McDonnell Boehnen Hulbert & Berghoff LLP

In a statement issued earlier today, United States Trade Representative Katherine Tai announced "the Biden-Harris Administration's support for waiving intellectual property protections for COVID-19 vaccines."

As we reported earlier this year, India and South Africa proposed last fall that the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO) recommend "a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19" to the General Council of the WTO.  The two countries also recommended that "[t]he waiver should continue until widespread vaccination is in place globally."

In March and April, the Biotechnology Innovation Organization (BIO), Pharmaceutical Research and Manufacturers of America (PhRMA), a group of fifteen industry and trade organizations (including BIO and PhRMA), four intellectual property organizations, and Sen. Thom Tillis (R-NC), the Ranking Member of the Subcommittee on Intellectual Property, sent separate letters to the Biden Administration, members of Congress, and officials at the Patent and Copyright Offices, asking the recipients to oppose the waiver proposal.

Ambassador Kai's statement regarding the waiver proposal was concise:

This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures.  The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines.  We will actively participate in text-based negotiations at the World Trade Organization (WTO) needed to make that happen.  Those negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved.

The Administration's aim is to get as many safe and effective vaccines to as many people as fast as possible.  As our vaccine supply for the American people is secured, the Administration will continue to ramp up its efforts -- working with the private sector and all possible partners -- to expand vaccine manufacturing and distribution.  It will also work to increase the raw materials needed to produce those vaccines.

Several media outlets reported on the Ambassador's statement this afternoon before it became publicly available on the Office of the United States Trade Representative website.  The New York Times reported that the WTO had held further discussions about waiving intellectual property protections earlier in the day, and that more discussions were expected in the coming weeks, as India and South Africa were preparing a revised waiver proposal (see "The Biden administration says it will support lifting patent protections to help produce more vaccines globally").  CNN reported that prior to the Ambassador's statement, "[t]here had been divisions within the administration over whether to ease some patent restrictions on vaccines, according to people familiar with the matter" (see "US supports vaccine patent waiver proposal at World Trade Organization").

Responding to the Ambassador's announcement, the U.S. Chamber of Commerce released the following statement from Executive Vice President and Chief Policy Officer Neil Bradley:

The administration has gotten this issue wrong; undermining intellectual property rights for complex, hard to manufacture vaccines will not accelerate global production, instead it will take us off track in the ongoing and successful efforts to license and scale global production of vaccines that individuals can be confident are safe and effective.  Make no mistake, this move will undermine the global fight against COVID and it will diminish our ability to prepare for and respond to the next pandemic.  We urge the administration to reverse course and work with the business community to deliver on the President's recent promise to make America the 'arsenal of vaccines.'

For additional information regarding this topic, please see:

• "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