(More on government funded inventions here. Other KEI comments on NIH licenses are found here.)
On June 5, 2017, KEI provided comments to the NIH/NCI, on a prospective grant of an exclusive license to PathoVax, relating to HPV vaccines. On July 10, 2017, Kevin Chang responded (Copy of NIH response here), indicating the NIH will “consider your comments.”
June 5, 2017
Kevin W. Chang, Ph.D.
Senior Technology Transfer Manager
NCI Technology Transfer Center
9609 Medical Center Drive,
RM 1E530 MSC 9702
Bethesda, MD 20892-9702
Via Email: email@example.com.
RE: Prospective Grant of Exclusive Patent License: Chimeric L1/L2 Protein and Virus-Like Particles Based Human Papillomavirus Vaccines
We are writing in response to the notice in 82 FR 23012, regarding the possible grant of an exclusive license to PathoVax, LLC located in Baltimore, MD, for patents relating to Chimeric L1/L2 Protein and Virus-Like Particles Based Human Papillomavirus Vaccines.
It is our understanding that PathoVax is a very small start-up, that has been funded by the NIH and a handful of investors. We would like to know the extent of the NIH funding of the firm, prior to the license, and also the extent to which the US government will be funding the clinical trials related to the licensed patents.
We are particularly interested in this human papillomavirus (HPV) vaccine, because the costs of the existing vaccines have been high, and access has been limited, both in the United States and elsewhere.
In the past, exclusive licenses of federally funded patented related to the HPV vaccines have created unfortunate barriers to the development of vaccines that protect against the widest range of HPV strains.
According the NIH  , HPVs causes several types of cancer, including:
Cervical cancer: Virtually all cases of cervical cancer are caused by HPV, and just two HPV types, 16 and 18, are responsible for about 70% of all cases (7, 8).
Anal cancer: About 95% of anal cancers are caused by HPV. Most of these are caused by HPV type 16.
Oropharyngeal cancers (cancers of the middle part of the throat, including the soft palate, the base of the tongue, and the tonsils): About 70% of oropharyngeal cancers are caused by HPV. In the United States, more than half of cancers diagnosed in the oropharynx are linked to HPV type 16 (9).
Rarer cancers: HPV causes about 65% of vaginal cancers, 50% of vulvar cancers, and 35% of penile cancers (10). Most of these are caused by HPV type 16.
High-risk HPV types cause approximately 5% of all cancers worldwide (11). In the United States, high-risk HPV types cause approximately 3% of all cancer cases among women and 2% of all cancer cases among men (12).
The vaccine should be available and affordable to all.
Question: Has the NIH done an analysis to see of a policy of non-exclusive licensing would better serve the goals of developing vaccines with the widest range of protection for HPV strains?
As regards pricing and access, it is our view that the NIH is required under 35 USC 209 and 35 USC 201(f) to ensure that any holder of an exclusive license will make the vaccine available to the public on reasonable terms.
One condition on pricing that is essential is that the price of the vaccine 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 of the vaccine in the United States be no more than the median price of the vaccine 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 the vaccine is available at prices that are affordable in developing countries. To this end, we suggest the following language in the license agreement:
A vaccine 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 vaccine manufacturers.
We requests that the license require PathoVax 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.
James Love, Knowledge Ecology International
Manon Ress, PhD. Union for Affordable Cancer Treatment