Newswise — A recent study conducted by Bentley University's Center for Integration of Science and Industry has revealed some intriguing findings regarding the National Institutes of Health (NIH) funding and its connection to patents that grant manufacturers market exclusivity. According to the study, the NIH allocated a significant amount of $950 million for basic or applied research linked to patents that ultimately provided manufacturers with exclusive rights in the market. Surprisingly, this amount represents less than 1% (0.59%) of the total $164 billion funding from the NIH for research that contributed to the approval of these specific products.
The research, titled "NIH funding for patents that contribute to market exclusivity of drugs approved 2010–2019 and the public interest protections of Bayh-Dole," was published in PLOS ONE. This groundbreaking study is the first of its kind, comprehensively examining the NIH funding associated with basic and applied research related to new drug approvals and the proportion of such research that led to patents granting manufacturers market exclusivity.
These patents play a crucial role as they afford manufacturers exclusive production and pricing authority, effectively granting them a monopoly. However, it's worth noting that these patents are also subject to the public interest provisions of the Bayh-Dole Act, which aims to promote the practical application of the research, its availability at reasonable terms, ensure a return on public sector investments, and stimulate broader economic growth. In essence, this study sheds light on the intricate relationship between NIH funding, patenting, and its implications for public interest protections in the pharmaceutical industry.
In this research, the focus was on 313 drugs that received approval from the FDA between 2010 and 2019. The researchers used data from the DrugPatentWatch database, which tracks patents cited as barriers to generic competition and those involved in litigation. The findings of the study revealed that prior to the first approval of these drugs, the National Institutes of Health (NIH) provided a substantial amount of $164 billion in project (grant) funding for basic or applied research related to these drugs.
Surprisingly, only a tiny fraction of this funding, specifically 0.59% (equivalent to $0.95 out of $164 billion), was associated with patents listed in the DrugPatentWatch database. When considering specific categories, only 0.38% ($0.52 out of $135) of the NIH funding for basic research on the drug target and 1.5% ($0.44 out of $28.6) of NIH funding for applied research on the drugs themselves were linked to patents in DrugPatentWatch.
Furthermore, the study revealed that while NIH-funded research was indeed related to each of the 313 drugs or their targets, only a small portion, precisely 34 drugs (10.9%), had patents connected to NIH funding. Moreover, a mere 29 drugs (9.3%) had patents arising from research specifically linked to the drug or its target.
These findings highlight the relatively low proportion of NIH-funded research leading to patents associated with these drugs and their targets.
According to Fred Ledley, Director of the Center for Integration of Science and Industry and senior author of this study, the National Institutes of Health (NIH) funding plays a crucial role in supporting approximately half of the research and development expenses leading to the creation of new drugs. However, the study's recent findings indicate that only a small portion of the taxpayer's contribution to new drug approvals is subjected to laws designed to safeguard the public interest and ensure a fair balance between the interests of the public and commercial manufacturers.
This research is part of a series of studies conducted by the Center for Integration of Science and Industry, aiming to characterize the NIH's contribution to new drug approvals and the government's role as a primary investor in pharmaceutical innovation. These studies reveal that the scale of NIH investment in new drug approvals is comparable to the investments made by the industry. Remarkably, over 80% of NIH funding is directed towards basic science, while less than 5% is allocated to phased clinical development. This pattern contributes to the relatively low number of patents associated with NIH-funded research since patents require evidence of utility and the ability to achieve practical applications.
The lead authors of this study were Dr. Fred Ledley and Dr. Ekaterina Galkina-Cleary.
DrugPatentWatch is a registered trademark of thinkBiotech LLC. The DrugPatentWatch database used in this study was obtained from DrugPatentWatch.com.
The research was supported by grants from the Institute for New Economic Thinking and the National Biomedical Research Foundation.
The Center for Integration of Science and Industry at Bentley University focuses on advancing the translation of scientific discoveries to create public value. It serves as an interdisciplinary platform for scholarship, encompassing basic science, data analytics, business, and public policy. For more information, please visit www.bentley.edu/sciindustry, and you can follow them on Twitter @sciindustry and LinkedIn.
Bentley University stands as one of the nation's leading business schools, fostering a lifelong-learning community that nurtures successful leaders who strive to bring positive change to the business world. By blending business with the arts and sciences and providing a personalized approach to education, Bentley equips students with critical thinking and practical skills, preparing them for rewarding and impactful careers. Established in 1917, the university enrolls over 4,000 undergraduate, graduate, and PhD students and is located on a 163-acre campus in Waltham, Massachusetts, just 10 miles west of Boston. For more information, please visit bentley.edu. You can also follow them on Twitter @BentleyU using #BentleyUResearch.
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