The idea of patent pools such as the COVID-19 Technology Access Pool (C-TAP) created by the World Health Organization a few months ago has drawn a lot of support from low- and middle-income countries and a handful of wealthier ones, but not so much from industry.
When BioWorld asked last week how many patents had been donated to the pool, WHO didn’t respond. Instead, the organization seems to be focusing its resources on COVAX, a global initiative aimed at working with vaccine manufacturers to provide countries equitable access to COVID-19 vaccines, once they’re licensed or approved. Instead of pooling patents, COVAX offers a procurement mechanism.
As of Aug. 24, COVAX boasted the world’s largest and most diverse COVID-19 vaccine portfolio, with nine candidate vaccines, another nine under evaluation and conversations underway with other major producers, according to WHO.
The organization’s shift from patent pools to pooled procurement is not surprising. From the time WHO launched C-TAP in May, industry officials have dismissed pooling and, in the alternative, compulsory licensing as unnecessary or even dangerous to the future of biopharma innovation.
Speaking at a May 28, 2020, International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA) media briefing on COVID-19 vaccine development, IFPMA Director General Thomas Cueni said expecting companies to give up their intellectual property for SARS-CoV-2 vaccines showed a lack of understanding. In the history of IP, there’s never been a need for compulsory licensing of vaccine patents, he noted.
“IP is a fundamental part of our industry,” Astrazeneca plc Executive Director and CEO Pascal Soriot agreed. “And if you don’t protect IP, then essentially there’s no incentive for anybody to innovate.” He maintained that it was because of strong IP the biopharma industry is robust and able to respond so quickly to a global pandemic caused by a novel coronavirus.
Pfizer Inc. Chairman and CEO Albert Bourla added that with hundreds of biotechs investing billions of dollars in vaccine development, having someone say they’re going to take that IP is dangerous. None of the vaccine developers at the briefing were participating in the pool.
Probably no one in the biopharma industry is supportive of patent pooling, Chad Landmon, chair of the intellectual property and FDA practice groups at Axinn, Veltrop & Harkrider LLP, told BioWorld. Even U.S. universities that license IP supported by publicly funded research wouldn’t support a pool that freely shares those patents, he said.
Rather than pooling their patents, companies are opting to collaborate, oftentimes on a huge scale, to ensure COVID-19 vaccines and therapies are developed and produced in the quantities the world is demanding, Bourla said.
IP tricky with collaborations
But industry collaborations, especially on a global scale, can be tricky when it comes to IP, whether companies are collaborating on vaccines, therapies or diagnostics. Companies need to be careful that, in the rush to collaborate and move forward during the pandemic, they carefully think through the IP issues and spell them out contractually, Landmon advised.
That means considering IP law in the EU, Japan, Korea, the U.S. and other countries. It also means recognizing that the value of IP differs country by country, Landmon said. Thus, during the pandemic, collaborators will need to think through where it’s more important to provide access than it is to protect a patent.
“These agreements get pretty complicated pretty quickly,” Landmon said. He advised companies to consider the following questions when drafting contracts to govern their collaborations:
- Who gets to use the patents? And for what purposes?
- How long do they get to use the patents?
- Who gets the IP if the collaboration splinters?
- When there’s a patent challenge or infringement, who will enforce the IP?
That last question could be especially important going forward. “I think there will be a lot of new patents” arising from the pandemic, Landmon said, especially for pandemic-related diagnostics and vaccines. Since much of the COVID-19 drug development is looking at repurposing older drugs, patents in that space likely will focus on methods of use and not so much on new compounds, he added.
“A lot of those patents probably will be weak,” Landmon said. With so many researchers and companies looking for answers, obviousness will be a big issue in challenging pandemic-related patent claims. In the U.S., that could lead to many inter partes review challenges to COVID-19 claims.
As for the clamor for march-in or free access to COVID-19 patents, Landmon said industry needs to recognize that the pandemic has increased and brought to the forefront demands to end biopharma patents, partly because of all the government resources going into the development of COVID-19 drugs and vaccines.
Because of that sentiment, companies should be careful in how they price and scale up those products. They should make their therapies and vaccines affordable and ensure a robust supply, Landmon said, otherwise they will face a public backlash and increased pressure on pricing and patents.
But even as the pandemic presents a lot of challenges, it also is offering an opportunity for the biopharma and med-tech space to show its value, Landmon said, pointing out how quickly the private sector got COVID-19 diagnostics out after the government failed.
Industry is recognizing that opportunity. “This is what a successful, healthy pharmaceutical industry can do,” Astrazeneca’s Soirot said at the IFPMA briefing. “I know we are often criticized. But today, hopefully, we can show … that the whole industry is stepping in.”