Moderna-NIH spat over inventorship opens new front in COVID-19 vaccine patent battle

By Michael Rosen

In recent weeks, a new front has opened in the long-running war over COVID-19 vaccine patents: a fight between Moderna and the National Institutes of Health (NIH) over who exactly deserves credit for inventing the Moderna vaccine.

via Reuters

For more than a year, a worldwide battle has unfolded over whether the World Trade Organization (WTO) should suspend patent rights related to the vaccines. In October 2020, South Africa and India introduced a resolution to waive Trade Related Aspects of Intellectual Property Rights (TRIPS) covering COVID-19 vaccines. While the Trump administration, along with the European Union (EU), resisted the measure, President Biden reversed course, signaling in May that the United States would support a waiver.

But since then, momentum toward a TRIPS suspension has stalled, with the EU, Australia, and other countries delaying WTO action on the proposal. Last month, those delays stretched further, with the WTO again failing to advance the Indian and South African measure ahead of the organization’s ministerial conference, scheduled for the end of November in Geneva. The chair of the WTO’s TRIPS council candidly acknowledged that the body “is not yet in a position to agree on a concrete and positive conclusion.”

But in the meantime, a new wrinkle has emerged, as The New York Times reported earlier this month that Moderna and the NIH have found themselves embroiled in a fierce fight over who invented the mRNA compositions critical to the groundbreaking vaccine.

Specifically, in a filing with the US Patent and Trademark Office last July, Moderna formally asserted that while “their collaborators at the National Institutes of Health submitted John Mascola, M.D.; Barney Graham, M.D., Ph. D.; and Kizzmekin Corbett, Ph.D. to [Moderna] as additional co-inventors of this patent application,” Moderna in fact “reached the good-faith determination that these individuals did not co-invent the mRNAs and mRNA compositions claimed in the present application.”

What’s going on here? How does the NIH claim to have contributed to the invention, and why does Moderna deny the importance of these contributions? Who is right?

To begin with, patent law is fairly clear — if a bit parsimonious — on this question. “Unless a person contributes to the conception of the invention,” according to the leading authority from the US Court of Appeals for the Federal Circuit, “he is not an inventor.”

In this case, it’s not disputed that Moderna received roughly $1.4 billion from the Biomedical Advanced Research and Development Authority, a division of the Department of Health and Human Services. And Moderna itself told the Times that it has “all along recognized the substantial role that the N.I.H. has played in developing Moderna’s Covid-19 vaccine.” Here, Moderna insists that “only Moderna scientists designed” the vaccine, and indeed, the specific patent application at issue, entitled “Coronavirus RNA Vaccines,” pertained to the specific mRNA sequence used in the vaccine.

For its part, the NIH told the Times that it “disagrees with Moderna’s inventorship determination,” and argued that “omitting N.I.H. inventors from the principal patent application deprives N.I.H. of a co-ownership interest in that application and the patent that will eventually issue from it.”

This is certainly true, although perhaps less consequential than it may seem. After all, Moderna has generally taken a different, more accommodating approach to its own intellectual property than some of its competitors, announcing in October 2020 that “while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic.” And while the company’s efforts to provide vaccine doses to the developing world haven’t proceeded as expeditiously as we might like, delays have resulted more from supply-chain disruptions and other distribution snags in the global south than from foot-dragging by Moderna and its peers.

As the pandemic drags on mercilessly, it will be interesting to follow how this latest patent battle plays out.

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