Carper, Toomey Highlight Importance of Protecting Medical Product Innovation, Request Additional Information About Possible Expansion of WTO Intellectual Property Waiver

Bipartisan Senators Urge Ambassador Tai to Support American Research and Development of Life-Saving Tools in Negotiations on a Possible IP Waiver Expansion for Therapeutics and Diagnostics

WASHINGTON, D.C. – U.S. Senators Tom Carper (D-Del.) and Pat Toomey (R-Pa.) led a bipartisan group of senators in writing U.S. Trade Representative Katherine Tai to urge the Biden Administration to safeguard American innovation in the World Trade Organization’s (WTO) negotiations on whether to expand its waiver of IP rights enforcement for COVID-19 vaccines to also include therapeutics and diagnostics, and to seek additional information about the Biden Administration’s approach to these deliberations.

In June 2022, WTO members agreed to waive obligations under the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement for COVID-19 vaccine patent subject matter for a five-year period. This requires the United States to not enforce certain IP rights on behalf of U.S.-based companies at the WTO. The expansion under consideration would enable eligible WTO member countries to ignore otherwise enforceable intellectual property (IP) protections for therapeutics and diagnostics that treat COVID-19.

“Intellectual property protections are a key driver of research and development (R&D) and job creation in Delaware and across the United States, and our innovation ecosystem has been critical for the development and deployment of tools to combat the COVID-19 pandemic,” said Senator Carper. “As World Trade Organization (WTO) member countries consider intellectual property waivers for COVID therapeutics and diagnostics, I strongly encourage the Biden Administration to consider the impact of these possible waivers on American innovation when developing a negotiating position. I look forward to receiving more detail on how the Administration is approaching the WTO negotiations, and I am eager to continue working with U.S. Trade Representative Katherine Tai on this important issue.”

“Strong protections for intellectual property are the bedrock of American innovation, as evidenced by the record development of multiple vaccines to combat COVID-19. Unfortunately, the Biden Administration continues to threaten to again abrogate American IP protections, which will have devastating, long-reaching effects on access to treatments beyond those used for COVID-19. The United States must reject any effort to extend the already erroneous waiver for vaccine IP to the much broader categories of therapeutics and diagnostics,” said Senator Toomey.

“The United States is a global leader in research and development (R&D) and innovation in part because of our strong protections for IP. Additionally, the United States will continue its leadership with our partners across the globe to ensure developing countries have access to the tools and treatments needed to combat COVID, and we believe this can be accomplished without undermining U.S. leadership in medical innovation,” wrote the Senators. “American companies are committed to numerous cooperative agreements to increase global access to therapeutics and diagnostics in addition to vaccines. In fact, many countries that initially proposed this waiver are producing their own products and have not indicated that domestic demand exceeds their own supplies.”

The Senators are requesting answers to several questions surrounding this waiver, including:

1.       What economic analysis USTR has conducted regarding the impact of the COVID-19 vaccine waiver on global vaccine supply, and how this information may inform a U.S. position on a possible waiver expansion;

2.       How the WTO will define a “diagnostic” and a “therapeutic”;

3.       Whether USTR has produced any analysis on the effect that waiving additional IP protections will have on R&D; and

4.       How USTR is meeting its legal requirement to consult transparently with Congress prior to December’s decision deadline at the WTO.

Senators Bill Cassidy (R-La.), Chris Coons (D-Del.), John Barrasso (R-Wyo.), Kyrsten Sinema (D-Ariz.), Thom Tillis (R-N.C.), Robert Menendez (D-N.J.), Richard Burr (R-N.C.), and Jon Tester (D-Mont.) also signed onto the letter. The full letter is available here.