(More on government funded inventions here. Other KEI comments on NIH licenses are found here.)
On May 31, 2017, we sent the following comment to the NIH regarding the proposed exclusive license on certain patents for cancer treatment to GeneXion Oncology.
May 31, 2017
Sury Vepa, Ph.D., J.D.,
Senior Licensing and Patenting Manager
National Center for Advancing Translational Sciences’
NIH, 9800 Medical Center Drive, Rockville, MD 20850,
Phone: 301-217-9197,
Fax: 301-217-5736,
email sury.vepa@nih.gov.
RE: Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors
Dear Dr. Vepa,
1. We propose there be language in the license to ensure that prices for products are “reasonable” — the standard in 35 U.S.C. § 201(f) — and do not discriminate against U.S. residents.
One very basic protection for US. residents is to ensure that prices are not higher than the median price of other high income industrialized countries.
For example, the license could say:
The [agency] will normally expect the licensee to make products available to the public in the United States at prices 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.
We may propose additional pricing safeguards later, including to address access in developing countries.
2. We would like to learn more about the technology being licensed. Could we set up a call with myself, Diane Singhroy and persons at the NIH who can answer questions about the technology and the NIH role in its funding?
James Love
KEI
This was followed up with a second May 31, 2017 email:
From: Jamie Love
May 31, 2017
to sury.vepa, Diane, Claire, Manon, Andrew
Also, is this the company seeking the license?
https://genexioncloud-web.sharepoint.com/Pages/aboutus.aspx
On July 18, 2017, we received the following reply from the NIH.
From Vepa, Sury (NIH/NCATS)
Jul 18, 2017
to Jamie, Diane, Claire, Manon, Andrew
Dear Mr. Love,
Thank you very much for your comments and suggestions in response to the Notice of Prospective Grant of Exclusive Patent License published by NCATS on June 1, 2017. (https://www.federalregister.gov/documents/2017/06/01/2017-11241/prospective-grant-of-exclusive-patent-license-mutant-idh1-inhibitors-useful-for-treating-cancer).
We appreciate your suggestions and below are our responses to the comments that you made and the clarifications that you sought:
Comments: 1. We propose there be language in the license to ensure that prices for products are “reasonable” — the standard in 35 U.S.C. § 201(f) — and do not discriminate against U.S. residents.
One very basic protection for US. residents is to ensure that prices are not higher than the median price of other high income industrialized countries.
For example, the license could say:
The [agency] will normally expect the licensee to make products available to the public in the United States at prices 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.
We may propose additional pricing safeguards later, including to address access in developing countries.
Response: “With respect to your recommendations regarding pricing of products made by the licensee, NIH has not included pricing provisions in its licenses for many years, for reasons that have been extensively discussed in the literature, which is readily and publicly available.”
Comment: 2. We would like to learn more about the technology being licensed. Could we set up a call with myself, Diane Singhroy and persons at the NIH who can answer questions about the technology and the NIH role in its funding?
Response: “The technology is thoroughly described in the published scientific articles and patent application, which can be found by following these links: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4922311/ and http://www.freepatentsonline.com/y2014/0296241.html. I do not have any information on funding.”
Comment: 3. Also, is this the company seeking the license?
https://genexioncloud-web.sharepoint.com/Pages/aboutus.aspx
Response: As stated in the notice, the intent is to grant the license to GeneXion Oncology, Inc., located in New York, NY.
Once again, we appreciate your comments.
Best regards,
Sury
Sury Vepa
On July 31, 2017, KEI wrote sent Sury Vepa this email:
Dear Sury Vepa,
Is GeneXion Oncology, Inc., located in New York, NY, a subsidiary of a company located in Switzerland? This is what the following URL suggested, but I wanted to confirm.
https://genexioncloud-web.sharepoint.com/Pages/aboutus.aspx
Original Federal Register Notice:
https://s3.amazonaws.com/public-inspection.federalregister.gov/2017-11241.pdf
https://www.gpo.gov/fdsys/pkg/FR-2017-06-01/pdf/2017-11349.pdf