This was our comment on the license. See below for the June 8, 2017 NIH response, rejecting our requests for changes to the license to address pricing or transparency.
June 2, 2017
David A. Lambertson, Ph.D.,
Senior Licensing and Patenting Manager
NCI Technology Transfer Center
9609 Medical Center Drive
RM 1E530 MSC 9702
Bethesda, MD 20892-9702
Via Email: email@example.com.
Re: 82 FR 23013, Prospective Grant of Exclusive Patent License: The Development of Monospecific and Bispecific Antibodies to GPC3 for the Treatment of Human Liver Cancers
Knowledge Ecology International (KEI) is a non-profit organization representing the public’s interest in the management of taxpayer funded biomedical inventions.
We are writing to oppose any license to AbPro for the patents referenced above, unless the NIH obtains assurances that products using the inventions will be available to the public on reasonable terms, a condition of 35 USC 209 and 35 USC 201(f).
One condition on pricing that is essential is that the price in the United States be no higher than the companies charge in other high income countries. To this end, language that requires that the price in the United States be no more than the median price in the seven countries with the highest GDP and a per capita income of at least 50 percent of the US per capital income, can and should be inserted into the patent license. This is a very minimal protection for U.S. residents, who after, all, have paid for the patented invention.
Secondly, it is important to ensure that products are available at prices that are affordable in developing countries. To this end, we suggest the following language in the license agreement:
A product based upon the patented inventions shall be available at prices that are affordable in countries with per capita incomes of 30 percent or less of the United States, and if the U.S. Department of Health and Human Services finds otherwise, it reserves the right to grant non-exclusive to generic manufacturers.
The federal register notice for the proposed license is here:
KEI also requests that the license require AbPro to provide the NIH annual reports on the R&D outlays related to the patents, including expenditures on each specific clinical trial, and annual reports providing the revenues from sales, the number of units sold, and prices per unit, and the royalties paid to the United States government, in each country where the products are commercialized, and that these reports be made public.
Knowledge Ecology International
On June 8, 2017, the NIH rejected our requests. A copy of the NIH letter is available here.