NIH’s New Policy for Licensing Inventions
(Thursday, May 23, 2024) The scientists at the National Institutes of Health (NIH) US, the world’s largest government-funded research center, invent hundreds of new patented medical technologies each year that are licensed to industry partners for commercial development. NIH is proposing a change in its licensing terms to include additional commitments from the licensees for post-approval commercial activity for these inventions. With an annual budget of almost $5 billion for intramural research, NIH is the world’s largest government-funded research institution. Each year, NIH files about 200 new patents for inventions by its scientists many of which are licensed to industry for commercial development. The NIH license deals bring in millions in royalties to the NIH. However, as a government-funded institution, NIH also sees itself as responsible for ensuring that its inventions are accessible to all populations irrespective of their ethnic distribution, financial situation, or geographic location. NIH has hence proposed a new clause in its standard licensing agreement whereby a licensee would commit to an “Access Plan” for the licensed NIH invention outlining steps that the licensee intends to take to promote patient access to those products from the perspective of product affordability, availability, acceptability, and sustainability. “NIH would employ a tiered approach, where licenses granted for late-stage inventions that are closer to market launch would include more specific, tailored access-oriented provisions, while licenses granted for early-stage inventions would be more flexible to reflect the higher uncertainty associated with technologies that lead to drugs, biologics, vaccines, or devices.”. NIH acknowledged that the final policy should be reasonable so that it does not obstruct the commercial development of the invention. A non-confidential version of the Access Plan would be made public by NIH. The licensees would commit to providing periodic progress updates to NIH on the commercial development and any updates on the Access Plan. While in principle the proposal looks fine, there will be a few obvious challenges in implementing this policy. The biggest challenge would be agreement on the stage of development of a technology. NIH expects the licensees to agree on the stage of development of the invention with the late-stage invention coming with stricter access commitments than an early-stage invention. Licensee would likely find it hard to accept NIH interpretation of the stage of development so an independent assessment criteria would need to be established. This policy is still at the public comment stage. No dates yet on when the final policy may be announced and implemented. ![]() AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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