McDonnell Boehnen Hulbert & Berghoff LLP

Earlier this month, United States Trade Representative Katherine Tai announced "the Biden-Harris Administration's support for waiving intellectual property protections for COVID-19 vaccines."  One day prior to Ambassador Tai's announcement, a group of Republican legislators sent a letter to the Ambassador urging the Biden Administration to continue the United States' opposition to the request by India, South Africa, and other nations to waive certain portions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for all members of the World Trade Organization (WTO).  The group asserted that "[t]he requested waiver is extraordinarily broad and unnecessary to accomplish the goal of giving as many people as possible access to vaccines and treatments for COVID-19, including in developing countries," and argued that "the waiver would undermine the very innovation that has led to the record-breaking rapid development of COVID-19 vaccines already saving lives around the world, and it would not meaningfully improve vaccine availability."  Instead, the legislators suggested that the focus should be "overcoming the real obstacles faced by developing countries in accessing vaccines and treatments, which does not require waiving intellectual property (IP) rights."

The group of Republican legislators who signed the letter, all of whom are members of the Subcommittee on Courts, Intellectual Property, and the Internet of the House Committee on the Judiciary, included Ranking Members Jim Jordan (R-OH) and Darrell Issa (R-CA), and Steve Chabot (R-OH), Louie Gohmert (R-TX), Matt Gaetz (R-FL), Mike Johnson (R-LA), Tom Tiffany (R-WI), Thomas Massie (R-KY), Dan Bishop (R-NC), Michelle Fischbach (R-MN), Scott Fitzgerald (R-WI), and Cliff Bentz (R-OR).  The group's letter presented four arguments against the proposed waiver.  First, the legislators argued that IP rights are not the bottleneck for worldwide access to COVID-19 vaccines and treatments.  Second, the group contended that worldwide access to COVID-19 treatments can be expanded without weakening IP rights.  Third, they asserted that the proposed waiver is excessively broad.  And finally, the group argues that the requested waiver would harm American innovation, technological leadership, and economic competitiveness.

With respect to their first argument, the legislators note that the sponsors of the proposed waiver have presented no convincing evidence to support their assertion that IP rights are a significant bottleneck to the widespread availability of COVID-19 vaccines and treatments.  Instead, they suggest that factors other than IP, such as the lack of cold storage, transportation and infrastructure problems, and shortages in basic supplies like syringes, have had a far greater effect on the availability of COVID-19 vaccines and treatments, particularly in developing countries.  The group also notes that the manufacturing of COVID-19 vaccines and therapeutics is complex and requires exacting standards to ensure patient safety, stating that:

Canceling IP rights would not improve the quality control of any manufacturing facilities.  In fact, allowing potentially any manufacturer to ignore IP rights and produce complex COVID-19 drugs on their own could instead increase the risk that defective and potentially unsafe medicines are produced, harming the patients who receive them, damaging public confidence, and ultimately undermining global vaccination efforts.

Turning to their second argument, the legislators point out that the United States has, along with its allies, pledged billions of dollars and other resources to support the World Health Organization's COVAX program and the Access to COVID-19 Tools (ACT) Accelerator initiative, which the group states are "providing real solutions for countries that need access to COVID-19 vaccines and treatments without dismantling IP protections, even temporarily."  They also present evidence that COVID-19-related IP rights have been successfully licensed, highlighting licenses secured by the Serum Institute of India to the Astrazeneca and Novavax vaccines, by South Africa's Aspen Pharmacare to the Johnson & Johnson vaccine, and by nine generic pharmaceutical manufacturers to Gilead's therapeutic drug remdesivir.  In addition, the legislators point out that "TRIPS already allows countries to impose compulsory licenses to access vital IP rights, and no country has availed itself of that capability to date for COVID-19 vaccines or treatments."

Regarding their third argument, the legislators argue that the proposed waiver is "excessively broad and far exceeds any reasonable measure to address the COVID-19 pandemic," noting that the waiver is not limited to patents on vaccines or treatments for COVID-19.  The group also states that it is "unclear how a waiver of TRIPS obligations would provide more access to trade secrets and proprietary technologies, which are confidential by definition and typically closely guarded."

Finally, with respect to their fourth argument, the legislators contend that "[e]ven if IP protections on the broad array of technology covered by the waiver are bypassed only temporarily, the damage could not be undone for key trade secrets and proprietary know-how if countries force the disclosure of such sensitive information."  The group argues that "the proposed waiver represents a danger to American technological leadership and economic competitiveness without any significant benefit to global public health" (emphasis in letter).  Highlighting the "ground-breaking mRNA vaccine technology that could revolutionize future vaccine development," the group argues that the waiver's sponsors "are seeking not only the COVID-19 vaccines produced using that technology but also that technology itself, which they could then use for other purposes."  And the Republican legislators assert that "[a]t a time when the Biden Administration is proposing trillions of debt-funded spending, the United States must not give away advanced technology developed with billions of Americans' tax dollars to other countries, including adversaries like China and Russia."

The legislators conclude their letter by stating that "[w]hile considerable work can still be done to improve access to COVID-19 medicines and other innovations, that work can be done without the drastic step of suspending IP rights, and significant progress has already been made to address the real obstacles hampering the global COVID-19 response," urging Ambassador Tai and the Biden Administration to maintain U.S. opposition to the waiver, and expressing their willingness to work with the Administration on solutions to the actual problems causing shortages and supply issues with COVID-19 vaccines and treatments.

For additional information regarding this topic, please see:

• "Population of Patents at Risk from Proposed WTO Patent Waiver," May 12, 2021
• "Sen. Daines Urges Biden Administration to Withdraw Support for COVID-19 IP Waiver," May 12, 2021
• "Pfizer CEO Pens Open Letter on COVID-19 Vaccine IP Waiver," May 10, 2021
• "If the Devil of the WTO IP Waiver Is in the Details, What Are the Details?" May 9, 2021
• "The Road to Hell Is Paved with What Everybody Knows," May 6, 2021
• "BIO & IPO Issue Statements on Biden Administration's Support for Proposed WTO Waiver," May 6, 2021
• "Biden Administration Supports Waiver of IP Protection for COVID-19 Vaccines," May 5, 2021
• "Suspending IP Protection: A Bad Idea (That Won't Achieve Its Desired Goals)," April 26, 2021
• "Sen. Tillis Asks Biden Administration to Oppose WTO Waiver Proposal," April 21, 2021
• "IP Organizations Support Continued Opposition to Waiver Proposal," April 5, 2021
• "Industry Coalition Supports Continued Efforts to Oppose Waiver Proposal," March 29, 2021
• "BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver," March 11, 2021
• "IPO Sends Letter on IP Law and Policy to President-Elect and Vice President-Elect," January 4, 2021