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Using Bayh-Dole Act March-In Rights to Lower US Drug Prices.

Lisa Larrimore Ouellette¹, Bhaven N Sampat²

¹Stanford Law School, Stanford, California.

JAMA Health Forum

|November 1, 2024

Summary

This summary is machine-generated.

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Government march-in rights under the Bayh-Dole Act could enable generic competition for a limited number of taxpayer-funded drugs. However, their overall impact on increasing generic drug access is expected to be minimal.

Area of Science:

Health Policy
Intellectual Property Law
Pharmaceutical Economics

Background:

The Bayh-Dole Act allows government "march-in rights" to license patents on federally funded inventions.
Recent proposals suggest using these rights for taxpayer-funded drugs to foster generic competition and reduce costs.
Concerns exist regarding the potential impact on pharmaceutical innovation and the feasibility of this approach.

Purpose of the Study:

To assess the potential of government march-in rights to overcome patent barriers for generic drug entry.
To quantify the prevalence of patents eligible for march-in rights among drugs listed in the FDA Orange Book.

Main Methods:

A cross-sectional study analyzed government funding data for patents in the FDA Orange Book (1985-2023).

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Data sources were combined to identify patents resulting from federal funding, distinguishing them from intramural research patents.

Included were new molecular entities (NMEs), all NDAs with Orange Book patents, and those with unexpired patents.

Main Results:

Only a small percentage of drugs had patents exclusively stemming from federal funding subject to the Bayh-Dole Act.
For NMEs (1985-2022), 2% had solely Bayh-Dole patents.
For all drugs with patents (1985-2023), only 1% had solely Bayh-Dole patents.

Conclusions:

While Bayh-Dole march-in rights could theoretically address patent barriers for a few drugs, their practical effect on generic competition is limited.
The low prevalence of exclusively federally funded patents suggests a constrained scope for march-in rights in promoting generic drug access.