Late last week, Representative Darrell Issa (R-CA), Chair of the House Judiciary Committee’s Subcommittee on Courts, Intellectual Property, and the Internet, introduced H.R. 10103, the TRIPS Waivers Act, into the U.S. House of Representatives. If enacted as drafted, this bill would require that the Judiciary Committees of both houses of Congress must receive analyses of proposed modifications to international agreements that would modify the scope or enforceability of American intellectual property (IP) rights. The bill is Issa’s latest effort to prevent the United States from supporting proposed waivers of international IP obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), an effort that stalled following the early stages of the COVID-19 pandemic.

Bill Would Create Reporting Obligations Before Initiating Negotiations

Co-sponsored by Representative Scott Fitzgerald (R-WI), a fellow member of the House IP Subcommittee, the TRIPS Waivers Act imposes obligations on the President or any agent of the United States who initiates negotiations on any international agreement that would reduce or restrict IP rights “in a manner that is more than trivial and more than merely speculative.” Under the bill’s language, this individual would be responsible for providing analysis of the quantitative and qualitative impacts of the potential range of negotiation outcomes at least 60 days before those negotiations begin.

While much of the debate surrounding the TRIPS waiver for COVID-19-related vaccines has focused on patent rights, the TRIPS Waivers Act targets several forms of IP that could be impacted by international agreements. Along with patents, the committee reporting obligations are triggered by negotiations that could impact copyright, trademark, trade secret and plant variety rights. Analyses delivered to the Judiciary Committees under this act must consider impacts to any IP right protected under statute, any right of U.S. persons with respect to those IP rights, or impacts to the overall U.S. IP system.

The TRIPS Waivers Act is the latest version of draft legislation introduced into Congress over concerns that the TRIPS waiver proposed at the World Trade Organization (WTO) would have deleterious impacts on American IP rights. In April 2022, Rep. Issa introduced H.R. 7582, the No Free TRIPS Act, which would have required explicit Congressional approval prior to any negotiations to waive or modify the TRIPS Agreement.

That same month, Representative Adrian Smith (R-NE) along with 10 original co-sponsors introduced H.R. 7430, the Protecting American Innovation Act, which would have prohibited negotiations on a TRIPS waiver without reports from Executive Branch officials concluding that a waiver will increase global vaccine access without adversely affecting U.S. national security. The U.S. Chamber of Commerce and other groups expressed support for both bills but they stalled in Congress after being referred to the House Ways and Means Committee.

Non-Exclusive Licensing Still At Issue in WHO Pandemic Accord

Issa has been outspoken against the Biden Administration’s support of a TRIPS waiver, commenting at a House IP Subcommittee hearing on the subject in June 2023 that “any expansion of the TRIPS waiver agreement will undermine the very innovation, record-breaking rapid development that we saw for COVID-19,” adding that such a result would aid our foreign economic rival China. Then this February, Reps. Issa and Jim Jordan (R-OH), Chair of the House Judiciary Committee, along with the remaining Republican membership of the House IP Subcommittee, sent a letter to U.S. Trade Representative Katherine Tai noting the U.S. International Trade Commission’s conclusion that the TRIPS waiver had not increased global access to COVID-19 vaccines.

The introduction of the TRIPS Waivers Act comes amid stalled progress for the proposed waiver of international IP obligations at the WTO. After proponents for the TRIPS waiver reached a compromise on draft language for the proposed waiver in March 2022, resulting in criticism from both sides of the debate, the WTO approved a waiver in June 2022 limited to IP rights for COVID-19 vaccines. International negotiations to expand the waiver to COVID-19 treatment and diagnostic products were ultimately unsuccessful, those provisions having been excised from draft TRIPS waiver proposals as of this February.

Although the waiver of IP obligations under TRIPS has stalled, language on non-exclusive licensing and royalty waivers remains in the global pandemic accord currently being developed by the World Health Organization (WHO), which announced this June that it plans to complete negotiations on the pandemic accord by the middle of 2025.