(Update: The NIH provided a response to our comments on August 1, 2020)
July 10, 2018
Sury Vepa, Ph.D., J.D.,
Senior Licensing and Patenting Manager
National Center for Advancing Translational Sciences
National Institutes of Health
Email sury.vepa@nih.gov
Re: Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer to Apexx Oncology. Notice for comment published in 83 FR 29562.
https://www.federalregister.gov/documents/2018/06/25/2018-13486/prospective-grant-of-exclusive-patent-license-mutant-idh1-inhibitors-useful-for-treating-cancer
Dear Dr. Vepa,
Knowledge Ecology International (KEI) offers the following comments on the, “Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer,” to Apexx Oncology, which was noticed in the Federal Register (83 FR 29562).
As far as the public can determine, Apexx Oncology is a secretive startup company. The only information we could find using a Google search about the company was a contest for a logo of the company. There is no record of a registered trademark for Apexx Oncology with the USPTO. No web page has been located. It is not obvious if Apexx Oncology is a new name for GeneXion Oncology (as indicated today), or a new company entirely, and in any case, there is next to nothing generally known about the company under either name.
When the NIH proposes giving an exclusive license on a patent to a company for which almost nothing is known, it should provide at the very least some basic information about the company. In seeking to respond to the first FR notice in this case, we had asked if GeneXion was owned by a company in Switzerland, but the NIH declined to answer. We don’t know who is on the board of directors, who the key staff are or if another company owns this company. We would like to know if any current or former NIH employees or contractors are part of the company.
We also seek to learn — why this company was selected in the first place? Do they have people who have worked on this particular technology, or have some special expertise? And since the patents are fairly new, did the NIH have no reasonable prospects for a license to an entity with more resources and a stronger track record than a company that seems to barely exist?
Here are some general provisions that we recommend for an exclusive license by the NIH.
1. No discrimination against US residents in pricing
Prices in the U.S. for any drug, vaccine, medical device or other health technology using the invention should not be 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.
2. Developing countries
The license should not be exclusive for countries with a per capita income that is less than 30 percent of the US.
3. Transparency
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 that uses the invention, 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.
4. Reduce term of exclusivity when revenues are large
The exclusivity of the license in the U.S. should be reduced by one year for every $500 million in revenue equivalents, earned after the first $1 billion, where revenue equivalent is defined as global cumulative sales plus market entry rewards as well as government grants or tax credits, for the product or products using the invention.
Sincerely,
James Love
Knowledge Ecology International
james.love@keionline.org
https://keionline.org