Moderna Won't Enforce COVID-19 Patents During Pandemic

By Kevin Stawicki
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Law360 (October 8, 2020, 8:25 PM EDT) -- Moderna Therapeutics said Thursday it won't enforce seven patents related to its coronavirus vaccine during the pandemic, an unprecedented move in an industry known for vigorously protecting its intellectual property and one that could have a ripple effect across other companies.

Biotechnology company Moderna says it has a "special obligation" to make its intellectual property available to other companies attempting to make a COVID-19 vaccine. In photo, a Moderna building in Cambridge, Massachusetts. (AP Photo/Bill Sikes)

The Massachusetts-based biotechnology giant said it has a "special obligation" to make its intellectual property for mRNA vaccines and therapeutics available to other companies attempting to make a vaccine during the pandemic.

"Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic," the company said in a statement. "To eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period."

Those patents include gene-based technologies that haven't yet been used in an approved product, the company said.

Thursday's announcement comes amid the global race to develop a viable vaccine and looming distribution challenges. James Love, the director of Knowledge Ecology International, a nonprofit organization that advocates for access to medical technologies, said the move "should be matched by every manufacturer of a therapeutic, vaccine or diagnostic test."

"Every manufacturer of a vaccine, drug or diagnostic should follow suit and publish the patents relevant to the technology, waive or license rights in those patents, and also provide constructive transfer of manufacturing know-how and access to cell lines and data when necessary," Love said.

KEI recently led the charge accusing Moderna of failing to tell the U.S. Patent and Trademark Office that the Defense Advanced Research Projects Agency was funding its efforts to develop mRNA vaccines for viral infections, including its COVID-19 vaccine candidate.

The U.S. Department of Defense launched a probe into the funding sources in August, and a U.S. Department of Health and Human Services subagency announced an investigation into the same issue in September. 

David Silverstein, an intellectual property attorney at Axinn Veltrop & Harkrider LLP, said Moderna's move is "unprecedented," but cautioned against thinking of it as anything more than a public relations stunt.

"It's like Elon Musk saying, 'Anybody who wants can use our rocket technology,'" he said, noting that there are very few companies that have the equipment and know-how to utilize these technologies.

Because there's no way any one company could satisfy all of the market's needs for coronavirus vaccines because virtually everyone will want one, Silverstein said there's no harm to Moderna in freely licensing the technology during the pandemic. 

"It's a clever public relations move," he said. "If the rest of the industry does this, then it just makes the whole industry look better to the public."

While the world is still in the vaccine development phase, the vaccine deployment phase will bring a host of new challenges and could raise new questions about distribution delays and whether companies like Moderna are perceived by the public as being "greedy" with their patents, Silverstein said.

"This is a great way to get ahead of that," he said.

The announcement could also be another tactic by Moderna in its legal battle with Arbutus Biopharma Corp., Silverstein said. In July, the Patent Trial and Appeal Board shot down Moderna's attempt to invalidate claims of an Arbutus patent involving some of the vaccine technology. The PTAB ruling raises questions about whether the company even needs a license for the technology at all, he said. 

Other companies have recently been inching toward expanding access to vaccines they develop during the pandemic. AstraZeneca announced in August that it would allow all European Union member states to access its vaccine "in an equitable manner at no profit."

The company has said it treats vaccine development "as a response to a global public health emergency, not a commercial opportunity."

There has also been a global push for wider access to intellectual property related to vaccine development. In another unprecedented move, India and South Africa asked the World Trade Organization on Oct. 2 to give countries the opportunity to not grant or enforce patents for COVID-19 drugs and vaccines.

"A global pandemic is no time for business-as-usual, and there is no place for patents or corporate profiteering as long as the world is faced with the threat of COVID-19," Leena Menghaney, the South Asia head of the access campaign of Doctors Without Borders, said in a statement.

--Additional reporting by Dave Simpson. Editing by Breda Lund.

Update: This article has been updated with additional information about the announcement.

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