Moderna and U.S. at Odds Over Vaccine Patent Rights

WASHINGTON — Moderna and the National Institutes of Health are in a bitter dispute over who deserves credit for inventing the central component of the company’s powerful coronavirus vaccine, a conflict that has broad implications for the vaccine’s long-term distribution and billions of dollars in future profits.

The vaccine grew out of a four-year collaboration between Moderna and the N.I.H., the government’s biomedical research agency — a partnership that was widely hailed when the shot was found to be highly effective. The government called it the “N.I.H.-Moderna Covid-19 vaccine” at the time.

The agency says three scientists at its Vaccine Research Center — Dr. John R. Mascola, the center’s director; Dr. Barney S. Graham, who recently retired; and Dr. Kizzmekia S. Corbett, who is now at Harvard — worked with Moderna scientists to design the genetic sequence that prompts the vaccine to produce an immune response, and should be named on the “principal patent application.”

Moderna disagrees. In a July filing with the United States Patent and Trademark Office, the company said it had “reached the good-faith determination that these individuals did not co-invent” the component in question. Its application for the patent, which has not yet been issued, names several of its own employees as the sole inventors.

[Read Moderna’s filing with the United States Patent and Trademark Office.]

The N.I.H. had been in talks with Moderna for more than a year to try to resolve the dispute; the company’s July filing caught the agency by surprise, according to a government official familiar with the matter. It is unclear when the patent office will act, but its role is simply to determine whether a patent is warranted. If the two sides do not come to terms by the time a patent is issued, the government will have to decide whether to go to court — a battle that could be costly and messy.

The dispute is about much more than scientific accolades or ego. If the three agency scientists are named on the patent along with the Moderna employees, the federal government could have more of a say in which companies manufacture the vaccine, which in turn could influence which countries get access. It would also secure a nearly unfettered right to license the technology, which could bring millions into the federal treasury.

The fight comes amid mounting frustration in the U.S. government and elsewhere with Moderna’s limited efforts to get its vaccine to poorer countries. The company, which has not previously brought a product to market, received nearly $10 billion in taxpayer funding to develop the vaccine, test it and provide doses to the federal government. It has already lined up supply deals worth about $35 billion through the end of 2022.

Drs. Mascola, Graham and Corbett declined to comment. But in statements to The New York Times, the N.I.H. and Moderna confirmed the conflict, which has been simmering for more than a year behind closed doors.

“N.I.H. disagrees with Moderna’s inventorship determination,” said Kathy Stover, a spokeswoman for the National Institute for Allergy and Infectious Diseases, the branch of the institutes that…