Biden backs plan to accelerate vaccine production by waiving patents

The Biden administration has thrown its weight behind an international effort to loosen patent and other legal protections for COVID vaccines.

“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,” wrote US Trade Representative Katherine Tai in a Wednesday statement.

If successful, that effort might open up the vaccine market to independent drug makers, speeding production and distribution and ending the pandemic more quickly. Or it might not.

The World Trade Organization has a treaty on Trade-Related Aspects of Intellectual Property (TRIPS) that requires countries to provide a minimum level of patent, copyright, and other protections. Back in October, India and South Africa submitted a proposal for the WTO to waive the TRIPS agreement for vaccine patents and other rights related to fighting the pandemic.

On its own, the proposal wouldn’t change any laws or nullify any patents. Rather, if the WTO accepted the proposal, that would free countries like India and South Africa to provide patent exemptions within their borders—without worrying about richer countries punishing them with retaliatory trade policies. Even with a TRIPS waiver in place, many richer countries might leave patent protections in place.

Over the last six months, the WTO’s TRIPS council has been unable to reach a consensus on the issue. The Biden administration’s change of heart could give the proposal new momentum.

“Negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved,” Tai said.

If the WTO ultimately decides to allow vaccine patents to be waived, it’s not clear if this would actually speed up vaccine distribution. One notable skeptic is Bill Gates, who has poured resources into vaccine production over the last year.

“There’s only so many vaccine factories in the world,” Gates said in an interview last month. “The thing that’s holding things back in this case is not intellectual property. There’s not like some idle vaccine factory with regulatory approval that makes magically safe vaccines.”

Pharmaceutical chemist and blogger Derek Lowe argues that there are several factors holding back vaccine production that are unrelated to patents. These include shortage of equipment, filtration materials, and “key materials like the lipids needed for the mRNA vaccines.”

Another issue that both Gates and Lowe pointed to is a shortage of expertise to enable vaccine production to transfer to new factories. “All of these processes (mRNA, adenovirus) need hands-on tech transfer to troubleshoot as they ramp up, otherwise production can be spotty with poor QC pass rates,” Lowe writes. “There simply aren’t enough experienced people to go around!”

But groups like Doctors without Borders argue that waiving patents and other rights would still be helpful.

“IP issues, including patents, can be a barrier to cheaper vaccines entering the market,” the group wrote in a recent fact sheet. “Patents have also been applied for or granted across the entire vaccine development, production and delivery process. These patents increase uncertainty and costs, delay competition and keep prices high for low- and middle-income countries.”