NIH funding for patents that contribute to market exclusivity of drugs approved 2010–2019 and the public interest protections of Bayh-Dole

Abstract

Previous studies have shown that National Institutes of Health (NIH) funding contributed >$187 billion for basic or applied research related to the 356 drugs approved 2010–2019. This analysis asks how much of this funding led to patents cited as providing market exclusivity, patents that would be subject to the provisions of the Bayh-Dole Act that promote and protect the public interest. The method involves identifying published research in PubMed related to the approved drugs (applied research) or their targets (basic research). NIH-funded projects (grants) funding these publications and patents arising from these projects were both identified in RePORT. Patents cited as providing market exclusivity were identified in DrugPatentWatch (which incorporates FDA Orange Book). NIH funded basic or applied research related to all 313 FDA-approved drugs 2010–2019 with at least one patent in DrugPatentWatch. This research comprised 350 thousand publications (9% applied research; 91% basic research) supported by 341 thousand fiscal years (project years) of NIH funding and $164 billion in NIH project year costs (17% applied research; 83% basic research). These NIH projects also produced 22,360 patents, 119 of which were cited in DrugPatentWatch as protecting 34/313 drugs. These patents were associated with 769 project years of NIH funding (0.23% total) and project year costs of $0.95 billion (0.59% total). Overall, only 1.5% of total NIH funding for applied research and 0.38% of total NIH funding for basic research was associated with patents in DrugPatentWatch. This analysis shows that very little of the NIH funding for research that contributes to new drug approvals leads to patents that provide market exclusivity and are subject to the provisions of the Bayh-Dole Act that promote the public interest in practical applications of the research, reasonable use and pricing, and a return on this public sector investment. This suggests that the Bayh-Dole Act is limited in its ability to protect the public interest in the pharmaceutical innovations driven by NIH-funded research.

Considering Returns on Federal Investment in the Negotiated “Maximum Fair Price” of Drugs Under the Inflation Reduction Act: an Analysis

“…Research is also made available to industry through education and workforce training that enables them to bring research knowledge or skills to industry and by faculty who converse, collaborate, or consult with companies(Link, Siegel and Bozeman 2007). While academic institutions may exclusively license inventions made with government funding to companies, only a small fraction of government-funded research results in patents subject to such licenses(Ledley and Cleary 2023).…”