Fast COVID-19 Vaccines Raise Call For More Collaboration

By Dani Kass
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Law360 (December 10, 2020, 10:27 PM EST) -- Patent experts are torn over whether intellectual property rights should be suspended during the COVID-19 pandemic, both in the U.S. and abroad, but they agree that the collaboration that developed vaccines at record-breaking speed should continue in the future.

During a panel at the Annual Berkeley-Stanford Advanced Patent Law Institute on Thursday, attorneys from Genentech, McDermott Will & Emery LLP and Fish & Richardson praised the "framework of collaboration" created by the pandemic.

"There are a lot of other diseases that are essentially epidemics — diabetes, we need to address Alzeheimer's and other neurodegenerative diseases — so this idea of collaboration and figuring out a way through contract, through IP, through other things, to potentially work together to move some of those forward, I think could be a useful learning [experience] from this," said Fish & Richardson principal Teresa Lavoie.

The broader conversation, which also featured a University of Utah S.J. Quinney College of Law professor and was moderated by Durie Tangri co-founder Daralyn Durie, touched on what challenges patents will face and how to best encourage innovation while guaranteeing broad distribution of needed medicines.

But the discussion was bookended by compliments to the "unprecedented collaboration" seen over the last several months in an industry that already was big on collaboration, as worded by Genentech Associate General Counsel Cara Coburn. Those collaborations included members of private companies, big and small, along with governments and nongovernmental organizations.

"IP is a huge component of the collaborations, who brings what to a collaboration, what can be done with the IP during a collaboration, protecting what is learned," Coburn said.

She also said this system couldn't have thrived without the patent system underpinning it. When the time came to search for treatments, drug companies were able to turn to their "medicine chest" of products they'd already developed to see what would work for the novel coronavirus. 

However, it's been a challenge deciding how to best patent those repurposed drugs, said McDermott partner Bhanu Sadasivan. The drug compositions are likely already patent protected — or the patents have expired — meaning new patents would have to be issued for combining drugs, different formulations or methods of using them.

That kicked off a race to try to patent methods of use before other companies, while making sure a patent can hold up to any scrutiny based on enablement or written description requirements, something the Federal Circuit has been approaching strictly

"The potential issue is how quick can you get that patent on file and make it be enabled and described sufficiently when it takes a long time to get sufficient data … before someone else," Lavoie said, adding later that "it's literally a race because it's a pandemic and people are dying."

The attorneys were also stressed about how the "tremendous uncertainty," as Coburn put it, surrounding patent eligibility is going to affect these patients, particularly for diagnostics and methods of treatment.

The panelists also discussed whether certain provisions of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property should be waived during the pandemic and if compulsory licensing should be on the table.

Coburn said there's no need to waive TRIPS, which she called a "drastic solution," saying that it's unclear how doing so would help. She said there were no "concrete examples" of patents putting up any obstacles during the pandemic.

Jorge Contreras, the University of Utah law professor, likewise said that focusing on TRIPS may not be the best method for ensuring access to drugs, but he added that some kind of patent flexibility will have to be on the table.

It's going to be nearly impossible for a handful of companies to meet the global supply for COVID-19 vaccines, so easing up on patent rights is going to be essential to making sure broad distribution can happen, he said.

"These types of measures don't have to be permanent, and they're not requests that companies give up their IP rights entirely," he pointed out. "It's really a request that companies ease up on some of these rights in the short term to meet a very pressing global problem."

Contreras' issue with the TRIPS discussion is that it may be unnecessary. Individual countries have compulsory licensing mechanisms, which many have said they're willing to use, and under the Doha Declaration of 2001, WHO members agreed not to let TRIPS get in the way of responding to a public health crisis.

He noted that governments are already paying companies massive amounts of money to procure the vaccines, which should be enough incentive to innovate.

At that point, Contreras said, "patents are just gravy."

--Editing by Steven Edelstone.

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