Moderna and NIH Dig in Over COVID-19 Vaccine Patent Dispute

Moderna and the National Institutes of Health (NIH) are in a patent dispute over the company’s messenger RNA (mRNA)-based COVID-19 vaccine developed with the aid of government scientists.

At issue is who deserves credit for the actual invention of the mRNA-1273 construct used in the vaccine ― the result of a four-year partnership between the NIH and Moderna to develop shots for several diseases, including MERS. Starting in January 2020, the collaborators shifted gears and began work on a COVID-19 vaccine, with the work bearing fruit and Moderna filing its first patent application for mRNA-1273 later that month.

But in a later July 2020 patent filing, Moderna sought to make its position unambiguous on the role of three collaborator NIH scientists: Kizzmekia Corbett, Barney Graham and John Mascola. “Applicants have reached the good faith determination that these individuals did not co-invent the mRNAs and mRNA compositions claimed in the present application,” the Cambridge, Mass., drugmaker said in a filing with the U.S. Patent and Trademark Office (USPTO).

The NIH disagrees with that characterization and makes clear it’s not backing down.

“NIH disagrees with Moderna’s inventorship determination regarding its mRNA-1273 patent and, as a result of its own thorough review of the matter, has determined that [the] NIH scientists … are co-inventors of Moderna’s principal patent application  ... and should be named as such,” an NIH spokesperson told FDAnewsyesterday, adding that “omitting NIH inventors” deprives the agency of a co-ownership of the “patent that will eventually issue from it.”

Meanwhile, Moderna asserts “only Moderna’s scientists designed mRNA-1273 itself,” but stresses that it “has all along recognized the substantial role that the NIH has played in developing Moderna’s COVID-19 vaccine.” In addition, the company acknowledges that the scientists “made inventive contributions during the course of developing the vaccine,” which is why it included them on another patent application related to how the vaccine is used.

But the NIH characterizes this “methods of using” filing as a “minor patent application.”

So, what’s next? The USPTO has not granted the mRNA-1273 patent yet, with timing unclear on when this would happen. And the NIH told FDAnewsit doesn’t have any further insight on a date. But once the USPTO does act, and if it grants a patent respecting Moderna’s designation, then the U.S. government would have to choose whether to take the drugmaker to court over a life-saving product it invested billions to help create.

Undeniably, the matter has important implications for both Moderna and the government. While the government can’t manufacture or distribute vaccines, the NIH could license the patent rights to other companies to use the mRNA product in their shots. That raises the prospect of millions of dollars in licensing fees for the U.S. government. If Moderna’s COVID-19 vaccine sales are any precedent, that means massive sums are at stake for that company, too. ― Jason Scott