Comments Deadline Looms for Proposed TRIPS Waiver Expansion

Following the formal request of the Office of the U.S. Trade Representative (USTR) last December, the USITC is soliciting public comment on the proposed expansion of the June 2022 WTO TRIPS Agreement waiving IP for COVID-19 vaccines to include diagnostics and other therapeutics. The USITC’s report will likely determine the U.S. position on the proposed TRIPS waiver expansion, which will in turn influence other WTO member countries.

• The USITC’s report will likely determine the U.S. position on the proposed TRIPS waiver expansion.
• U.S. opposition to the TRIPS waiver expansion is likely to sway other WTO members to oppose.
• A majority of written submissions to date oppose the TRIPS waiver expansion.
• May 5, 2023 is the final deadline for submission of written comments from industry organizations.

The TRIPS Waiver and Proposed Expansion

In June 2022, citing “the exceptional circumstances of the COVID-19 pandemic,” WTO member countries decided to waive certain articles relating to patent rights in the TRIPS Agreement. Specifically, the decision permitted member countries for a period of five years to authorize “to the extent necessary to address the COVID-19 pandemic” the use of a patent, without consent of the patent owner, if it is required for the production and supply of COVID-19 vaccines provided the member countries undertake “all reasonable efforts to prevent the re-exportation of the products manufactured under the authorization.” The June 2022 decision thus applied to the COVID-19 vaccines themselves, and also to the ingredients and processes necessary to manufacture the COVID-19 vaccines. However, the decision did not cover the production and supply of COVID-19 diagnostics and therapeutics, in addition to vaccines. Instead, WTO member countries agreed to decide by a deadline of December 17, 2022, on whether the TRIPS waiver should be expanded to cover COVID-19 diagnostics and therapeutics.

Ahead of the December 17, 2022, deadline, the Office of the U.S. Trade Representative (USTR) sought extension of the deadline and requested that the USITC “launch an investigation into COVID-19 diagnostics and therapeutics and provide information on market dynamics to help inform the discussion around supply and demand, price points, the relationship between testing and treating, and production and access” pursuant to section 332 of the Tariff Act of 1930. Investigation No. 332-596 was then instituted with a charge to solicit public comment and prepare a report “that analyzes the universe of existing COVID-19 diagnostics and therapeutics in relation to the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) – including the range of definitions for diagnostics and therapeutics; diagnostics and therapeutics covered by patents and those in development; an overview of production, distribution, and demand; information on market segmentation of global demand and consumption; and other information relevant to the discussion of TRIPS Agreement flexibilities.”

The USITC scheduled a public hearing for March 29-30, 2023. Public response was robust with over 60 requests to appear, over 40 pre-hearing briefs, and numerous post-hearing submissions streaming in ahead of the May 5 deadline. The USITC is scheduled to transmit its report to USTR on October 17, 2023.

Arguments for and Against the TRIPS Waiver Expansion

Generally the arguments in favor of expanding the TRIPS waiver are that:

1. IP is a barrier to access in many countries;
2. compulsory licenses are not sufficient because they are burdensome and time-consuming since they are product-by-product and country-by-country and the U.S. pharmaceutical industry has lobbied to punish countries that attempt to issue compulsory licenses;
3. voluntary licenses are insufficient because they are slow, exclusive, and not transparent;
4. the current scope of waiver is too narrow because it does not extend to non-vaccine COVID-19 products; and
5. there remains a need for more equitable access to COVID-19 treatments around the globe.

Arguments against the TRIPS waiver expansion generally include the following:

1. IP is not a barrier to COVID treatment;
2. voluntary and compulsory waivers are sufficient and no country has notified WTO of need to force compulsory license under the TRIPS waiver;
3. expansion will undermine existing voluntary licensing agreements;
4. problems with patient access are not IP-related but are due to supply chain roadblocks, distribution challenges, vaccine hesitancy, and global trade issues;
5. the proposed expansion is vague because COVID diagnostics and therapeutics are not defined;
6. the TRIPS waiver has done little to advance the global response to COVID-19;
7. expansion heightens risk of foreign (particularly China and Russia) expropriation of U.S. innovators’ IP undermining well-paying jobs and investment in innovative manufacturing;
8. there will be a chilling effect on drug research and development;
9. there will be a drop in investment in pharmaceuticals; and
10. expansion creates a slippery slope leading to similar waivers being granted with respect to other technologies, including for future pandemics, green energy, climate change, and food security.

What You Can Do

Whether WTO members decide to expand the TRIPS waiver will depend in large part on the position of the United States. For those who hope to have their voice heard on this question, engaging in the USITC investigation through submission of written comments may be one of the few opportunities to do so.

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