KEI August 18, 2023 Comments to the NIH licensing practices highlight failure to enforce Section 209 restrictions on exclusivity, transparency concerns, and KEI’s past engagement

As a part of the workshop hosted by the National Institutes of Health (NIH) on July 31, 2023 on the topic of, “Transforming Discoveries Into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer,” the NIH solicited public comments. In addition to our comments filed on August 11th on the shrinking public comment period, on August 18, 2023, KEI submitted two sets of comments to the NIH concerning:

  • the NIH’s lack of enforcement of the statutory requirement to restrict the scope of exclusive rights in a patent license as set out in 35 USC § 209(a)(1-2); and
  • KEI engagement with the NIH and the need for increased transparency and public safeguards in NIH licenses.

Under 35 USC § 209, the NIH is allowed to grant exclusive rights to a federally-owned invention only when it is a “reasonable and necessary incentive”, and is obligated to reduce the scope of exclusive rights to that which is “reasonably necessary.” The NIH has shown that as a practice, the agency does not enforce this statutory requirement. KEI’s comments on Section 209 are available here: KEI-Comments-NIH-Section-209-Issues-18August2023

KEI’s second set of comments filed on August 18th outline KEI’s experiences engaging with the NIH on its exclusive licensing practices and public notices, highlighting the lack of transparency by the NIH and the need for the inclusion of public safeguards in NIH licenses (and KEI’s proposals for such safeguards). KEI’s comments are available here: KEI-Comments-NIH-Engagement-Transparency-Exclusive-Licenses-18Aug2023