The Biden administration has indicated support for the temporary waiver of patent protections related to COVID-19 vaccine development.

In the United States, there are three COVID-19 vaccines that received emergency use authorization from the U.S. Food and Drug Administration. Millions of Americans are receiving vaccine dosages daily to inch the country closer toward herd immunity. Mass vaccination and achieving herd immunity would limit the ability of the virus to spread and develop further mutations that may evade current vaccines.

Global herd immunity can be achieved through mass vaccinations worldwide. However, most of the vaccine supply is with certain nations because those governments placed advance orders with and/or invested in vaccine innovators. As a result, countries of the developing world, and even many first world countries, have fewer available doses for distribution.

The World Trade Organization (WTO) is considering a proposal, advanced by India and South Africa in October 2020, to waive intellectual property rights (IPR) related to the development of the vaccines against COVID-19 for the duration of the pandemic. The proposed waiver defers enforcement of certain sections of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), namely Section 1 related to copyrights, Section 4 covering industrial designs, Section 5 on patent rights and Section 7 regarding the protection of undisclosed information. The proposed waiver, to be reviewed annually, would remain in place until mass vaccination and immunity is achieved globally. At the most basic level, the TRIPS Agreement establishes minimum standards of protection, regulation and enforcement of IPR among WTO member nations. The proposed waiver temporarily suspends IPR enforcement provisions to allow developing nations to practice the IPR in developing generic versions of the COVID-19 vaccines. Such a waiver would be akin to the Doha Declaration on TRIPS and Public Health, adopted November 14, 2001, at the height of the HIV/AIDS pandemic, which reaffirmed the ability of member nations to issue compulsory licenses for medicinal patents during a public health crisis. The approximately 160 member nations that make up the WTO must reach a consensus for any waiver of the provisions of the TRIPS Agreement.

The Biden administration has indicated support for the temporary waiver of patent protections related to COVID-19 vaccine development.

Those who support the proposed waiver of the TRIPS Agreement argue that waiving such patent rights would allow nations that currently have little or no access to vaccines to benefit from this knowledge and use it to establish vaccine production, which would speed up vaccine availability to move us all toward achieving global herd immunity.

On the other side, in a May 5, 2021, press release, the Pharmaceutical Research and Manufacturers of America (PhRMA) expressed opposition to this proposal, indicating that the waiver of patent protections:

[W]ill undermine our global response to the pandemic and compromise safety. and sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines. and does nothing to address the real challenges to getting more shots in arms, including last-mile distribution and limited availability of raw materials. the real challenges. this empty promise ignores.

Other questions remain, including whether the waiver of patent protections related to the development of COVID-19 vaccines will indeed lead to faster production of vaccine doses, especially if there is a lack of infrastructure in developing nations to produce the vaccine, and if will it actually harm and stifle future innovation because valuable vaccine information may be shared with international rivals and competitors without patent protection.

A perspective as to the United States is that a waiver of patent rights may present a number of issues. Absent an act of Congress, for instance, that claims of infringement of patent rights related to the development of COVID-19 vaccines do not fall under the provisions of 35 U.S.C. § 271, or that such claims fall under 35 U.S.C. § 287(c), which exempts medical practitioners from infringement liability of medical process patents, any administrative action that waives patent protection as to a U.S. patent is tantamount to a taking under the Takings Clause of the Fifth Amendment of the Constitution. The federal government would be taking the private rights held by the patentees for public use in distributing the COVID-19 vaccine knowledge to other nations to develop their own vaccine supply. In this situation, the patentees may have recourse to obtain just compensation for the federal government’s use of the property, namely the patent rights. Another related question is is an administrative action that allows for the waiver of patent rights outside the United States would also be considered a taking under the Takings Clause.

It is a wait-and-see situation as to whether a temporary waiver of COVID-19 vaccine-related IPR will be implemented, as well as the conditions of such a waiver, including whether there will be any compensation to patent holders as a result of the waiver (or whether patent holders will be arguing in litigation in various jurisdictions that property rights were taken through such a waiver). Moreover, the implications of the waiver may reach further beyond the current pandemic and impact patent owners and patents beyond those involving COVID-19 vaccines. Thus, we are continuing to follow developments as to COVID-19 vaccine-related IPR and will offer analysis in additional Alerts.

For More Information

If you have any questions about this Alert, please contact Thomas J. Kowalski, Deborah L. Lu, Ph.D., Heidi Lunasin, Brandon A. Chan, Ph.D., any of the attorneys in our Life Sciences and Medical Technologies Industry Group, any of the attorneys in our Intellectual Property Practice Group or the attorney in the firm with whom you are regularly in contact.