Under the IRP Access Planning Policy, an organization applying to NIH for a commercial patent license is required to submit an Access Plan:

• 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 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 licenses

The IRP Access Planning Policy does not apply to licenses that are unrelated to the development of drugs, biologics (including vaccines), or devices. For example, NIH does not require Access Plans for licenses 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.