Knowledge Ecology International (KEI) offered the following comments to the National Institutes of Health (NIH) concerning the “Prospective Grant of an Exclusive Patent License: Antibody-Drug Conjugates (ADCs) for Targeting CD56-Positive Tumors” (89 FR 40495) to McSAF Inside Oncology SAS (McSAF).
One issue raised by KEI was that McSAF is based in Tours, France and per the Bayh-Dole Act, one of the requirements of granting an exclusive license is that licensees “substantially” manufacture the invention in the United States. KEI asked the NIH in our comments whether McSAF has requested a waiver of the domestic manufacturing requirement. The NIH should disclose in its notices whether the companies seeking exclusive licenses have requested waivers of this requirement. Also, particularly as McSAF is a foreign-based company, the NIH should particularly take care to include license terms that protect US patients from paying higher prices than other high income countries.
KEI’s full comments are available here: KEI-Comments-NIH-License-McSAF-28May2024