“Not a single country took advantage of the waiver for IP protections to increase the supply of vaccines…. I fear we’re creating a precedent that will weaken the U.S. innovation economy, which is so important if we want to look at developing cures for some of the most dreaded diseases out there.” – Gary Locke
In a webinar hosted today by the Council for Innovation Promotion (C4IP), the organization’s founders, Andrei Iancu and David Kappos, both former Directors of the U.S. Patent and Trademark Office (USPTO), spoke with former U.S. Secretary of Commerce, Gary Locke, about the increased skepticism surrounding a plan to extend the waiver of intellectual property protections for COVID-19 vaccines under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to COVID-19 diagnostics and therapeutics.
According to Kappos, while World Trade Organization (WTO) member countries were supposed to decide on December 17 whether to extend the waiver, “given the rising opposition and other countries starting to raise their hands” with questions, “it’s seeming likely the WTO will defer its decision until the New Year.”
Countries including Mexico and Switzerland have recently indicated they are hesitant to extend the waiver in light of the fact that no systemic problem has been demonstrated with respect to access to COVID-19 therapeutics and diagnostics. According to an Airfinity report compiled for the Pharmaceutical Research and Manufacturers of America (PhRMA), “[g]overnments and NGOs have purchased 35 million COVID-19 treatments for LMIC [Low and Middle-Income Countries] for 2022 but have only been able to administer 10 million as of September this year.” Thus, the problems are rooted in logistics and distribution problems, rather than access to the products; in fact there is a surplus of treatments in many places, the Mexico-Switzerland communication said.
Locke—who served as Commerce Secretary under President Barack Obama—explained that there is bipartisan recognition that IP is not the problem when it comes to COVID-19 treatment access and offered his insight as a former member of the Cabinet on what the current administration leaders should be doing to ensure U.S. businesses and workers are protected. Locke said the current Secretary of Commerce, along with the U.S. Trade Representative (USTR) the Secretary of Health and Human Services and members of congress should all be weighing in to present the evidence that waiver has not worked for vaccine access and would set a dangerous precedent for future technologies, and innovation generally, if extended. Locke explained:
“The evidence is overwhelming that IP protections have not impeded people’s access to treatment, and did not in any way impede the development of vaccines. Drug companies have been voluntarily licensing their technology to accelerate global manufacturing and distribution of treatments. Pfizer and Merck have signed hundreds of agreements to allow generic versions of their medicines to be manufactured all around the world, they’ve worked with the UN Medicines Patent Pool to allow generics to be manufactured by 200 companies worldwide and many other companies have entered into voluntary licensing agreements…. India threw out 100 million doses of vaccines that expired [and] South Africa is trying to cancel the contract for over 10 million doses of the vaccine. Not a single country took advantage of the waiver for IP protections to increase the supply of vaccines and that’s because so many companies from around the world had agreements with companies like Moderna and Pfizer to produce generic versions, but the problem was they couldn’t refrigerate it or had distribution problems. So, I fear we’re creating a precedent that will weaken the U.S. innovation economy, which is so important if we want to look at developing cures for some of the most dreaded diseases out there.”
Locke added that the Commerce Department is well positioned to advocate for U.S. industry and should be working with the USPTO and USTR to develop clear messaging. Kappos agreed, proffering that when he was serving as USPTO Director under Locke, he’s certain that Locke would have consulted with him on the topic. “When I was running the USPTO, you certainly would have called on us as advisors,” Kappos said. “And I would have been saying ‘this is my job.’ I would hope that same kind of thing is happening now.”
Kappos also said that the United States should be leading on this issue and advocating to oppose an extension of waiver in a “fact-based and candid way.”
However, so far, the United States has not taken a vocal stance on the extension; the Biden Administration backed the initial call for waiver of IP rights for COVID-19 vaccine technologies in May of 2021.
Iancu, who introduced the C4IP webinar, chimed in to say that “it’s hard to imagine that a decision like this that impacts the IP system would be made without the involvement of the USPTO Director and Commerce Secretary,” and went so far as to suggest that such a decision shouldn’t even be made without their approval. Locke said that if the Commerce Secretary were to vocally oppose extension, it would be heard within the White House, but also underscored the importance of stakeholders weighing in via their respective industry organizations to Commerce and the USTR in order to impress upon them the importance of the decision. “If people are silent, the implication is that American businesses don’t really care about it and they’ll make their decision in a vacuum,” Locke said.
C4IP was formed in September of this year to counter anti-IP narratives. It’s headed by former vice president of U.S. policy at the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC), Frank Cullen, and its Board of Directors is comprised of Iancu, Kappos, Retired U.S. Court of Appeals for the Federal Circuit (CAFC) Judge Kathleen O’Malley and Retired CAFC Chief Judge Paul Michel.