COGR Testimony at NIH Hearings on March-in Rights

The document details the National Institutes of Health’s (NIH) response to public and Congressional requests that the government exercise its march-in rights under the Bayh-Dole Act regarding patents covering Norvir® (ritonavir), an HIV/AIDS medication manufactured by Abbott Laboratories. Concerns prompting these requests focused on the high price of Norvir® and its impact on patient access. The Bayh-Dole Act permits federal agencies, in certain limited circumstances, to require licensing of federally funded inventions to ensure public access, address unmet health or safety needs, or correct failures to commercialize. After a thorough review of the statutory framework, background of the invention, public comments—including a formal meeting and written submissions from a broad range of stakeholders—and the commercial availability of Norvir®, the NIH concluded that Abbott met the Act’s requirements by achieving practical application and satisfying health and safety needs. The NIH reasoned that Norvir® has been widely available since 1996 and there was no evidence that a march-in would better serve health or safety needs.

Furthermore, the NIH emphasized that drug pricing, while an important issue, falls outside the intended scope of march-in rights and is a complex matter more appropriately addressed by Congress. The agency also acknowledged that any potential anti-competitive conduct would fall under the purview of the Federal Trade Commission, not NIH. Ultimately, the NIH ruled that there was insufficient basis under the Bayh-Dole Act to initiate a march-in proceeding in the case of Norvir®, reinforcing a cautious and deliberate interpretation of its statutory authority while recognizing broader policy concerns inherent in drug pricing and market competition.