Moderna is pausing a patent dispute with the federal government over its groundbreaking coronavirus vaccine, saying it is "grateful" to government scientists who collaborated with the company and wants to "avoid any distraction" in the fight against the omicron variant.
The decision could have implications for the Biden administration's global vaccination strategy, as officials look for leverage to share mRNA vaccine discoveries with developing countries in an effort to ramp up worldwide supply.
It is also expected to turn down the heat on the Cambridge, Mass., vaccine maker, which projected as much as $18 billion in sales from its vaccine this year, and has received stinging criticism for doing too little to share its breakthroughs with poorer nations.
Government scientists worked with Moderna in January 2020 to rapidly develop the spike protein technology key to the company's messenger RNA vaccine.
But Moderna had disputed claims that three scientists from the National Institutes of Health were co-inventors, complicating the government's ability to license the shot and share it with vaccine makers in low- and middle-income countries, where vaccines are still scarce.
Moderna officials said attention to the patent issue had ballooned and threatened to disrupt the pandemic response.
"The Company would like to avoid any distraction to the important public-private efforts ongoing to address emerging SARS-CoV-2 variants, including Omicron," Moderna said in a statement on Friday night shared with The Washington Post. Moderna also said it filed a continuation that will allow it to pursue discussions about the patent at a later date.
Moderna first informed NIH of its plan to drop the patent application at a Dec. 10 meeting, a Moderna spokesperson said.
NIH did not respond to requests for comment. Two administration officials on Friday night said they were still studying whether Moderna's decision would enable the government to revise its global strategy.
Celine Gounder, an infectious-disease doctor who advised President Joe Biden's transition team on the coronavirus, said she hoped Moderna's decision would empower the White House to compel the company to share its technology - particularly given the need for additional shots to fight virus variants like omicron.
"It would make a huge difference if they're willing to do that, where there is some sharing of vaccine manufacturing, recipes and know-how . . . that really could lead to establishment of regional manufacturing capacity," Gounder said. "We need to think about other ways to scale up manufacturing."
The White House has been at odds with Moderna over the vaccine maker's broader strategy, with Biden officials privately adamant that the 11-year-old company - which had never turned a profit before the pandemic - owes its success to the U.S. government. The company was staked with about $2.5 billion in federal funds to develop its vaccine last year, and has since received billions more to boost its manufacturing capacity.
Moderna's decision to back down on the patent application "reflects a realization that the federal government would stand up for the critical role its scientists and taxpayer money played in the invention," Ameet Sarpatwari, a Harvard University professor who specializes in health-care law, wrote in an email.
Advocacy group Public Citizen, which first called attention to the patent dispute, framed Moderna's decision as a qualified victory.
"It's obvious that Moderna is feeling the heat, and they're trying to turn it down a notch," said Zain Rizvi, research director at Public Citizen. "But I think it's important to recognize that this is, in part, Moderna kicking the can down the road" because the company has not ruled out resuming its patent fight in the future.
Moderna officials previously said that they had offered NIH an opportunity to co-own the patent, but the talks had not produced an agreement. The company also announced last year that it would not enforce its patents if other manufacturers wanted to pursue making their own versions of the vaccine.
"At Moderna, we probably didn't think much of it because we'd offered co-ownership [to NIH]. And we'd said we weren't enforcing the patent," Moderna president Stephen Hoge said in a Nov. 17 interview. "But now, I regret that we didn't resolve it, because it's become a greed narrative."
But some experts said that Moderna's moves hadn't gone far enough.
"The barrier to expanding vaccine manufacturing isn't patents - it's trade secrets and scarce physical supplies," Lisa Larrimore Ouellette, a law professor at Stanford University, wrote in an email. "Other manufacturers still aren't able to make the vaccine without active cooperation from Moderna."
While Moderna had acknowledged NIH-funded scientists' role in devising the vaccine, some of its patent applications excluded the government's contributions, the New York Times first reported last month.
"Moderna believes that its scientists invented the specific mRNA sequence at the heart of the patent in question," according to Moderna's statement on Friday. "The Company acknowledges that NIH feels equally strongly that its scientists should be listed as co-inventors for their contemporaneous work on the protein sequence."
THE WASHINGTON POST