The Biden administration announced its support for a waiver of intellectual property (IP) protections relating to the production of COVID-19 vaccines. Few would take issue with the purported goal of such a waiver—speeding global access to these life-saving vaccines. But in reality, the waiver proposal creates more problems than it solves.
As a member of the World Trade Organization (WTO), the United States is party to the Agreement on Trade-Related Aspects of Intellectual Property Rights, called the TRIPS Agreement. The TRIPS Agreement sets forth minimum requirements to which each member nation agrees with respect to the protection of intellectual property of other members. Thus, any IP waiver would require broad support among the members of the TRIPS Agreement.
Such support is unlikely at best. The proposed waiver has popularity among some nations. But many other WTO members, including among them the chief members of the European Union, have expressed great concern about the possibility and efficacy of a TRIPS waiver.
The Biden administration’s support for a TRIPS vaccine waiver has received similar pushback at home. Many intellectual property groups have expressed clear opposition to the TRIPS waiver. These organizations collectively assert that the waiver proposal discussed at the WTO is erroneous in its portrayal of IP as a barrier to the production of life saving technologies.
In a joint letter to United States Trade Representative Katherine Tai, these organizations noted that they “know of no data to suggest that patents and other IP rights are hindering vaccine development or delivery.” The organizations likewise expressed concern over a negative impact on future vaccine development.
Nor is it even a foregone conclusion that the Biden administration has the power to authorize the proposed TRIPS waiver. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) has argued that any waiver of the terms of that Agreement would require an act of Congress. Thus far, neither house of Congress has acted on any resolution that would relax US IP protections for COVID-19 vaccines.
The consensus opinion is that the primary obstacle to vaccine supply across the globe is distribution. The short-term problem of vaccine supply would be more directly remedied not by a waiver of IP rights, but by a willingness of nations with a vaccine surplus and manufacturing wherewithal to share their supply.
Not to be ignored in any discussion of short-term effects is the potential impact a waiver would have on current vaccine manufacture. The manufacture of vaccines is contingent on the availability of raw materials, which are not unlimited in supply. The waiver of IP rights would in principle substantially increase demand for these raw materials, resulting not only in higher prices but potential interference in the supply chain for established and proven vaccine manufacturers.
While it is easy to focus on the short-term goals of getting vaccines to those in need, it is dangerous to do so without also considering the potential long-term impacts of a TRIPS waiver. Vaccine developers argue that the strong and predictable system of intellectual property protection established by the TRIPS Agreement has promoted the production of vaccines and weakening those rights would make it more difficult for the type of collaboration that brought forth these COVID-19 vaccines in the first place.
It also must be recognized that patent rights are not the only form of intellectual property implicated by the proposed TRIPS waiver. Vaccine production relies just as much on valuable trade secrets and there is no guarantee that all but a few could effectively and safely produce vaccines at levels exceeding the rates currently being manufactured.
Compelling a waiver of trade secret knowledge would also be an issue of incredible concern. A trade secret derives its value from not being publicly known—compelling disclosure of a vaccine manufacturer’s trade secret would destroy the value of that intellectual property forever. Indeed, the trade secrets relied on to safely develop and manufacture COVID-19 vaccines would be expected to extend beyond these vaccines themselves, potentially impacting numerous unrelated pharmaceutical products.
The importance of distributing these vaccines efficiently and safely cannot be overstated. But those involved in vaccine distribution look at vaccine export and supply chain hurdles as the chief obstacles to global vaccine distribution, not IP. Such a waiver could even cause a reduction in availability and distribution of safe vaccines. And in terms of a long-term impact, there is almost nothing to support the idea that a waiver would increase the likelihood of accelerating the development or production of future vaccines, be it to treat COVID-19 variants or any other health crisis. There are compelling reasons to maintain the IP protections afforded under the TRIPS Agreement.
The full article in its original form can be found here.
Andrew J. Koopman (LAW ’08) is a practicing attorney at RatnerPrestia specializing in both patent prosecution and patent and trademark litigation, and is a leading member of the firm’s inter partes review practice group. With his breadth of experience, he assists clients with all areas of intellectual property protection and enforcement.
Jonathan H. Spadt is the Chief Executive Officer and President of RatnerPrestia focusing on IP law. He routinely writes and lectures throughout the United States and Europe in both the private and public sectors, and actively participates in policy discussions relevant to transatlantic trade and IP law.