By Andrew Karpan

Law360 (May 11, 2021, 5:05 PM EDT) -- U.S. President Joe Biden's backing last week of a temporary waiver of intellectual property protections on COVID-19 vaccines reinforces the support the World Trade Organization proposal has received from more than 100 countries, but European leaders, some U.S. lawmakers and pharmaceutical companies remain wary.

After U.S. Trade Representative Katherine Tai announced last week that the Biden administration would no longer oppose the proposed waiver at the WTO, European Commission President Ursula von der Leyen on Saturday declined to follow the U.S.'s lead. The heads of the 27 EU member states met this past weekend in Porto, Portugal, as part of the annual EU-India summit, according to a press statement. India, along with South Africa, are among the proposal's major backers.

"We should be aware of the fact that these are topics for the long term. It is not a topic for the short term or the medium term," she said, regarding the proposed waiver. "This is something that will not bring, within the next month or perhaps the next year, any vaccines."

Some leaders of EU member states were less discreet. German Chancellor Angela Merkel said at her own press conference on Saturday that she did not believe patent protections were holding back vaccine distribution.

"I have made it clear once again that I do not believe that the release of patents is the solution to make vaccines available to more people, but I believe that we need the creativity and innovative strength of companies. For me, this includes patent protection," she said, according to a transcript.

With Mainz, Germany-based BioNTech serving as one of the world's major vaccine producers, Merkel said she was aware of the need to safeguard quality control in vaccine production. Pfizer's blockbuster mRNA vaccine had been developed in collaboration with BioNTech.

"The problem, at the moment, is not that someone is sitting on their patents," Merkel added.

In a statement Friday, Ulrike Demmer, a deputy spokesperson for the German government, directly addressed the U.S.'s changing stance on the IP waiver.

"The [U.S.] proposal to remove patent protection for COVID-19 vaccines has significant implications for vaccine production as a whole," she said. "The protection of intellectual property is and should remain a source of innovation in the future."

French President Emmanuel Macron, who also appeared at the EU-India summit, responded Saturday to questions about the Biden administration's new support for the waiver by demanding that the U.S. first begin exporting some of the vaccines that it's producing. He also committed to working "hand in hand with [Merkel] on the issue."

Like the EU, the U.K. has remained cool to President Biden's new position on the waiver.

In a speech before the WTO last week, Simon Manley, the country's ambassador to the WTO, instead endorsed "the positive steps that we have made in recent weeks and months towards vaccine equity."

Meanwhile, Canada and Brazil, countries that had previously opposed the waiving of IP protections at the WTO, have indicated that they would now be looking to join the U.S. in supporting the new, revised proposal.

"We've been working with partners at the WTO to find a consensus-based solution and are ready to discuss proposals, in particular for COVID-19 vaccines," Canadian Prime Minister Justin Trudeau said in a press conference on Friday.

The Brazilian government put out a statement last week that officially "welcomed the U.S. willingness to negotiate a multilateral solution within the WTO that contributes to the fight against COVID-19."

Closer to home, however, the Biden administration faces stiff opposition to the waiver from Republican lawmakers. A day after Tai announced the administration's support of the waiver, Rep. Byron Donalds, R-Fla., proposed a bill that would "prohibit the Biden Administration from giving away the fruits of American ingenuity to foreign adversaries," according to a press release.

Vaccine Makers Voice Opposition

Both before and after Tai announced the change in policy, drugmakers behind the vaccines have kept up their industry's criticism of the WTO proposal. New York-based pharmaceutical giant Pfizer was one of the first to respond after the announcement, doing so in an open letter addressed to the company's employees.

Pfizer CEO Albert Bourla said Friday that issues with exporting the company's vaccine to other countries was the fault of decisions made by the leaders of those countries.

"I reached out to many heads of middle/low-income countries by letter, phone and even text to urge them to reserve doses because the supply was limited. However, most of them decided to place orders with other vaccine makers," Bourla said in a statement. "Unfortunately, other vaccine producers were not able to meet their supply commitments for varying technical reasons."

Approving the intellectual property waiver now would only "derail" the company's progress in selling the vaccine to those countries now, he added.

"Is the proposed waiver going to improve the supply situation or create more problems? And my answer is categorically the latter," Bourla said.

Stéphane Bancel, chief executive officer of Massachusetts-based Moderna, which created another vaccine using mRNA technology, responded more cautiously toward the prospect of the waiver. In an earnings call with investors last week, he reiterated the company's commitment to not enforcing its COVID-19-related patents during the pandemic.

But he also told investors that the waiver would have very little effect on producing mRNA-based vaccines.

"There is no mRNA in manufacturing capacity in the world. This is a new technology. You cannot go hire people who know how to make the mRNA. Those people don't exist," Bancel said.

Other vaccine developers have taken a more aggressive stand against the waiver. Robert DeBerardine, the chief patent attorney for New Jersey-based Johnson & Johnson, warned last month that "if you were to give everything to everybody, you may see a flood of vaccines, but you would have no idea if they're safe and effective."

The pharmaceutical company Novavax, which was awarded a $1.6 billion contract from the U.S. government last year to develop a vaccine for COVID-19, has also come out against the waiver.

"A [Trade-Related Aspects of Intellectual Property Rights] waiver could further constrain resources by diverting them to entities incapable of manufacturing safe and effective vaccines in the near term," the company said in a statement last week. "Even under the best circumstances, it can take years to stand up the manufacturing capabilities required to safely produce vaccines."

Representatives for U.K.-based vaccine maker AstraZeneca did not respond to a request for comment on the WTO proposal.

--Additional reporting by Alyssa Aquino and Ryan Davis. Editing by Adam LoBelia.

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