On September 13, 2019, Knowledge Ecology International (KEI), Union for Affordable Cancer Treatment (UACT), Public Citizen (PC), Social Security Works (SSW), LWC Health, Ruth Lopert, Manon Ress, and Terry Love submitted comments regarding the “Prospective Grant of an Exclusive Patent License: Genetically-Modified Lymphocytes for Cancer Therapy” (84 FR 45503). The proposed exclusive license is to be granted to Intima Biosciences, headquarted, but not registered in New York. The inventions to be licensed expand upon existing gene therapies, which have mostly been limited to hematological malignancies, to treat solid tumors in diseases such as breast cancer, gastrointestinal epithelial cancer, and lung cancer. The decision to grant an exclusive license and the duration of exclusivity are thus matters of great importance to public health outcomes and should not be treated lightly. As always, any license the NIH negotiates must comply with the criteria set forth at 35 U.S.C. § 209 and 37 C.F.R. § 404.7.
The joint comments filed outline four grounds upon which we object to the prospective license:
- The NIH has not demonstrated that it properly analyzed whether an exclusive license is “a reasonable and necessary incentive” under 35 U.S.C. § 209(a)(1);
- We object to any license that is broader than necessary to induce the investment needed to bring the technology to market, in violation of 35 U.S.C. § 209(a)(2);
- The NIH has not been fully transparent about the license, impeding the public’s right to comment under 35 U.S.C. § 209(e), because it has refused to disclose the government funding that supported the inventions and identify the principals of the licensee – matters that are both relevant and nonconfidential; and
- The NIH apparently has not sought the antitrust advice of the U.S. Attorney General regarding the license, as required by 40 U.S.C. § 559.
Please see below for PDFs of the comments submitted, as well as the accompanying attachments: