has expertise in public health, drug pricing, and access to medicines.
KEI has the ability and intention to effectively convey the information contained in the requested records to the public. KE] operates a website (https://keionline.org) which hosts an extensive archive that is regularly consulted by advocates, academics, and the press. KEI will review the requested records and produce a clear and concise analysis of those records. KEI will use social media and listservs to distribute that analysis to the broad audience of persons interested in the subject of the request.
KEI regularly publishes and analyzes records requested under the FOIA on its website, including recently on various government operations and activities at parts of DHHS:
* 28 February 2017, “CDC FOIA shows US, WHO opposed request to discuss UNSG's High-Level Panel on Access to Medicines Report at EB,” https://keionline.org/node/2727 # 18 October 2016, “Kite Pharma Uses CRADAs to Conduct Important Clinical Research on New Cancer Treatments,” https://keionline.org/node/2640
# 19 September 2016, “500+ Pages of Documents on NFL Attempts to Influence NIH Funding of Concussion Studies,” hitps://keionline.org/node/2630
# 16 September 2016, “NIH Waivers for U.S. Manufacturing Requirements for Federally-Funded Drugs,” https://keionline.org/node/2629 Additionally, KE! works closely with journalists to provide analysis for documents requested by KEI under the FOIA.
KEI does not merely distribute documents to journalists, but provides in-depth analysis that later becomes the basis for stories:
REL0000023706.0001.0001.0001
e 3 March 2017, Vidya Krishnan, “U.S. nixed India’s plea on reforms in medicine,” The Hindu, http:/Avww.thehindu.com/news/national/us-nixed-indias-plea-on-reforms-in-medici ne/article17403526.ece
# 31 December 2016, Dan Vergano, “If Taxpayers Invent A Drug, Should The Government Just Give It Away?,” Buzzfeed News, https:/Awww.buzzfeed.com/danvergano/nih-drug-giveaway
e 20 December 2016, “Front page New York Times story explores Kite Pharma's profitable relationship with NIH regarding expensive cancer drug,” https://keionline.org/node/2703
3. § 5.54(b)(3): The disclosure must not be primarily in the commercial interest of the requester.
Knowledge Ecology International is a non-profit 501(c)(3) organization that does not have any commercial, trade, or profit interest in disclosure of the requested records.
Other
We request the identification of any withheld records with specificity, including descriptions of the withheld material in detail, the specific statutory exemption or basis for denial, the reasons that the statutory exemption or denial applies in this instance, and the interests that would be
foreseeably harmed by disclosure of the record.
We look forward to your acknowledgement of this request within 10 working days and your final determination within 20 working days. 5 U.S.C. § 552(a)(6)(A)(i). Please inform us of any unusual circumstances that would require you to extend the 20-day statutory time limit, “setting forth the unusual circumstances for such extension and the date on which a determination is expected to be dispatched.” 5 U.S.C. § 552(a)(6)(B)(i).
If possible, please conduct all correspondence by email and disclose all records via electronic copy. Please contact me if you have any questions about our request for records or if you require additional information in support of our request for a fee waiver. Thank you in advance for your assistance.
Sincerely,
Andrew S. Goldman, Esq. Counsel, Policy and Legal Affairs Knowledge Ecology International +1.202,332.2670
REL0000023706.0001.0001.0001
andrew.goldman@keionline.org
REL0000023706.0001.0001.0001
National Institutes of Health
Fe uy DNacovery Aibe Aealtls
REL0000023706.0001.0001.0002
Freedom OF Information Act Tracking System (FOIA) Page | of 1
DATE: 2/22/2018
TO: Marianne Manheim NHLBI FOIA Coordinator Building Rockledge 1, Rm. 6182 6705 Rockledge Drive Bethesda, MD 20892
FROM: NIH FOIA Office, OD/OCPL SUBJECT: FOIA Log No. 2018/052
The attached FOIA request is forwarded to you for the following action:
FOR DIRECT REPLY. Enter the case into the FOIA Tracking System. Upon completion, please complete the Close-Out, and if there is an invoice, please send a copy of the invoice with the final letter to the NIH FOIA Office.
If you forward this request to a program office within your IC, keep a copy of this request in your FOIA Case file. As the IC FOIA Coordinator, you are responsible for the collection of records and follow-up until the request is closed.
Please contact the NIH FOIA Office on 301-496-5633 or at silt have any questions.
dmailnih.aeyv if you
COMMENTS: See Emai
https://foia.od.nih.gov/Requests/CoverMemo.aspx 2/22/2018 REL0000023706.0001.0002
From: Andrew Goldman <andrew.goldman@keionline. org>
Sent: Wednesday, February 21,2018 1:05 PM To: NIH FOIA Subject: Re: FO! Seeki Advice Under 40 U.S.C. § 559
Attachments:
Dear Sir or Madam:
Yesterday | sent four related FOIA requests, but | unfortunately attached the incorrect requests. If you could please replace those requests with the corrected versions attached, | would appreciate it.
Best, Andy
Andrew & Goldman
Counsel, Policy and Legal Affairs Knowledge Ecology International
andrew golden @teioniine ore // www. tel.
miter comyAsG KE!
Fa
On Tue, Feb 20, 2018 at 12:51 PM, Andrew Goldman <andrew.goldman@keionline.org> wrote: Dear Sir or Madam:
Thank you in advance for your attention to this request.
Sincerely,
Andrew §, Goldman Counsel, Policy and Legal Affairs Knowledge Ecology International
tel: £1,202. wow. keloaline.org
REL0000023706.0001.0002
FROM: Andrew S. Goldman
clo Knowledge Ecology International 1621 Connecticut Ave NW Suite 500 Washington, DC 20009 andrew.goldman@keionline.org
TO: FOIA Officer
FOIA Information Office
NIH Building 31, Room 5B35 31 Center Drive, MSC 2107 Bethesda, MD 20892-2107 - nihfoia@mail.nih.gov Ab Rips
DATE: February 21, 2018
RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40 U.S.C. § 559
Dear FOIA Officer:
Under the Freedom of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR 5), Knowledge Ecology International (KE) :
40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice from the Attorney General prior to the disposal of property, including patents, to private interests.
We are specifically interested in any documents which discuss the obligations of NIH, including any of its institutes and centers, with regard to seeking antitrust advice in the context of licensing federally-owned and/or federally-funded inventions.
Knowledge Ecology International (KEI) requests a full waiver of fees under the Freedom of Information Act and under 45 CFR Part 5.54.
KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable access to affordable medicines.
Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit
public interest groups, such as KEI, that seek to disseminate information that is in the public interest:
REL0000023706.0001 .0002
“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies from using high fees to discourage certain types of requesters and requests,’ in a clear reference to requests from journalists, scholars and, most importantly for our purpogés, nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86, 94 (D.C. Cir. 1986) (citations omitted).
Disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the Government.
1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or activities of the government.”
Disclosure of the requested records would shed light on the operations and activities of the federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations federal agencies have in seeking antitrust advice in the context of licensing federally-owned patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).
2. § 5.54(b)(2): Disclosure of the requested information would be likely to contribute significantly fo public understanding of those operations or activities.
This factor is satisfied because the following criteria are met.
2.1. § 5.54(b)(2)(i): Disclosure of the requested records must be meaningfully informative about government operations or activities.
Disclosure of the requested records would be meaningfully informative about government operations and activities because it would reveal information that is not yet in the public domain. In particular it would provide information regarding whether the National Institutes of Health is abiding by the law when licensing medical technologies that have received federal funding. This information would be helpful in informing policy discussions regarding the public interest and the disposal of federal property.
As mentioned previously, the information is not publicly available and our atternpt to seek that information from the NIH was denied.
