The public/private partnership between the U.S. government and Moderna to quickly develop a COVID-19 vaccine has been lauded as a feel-good success story—and a blueprint for future health crises.
But less than a year after Moderna gained FDA authorization for its vaccine, its marriage with the feds is on the rocks. The company has done little appease the Biden administration’s call to make the vaccine available to poor countries, and now a much bigger battle over patent rights is brewing, The New York Times reports.
The issue surrounds a July filing by Moderna with the U.S. Patent and Trademark Office which claims that it invented the vaccine. Meanwhile, the NIH says that three of its scientists created key elements of the shot.
The squabble has been ongoing for more than a year, the Times reports. The consumer rights advocacy group Public Citizen has helped bring the dispute from behind closed doors after reviewing patent documents. Without a resolution between the parties, the battle could be headed for court.
At the outset of the pandemic, the government provided funds to several companies—including $1.4 billion to Moderna—to develop COVID-19 vaccines. Assisting in the effort was the NIH and scientists from its Vaccine Research Center—John Mascola, M.D., Barney Graham, M.D., and Kizzmekia Corbett, M.D.
But in a patent document, Moderna claims that it has “reached the good-faith determination that these individuals did not co-invent the mRNAs and mRNA compositions claimed in the present application.”
In the application, Moderna includes the names of several employees who are credited with the invention.
Of the four patents filed by Moderna and reviewed by Public Citizen, only one cites the contributions of the NIH. Public Citizen is urging the NIH to take up the cause of its scientists.
The advocacy group saw the patent fight coming. Last December, Peter Maybarduk, Access to Medicines Director at Public Citizen, dubbed it the “People’s vaccine.”
“It’s not merely Moderna’s vaccine,” Maybarduk told Forbes. “Federal scientists helped invent it and taxpayers are funding its development. We all have played a role. It should belong to humanity.”
Much is at stake in the patent fight. With rights to the vaccine, the government could license it to other companies to ensure broader access and recoup some of the funding it provided.
It is not the only patent battle in which Moderna is engaged. Last month, Bloomberg revealed that Moderna is seeking to invalidate two patents owned by Arbutus Biopharma. The move is a preemptive strike against the Pennsylvania company, which may be in position to sue Moderna for infringement of its drug-delivery technology, according to the news service.
The patent concerns come amid other troubles for Moderna. Last week, in reporting third quarter earnings, the company slashed its previous estimate of 2021 COVID-19 vaccine revenue from $20 billion to between $15 billion to $18 billion. The company said that international shipping delays have become more of a hinderance as Moderna tries to deliver the shot to more countries.
Over the last week, Moderna stock price has fallen by more than 30%.