KEI Comments on NIH Proposed Exclusive License to Iovance for Cancer Cell Therapy

On Friday March 12, 2021, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: Engineered Tumor Infiltrating Lymphocytes for Cancer Therapy” (86 FR 11548). The technology is to be licensed to Iovance Biotherapeutics, Inc. (Iovance), a company based in San Carlos, CA.

The inventions at hand concern tumor infiltrating lymphocyte (TIL) adoptive cell therapies, and the NIH has proposed granting Iovance a worldwide exclusive license to the technologies and conveys the rights to “develop, manufacture, distribute, sell, and use unselected whole autologous tumor infiltrating lymphocyte (TIL) adoptive cell therapy products for the treatment of metastatic melanoma, lung, breast, bladder, and HPV-positive cancers.”

Iovance has recently reported developments concerning its TIL therapy for metastatic melanoma, and if granted this license would garner Iovance further rights to technologies that cover an even broader library of indications. The published notice does not explain why an exclusive license for the new indications is necessary, if the company already has the resources to bring Lifileucel (LN-144) to market.

KEI has asked the NIH to seek the antitrust advice of the Attorney General in considering this licence, as required by 40 U.S.C. § 559, and has outlined protections and safeguards that the NIH should include – at a minimum – to ensure affordable patient access to any resultant treatment.

KEI’s full comments are available here: KEI-Comments-NIH-License-Iovance-12March2021