Moderna Delays Bid for Covid Shot Patent Disputed by NIH

(Bloomberg) --

Moderna Inc. said it has delayed efforts to obtain a patent on its Covid vaccine that’s in dispute with the U.S. government over who should be listed as inventors, allowing more time for negotiations. 

The National Institutes of Health objected to Moderna listing only company scientists, and not those from the NIH’s Vaccine Research Center, as inventors on the patent application. Moderna acknowledged the NIH as “collaborators” but said in a July filing with the U.S. Patent and Trademark Office that it had made a “good-faith determination that these individuals did not co-invent the mRNAs and mRNA compositions claimed” in the specific application.

The application has been abandoned, and Moderna has instead filed a new related patent application that gives it time to negotiate with the NIH. Moderna’s actions may ratchet down the unusually public clash with the government and ensure that, at least for now, there won’t be a court fight over the issue. 

“Moderna has taken this action to allow more time for discussions with the NIH,” the company said in a statement. While the company believes that its scientists invented the mRNA sequence at the heart of the patent. “NIH feels equally strongly that its scientists should be listed as co-inventors,” Moderna said. 

The patent office had said the application could be approved, but the company never paid the fee to have it issued by the Nov. 29 deadline and it was labeled abandoned this week. 

NIH said applauded the company’s actions. 

“NIH values its collaborations with Moderna, which have led to the development of a life-saving vaccine,” the agency said in a statement. “We welcome the opportunity to work with the company to resolve pending intellectual property issues in a way that recognizes the profoundly important contributions of NIH scientists as co-inventors.”

Moderna shares rose 0.6% after U.S. markets closed. 

Murky Area of Law

Every person listed as an inventor has full rights to a patent, though most corporate and government researchers are required to sign over those rights to their employers. Having its scientists listed as inventors would give the NIH co-ownership and enable it to license the invention to third parties without Moderna’s permission.

The new application gives Moderna time to consider its options, said James Love, director of the advocacy group Knowledge Ecology International.

It “sounds as if Moderna wants to find out what the NIH would do if it ended up with equal inventorship rights in the patent, before Moderna allows the patent application to go forward,” Love said. 

“In some scenarios, Moderna would probably prefer there to be no patent, while in others, such as Moderna exercising some control over licensing and sharing royalties when the patent is licensed to third parties, a patent grant is a positive for the company, even with shared inventorship,” he said.

Determining who should be listed as an inventor is a complicated issue that involves analyzing the specific wording of the patent claims and the work done by individuals, said Eldora Ellison, a biotechnology patent lawyer with Sterne Kessler in Washington, who isn’t involved in the case.

“Even courts have acknowledged that inventorship is one of the murkiest areas of the law,” she said in an interview before Moderna’s announcement. “We try to understand what happened, factually, and where the ideas underlying the invention came from and think about the intellectual contributions of individuals.”

The patent office focuses on whether the application covers a new invention and doesn’t get involved in deciding who should be listed as an inventor, she said. That has to be decided by the courts if there’s a dispute, and errors in listing the proper inventors can lead to the patent being labeled invalid or unenforceable.

Consumer groups have accused Moderna of failing to disclose how much money it received to develop and manufacture its vaccine and say greater transparency would ensure that the Moderna vaccine is free and widely available around the world. 

Being listed as inventors would enable the government scientists to get royalties above their regular pay, though the amount is limited by law. 

“It was their guys, it’s their inventors and their collaboration,” Love said before Moderna’s actions. “There’s glory, there’s prizes to be made. There’s career advancement. There’s a lot of professional reasons for why the patent has a status fully apart from the money.”

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