Today, KEI submitted comments to the Notice published in the Federal Register on October 5, 2016, entitled “Prospective Grant of Exclusive Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the Treatment of CD70 Expressing Cancers.” KEI’s comments addressed issues with the NIH’s processes for granting exclusive licenses, and transparency in those licenses, resulting data, trials, pricing, and revenue.
Regarding the proposed license to Kite Pharma, KEI opposes the grant of an exclusive license unless:
- The NIH conducts sufficient analysis and limits the terms and scope of the license as required under 37 CFR 404.7 (a)(1)(iiiii);
- The license contains sufficient safeguards regarding affordability and reasonable pricing of the products, users and/or services developed under the patent licenses;
- The license places restrictions on charging US residents higher prices than the median prices charged in countries with the seven largest GDP and per capita incomes of 50 percent or more than the United States per capita income;
- In any case, and in addition to any other considerations of what constitutes a reasonable price, the license holder is expected to limit the cost of the products or services to U.S. residents to no more than the lesser of either (a) the average annual per capita income in the United States, or (b) the amount of the average annual per capita income in the United States, per quality adjusted life year (QALY) benefit of the product.
- The exclusive rights will extend to five years from the first sale of a product receiving approval by the U.S. FDA, or until the license holder recovers at least $1 billion in cumulative global sales from the product, whichever is shorter, and thereafter, the license will become non-exclusive. After the first five years of exclusivity, the NIH can extend the exclusivity by another 3 years, upon a showing that such extension is reasonable in light of the risk adjusted R&D costs to bring the product market, and the net revenues from sales.
- The license requires products and/or services are affordable in developing countries, and explicitly allows the NIH to grant licenses to the patents to the Medicines Patent Pool (MPP) for use in developing countries? and
- The license requires transparent reporting on drug development costs, royalties and revenues.
Zack Struver also submitted KEI’s additional comments noting the relationship between the NIH National Cancer Institute and Kite Pharma, and seeking information on the analysis carried out and data provided to establish that an exclusive license was necessary to bring this technology to market and that Kite Pharma was the appropriate means to do so.
The full texts of KEI’s comments are available below.