More on Leaked WTO COVID-19 Vaccine Patent Waiver Compromise

By Donald Zuhn --

A Reuters report published last week indicated that the United States, European Union, India, and South Africa had reached an agreement on a waiver with respect to patents for COVID-19 vaccines.  The text of the compromise proposal, however, was not released.  Following the announcement of the compromise, both the Biotechnology Innovation Organization (BIO) and U.S. Chamber of Commerce issued statements on the reported compromise (see "Compromise Reportedly Reached on COVID-19 Vaccine Patent Waiver").

Earlier today, BIO provided a link to the alleged compromise in its daily email newsletter.  The "TRIPS COVID-19 solution," if approved by World Trade Organization (WTO) members, would allow "an eligible Member [to] authoriz[e] the use of patented subject matter required for the production and supply of COVID-19 vaccines without the consent of the right holder to the extent necessary to address the COVID-19 pandemic."  The compromise defines "eligible Member" as "any developing country Member that exported less than 10 percent of world exports of COVID-19 vaccine doses in 2021," and defines "patented subject matter" as "includ[ing] ingredients and processes necessary for the manufacture of the COVID-19 vaccine."

Under the compromise, eligible Members could authorize the use of patented subject matter "through any instrument available in the law of the Member such as executive orders, emergency decrees, government use authorizations, and judicial or administrative orders, whether or not a Member has a compulsory license regime in place."  The compromise permits "a single authorization to use the subject matter of multiple patents necessary for the production or supply of a COVID-19 vaccine," and would require eligible Members to "communicate to the Council for TRIPS any . . . granting of an authorization," and "list all patents covered" by the authorization.  Eligible Members would not have to require "the proposed user of the patented subject matter to make efforts to obtain an authorization from the right holder," and could "allow any proportion of the authorized use to be exported to eligible Members," provided that they "undertake all reasonable efforts to prevent the re-exportation of the COVID-19 vaccine that has been imported into their territories."  The compromise proposal also states that "[n]o later than six months from the date of this Decision, Members will decide on its extension to cover the production and distribution of COVID-19 diagnostics and therapeutics."

In a statement issued by WTO Director-General Ngozi Okonjo-Iweala on March 16, the Director-General "warmly welcomed the breakthrough," calling the compromise "a major step forward," but cautioning that "not all the details of the compromise have been ironed out."

A statement from the Office of the U.S. Trade Representative indicated that the compromise proposal "offers the most promising path toward achieving a concrete and meaningful outcome," noting that "[w]hile no agreement on text has been reached and we are in the process of consulting on the outcome, the U.S. will continue to engage with WTO Members as part of the Biden-Harris Administration's comprehensive effort to get as many safe and effective vaccines to as many people as fast as possible."

In its latest report regarding the waiver compromise, BIO provided reactions from Steve Bates, CEO of the UK Bioindustry Association and Chair of the International Council of Biotechnology Associations (ICBA), which includes BIO, who argued that the proposal would "have a chilling impact on investment into the small companies that have been at the heart of the solutions to COVID-19," adding that the proposal "directly threatens this innovative ecosystem's ability to attract the capital needed to develop next generation of vaccines whilst doing nothing to solve the access challenges we have in 2022."  Mr. Bates also noted that the biotech industry manufactured more than 11 billion vaccine doses in 2021, and stated that "[w]eakening IP rights does nothing to facilitate the distribution of these manufactured vaccines to people around the world who most need them—rather prioritizing addressing healthcare infrastructure and vaccine hesitancy in the developing world would lead to more shots in arms."  BIO Deutschland Chair Oliver Schacht suggested that the proposal "would jeopardize drug development with respect to other research areas, since drugs and vaccines are protected not only by one patent but by a whole bundle of patents, with individual patents in such a bundle in turn often protecting other drugs and vaccines."  BIO noted that the waiver compromise was "not a done deal," and that BIO would be "keeping a close eye on it."

