Section 1498 in Pharmaceutical Patent Litigation: The Overlooked But Stronger Sister to March-In Rights

Abstract

Few statutory provisions have generated as much controversy in the pharmaceutical space as the federal government’s retained authority to override patent rights in the public interest. While patent exclusivity is often described as absolute, Congress has long preserved mechanisms that allow the government intervention in certain limited circumstances. Two such tools, Bayh-Dole’s march-in rights and 28 U.S.C. § 1498, sit at the intersection of innovation policy, public funding, and drug pricing. Each was enacted for different historical reasons and each reflects a distinct theory of how patent rights should operate when federal interests are implicated. Yet both now occupy center stage in debates over affordability, access to medicines, and the role of government in pharmaceutical patent enforcement.