US wants COVID-19 vaccine patent waiver to benefit world, not boost China biotech

The Biden administration is examining methods to make certain that a waiver of COVID-19 vaccine patents to assist poor countries won't hand sensitive US biopharmaceutical technology to China and Russia, giving an answer to a chorus of concerns, US and industry officials say.

President Joe Biden on Wednesday backed the US entering negotiations at the World Trade Organization for the waiver of intellectual property rights as a way to improve vaccine supplies by allowing poorer countries to make their own.

So far, vaccines have gone overwhelmingly to richer nations, which scooped up contracts for them earlier this season. COVID-19 infection rates in wealthy countries have dropped as vaccination rates increased this year, but infections are still rising in 36 countries, with India's daily cases skyrocketing to nearly 400,000 a day.

Western pharmaceutical companies, a lot of that have received government support to build up vaccines, strongly oppose the transfer of intellectual property to create them. They state poorer countries will be slow to set up manufacturing capacity and compete for scarce supplies, hitting production.

Albert Bourla, CEO of Pfizer, said on Friday that the proposed waiver would disrupt progress made so far in boosting vaccine supplies. 

"It'll unleash a scramble for the critical inputs we require in order to make a effective and safe vaccine. Entities with little or no experience in manufacturing vaccines are likely to chase the very recycleables we require to scale our production, putting the safety and security of all at risk."

Many companies and today some US officials fear the move allows China to leapfrog years of research and rot the US advantage in biopharmaceuticals.

A senior Biden administration official said that while the priority is saving lives, america "would like to examine the result of a waiver on China and Russia before it went into effect to make sure that it's fit for purpose".

A question and answer document produced by the administration and distributed to industry representatives also acknowledges concerns that intellectual property sharing could damage the United State's competitive advantage over China, a business source acquainted with the discussions told Reuters.

The contents of the document read to a Reuters reporter by a business representative said the Biden administration believes it can address those concerns through the WTO negotiations, but didn't specify how. The foundation added that some agencies in the Biden administration have conflicting views of how to address the concerns in negotiations that are anticipated to take months.

Spokespersons at the White House and US Trade Representative's office had no immediate comment on the matter.

Pfizer and Moderna spokespersons did not react to requests for touch upon technology transfer concerns, while a Novavax spokesperson referred Reuters to the company's statement opposing the waiver on Friday, which said proposals to "weaken intellectual property protections wouldn't normally achieve equitable vaccine access".

Enforcing limits on use of the technology could possibly be very difficult, once handed over, some analysts say. Messenger RNA, found in COVID-19 vaccines by leaders Pfizer-BioNTech and Moderna, is a newly developed biotechnology that holds promise for treatments far beyond vaccines.

China and Russia have their own vaccines that do not use this biotechnology.

"It took Pfizer and Moderna a long time of research to build up these vaccines," said Gary Locke a former US ambassador to China and US Commerce Secretary. "China, Russia, India, South Africa and others want to gain access. Their intention is to get the underlying know-how to allow them to make make use of it to develop further vaccines," Locke said.

China's Fosun Pharma has struck a cope with BioNTech on COVID-19 vaccine product development, which would potentially give it usage of a number of the technology.

China has high ambitions for its pharma industry and already is developing its mRNA vaccine.

Patents themselves are publicly accessible, noted James Pooley, intellectual property attorney and former deputy director general of the United Nations' World Intellectual Property Organization. 

But trade secrets developed by Pfizer-BioNTech, Moderna and others, "cook books" of manufacturing processes such as for example temperature and growing conditions, have not been made public. That may in the end be a dual problem for negotiators. Before they protect the data, US officials would need to ensure access to it.

Those companies would have to be persuaded to come to the bargaining table to stop such trade secrets.

"What happens when as it happens that the US can’t actually deliver the info that is critically important to implementing the inventions?" Pooley asked. 

"This will be observed as another failure by the US and other rich countries to keep their promises."