National Institutes of Health's Compliance With Exclusive Commercial Licensing Agreements and Royalty Payments

NIH licenses its inventions and intellectual property to private companies for further development and commercialization. Exclusive and nonexclusive patent licenses allow a company to develop and commercialize an NIH invention, under appropriate circumstances, for a specific use and according to applicable statutes and regulations. In return, when a licensee brings the product to market, NIH collects royalty payments, which are usually based on the product's sales. NIH then makes royalty distributions to NIH inventors and NIH institutes and centers.

Congress has expressed concerns over certain NIH royalty payments and, separately, private companies potentially profiting from NIH exclusive licenses for intellectual property that is invented by NIH. We will determine whether NIH: (1) monitored compliance with its exclusive commercial licensing agreements and (2) collected and distributed royalty payments in accordance with Federal requirements.

Announced or Revised	Agency	Title	Component	Report Number(s)	Expected Issue Date (FY)
February 2025	NIH	National Institutes of Health's Compliance With Exclusive Commercial Licensing Agreements and Royalty Payments	Office of Audit Services	OAS-25-01-012	2026