NIH is issuing an Intramural Research Program (IRP) Access Planning Policy, to expand equitable patient access to products that emerge from NIH-owned patents. Under this Policy, organizations applying to NIH for certain commercial patent licenses are required to submit Access Plans to NIH outlining steps they intend to take to promote patient access to those licensed products. Once approved by NIH, Access Plans will be incorporated into the licenses granted by NIH. This Policy will apply to license applications and licenses granted by the NIH IRP for patents wholly owned by the government. Overall, the Policy emphasizes the importance of proactive planning for patient access in the distribution and commercialization process for NIH-owned inventions.
Scope
Under the IRP Access Planning Policy, an organization applying to NIH for a commercial patent license is required to submit an Access Plan—as part of the plan required by 35 U.S.C. 209 and 37 CFR part 404.5—if the applicant is seeking a license that would authorize the commercialization of drugs, biologics (including vaccines), or devices for the prevention, diagnosis, or treatment of human disease. The Policy applies to commercial patent licenses (hereinafter referred to as licenses) granted by the NIH IRP, for patents wholly owned by the U.S. government, e.g., inventions made by investigators in the NIH IRP. The Policy applies to exclusive, co-exclusive, partially exclusive, and non-exclusive license applications and licenses.
The IRP Access Planning Policy does not apply to licenses and applications that are unrelated to the development of drugs, biologics (including vaccines), or devices. For example, NIH does not require Access Plans for license applications that are limited to the sale of reagents for research purposes only (with no clinical or therapeutic scope). The IRP Access Planning Policy also does not apply to patents owned by third parties (i.e., parties external to the U.S. government), and it does not apply to patents that are developed under NIH funding agreements and owned by NIH grantees or contractors.
Phase-In
The IRP Access Planning Policy applies to license applications submitted to NIH on or after June 1, 2025.
Requirements
Organizations applying to NIH for licenses within the scope of this Policy are required to:
- Submit an Access Plan as part of their license application, for NIH review and approval;
- Commit to provide updates on progress and, as appropriate, reassess the approved Access Plan as product development progresses; and
- Submit a non-confidential version of their Access Plan within 3 months after FDA approval of the licensed product (or a foreign equivalent) that NIH may publish or otherwise make available to third parties.
An Access Plan refers to a license applicant or licensee’s strategy to support broad access to a licensed product for the U.S. population, and it can include, as applicable, strategies through the lens of promoting equity for underserved communities in the U.S. and for populations in low- and lower-middle-income countries, as defined using the World Bank classification system. Access plans shall include, but not be limited to: a brief description of the licensed product(s); the anticipated patient population(s); other products, tools, facilities, or unique resources that would be necessary for use of the product(s); and strategies to promote patient access across criteria of affordability, availability, acceptability, and sustainability, to the extent such access can be advanced on terms that are commercially reasonable.
NIH will not consider license applications that fall within the scope of the IRP Access Planning Policy unless those applications include an Access Plan. The agency will not grant licenses within the scope of the Policy without an NIH approved Access Plan. Once approved by NIH, these Access Plans will be incorporated into licenses granted by NIH as part of the licensee’s development plan.
Waivers
NIH may waive the requirements of the IRP Access Planning Policy upon a showing by a licensee or license applicant that access planning, in whole or in part, would not be commercially feasible and would hinder the overall benefit of access to the licensed product. The agency anticipates waivers would be very rare and only appropriate in exceptional circumstances.
Detailed background and implementation guidance are included in the full announcement.
National Institutes of Health
NOT-OD-25-062
January 10, 2025
