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