November 10, 2021
Andrew Burke, Ph.D.
Senior Technology Transfer Manager,
NCI Technology Transfer Center,
Email: andy.burke@nih.gov.
Re: Prospective Grant of an Exclusive Patent License: Development and Commercialization of CRISPR-Engineered T Cell Therapies for the Treatment of Cancer to Neogene Therapeutics
First, we would like to register a complaint about the failure by the NIH to answer several questions about the license.
NEED FOR MORE TRANSPARENCY IN THE LICENSING OF NIH OWNED INVENTIONS
An email response by Dr. Andrew Burke on November 3 included several non-responsive answers about the license.
- When asked if “the NIH sought advice from the Attorney General (as is required under 40 USC § 559) to determine if the ‘disposal to a private interest would tend to create or maintain a situation inconsistent with antitrust law’?”, there was no answer at all, even though a simple yes or no was all that was required.
- KEI asked “What analysis did the NIH undertake, if any, in order to conclude that exclusivity is a reasonable and necessary incentive?” Dr. Burke gave the following non-answer:
“With respect to 37 CFR 404.7(a)(1)(ii)(B), the Agency’s determination cannot be made until the public notice period required under 37 CFR 404.7(a)(1)(i) has expired and all timely submitted written objections been considered.”
By the time the NIH publishes a notice in the Federal Register, some analysis must have been done to justify the grant of an exclusive license, given the restrictions in 35 USC 209.
- When KEI ask “Is the NIH in any concurrent negotiations to waive the domestic manufacturing requirement (35 USC 204) for this license?”, Dr. Burke replied “I cannot confirm or deny any confidential discussions.”
Why is this considered confidential? In the past the NIH has shared all sorts of information about the license proposals. The purpose of the public notice requirement in the statute is undermined if the public is kept in the dark over basic details of the licensing.
- When KEI asked, “Have you received any other applications for the license at this stage?” Dr. Burke replied:
“As the Federal Register notice makes clear, the release of any information concerning license applications submitted in response to the notice ‘will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.’”
Knowing if there is any interest in the proposed technology is not something that the NIH should treat as a trade secret, and it goes to the leverage the NIH should have in setting the license terms or even the decision to have an exclusive license.
This is a company founded in the Netherlands that is seeking a monopoly on US government funded inventions. What is the actual rationale for the NIH refusing to confirm or deny if there are discussions on the question of a waiver of the U.S manufacturing requirements in the Bayh-Dole Act?
- When KEI asked “Is the term in the proposed licenses to be life of patent or less than life of patent?” Dr. Burke answered, “The term of the proposed license is subject to negotiation and is not known at this time.”
That’s not a candid response and Dr. Burke knows it.
COMMENTS ON THE PROPOSED LICENSE
- This is a large and complicated patent portfolio.
There are 133 US and foreign patents and patent applications in Group A, and 24 in Group B.
- Neogene Therapeutics was founded in the Netherlands.
The Federal Register says the firm is “headquartered in Santa Monica.” The company web page says it was founded in the Netherlands, which is where it also has operations. Calling every firm with a U.S. subsidiary or office a U.S. firm provides a misleading impression of the nationality of the firms seeking exclusive licenses on U.S. funded inventions. This is how the company described itself in one of its press releases:
Neogene, a Two River company, was founded in 2018 by a team of world-class cell therapy experts to advance the development of neo-antigen T cell therapies. Carsten Linnemann, Ph.D., Chief Executive Officer of Neogene, and Ton Schumacher, Ph.D., Principal Investigator at the Netherlands Cancer Institute, Oncode Institute and 2020 recipient of the Dutch Research Council’s Stevin Award co-founded the company with individual investments by cell therapy industry veterans Arie Belldegrun, M.D. FACS, founder of Kite Pharma, Inc. and Co-Founder and Executive Chairman of Allogene Therapeutics, Inc. and David Chang, M.D., Ph.D., Co-Founder, President and Chief Executive Officer of Allogene. Dr. Linnemann and Dr. Schumacher previously co-founded T-Cell Factory B.V., a company acquired by Kite Pharma in 2015.
- People living in developing countries will be harmed by worldwide exclusivity.
The inventions include several patents or patent applications in developing countries and several recent PCT applications that have yet to enter the national phase (see below), so it is not yet clear where patent protection will extend, other than that the NIH has proposed “worldwide” as the geographic area.
As you know, KEI is opposed to exclusive licensing of treatments for cancer or other severe diseases in developing countries, where exclusivity predictably leads to high prices and inequality of access. If exclusive rights extend to lower income countries and the inventions actually reach the market, the products or services are highly likely to be so expensive that people will die for lack of access. Someone at the NIH might want to take responsibility for this.
