The U.S. government is facing pressure to support a proposal before the World Trade Organization (WTO) to suspend patents related to COVID-19 vaccines [and on May 5 came out in support of waiving intellectual property protections for those vaccines]. Here, Stanford Law Professor Lisa Larrimore Ouellette explains this patent waiver proposal and how it relates to efforts to expand global vaccination.
First, what does the WTO have to do with patent rights?
Most of the world’s countries—164 in total—are members of the WTO, which means they must follow WTO agreements or face the threat of trade sanctions. One of those agreements, the 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), requires all but the least-developed nations to protect the intellectual property rights of all WTO members at or above a certain level. This means, for example, that when Germany-based BioNTech developed novel mRNA technology that is the basis of the Pfizer vaccine, it could receive patents not only in Germany but also in any other WTO country where it paid the necessary legal and translation costs.
Who is asking for a waiver of these patent requirements?
In October, India and South Africa asked the WTO to waive enforcement of TRIPS for all intellectual property related to the prevention, containment, and treatment of COVID-19. The proposal has been supported by many countries but opposed by others, including governments from the United States, EU, UK, Switzerland, Japan, Brazil, Canada, and Australia. India and South Africa are now taking the lead in drafting a revised proposal, which will focus on the urgent need to increase vaccine production in light of the record-breaking and devastating wave of COVID-19 infections in India. In response to pressure from these countries and from patient advocacy groups, the Biden Administration is reportedly considering changing its position on the waiver.
Would a vaccine patent waiver help with the current crisis in India?
In the short term, it’s unlikely. Some supporters of patent waivers point to compulsory licenses on HIV therapies in the 2000s, which increased generic production and drove down prices in low-income countries. But unlike for those HIV therapies and other “small-molecule” drugs, there’s no such thing as a “generic” vaccine. Vaccines are complex biologics that are more difficult to replicate than small-molecule drugs, so a new manufacturer that wanted to create its own version of the Pfizer-BioNTech vaccine would need to run its own clinical trials to demonstrate that its vaccine is safe and effective. And even with the involvement of the original developer, building new manufacturing capacity takes time—time that India doesn’t have. That’s why sharing existing vaccine supply is so critical right now.
What effect would a vaccine patent waiver have in the longer term?
A vaccine patent waiver might help increase long-term supply, but only if accompanied by other policies. The key barrier to expanding vaccine manufacturing isn’t patents—it’s the trade secrets, know-how, and scarce physical supplies needed to get a new manufacturing plant up and running. The WTO waiver wouldn’t address these hurdles. For example, Moderna already voluntarily waived its patent rights in October, but other manufacturers still aren’t able to use Moderna’s technology without active cooperation from Moderna. It’s unclear whether a WTO patent waiver would make it easier or harder for governments to push existing manufacturers to share their trade secrets. But that’s the key issue policymakers should be focused on—figuring out how to encourage active knowledge transfer of vaccine technologies as quickly as possible, and then ensuring more equitable global distribution of these vaccines.
Would the proposed WTO patent waiver increase access to technologies other than vaccines?
Maybe. Even though much of the recent reporting on the proposed WTO patent waiver has focused on vaccines, India and South Africa’s proposal in October applied to all technologies for controlling the pandemic, including diagnostics, treatments, and personal protective equipment. Waiving patents could do more to expand access to COVID-19-related technologies that are easier to replicate, although it is unclear what role patents play in existing shortages relative to other barriers like supply chain disruptions and constraints. Again, waiving patents should be viewed as a complement to other policies.
Could the United States do anything else to expand global vaccine distribution?
Yes, and it should. Expanding global access to COVID-19 vaccines is a moral imperative. The record-breaking development of these vaccines is a scientific triumph, but existing distribution has reflected racial disparities within the United States and even starker inequities abroad, with only 0.2% of doses administered in low-income countries.
In the short term, the United States can share existing vaccine doses, along with other aid and medical supplies. It was a step in the right direction when the Biden Administration agreed to start sending doses to India, although the commitment is a drop in the bucket compared with the Indian population. The United States purchased far more doses than its population as a hedge against vaccine failures, so it can share more of its existing supply—including with COVAX, the leading international effort for equitable access to COVID-19 vaccines.
To produce enough doses to vaccinate the world, a drastic global scale-up of existing manufacturing is also needed. As I noted earlier, the key is incentivizing or mandating knowledge transfer from existing producers, and the United States can help invest in and coordinate these efforts, with help from legal tools like the Defense Production Act. Building a more robust network of vaccine manufacturing infrastructure would not only help bring this pandemic to a close, but would also leave the world better prepared for the next one.
Lisa Larrimore Ouellette is a Professor of Law and Justin M. Roach, Jr. Faculty Scholar at Stanford Law School, and a Senior Fellow at the Stanford Institute for Economic Policy Research. She has been blogging about legal issues related to COVID-19 innovation at Written Description.