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Here’s a summary of a new article that used DrugPatentWatch data:
NIH Funding for Patents That Contribute to Market Exclusivity of Drugs Approved 2010–2019 and the Public Interest Protections of Bayh-Dole examines the relationship between National Institutes of Health (NIH) funding and patents that provide market exclusivity for drugs approved from 2010 to 2019. The study investigates the extent to which NIH-funded research led to patents cited as providing market exclusivity and subject to the Bayh-Dole Act’s provisions promoting the public interest.
The study found that NIH funding supported research related to all 313 FDA-approved drugs from 2010 to 2019 that had at least one patent in DrugPatentWatch. This research encompassed 350 thousand publications, with 9% being applied research and 91% basic research, supported by $164 billion in NIH project costs, with 17% for applied research and 83% for basic research.
Out of the 22,360 patents produced by these NIH projects, 119 were cited in DrugPatentWatch as protecting 34 out of the 313 drugs approved. These patents were associated with 769 project years of NIH funding (0.23% of total) and project year costs of $0.95 billion (0.59% of total). In conclusion, only a small fraction of NIH funding for research that contributes to new drug approvals leads to patents providing market exclusivity subject to the Bayh-Dole Act, suggesting limitations in the act’s ability to protect the public interest in pharmaceutical innovations driven by NIH-funded research.