By Bailey Kennedy, J.D.
The race to vaccinate the world against COVID-19 is on. Though Americans may be lamenting that they have to wait a few more weeks to get their dose, the delay may be much longer for most people around the world. Even before approval, three vaccines — AstraZeneca, Moderna, and Pfizer — had been gobbled up by wealthy governments across the globe. In November, about half of the doses of these vaccines had been spoken for by the EU, Canada, U.S., U.K., Australia, and Japan. Meanwhile, COVAX, an international coalition with plans to secure vaccines for developing countries that lack the resources to develop a vaccine of their own, has only secured legally binding agreements for 200 million vaccine doses. Over the course of the next year, 67 low-income countries may be able to vaccinate only about 10% of their populations — a level well below the amount required to ensure herd immunity.
As the race takes off, it’s becoming clear that the economic interests of those who are manufacturing and distributing vaccines may not be aligned with the public health interests of the world at large. Vaccines — including these ones — are protected by patents. They can’t be produced without the permission of the patent holders. This concept is supposed to incentivize the creation and invention of new medical technologies. Drug companies know that many drugs which they invest in will never be brought to market. In this case, it wasn’t necessarily clear at the beginning of the crisis that companies would be able to successfully create vaccinations against COVID-19. Drug patents — along with, in this case, significant investments by the federal government — encourage companies to take risks on new innovations in the hope of earning future profits. The problem arises when medical patents make medicine inaccessible to many people. In some cases, for diseases which are not acute or which have other effective treatments, people and governments may be willing to wait for patents to expire. However, in this case, waiting for COVID-19 vaccination patents to expire would ensure that the current crisis is prolonged indefinitely.
Non-Enforcement of Patents: An Escape from the Covid Crisis?
In light of this situation, some actors have called for non-enforcement of vaccine patents around the globe. South Africa and India have asked the World Trade Organization (WTO) to suspend enforcement of Covid-related intellectual property. If granted, this request, which was described in a Wall Street Journal editorial as a “shakedown,” would allow generic drug manufacturers in developing nations to manufacture doses of the drugs that have been invented this year. In expressing support for the measure, a Doctors Without Borders/MSF press release notes that enforcement of intellectual property rights has already been a contentious issue in this pandemic: holders of ventilator valves threatened patent infringement lawsuits in Italy, a country that was hit hard by the virus early in the crisis.
In recognition of the global emergency, one drug manufacturer, Cambridge-based Moderna, has noted that it will not enforce any patent rights related to its vaccine while the pandemic is active. While this may be based in part on Moderna’s long-term economic interests, it is also an example of a company sacrificing potential short-term profits for the moral good of widespread vaccination. Whether the lack of enforcement of the patent will have much practical effect remains to be seen. In response to the India and South Africa petition for non-enforcement of Covid-related intellectual property, several people noted that lack of enforcement alone does not create the capacity to produce a vaccine. mRNA vaccines, such as the one created by Moderna, require highly specialized knowledge and technology to produce; they can’t easily or instantaneously be created in a pre-existing factory. There is some capacity for mRNA production around the world — India is currently developing its own mRNA drug — but it is remains to be seen how rapidly those capacities will expand. It’s also worth noting that not all Covid-19 vaccinations rely on mRNA technology. Johnson & Johnson has developed a more traditional vaccine, which might be easier to replicate around the globe.
Alternatives to Non-Enforcement of Patents
Even if the other two major players in the vaccine race (Pfizer and AstraZeneca) choose to enforce their patent rights, governments worried about protecting their citizens might still take desperate measures to ensure the accessibility of drugs. India has used compulsory licensing to ensure affordable access to HIV drugs; a similar strategy could be used to combat the coronavirus epidemic. Critics claim that compulsory licensing is ineffective in ensuring that the world’s neediest populations will have actual access to the vaccine in a timely fashion and poses the additional risk of retaliatory measures by pharmaceutical companies. The WTO has yet to issue a decision on India and South Africa’s petition.
On the other hand, patents and the protection of intellectual property can also be engines of growth and innovation. With this in mind, as of last May, the U.S. Patent and Trademark Office announced that it would accelerate examination of Covid-19 related patents and waive the usual fees for doing so. At the same time, the American government possesses legal tools — not yet exercised in this case —for prioritizing emergency needs over the protection of patents.
Ultimately, it is in the best interests of governments and people around the globe—in high and low-income countries alike—to bring the pandemic to a complete stop as quickly as possible. If the virus is eradicated in rich countries but remains active in the Global South, there is nothing to prevent it from creeping back in through porous borders—or mutating into a deadlier or more difficult-to-control disease. So, while it’s understandable that the governments of wealthy countries, which have borne a disproportionate share of deaths due to Covid-19, would prefer to vaccinate their own citizens first, life won’t truly return to normal until all citizens across the globe have access to a coronavirus vaccine.
A crisis without a solution
Non-enforcement of vaccine patents may be important symbolically, but its actual efficacy is questionable. The vaccines require specialized knowledge and facilities to be produced, so non-enforcement of patents can’t ensure rapid vaccination of low-income countries. It’s also possible that failure to enforce patents in this case might disincentivize expensive drug development programs in future emergency situations. While it’s fair to say that COVID-19 presents a once-in-a-lifetime crisis that calls for a once-in-a-lifetime response, we shouldn’t neglect concern for potential future pandemics.
This article was originally published on the COVID-19 and the Law blog.
Bailey Kennedy graduated from Harvard Law School in May 2022.
