On October 26, 2019, Knowledge Ecology International (KEI), Union for Affordable Cancer Treatment (UACT), Public Citizen, Social Security Works (SSW), LWC Health, Ruth Lopert, Manon Ress, and Terry Love filed an administrative appeal with the National Institutes of Health (NIH). The appeal was filed in regards to the decision by the NIH to grant an exclusive license to Intima Bioscience, Inc. for genetically-modified lymphocytes for cancer therapy. The licensed inventions 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 appellants submitted comments to the comment period noticed in the Federal Register (84 FR 45503) for the then-proposed exclusive license, “Prospective Grant of an Exclusive Patent License: Genetically-Modified Lymphocytes for Cancer Therapy.”
The NIH’s response to our comments was wholly insufficient, and our appeal addresses the following questions:
- Did the NIH properly evaluate the necessity of granting an exclusive license in the subject inventions, as it is required to do under 35 U.S.C. § 209(a)(1)?
- Assuming that the NIH can establish that an exclusive license was necessary in this case, did the NIH meet its statutory responsibility to limit the scope of rights to that which is “reasonably necessary” to induce the investment required to bring the invention to practical application, as required by 35 U.S.C. § 209(a)(2)?
- Has the NIH withheld relevant, nonconfidential information about the license from the public, impeding its right to comment under 35 U.S.C. § 209(e)?
- Did the NIH request the antitrust advice of the Attorney General, pursuant to 40 U.S.C. § 559?
- Has the NIH implemented the objectives in the Public Health Service (PHS) Technology Transfer Policy Manual regarding promoting access in developing countries?
For a PDF of the administrative appeal filed please see: Joint_Administrative_Appeal_NIH_Exclusive_License_Intima_Bioscience_26Oct2019