The NIH seems determined under Francis Collins leadership to ignore the provisions in the United States Public Health Service Technology Transfer Policy Manual, Chapter No. 300, PHS Licensing Policy, which states: “PHS seeks to promote commercial development of inventions in a way that provides broad accessibility for developing countries.” It’s not complicated. If the NIH includes developing countries in the licensed area, with no pricing or affordability safeguards, and the exclusivity prevents the supply of affordable alternatives, the NIH practice will be appallingly contrary to the PHS stated policy, as well as paragraph 4 of the WTO Doha Declaration on TRIPS and Public health, and dozens of UN and WHO resolutions on human rights and access to medical inventions. And it’s not as if the leaders of the NIH technology transfer offices don’t know this.
- The NIH should include conditions to provide transparency of the markets for the products using the patented inventions, consistent with the agreement supported by the United States government at the World Health Assembly and codified in WHA72.8.
The WHO resolution on transparency WHA72.8 is titled “Improving the transparency of markets for medicines, vaccines, and other health products.1” The lead U.S. negotiator on the resolution was Colin Mciff, then and currently the Deputy Director of the Office of Global Affairs at the U.S. Department of Health and Human Services.
These are among the measures the United States agreed are needed:
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1. URGES Member States in accordance with their national and regional legal frameworks and contexts:
(1) to take appropriate measures to publicly share information on the net prices2 of health products;
(2) to take the necessary steps, as appropriate, to support dissemination and enhanced availability of, and access to, aggregated results data and, if already publicly available or voluntarily provided, costs from human subject clinical trials regardless of outcomes or whether the results will support an application for marketing approval, while ensuring patient confidentiality;
(3) to work collaboratively to improve the reporting of information by suppliers on registered health products, such as reports on sales revenues, prices, units sold, marketing costs, and subsidies and incentives;
Fn 1. Including but not limited to data on: availability, especially in small markets; units sold and patients reached in different markets; and the medical benefits and added therapeutic value of these products.
Fn 2 For the purposes of this resolution, “net price,” “effective price,” “net transaction price” or “manufacturer selling price” are the amount received by manufacturers after subtraction of all rebates, discounts, and other incentives.
- US residents should not pay more than residents in other high income countries.
These are US government owned patents and patent applications — more than a hundred of them.
We ask that the NIH include language in the proposed exclusive license to ensure that the prices in the U.S. for any drug, vaccine, medical device or other health technology using the inventions are not higher than the median price charged in the seven countries with the largest gross domestic product (GDP), that also have a per capita income of at least 50 percent of the United States, as measured by the World Bank Atlas Method. We consider this a minimalist request to protect U.S. residents, who paid for the R&D that created the licensed inventions.
- The United States should require the licensee to provide transfer of the manufacturing know-how to companies not infringing on the patents.
The NIH needs to ensure that monopolies for biologic products and gene and cell therapies do not extend forever.
Sincerely,
James Love
Director, Knowledge Ecology International
Member, Union for Affordable Cancer Treatment
james.love@keionline.org
ANNEX: PCT applications for which the national phase is not known.
Group A
115. PCT Patent Application No. PCT/US2021/017794, filed February 12, 2021 entitled “HLA Class I-Restricted T Cell Receptors Against RAS with G12D Mutation” [HHS Ref. No. E-031-2020-0-PCT-02];
118. PCT Patent Application No. PCT/US2021/017852, filed February 12, 2021 entitled “HLA Class I-Restricted T Cell Receptors Against RAS with G12V Mutation” [HHS Ref. No. E-074-2020-0-PCT-02];
121. PCT Patent Application No. PCT/US2021/019775, filed February 26, 2021 entitled “HLA Class II-Restricted T Cell Receptors Against RAS with G12V Mutation” [HHS Ref. No. E-088-2020-0-PCT-02];
124. PCT Patent Application No. PCT/US2021/041375, filed July 13, 2021 entitled “HLA Class II-Restricted DRB T Cell Receptors Against RAS with G12D Mutation” [HHS Ref. No. E-165-2020-0-PCT-02];
126. PCT Patent Application No. PCT/US2021/041737, filed July 15, 2021 entitled “HLA Class II-Restricted DRB1*01:01 T Cell Receptors Against RAS with G12V Mutation” [HHS Ref. No. E-172-2020-0-PCT-02];
128. PCT Patent Application No. PCT/US2021/053060, filed October 1, 2021 entitled “HLA Class II-Restricted DQ T Cell Receptors Against RAS with G13D Mutation” [HHS Ref. No. E-189-2020-0-PCT-02];
Group B
23. PCT Patent Application No. PCT/US2021/048786, filed September 2, 2021 entitled “T Cell Receptors Recognizing R273C or Y220C Mutation in P53” [HHS Reference No. E-173-2020-0-PCT-02]; and