“Legislative history suggests that information has more of this potential [to contribute to public understanding] to the degree that the information is new and supports public oversight of agency operations, including the effect of agency policy on public health.” McClellan Ecological Seepage Situation v. Carlucci , 835 F.2d 1282, 1286 (9th. Cir. 1987) (citations omitted).
REL0000023706.0001.0002
2.1. § 5.54(b)(2){ii): The disclosure must contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester.
The subject of the request concerns government operations and activities related to the antitrust ramifications of the licensing of federally-owned and federally-funded patents, including on medical technologies, and is intertwined with policy discussions affecting the prices of prescription drugs in the United States.
There is a broad audience of persons interested in the subject, including, inter alia, advocates for affordable access to medicines; doctors, nurses, and other medical providers; patients and caretakers; policy experts; and people who purchase insurance or other forms of medical care. Disclosure would contribute to the understanding of that broad audience of persons because it would provide context for the policies, positions, and decisions of the National Institutes of Health related to federal R&D funding and its approach to drug pricing issues.
KEI is an NGO that works on drug pricing and access to medicines, and has expertise in public health, drug pricing, and access to medicines.
KEI has the ability and intention to effectively convey the information contained in the requested records to the public. KE] operates a website (https://keionline.org) which hosts an extensive archive that is regularly consulted by advocates, academics, and the press. KEI will review the requested records and produce a clear and concise analysis of those records. KEI will use social media and listservs to distribute that analysis to the broad audience of persons interested in the subject of the request.
KEI regularly publishes and analyzes records requested under the FOIA on its website, including recently on various government operations and activities at parts of DHHS:
* 28 February 2017, “CDC FOIA shows US, WHO opposed request to discuss UNSG's High-Level Panel on Access to Medicines Report at EB,” https://keionline.org/node/2727 * 18 October 2016, “Kite Pharma Uses CRADAs to Conduct Important Clinical Research on New Cancer Treatments,” https://keionline.org/node/2640
@ 19 September 2016, “500+ Pages of Documents on NFL Attempts fo Influence NIH Funding of Concussion Studies,” https://keionline.org/node/2630
e 16 September 2016, “NIH Waivers for U.S. Manufacturing Requirements for Federally-Funded Drugs,” https://keionline.org/node/2629 Additionally, KEI works closely with journalists to provide analysis for documents requested by KEI under the FOIA.
KEI does not merely distribute documents to journalists, but provides in-depth analysis that later becomes the basis for stories:
REL0000023706.0001.0002
# 3 March 2017, Vidya Krishnan, “U.S. nixed India’s plea on reforms in medicine,” The Hindu, http:/Avww.thehindu.com/news/national/us-nixed-indias-plea-on-reforms-in-medici ne/article17403526.ece
# 31 December 2016, Dan Vergano, “If Taxpayers Invent A Drug, Should The Government Just Give It Away?,” Buzzfeed News, hitps:/Awww.buzzfeed.com/danvergano/nih-drug-giveaway
e® 20 December 2016, “Front page New York Times story explores Kite Pharma's profitable relationship with NIH regarding expensive cancer drug,” https://keionline.org/node/2703
3. § 5.54(b) (3): The disclosure must not be primarily in the commercial interest of the requester.
Knowledge Ecology International is a non-profit 501(c)(3) organization that does not have any commercial, trade, or profit interest in disclosure of the requested records.
Other
We look forward to your acknowledgement of this request within 10 working days and your final determination within 20 working days. 5 U.S.C. § 552(a)(6)(A)(i). Please inform us of any unusual circumstances that would require you to extend the 20-day statutory time limit, “setting forth the unusual circumstances for such extension and the date on which a determination is expected to be dispatched.” 5 U.S.C. § 552(a)(6)(B)(i).
lf possible, please conduct all correspondence by email and disclose all records via electronic copy. Please contact me if you have any questions about our request for records or if you require additional information in support of our request for a fee waiver. Thank you in advance for your assistance.
