Patents on COVID-19 Vaccines – Feel free to infringe?
There was big news from the Biden administration yesterday regarding patent protection for COVID-19 vaccines. Katherine Tai, United States Trade Representative, announced in an official statement dated May 5, 2021 that the Biden-Harris Administration supports waiving intellectual property protections for COVID-19 vaccines. Her statement noted that “[t]he Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines[, and w]e will actively participate in text-based negotiations at the World Trade Organization (WTO) needed to make that happen.”1 This is a significant reversal of the position the United States has taken to date in discussions at the WTO regarding a potential waiver in accordance with the international Trade-Related Aspects of Intellectual Property Rights Agreement (i.e., the TRIPS Agreement).
The TRIPS Agreement requires all but the “least-developed countries”2 to provide a certain level of protection for intellectual property. Article 31 of the TRIPS Agreement allows WTO member countries (164 countries worldwide) to have compulsory licensing provisions, but such provisions must require negotiations of “adequate remuneration” in a procedure that can be cumbersome.3 Other provisions of the Agreement arguably go further. Articles 7 and 8 provide that
“[WTO m]embers may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health . . . provided that such measures are consistent with the provisions of this Agreement.”4 and
“[P]rotection and enforcement of intellectual property rights . . . [shall be] in a manner conducive to social and economic welfare.”5
Based on Articles 7 and 8, India and South Africa requested in October 2020 that the WTO members agree to waive patent protection as to “prevention, containment or treatment of COVID-19 . . . until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity.”6 Their proposal has since been co-sponsored by Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt, the African Group, and least developed countries.7
Developed countries, such as the United States, United Kingdom, and European Union have opposed the waiver,8 at least until the United States broke rank yesterday. Trade organizations such as the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) have similarly opposed the waiver, stating “diluting national and international IP frameworks during this pandemic is counterproductive. . . . IP enables research and development and ensures that the next generation of inventors and investors will remain engaged.”9 Joining in the fray have been a number of companies including Johnson and Johnson, Moderna, and Pfizer.10 However, Moderna released the following statement in October 2020:
We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible. Accordingly, while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic. Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period.11
Additionally Pfizer and other companies have already shared vaccine formulas with potential manufacturers in developing countries.12 Supporters of the TRIPS waiver, however, have not considered such altruistic steps to be sufficient, pointing to problems that evolved from lack of access to HIV therapies in less developed countries and problems with negotiations of compulsory licenses.13 Many have weighed in on the controversy, including Bill Gates, who opposed the waiver, stating, “The thing that's holding things back in this case isn't intellectual property. It's not like there's some idle vaccine factory with regulatory approval that makes magically safe vaccines. You've gotta do the trials on these things. And every manufacturing process has to be looked at in a very careful way.”14 Gates seems to appreciate that, unlike small molecule therapeutics, vaccines are complex biologic agents that can be difficult to replicate. In the cases of the Pfizer and Moderna vaccines, these are among the first RNA vaccines to be utilized and their production is not trivial.
The proposed waiver notably is not limited to vaccines and reaches to include other technologies, such as diagnostics, treatments, and protective equipment. Although no consensus has been reached at the WTO to date, the United States has clearly signaled a willingness to negotiate an agreement as to a waiver, which could end with a narrower scope than presently proposed. For example, the waiver may reflect the scope of Moderna’s waiver – limited to vaccines and limited to the pandemic period.
Discussions as to a waiver among WTO members will undoubtedly continue, and such negotiations could take weeks before a consensus is reached. However, even if the waiver passes, an active transfer of vaccine technologies would be required to enable other manufacturers to make a reliable vaccine quickly. Some have argued that the Biden-Harris Administration could compel companies in the United States to provide the needed technology to enable vaccines similar to those that have regulatory approval.15 Thus, even once the WTO reaches a consensus on a waiver, which the United States statement will likely spur, substantial steps will be needed to promote sufficient vaccine production for all WTO member countries.
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