The Pharmaceutical Research and Manufacturers of America (PhRMA) and Médecins Sans Frontières have also provided statements on the compromise proposal.  PhRMA stated that:

The fact remains that efforts to waive intellectual property commitments are unnecessary and harmful to our collective work to end the pandemic.  Strong intellectual property protections, voluntary technology transfers and partnerships are on target to facilitate the production of more than 20 billion doses in 2022 – more than enough to vaccinate the world – without confiscating intellectual property.  Global leaders should now focus on the real challenges of distributing and administering vaccines to people around the world.

Médecins Sans Frontières (Doctors Without Borders) contended that "WTO members should remain vigilant to the fact that this leaked text contains considerable limitations, and needs to be urgently improved," arguing that "[i]t is incredibly concerning that the leaked text currently only covers vaccines, but neither treatments nor diagnostics."

For additional information regarding this topic, please see:

• "Compromise Reportedly Reached on COVID-19 Vaccine Patent Waiver," March 16, 2022
• "Sen. Tillis Writes to U.S. Trade Representative (Again) Regarding TRIPS Waiver," December 12, 2021
• "U.S. Trade Representative Responds to Letters from Senators Regarding TRIPS Waiver," November 14, 2021
• "U.S. Chamber of Commerce Urges Administration to 'Double Down' on Global Vaccine Distribution," November 3, 2021
• "Is This the WTO Waiver End Game?" July 25, 2021
• "BIO Declaration on Global Access to COVID-19 Vaccines and Treatments and Role of IP," June 24, 2021
• "GOP Legislators Write in Opposition to Proposed TRIPS Waiver," May 16, 2021
• "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

Comments

[Greg DeLassus]

"Steve Bates... argued that the proposal would 'have a chilling impact on investment into the small companies that have been at the heart of the solutions to COVID-19'... ."

Really? How? We are talking about IN, ZA, and the like. How much "capital needed to develop next generation of vaccines" actually comes from these markets? At a first approximation, I would say "none."

The big joke here is that neither Biontech nor ModeRNA ever entered the ZA national phase. ZA does not even have patents to waive, and yet it is fighting for a patent waiver. Why bother?

This compromise is the biggest nothing-burger imaginable. No industry is threatened in the least by the proposal (which is, of course, all to the good). BIO should be pleased that the whole thing is a toothless, meaningless waste of time. Why continue to oppose it at this point?

[skeptical]

Mr. DeLassus continues his crusade to be obtuse (and will no doubt continue to be "surprised" as he notes at this location: https://www.ipwatchdog.com/2022/03/16/latest-wto-waiver-compromise-text-targets-covid-vaccine-patents-draws-criticism-sides/id=147576/ )

His comment of "How much 'capital needed to develop next generation of vaccines' actually comes from these markets? At a first approximation, I would say 'none.'" is a tone deaf response as to WHY the IP waiver (and yes, please, read that as more than merely a patent waiver) was being pursued in the first instance.

I suppose this is what happens when one only wants to speak their own speaking point, and has no interest in gaining a larger view of the issues.

Will Greg learn?

Call me:

[Kevin E Noonan]

Greg: I think the game is not COVID patents per se (although a general weakening of patent protection globally would fit the agendas of IN, ZA, and BR (and others) in rolling back the GATT/TRIPS regime embodied in the WTO).

The bigger fish is getting access to the trade secrets that underlie the vaccines (mostly having to do with delivery agents). Once the "patent waiver" permits access to these (which it does; see footnote 2 in the waiver proposal disclosed by BIO) then there will be a mechanism for countries to get this info from regulatory filings for any drug.

There are alternatives to this scenario but should it come to pass how long will it take for Western pharma companies to conclude that "the game is no longer worth the candle" )to paraphrase Sequenom's CEO in another context)?

Thanks for the comment.

[skeptical]

Dr. Noonan, that also paraphrases some of Cleveland Clinic's decision on its patent aims.

And the world is worse off for that.