NIH New Patent Licensing Policy

The National Institutes of Health recently instituted a new patent licensing policy aimed at expanding access to new drugs and medical devices. The policy applies to license applications submitted on or after October 1, 2025. Under this new policy, organizations are required to include an Access Plan outlining the steps and strategies they intend to take to support broad access to the product that will be commercialized from the license.

The NIH provided a list of approximately 40 example strategies. The list provided is non-limiting, but it seems to illustrate the ways the NIH intends to expand patient access. The list provided high level examples along with more detailed examples. Some of the high-level examples include partnering with public health, non-profit, or patient advocacy organizations, addressing accessibility as a design objective, committing to sublicense relevant intellectual property and know-how, and promoting equitable access and affordability in product deployment. Some of the more detailed examples that fell within these high-level examples include: selling products to organizations that treat underserved populations (e.g., Federally Qualified Health Centers), committing to develop products that can be best delivered in settings that expand access (e.g., developing products that can be delivered in home settings, if that is what patients need), committing to license all intellectual property and know-how needed to make a product if the licensee exits a market and/or committing to surviving rights/technology transfer in case of license termination, committing to keep prices in the U.S. equal to those in other developed countries, and not raising prices at rates outpacing inflation.

The Access Plans will be incorporated into the licenses granted by NIH. In addition to submitting the initial Access Plan, organizations are required to provide updates on progress, reassesses the approved Access Plan as product development progresses, and submit a non-confidential version of the Access Plan within 3 months of FDA approval of the licensed product.

The requirements to provide updates and reassess the Access Plan will allow the NIH to work closely with licensees to monitor progress and allow the licensees to update their Access Plans as the licensed products move closer to market.

Publication of the non-confidential versions of the Access Plans may boost public confidence in NIH's patient access efforts. Some critics raised concerns that publication of Access Plans may create undue scrutiny of plans, including the potential of companies to harass competitors by arguing their access plans are inadequate or that NIH should revoke the license due to noncompliance. However, the policy makes clear that if compliance concerns emerge, NIH will first notify the licensee and work with them to take appropriate action, likely through, but not limited to, amending Access Plans or negotiating other modifications with NIH. It is only if compliance issues remain unaddressed that NIH will consider further enforcement action such as terminating the license.

Waivers to this policy are available if the access planning requirement creates a substantial risk that product development will fail altogether, such as when the market for the product is very small (e.g., population affected by a rare disease) or where there is heightened scientific uncertainty involved with further R&D on the patented technology. Waivers may also be available if the access planning requirement will negatively impact the long-term viability of the licensed product in the market, such as when there is a risk of later drug shortages or inadequate product quality.

This new policy is a continuation of efforts to reduce healthcare costs, this time through management of NIH's patent portfolio. TC's IP group regularly advises clients on how to navigate Intellectual Property licensing issues. Please consult with a member of TC's IP group if you have any Intellectual Property licensing questions.

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