Sincerely,
Andrew S. Goldman, Esq. Counsel, Policy and Legai Affairs Knowledge Ecology International +1.202.332.2670
REL0000023706.0001.0002
andrew.goldman@keionline.org
REL0000023706.0001.0002
FROM: Andrew S. Goldman
cio Knowledge Ecology International 1621 Connecticut Ave NW Suite 500 Washington, DC 20009 andrew.goldman@keionline.org
TO: FOIA Officer
FOIA Information Office
NIH Building 31, Room 5B35 31 Center Drive, MSC 2107 Bethesda, MD 20892-2107 nihfoia@mail.nih.gov
DATE: February 21, 2018
RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40 U.S.C. § 559
Dear FOIA Officer:
Under the Freedam of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR Part 5), Knowledge Ecology International (KE!) feques
40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice from the Attorney General prior to the disposal of property, including patents, to private interests.
We are specifically interested in any documents which discuss the obligations of NIH, including any of its institutes and centers, with regard to seeking antitrust advice in the context of licensing federally-owned and/or federally-funded inventions.
Request for Full Waiver of Fees
Knowledge Ecology International (KE!) requests a full waiver of fees under the Freedom of information Act and under 45 CFR Part 5.54.
KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable access to affordable medicines.
Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit
public interest groups, such as KEI, that seek to disseminate information that is in the public interest:
REL0000023706.0001.0002
“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies from using high fees to discourage certain types of requesters and requests,’ in a clear reference to requests from journalists, scholars and, most importantly for our purposes, nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86, 94 (D.C. Cir. 1986) (citations omitted).
Disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the Government.
1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or activities of the government.”
Disclosure of the requested records would shed light on the operations and activities of the federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations federal agencies have in seeking antitrust advice in the context of licensing federally-owned patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).
2. § 5.54(b)(2): Disclosure of the requested information would be likely to contribute significantly to public understanding of those operations or activities.
This factor is satisfied because the following criteria are met.
2.1. § §.54(b)(2){i): Disclosure of the requested records must be meaningfully informative about government operations or activities.
Disclosure of the requested records would be meaningfully informative about government operations and activities because it would reveal information that is not yet in the public domain. In particular it would provide information regarding whether the National Institutes of Health is abiding by the law when licensing medical technologies that have received federal funding. This information would be helpful in informing policy discussions regarding the public interest and the disposal of federal property.
As mentioned previously, the information is not publicly available and our atternpt to seek that information from the NIH was denied.
“Legislative history suggests that information has more of this potential [to contribute to public understanding] to the degree that the information is new and supports public oversight of agency operations, including the effect of agency policy on public health.” McClellan Ecological Seepage Situation v. Carlucci , 835 F.2d 1282, 1286 (9th. Cir. 1987) (citations omitted).
REL0000023706.0001.0002
2.1. § 5.54(b) (2) (ii): The disclosure must contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester.
The subject of the request concerns government operations and activities related to the antitrust ramifications of the licensing of federally-owned and federally-funded patents, including on medical technologies, and is intertwined with policy discussions affecting the prices of prescription drugs in the United States.
There is a broad audience of persons interested in the subject, including, inter alia, advocates for affordable access to medicines; doctors, nurses, and other medical providers; patients and caretakers; policy experts; and people who purchase insurance or other forms of medical care. Disclosure would contribute to the understanding of that broad audience of persons because it would provide context for the policies, positions, and decisions of the National Institutes of Health related to federal R&D funding and its approach to drug pricing issues.
KEI is an NGO that works on drug pricing and access to medicines, and has expertise in public health, drug pricing, and access to medicines.
KEI has the ability and intention to effectively convey the information contained in the requested records to the public. KEI operates a website (https://keionline.org) which hosts an extensive archive that is regularly consulted by advocates, academics, and the press. KEI will review the requested records and produce a clear and concise analysis of those records. KEI will use social media and listservs to distribute that analysis to the broad audience of persons interested in the subject of the request.
