Sapna Kumar

Document Type

Article

Disciplines

Intellectual Property Law

Abstract

Wealthy countries with major pharmaceutical industries have historically supported strong patent rights and opposed temporarily abrogating them—even to save lives. However, as drug shortages have become commonplace due to COVID-19, governments have begun reassessing their views. The European Union and various countries have issued new policies and passed legislation facilitating their ability to provide drugs to their citizens for the duration of the pandemic. They have signaled a willingness to do so through “compulsory licensing,” in which the government issues a license to a third party to produce a patented invention without the patent holder’s permission and pays the patent holder compensation. By contrast, the United States has opposed compulsory licensing of drugs for several decades. Although the Biden administration supports lower-income countries seeking to license patented drugs, it remains opposed to the practice to provide drugs for its own citizens, even during drug shortages. This Article provides an overview of compulsory licensing and examines the U.S. government’s inconsistent views regarding its use. It further discusses how other high-income countries have facilitated compulsory licensing during the pandemic. It then proposes legislative and contractual solutions for addressing future pandemic-related drug shortages in the United States. This includes expanding third-party manufacturers’ ability to petition for a compulsory license and requiring companies to provide an adequate supply of patented drugs that were developed with government funds, or else be required to license out their technology and know-how to willing third-party manufacturers.

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