Moderna Delays Application for Shot Patent Disputed by NIH

Bloomberg

• The National Institutes of Health has objected to Moderna listing only company scientists, and not those from the NIH’s Vaccine Research Center, as inventors on the patent application
• 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

Moderna Inc said it has delayed issuance of a patent on its Covid vaccine that’s in dispute with the US government over who should be listed as inventors, a move that will allow more time for negotiations.
The National Institutes of Health (NHS) has 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 US 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.
Moderna’s actions may ratchet down the unusually public dispute with the government and ensure that, at least for now, there won’t be a court fight over the issue. The patent office had said the application could be approved, but the company never paid the fee to have it issued by the November 29 deadline and it was labeled abandoned earlier this week. Instead, Moderna filed a new, related application that gives it time to negotiate with the NIH.
“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.
NIH representatives didn’t respond to a request for comment late in the day. Moderna shares rose 0.6% after US markets closed.
Determining who should be listed as an inventor is a complicated issue that involves analysing 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.
Each inventor has full rights in a patent, and having government researchers would give the NIH co-ownership. That would enable it to license the invention to third parties without Moderna’s permission.
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. The Defense Department’s Defense Advanced Research Projects Agency is investigating the claims, according to a letter the agency sent to Knowledge Ecology International, an advocacy group, earlier this year.
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,” said KEI Director James Love. “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.”