KEI regularly publishes and analyzes records requested under the FOIA on its website, including recently on various government operations and activities at parts of DHHS:
* 28 February 2017, “CDC FOIA shows US, WHO opposed request to discuss UNSG's High-Level Panel on Access to Medicines Report at EB,” https://keionline.org/node/2727 # 18 October 2016, “Kite Pharma Uses CRADAs to Conduct Important Clinical Research on New Cancer Treatments,” https://keionline.org/node/2640
# 19 September 2016, “500+ Pages of Documents on NFL Attempts to Influence NIH Funding of Concussion Studies,” https://keionline.org/node/2630
# 16 September 2016, “NIH Waivers for U.S. Manufacturing Requirements for Federally-Funded Drugs,” https://keionline.org/node/2629 Additionally, KE] works closely with journalists to provide analysis for documents requested by KEI under the FOIA.
KE! does not merely distribute documents to journalists, but provides in-depth analysis that later becomes the basis for stories:
REL0000023706.0001.0002
@ 3 March 2017, Vidya Krishnan, “U.S. nixed India’s plea on reforms in medicine,” The Hindu, http:/Awww.thehindu.com/news/national/us-nixed-indias-plea-on-reforms-in-medici ne/article17403526.ece
@ 31 December 2016, Dan Vergano, “If Taxpayers Invent A Drug, Should The Government Just Give It Away?,” Buzzfeed News, https:/Awww.buzzfeed.com/danvergano/nih-drug-giveaway
# 20 December 2016, “Front page New York Times story explores Kite Pharma's profitable relationship with NIH regarding expensive cancer drug,” https://keionline.org/node/2703
3. § 5.54(b)(3): The disclosure must not be primarily in the commercial interest of the requester,
Knowledge Ecology International is a non-profit 501(c)(3) organization that does not have any commercial, trade, or profit interest in disclosure of the requested records.
Other
We request the identification of any withheld records with specificity, including descriptions of the withheld material in detail, the specific statutory exemption or basis for denial, the reasons that the statutory exemption or denial applies in this instance, and the interests that would be
foreseeably harmed by disclosure of the record.
We look forward to your acknowledgement of this request within 10 working days and your final determination within 20 working days. 5 U.S.C. § 552(a)(6)(A)(i). Please inform us of any unusual circumstances that would require you to extend the 20-day statutory time limit, “setting forth the unusual circumstances for such extension and the date on which a determination is expected to be dispatched.” 5 U.S.C. § 552(a)(6)(B)(i).
If possible, please conduct all correspondence by email and disclose all records via electronic copy. Please contact me if you have any questions about our request for.records or if you require additional information in support of our request for a fee waiver. Thank you in advance for your assistance.
Sincerely,
Andrew S. Goldman, Esq. Counsel, Policy and Legal Affairs Knowledge Ecology International +1,202.332,.2670
REL0000023706.0001.0002
andrew.goldman@keionline.org
REL0000023706.0001.0002
FROM: Andrew S. Goldman
c/o Knowledge Ecology International 1621 Connecticut Ave NW Suite 500 Washington, DC 20009 andrew.goldman@keionline.org
TO: FOIA Officer
FOIA Information Office
NIH Building 31, Room 5B35 j 31 Center Drive, MSC 2107 Hl Bethesda, MD 20892-2107 \ nihfoia@mail.nih.gov
DATE: February 21, 2018
RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40 U.S.C. § 559
Dear FOIA Officer:
Under the Freedom of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR Part 5), Knowledge Ecology International (KEI) reques
40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice from the Attorney General prior to the disposal of property, including patents, to private interests.
We are specifically interested in any documents which discuss the obligations of NIH, including any of its institutes and centers, with regard to seeking antitrust advice in the context of licensing federally-owned and/or federally-funded inventions.
Request for Full Waiver of Fees
Knowledge Ecology International (KE!) requests a full waiver of fees under the Freedom of Information Act and under 45 CFR Part 5.54.
KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable access to affordable medicines,
Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit
public interest groups, such as KEI, that seek to disseminate information that is in the public interest:
REL0000023706.0001.0002
“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies from using high fees to discourage certain types of requesters and requests,’ in a clear reference to requests from journalists, scholars and, most importantly for our purposes, nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86, 94 (D.C. Cir. 1986) (citations omitted).
Disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the Government.
1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or activities of the government.”
Disclosure of the requested records would shed light on the operations and activities of the federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations federal agencies have in seeking antitrust advice in the context of licensing federally-owned patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).
2. § 5.54(b)(2): Disclosure of the requested information would be likely to contribute significantly to public understanding of those operations or activities.
This factor is satisfied because the following criteria are met.
2.1. § 5.54(b)(2)(i): Disclosure of the requested records must be meaningfully informative about government operations or activities.
Disclosure of the requested records would be meaningfully informative about government operations and activities because it would reveal information that is not yet in the public domain. In particular it would provide information regarding whether the National Institutes of Health is abiding by the law when licensing medical technologies that have received federal funding. This information would be helpful in informing policy discussions regarding the public interest and the disposal of federal property.
As mentioned previously, the information is not publicly available and our attempt to seek that information from the NIH was denied.
“Legislative history suggests that information has more of this potential [to contribute to public understanding] to the degree that the information is new and supports public oversight of agency operations, including the effect of agency policy on public health.” McClellan Ecological Seepage Situation v. Carlucci , 835 F.2d 1282, 1286 (Sth. Cir. 1987) (citations omitted).
REL0000023706.0001.0002
2.1. § §.54(b)(2) (ii): The disclosure must contribute to fhe understanding of a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester.
The subject of the request concerns government operations and activities related to the antitrust ramifications of the licensing of federally-owned and federally-funded patents, including on medical technologies, and is intertwined with policy discussions affecting the prices of prescription drugs in the United States.
There is a broad audience of persons interested in the subject, including, inter alia, advocates for affordable access to medicines; doctors, nurses, and other medical providers: patients and caretakers; policy experts; and peaple who purchase insurance or other forms of medical care. Disclosure would contribute to the understanding of that broad audience of persons because it would provide context for the policies, positions, and decisions of the National Institutes of Health related to federal R&D funding and its approach to drug pricing issues.
KEI is an NGO that works on drug pricing and access to medicines, and has expertise in public health, drug pricing, and access to medicines.
KEI has the ability and intention to effectively convey the information contained in the requested records to the public. KE! operates a website (httos://keionline.org) which hosts an extensive archive that is regularly consulted by advocates, academics, and the press. KE] will review the requested records and produce a clear and concise analysis of those records. KEI will use social media and listservs to distribute that analysis to the broad audience of persons interested in the subject of the request.
KEI regularly publishes and analyzes records requested under the FOIA on its website, including recently on various government operations and activities at parts of DHHS:
# 28 February 2017, “CDC FOIA shows US, WHO opposed request to discuss UNSG's High-Level Panel on Access to Medicines Report at EB,” https://keionline.org/node/2727 # 18 October 2016, “Kite Pharma Uses CRADAs to Conduct Important Clinical Research on New Cancer Treatments,” https://keionline.org/node/2640
e 19 September 2016, “500+ Pages of Documents on NFL Attempts to Influence NIH Funding of Concussion Studies,” https://keionline.org/node/2630
@ 16 September 2016, “NIH Waivers for U.S. Manufacturing Requirements for Federally-Funded Drugs,” https://keionline.org/node/2629 Additionally, KEI works closely with journalists to provide analysis for documents requested by KEI under the FOIA.
