Below are the comments filed by Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) regarding a prospective grant of an exclusive license of NIH-owned patents to the California-based company Midissia Therapeutics. The prospective exclusive license is for the development and commercialization of cancer immunotherapy. The original Federal Register notice is here.
The NIH describes the geographic area as “worldwide” and the field of use as:
“development and commercialization of Ad-HER2 vaccines as a therapeutic against HER2-positive cancers as covered within the scope of the Licensed Patent Rights, excluding uses in combination with vectors/adjuvants, checkpoint inhibitors or other immune modulators.”
According to the NIH notice:
This technology describes a recombinant adenoviral vector that expresses the extracellular (EC) and transmembrane (TM) domains of the human HER2 protein and is designed to induce a polyclonal anti-tumor response. HER2 is a member of the epidermal growth factor family and is overexpressed in subsets of breast, ovarian, gastric, colorectal, pancreatic and endometrial cancers. This vaccine encodes for the entire EC and TM domains of human HER2neu and is specifically contained within a recombinant adenoviral vector that has the knob of Adenovirus 5 and substituted fiber of Adenovirus 35. The substitution of the knob of Adenovirus 35 whose receptor is CD46 allows for efficient and maximal transduction of human dendritic and hematopoietic cells.
These are the second set of comments KEI files on a prospective license of NIH-owned inventions to the same company, Midissia Therapeutics. The first set of comments, filed on April 8, 2016, are available here.
Below are the comments that KEI and UACT filed on the 13th.
August 13, 2018
Ricquita Pollard, Technology Transfer Manager,
NCI Technology Transfer Center,
Via Email: email@example.com.
Re: Prospective Grant of an Exclusive Patent License to Midissia Therapeutics for the Development and Commercialization of Cancer Immunotherapy, per 83 FR 35665
Dear Ricquita Pollard:
The following are comments from Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT), on the proposed exclusive license for patents noticed in the Federal Register for a license to Midissia Therapeutics located in San Francisco, California.
1. No discrimination against US residents in pricing
We ask that the NIH include language in the proposed exclusive license to ensure that the prices in the U.S. for any drug, vaccine, medical device or other health technology using the inventions are not 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.
We consider this a modest request to protect U.S. residents, who paid for the R&D that created the licensed inventions.
2. Reduce term of exclusivity when revenues are large
In addition to an external reference pricing test, we propose that the exclusivity of the license in the U.S. should be reduced when the global cumulative sales from products or services using the inventions exceed certain benchmarks.
Given the modest cost of acquiring an NIH patented invention, the amount of money the developer needs in sales to justify additional investments in R&D is reduced, as compared to cases where a company developes or acquires the technology from non government sources.
This request is consistent with the statutory requirements of 35 USC 209, which requires that “the proposed scope of exclusivity is not greater than reasonably necessary to provide the incentive for bringing the invention to practical application.”
One possible implementation of revenue benchmarks is as follows: exclusivity will 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. However, the NIH could choose different benchmarks, so long as the limits on exclusivity address the requirements of 35 USC 209, that the incentive is “not greater than reasonably necessary.”
3. Developing countries
We are concerned that several NIH funded inventions are not accessible in developing countries, due to prices that are high and not affordable in markets where per capita incomes are significantly lower than the United States. For this reason, we ask the NIH to limit the exclusivity in the license to countries that have per capita incomes that are at least 30 percent of the United States.
We also ask the NIH to reach out to the Medicines Patent Pool (MPP), in order to enter into an agreement that gives the MPP an option to negotiate non-exclusive open licenses for the inventions in developing countries.
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 inventions, 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. Reporting on actual R&D outlays is important for determining if the NIH is meeting the requirements of 35 USC 209, that “the proposed scope of exclusivity is not greater than reasonably necessary to provide the incentive for bringing the invention to practical application.” Specifically, having data on actual R&D outlays on each clinical trial used to obtain FDA approval provides evidence that is highly relevant to estimating the risk adjusted costs of bringing NIH licensed inventions to market.
Knowledge Ecology International
Manon Anne Ress
Union for Affordable Cancer Treatment