The biotech and medical device communities need to push the Biden administration to oppose expanding the intellectual property waiver for Covid-19

Innovator’s Legal Senior Patent Agent Rick Timmer had an opinion piece recently published in the Albany Herald regarding the petition by some WTO members to expand the waiver of intellectual property protections to cover all vaccines, treatments, and diagnostics related to Covid-19. While the opinion piece focused on the implications for one of our clients and more broadly on Georgia’s growing biotech and medical device industry, the potential ramifications of such a waiver could have unintended consequences on the global biotech industry and society’s ability to respond to the next pandemic. 

In June of 2022, WTO members agreed to waive intellectual property protections for Covid-19 vaccines under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Almost immediately, some developing countries petitioned to expand that waiver to include Covid-19 treatments and diagnostic tests, too.  The global trade body was set to decide by mid-December, but the Biden administration asked for a delay to study the matter further. At the same time, the Office of the U.S. Trade Representative (USTR) announced it would ask the U.S. International Trade Commission (USITC) to “…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.”

On December 16, US Trade Representative Ambassador Katherine Tai sent a letter to US International Trade Committee (ITC) Chairman David Johanson requesting a report under section 332(g) of the Tariff Act of 1930 to examine these issues and to provide that report by October 17, 2023.

The USITC is expected to hold hearings and solicit public comments on the issue this year. The fact-finding investigation is already listed on the USITC website. The federal register notice should follow in the coming weeks. Supposing the officials at the USITC do their jobs, their study will undoubtedly show that a waiver expansion would do nothing to fight the coronavirus but would greatly reduce our chances of developing important new medicines – both to fight existing scourges like cancer and Alzheimer’s and to quell the next pandemic. By every reliable measure, there is excess capacity and availability of COVID-19 diagnostics and therapeutics through voluntary licenses, purchasing programs, and donations. 

We will be monitoring for the public comment period to begin and responding accordingly. The decision could have tremendous ramifications for our country’s universities, research hospitals, biotech and medical device companies, and investors.