In 2016, the NIH signed a CRADA with NantBioScience, a company lead by Patrick Soon-Shiong, MD. to develop “Further Develop Recombinant NK Cells and Monoclonal Antibodies as Monotherapies and Combination Cancer Immunotherapies. ”
On July 17, 2017, the NIH asked for public comment on an exclusive license with NantBioScience. These were the KEI comments. We sent a letter on July 22, 2017, asking 8 questions and proposing certain terms for the license. The NIH did not answer any of our questions, and sent this generic response on July 28, 2017.
July 22, 2017
Sabarni K. Chatterjee, Ph.D., M.B.A.,
Senior Licensing and Patenting Manager,
NCI Technology Transfer Center,
9609 Medical Center Drive,
RM 1E530 MSC 9702,
Bethesda, MD 20892-9702 (for business mail),
Rockville, MD 20850-9702
Telephone: (240) 276-5530
Facsimile: (240) 276-5504
Via Email: email@example.com.
Re: Request for Information and Comments on Prospective Grant of Exclusive Patent License: Development, Commercial Application and Use of Fulvestrant in Combination Therapy for the Treatment of Cancers, to NantBioScience, Inc.
Dear Dr. Chatterjee,
I am writing to request information and to provide comments regarding the proposed exclusive license noticed in the Federal Register on July 17, 2017, document citation: 82 FR 32712, regarding the Use of Fulvestrant in Combination Therapy for the Treatment of Cancers.
My requests for information are as follows:
Is the patent application public, and if not, can you share it?
How many companies have expressed interest in licensing the patents?
How much money did the federal government spend on the development of this technology?
What is the term of the proposed license?
What is the royalty obligation?
How much money has NantBioScience invested in the technology?
Did the NIH propose any provisions in the license that would protect US residents from paying high prices on products, or ensure access in developing countries, and if so, can you share the proposals and the response by the NantBioScience, Inc?
Please provide a copy of all CRADA agreements between the NIH and NantBioScience, and any other firm where Patrick Soon-Shiong, MD, is a principal.
KEI proposes the NIH include the following measures in the license to address pricing and availability of products based upon the patented invention:
1. The lessee is expected to either (a) register and make available the products based upon the invention in developing countries at an affordable price and with sufficient quantities, or (b) offer sufficient technology transfer and rights in intellectual property for third parties to do so.
2. The lessee agrees to make products based upon the invention available to the public in the United States at prices [that are reasonable, and in any case] no higher than the median price charged in the seven countries with the largest GDP, that have per capita incomes of at least half that of the United States.
KEI proposes the NIH include the following measures in the license to address transparency.
1. The lessee will agree to provide a report annually that will be made available to the public without redaction that provides the following information.
a. Expenditures on specific clinical trials,
b. Average prices and revenues in every national market.
c. All government subsidies for the development of the product,
d. All outlays on marketing the product, by national market.
2. An un-redacted copy of the license agreement and any associated CRADA.
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