KEI does not merely distribute documents to journalists, but provides in-depth analysis that later becomes the basis for stories:
REL0000023706.0001.0002
* 3 March 2017, Vidya Krishnan, “U.S. nixed India’s plea on reforms in medicine,” The Hindu, http:/Avwww.thehindu.com/news/national/us-nixed-indias-plea-on-reforms-in-medici ne/article17403526.ece
# 31 December 2016, Dan Vergano, “If Taxpayers Invent A Drug, Should The Government Just Give It Away?,” Buzzfeed News, hitps:/Awww.buzzfeed.com/danvergano/nih-drug-giveaway
* 20 December 2016, “Front page New York Times story explores Kite Pharma's profitable relationship with NIH regarding expensive cancer drug,” https://keionline.org/node/2703
3. § 5.54(b)(3): The disclosure must not be primarily in the commercial interest of the requester.
Knowledge Ecology International is a non-profit 501(c)(3) organization that does not have any commercial, trade, or profit interest in disclosure of the requested records.
Other
We request the identification of any withheld records with specificity, including descriptions of the withheld material in detail, the specific statutory exemption or basis for denial, the reasons that the statutory exemption or denial applies in this instance, and the interests that would be
foreseeably harmed by disclosure of the record.
We look forward to your acknowledgement of this request within 10 working days and your final determination within 20 working days. 5 U.S.C. § 552(a)(6)(A){i). Please inform us of any unusual circumstances that would require you to extend the 20-day statutory time limit, “setting forth the unusual circumstances for such extension and the date on which a determination is expected to be dispatched.” 5 U.S.C. § 552(a)(6)(B)(i).
If possible, please conduct all correspondence by email and disclose all records via electronic copy. Please contact me if you have any questions about our request for records or if you require additional information in support of our request for a fee waiver. Thank you in advance for your assistance.
Sincerely,
Andrew S. Goldman, Esq. Counsel, Policy and Legal Affairs Knowledge Ecology International +4.202.332.2670
REL0000023706.0001.0002
andrew.goldman@keionline.org
REL0000023706.0001.0002
FROM: Andrew S. Goldman
clo Knowledge Ecology International 1621 Connecticut Ave NW Suite 500 Washington, DC 20009 andrew.goldman@keionline.org
TO: FOIA Officer
FOIA Information Office
NIH Building 31, Room 5B35 31 Center Drive, MSC 2107 Bethesda, MD 20892-2107 nihfoia@mail.nih.gov
Qe 852
DATE: February 21, 2018
RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40 U.S.C. § 559
Dear FOIA Officer:
Under the Freedom of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR Part 5), Knowledge Ecology International (KE
40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice from the Attorney General prior to the disposal of property, including patents, to private interests.
We are specifically interested in any documents which discuss the obligations of NIH, including any of its institutes and centers, with regard to seeking antitrust advice in the context of licensing federally-owned and/or federally-funded inventions.
Request for Full Waiver of Fees
Knowledge Ecology International (KE!) requests a full waiver of fees under the Freedom of information Act and under 45 CFR Part 5.54.
KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable access to affordable medicines.
Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit
public interest groups, such as KEI, that seek to disseminate information that is in the public interest:
REL0000023706.0001.0002
“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies from using high fees to discourage certain types of requesters and requests,’ in a clear reference to requests from journalists, scholars and, most importantly for our purposes, nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86, 94 (D.C. Cir. 1986) (citations omitted).
Disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the Government.
1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or activities of the government.”
Disclosure of the requested records would shed light on the operations and activities of the federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations federal agencies have in seeking antitrust advice in the context of licensing federally-owned patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).
2. § §.54(b)(2): Disclosure of the requested information would be likely to contribute significantly to public understanding of those operations or activities.
This factor is satisfied because the following criteria are met.
2.1. § 5.54(b)(2)(i): Disclosure of the requested records must be meaningfully informative about government operations or activities.
Disclosure of the requested records would be meaningfully informative about government operations and activities because it would reveal information that is not yet in the public domain. In particular it would provide information regarding whether the National Institutes of Health is abiding by the law when licensing medical technologies that have received federal funding. This information would be helpful in informing policy discussions regarding the public interest and the disposal of federal property.
As mentioned previously, the information is not