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Apr 14, 2021 9:31:54 AM

Patents and COVID-19 Vaccines

by Matt Osenga

COVID-19 vaccination is now well underway in the United States, with large percentages of the population having received a dose of the vaccine and many people now being fully vaccinated. The vaccines that have been approved for Emergency Use Authorization were developed by Moderna, Pfizer, and more recently, Johnson & Johnson. Other companies, including AstraZeneca, are conducting clinical trials and should receive emergency approval in the near future.

COVID-19 vaccines and patentsThe development and approval of these vaccines within a year of the emergence of the global pandemic seems to have been a success in the US. Operation Warp Speed worked more quickly than most experts believed possible to get large numbers of people vaccinated and to get the US economy open again.

But this does not tell the whole story. While many of the richer countries, including the US, the EU, the UK, and others are in the midst of vaccination campaigns, many developing nations have not yet begun vaccinating their citizens. In order to fully eliminate the pandemic, experts suggest that 70% of people will need to be vaccinated worldwide. This raises the question of how to get the vaccines to poorer nations and how to administer them to those nations’ citizens.

Intellectual property rights in the worldwide vaccination effort

Several developing nations and organizations such as Doctors Without Borders have requested that the World Trade Organization suspend intellectual property rights surrounding the COVID-19 vaccines, at least until the pandemic is over. They argue that forcing the pharmaceutical companies and researchers to share information about the development and manufacture of the vaccine would permit the poorer countries to begin to make and distribute the vaccines themselves.

The pharmaceutical companies and wealthier countries have responded that there is a lot more to the development, manufacture, and distribution of the vaccine than simply following a set of instructions. If many of the steps are not followed precisely or not completed in the correct type of facilities with proper equipment, the resulting vaccines will not be effective. Until recently, these arguments of the wealthier nations had been prevailing. After facing political pressure, however, the Biden Administration is now committed to studying the option of suspending intellectual property, and specifically patent, rights covering the vaccines.

Alternatives to suspending patent rights for COVID-19 vaccines

Former FDA commissioner Scott Gottlieb recently wrote an op-ed in the Wall Street Journal where he argued against the suspension of patent rights. He argued that manufacturing the vaccines is complex and requires certain materials that are in very high demand. By permitting other manufacturers to make the vaccines regardless of the patent rights would simply increase the demand for these raw materials and would actually decrease the overall supply of the vaccines. Instead, the US government can help by increasing manufacturing capacity for the raw materials and the specialized equipment needed for the vaccines. The government could then work on donations of high quality vaccines to the developing nations.

A different proposal involves the intellectual property rights of Moderna specifically. Because the US government was involved in the research that led to the Moderna vaccine, some have suggested that the government should require Moderna to increase the global supply of its vaccine as part of its license deal with the company.

The Moderna vaccine was developed using new spike protein technology that was under development for a number of years prior to the COVID-19 pandemic. The technology was conceived by scientists at the National Institute of Health (NIH) and the University of Texas, which gives the US government ownership rights in the patented technology. The technology is considered to be a true breakthrough that will have applications in many other vaccines and health technology.

Lack of financial incentives can lead to vaccine supply shortages

As a general matter, vaccines are in short supply because pharmaceutical companies lack sufficient financial incentives to develop and manufacture them. They often require expensive raw materials and equipment to, for example, keep the vaccine at a very low temperature until it can be administered. They can take many years to develop, and even longer to be tested and approved through clinical trials. Moreover, unlike pharmaceuticals that often require an extended, or possibly even lifetime, course of treatment, many vaccines are – to pardon the pun – a one-shot deal, and are less financially lucrative. Unless pharmaceutical companies are able to receive financial remuneration commensurate with the investment required, there is little reason to make vaccines.

Decisions surrounding the COVID-19 vaccines are complex for the governments and companies involved. Even in countries where vaccinations are going well, new variants of the disease have been seen, some of which have emerged in countries where few people have been vaccinated. On the other hand, if the governments simply seize the patent rights involved, will the pharmaceutical companies have any incentive to develop vaccines for the next pandemic, if and when it arrives? And will the reduction in the supply of necessary raw materials actually slow the rate of global vaccination?

Your patent concerns may not have worldwide implications, but they're important to address. Contact Matt Osenga at (804) 565-3531 or mosenga@goodmanallen.com for assistance with your patent questions. 


This blog is made available by Goodman Allen Donnelly for general information, and does not constitute legal advice. By reading this blog, you understand that there is no attorney-client relationship between you and the firm. This blog should not be used as a substitute for competent legal advice from a licensed professional attorney in your state.

 

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