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Mandatory Patent Waivers: A Debate Gone Viral

Published onJul 26, 2021
Mandatory Patent Waivers: A Debate Gone Viral

A conversation regarding patent rights has entered the international pharmaceutical stage as the World Trade Organization has debated requiring a temporary waiver of patent protections granted to companies for their COVID-19 vaccines. Patent waivers temporarily suspend protection for a creation, allowing others the opportunity to utilize the patented subject matter without fear of “being sanctioned or fined.” The federal government holds the right to administer legal protection to unique inventions that are a “new and useful process, machine, manufacture, or composition of matter.” It has retained this right since the drafting of the Constitution.

For 235 years, this has encouraged people in the United States to create, improve, develop, and innovate, as they do not have to fear that others may capitalize unfairly on their original work. For business organizations, from technology startups to medical research labs and consumer products corporations, this is especially pertinent, as it promotes companies working together to “co-develop new advancements using each other’s technologies” and information, as the patent law provides each company with assurance that their innovations will remain free from infringement, even when shared. While the intellectual property system imputes many legal and business benefits upon companies and consumers, concerns have arisen regarding to allowance of companies to obtain patent protection for their innovations. For example, critics note that patent rights can enable companies and developers to retain monopolies over their creations. An example of such power is in the biotechnology industry where “each advance builds on the last one and everyone relies on patented research tools, patent holders may be stymieing progress.”

Vaccines, in particular, are one category of creations that are eligible for patent protection. On December 11, 2020, nearly one year after the Center for Disease Control (“CDC”) announced the presence of COVID-19 in the United States, the FDA authorized the first vaccine for domestic, emergency use. Now, eight months later, pharmaceutical innovation has spurred the development of a variety of vaccine options, including those from Moderna, Johnson & Johnson, and pending vaccines from AstraZeneca and Novavax. With the creation of multiple vaccine brands and the increasing availability of vaccinations across the world, particularly in what the World Trade Organization considers to be more developed countries, concerns have arisen regarding the distribution, development, and availability of vaccines in developing nations.

The Washington Post explained that a mandatory COVID-19 vaccine patent waiver “would effectively exempt countries from enforcing intellectual property rights for [COVID] vaccines and related diagnostics. That would mean that any country or company with the recipe for a vaccine could produce it.” Proponents of the waiver largely focus on health policy arguments. For example, they argue that implementing the vaccine waiver could expedite the vaccine distribution process in developing countries, removing the patent protection so that “generic or other manufacturers [could] make more vaccines.”

Opponents of the mandatory vaccine waiver, on the other hand, believe that removing these patent protections is unnecessary and potentially counterproductive. Seemingly, these patents merely protect the vaccine formula, yet the vaccine production is a severely nuanced process. The raw materials to produce the COVID-19 vaccine are limited in supply, so by waiving patent protections, more companies could produce vaccines. This could potentially result in a severe shortage of materials, thus limiting the distribution gains proponents of the waiver were hoping to create. Rachel Silverman, a policy fellow at the Center for Global Development, says that vaccine patents can be necessary for pharmaceutical companies since protection of their innovation enables them “to make a profit … [a]nd that profit is what’s going to incentivize research and development.”

As the COVID cases decrease in countries around the world, the debate surrounding the waivers continues, as people consider where the line between protecting innovation and the public good falls.

Carli Berasi is a second-year law student at Wake Forest University School of Law. Carli graduated from UNC-Chapel Hill in 2018 with a major in Biology and minors in Chemistry and Neuroscience. Prior to starting law school, Carli worked for a law firm in Washington, D.C.

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