Federal government-interest patent disclosures for recent top-selling drugs

Long, Genia

doi:10.1080/13696998.2019.1631832

Cited by 5 publications

(5 citation statements)

References 10 publications

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“…Of these, 295 (95%) had at least one patent in the Orange Book and 27 had a patent in the Orange Book that was associated with the research identified in this study (Table 8). This fraction is similar to the fraction of drugs with NIH-funded patents in the Orange Book identified using a variety of other methods (Li et al, 2017;Long, 2019;Sampat, 2006;Sampat & Lichtenberg, 2011;Stevens et al, 2011).…”

Section: Nih-funded Patents Associated With Approved Drugssupporting

confidence: 54%

Government as the First Investor in Biopharmaceutical Innovation: Evidence From New Drug Approvals 2010–2019

Cleary

Jackson

Ledley

2020

INET Working Paper Series

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The discovery and development of new medicines classically involves a linear process of basic biomedical research to uncover potential targets for drug action, followed by applied, or translational, research to identify candidate products and establish their effectiveness and safety. This Working Paper describes the public sector contribution to that process by tracing funding from the National Institutes of Health (NIH) related to published research on each of the 356 new drugs approved by the U.S. Food and Drug Administration from 2010-2019 as well as research on their 219 biological targets. Specifically, we describe the timelines of clinical development for these products and proxy measures of their importance, including designations as first-in- class or expedited approvals. We model the maturation of basic research on the biological targets to determine the initiation and established points of this research and demonstrate that none of these products were approved before this enabling research passed the established point. This body of essential research comprised 2 million publications, of which 424 thousand were supported by 515 thousand Funding Years of NIH Project support totaling $195 billion. Research on the 356 drugs comprised 244 thousand publications, of which 39 thousand were supported by 64 thousand Funding Years of NIH Project support totaling $36 billion. Overall, NIH funding contributed to research associated with every new drug approved from 2010-2019, totaling $230 billion. This funding supported investigator-initiated Research Projects, Cooperative Agreements for government-led research on topics of particular importance, as well as Research Program Projects and Centers and training to support the research infrastructure. This NIH funding also produced 22 thousand patents, which provided marketing exclusivity for 27 (8.6%) of the drugs approved 2010-2019. These data demonstrate the essential role of public sector-funded basic research in drug discovery and development, as well as the scale and character of this funding. It also demonstrates the limited mechanisms available for recognizing the value created by these early investments and ensuring appropriate public returns. This analysis demonstrates the importance of sustained public investment in basic biomedical science as well as the need for policy innovations that fully realize the value of public sector investments in pharmaceutical innovation that ensure that these investments yield meaningful improvements in health.

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Section: Nih-funded Patents Associated With Approved Drugssupporting

confidence: 54%

Government as the First Investor in Biopharmaceutical Innovation: Evidence From New Drug Approvals 2010–2019

Cleary

Jackson

Ledley

2020

INET Working Paper Series

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“…A 2019 study found that 75% of all U.S. Food and Drug Administration (FDA) approved drugs—excluding new vaccines, biologic medicines, and gene therapies—between January 2008 and December 2017 were fully funded and researched by private companies [ 6 ]. The results were comparable with those of an earlier study that found only 9% of new drugs approved between 1988 and 2005 had either a government interest statement disclosure or a government agency first-listed as a patent assignee [ 7 ]. Finally, research published in 2011 by Rohrbaugh et al found that the Bayh–Dole Act (Public Law 96–517) had been responsible for the transfer of federally funded research and intellectual property that had led directly to 153 FDA-approved drugs that were discovered, at least in part, by public-sector research from a total of 1541 approved therapies [ 8 ], less than 10% of the total.…”

Section: Introductionsupporting

confidence: 83%

“…For example, for the 12 approved products in our analysis that appear in the FDA Orange Book, the NIH-supported patents we identified accounted for only 5 of the 41 total patents listed as protecting these products. Furthermore, a 2019 analysis of 197 top-selling therapies found that only 10.2% had at least one patent recorded in the Orange Book with a government interest statement or U.S. government agency assignee [ 7 ].…”

Section: Discussionmentioning

confidence: 99%

The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals

Schulthess¹,

Bowen

Popovian

et al. 2022

Ther Innov Regul Sci

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Objectives There remains ongoing debate regarding the relative efficacy of public (NIH) and private sector funding in bringing biopharmaceutical innovations to market. This paper investigates the significance of each party’s level of funding for obtaining Food and Drug Administration (FDA) authorization. Methods A cohort of research projects linked to 23,230 National Institute of Health grants awarded in the year 2000 was audited to account for patents, where the project led to a product in clinical development and potentially FDA approval. A total of 8126 associated patents led to the identification of 41 therapies that registered clinical trials; 18 of these therapies received FDA approved. Results NIH funding for the 18 FDA-approved therapies totaled $0.670 billion, whereas private sector funding (excluding post-approval funding) totaled $44.3 billion. A logistic regression relating the levels of public and private funding to the probability of FDA approval indicates a positive and significant relationship between private sector funding and the likelihood of FDA approval (p ≤ 0.0004). The relationship between public funding and the likelihood of FDA approval is found to be negative and not statistically significant. Conclusion Our study results underscore that the development of basic discoveries requires substantial additional investments, partnerships, and the shouldering of financial risk by the private sector if therapies are to materialize as FDA-approved medicine. Our finding of a potentially negative relationship between public funding and the likelihood that a therapy receives FDA approval requires additional study.

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“…For example, Sampat and Lichtenberg examined “public sector” or “academic” patents related to drugs approved 1988–2005, finding that 9% of new drugs were associated with a public sector patent [ 7 ]. Similarly, Long reported that 8.6% of drugs had at least one patent with a “government-interest” statement [ 38 ] and Stevens et al estimated that from 1990–2007, 9.3% of new drugs were first patented in public sector research institutions [ 39 ].…”

Section: Discussionmentioning

confidence: 99%

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

Ledley

Cleary

2023

PLoS ONE

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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.

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Federal government-interest patent disclosures for recent top-selling drugs

Cited by 5 publications

References 10 publications

Government as the First Investor in Biopharmaceutical Innovation: Evidence From New Drug Approvals 2010–2019

Government as the First Investor in Biopharmaceutical Innovation: Evidence From New Drug Approvals 2010–2019

The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals

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

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