We first posted about a potential waiver of patent rights related to COVID-19 medical tools on May 6, 2021 (Patents on COVID-19 Vaccines Feel free to infringe (kilpatricktownsend.com)). A recent version of the waiver released on May 3, 2022, by Ambassador Lansana Gberie of Sierra Leone, the Chair of the Council for Trade Related Aspects of Intellectual Property Rights of the World Trade Organization (WTO), however, shows negotiations at the WTO are far from complete. In a cover letter to Ambassador Gberie, Ngozi Okonjo-Iweala, the Director-General of the WTO, notes the waiver reached an “impasse” in the Council and the current proposal is the result of an “informal process” entered into by “an informal group of Ministers.”¹  More specifically, the informal group included ministers from the European Union, India, South Africa, and the United States. The draft proposal should go to the 164 WTO members shortly for consideration.

The waiver parameters of the current proposal are different from that originally proposed by India and South Africa in October 2020. Whereas the original proposal included waiver of patent protection related to prevention, containment, or treatment of COVID-19, the current proposal is limited to “production and supply of COVID-19 vaccines.” The current proposal makes clear that the use of the eligible subject matter can be authorized by “any instrument available” under the laws of the member country, such as executive orders, emergency decrees, and judicial or administrative orders, without the need for legislative acts. Furthermore, the current proposal makes clear that the eligible member country need not make efforts to obtain permission from the patent owner prior to authorization of the waiver. The current proposal also makes clear the eligible member countries “shall undertake all reasonable efforts to prevent re-exportation of the COVID-10 vaccine” imported in accordance with the waiver.

Several provisions in the current proposal, however, show the need for further resolution on at least three points. The first pertains to which member countries are eligible to authorize a waiver. The current proposal limits the right to waive patent protection to “developing country Members,” who are encouraged to opt out if they have the capacity to export, or, in the alternative, excludes “developing country Members who exported more than 10 percent of world exports of COVID-19 vaccine doses in 2021.”² The exclusion of exporters of more than 10% seems to be directed to China, which is designated a developing country but currently exports 32% of world exports of COVID-19 vaccines.³ Developing countries that would be encouraged to opt out, however, could also include countries like India and South Africa which also export COVID-19 vaccines.⁴ 

The second provision in the current proposal pertaining to the scope of authorization by an eligible member is designated as “under further consideration to whether to keep or delete.” Specifically, the provision states that a single authorization for the use of multiple patents can be used and may be updated to add additional patents. The provision further states that the Member can be assisted by WIPO’s patent landscaping work⁵ in order to determine relevant patents, including those related to “underlying technologies on COVID-19 vaccines.” Thus, it appears that the WTO members will determine whether a developing country member can authorize a blanket waiver of all the listed vaccine patents on the WIPO landscape report. The list currently includes 417 patents.⁶ 

A third provision designates a period during which an eligible member country may authorize the waiver as either 3 or 5 from the date of any final decision. Given this and the remaining aspects of the proposal requiring negotiation and given that the Director-General makes clear in her cover letter that none of the participating members of the informal group that produced the proposal is bound by the terms, the proposal will still be subject to much debate and modification. 

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