BETHESDA, MD - JUNE 29, 2019: NIH NATIONAL INSTITUTES OF HEALTH sign emblem seal on gateway center entrance building at NIH campus. The NIH is the US's medical research agency.

Will NIH Learn from Myriad when Settling Its mRNA Inventorship Dispute with Moderna?

By Jorge L. Contreras

The National Institutes of Health (NIH) is currently embroiled in a dispute over the ownership of patent rights to Moderna’s flagship mRNA COVID-19 vaccine (mRNA-1273).

The NIH, which funded much of Moderna’s research on the COVID-19 vaccine, should be assertive in exerting control over the results of this taxpayer-funded research. Failing to do so would be a missed opportunity for the public sector to have a say in the distribution and pricing of this critical medical technology.

The Patent Dispute

The groundwork for the dispute predates the pandemic; documents indicate that from 2015 onward, the NIH collaborated with Moderna in scientific research on vaccine development for a number of viruses, including coronaviruses.

The main issue at stake in the dispute over mRNA-1273 is whether three researchers at NIH’s Vaccine Research Center contributed enough to Moderna’s vaccine technology during their years-long collaboration to qualify as “inventors” on Moderna’s vaccine patents. If so, NIH, their employer, would be a co-owner of the vaccine technology and could, in theory, make it more broadly available around the world.

In October 2020, Moderna publicly pledged not to assert its mRNA patents against suppliers of COVID-19 vaccines — a concession that I predicted (incorrectly, it turns out) would defuse the NIH dispute.

But in July 2021, Moderna made a filing with the Patent Office disclosing NIH’s contention that its researchers co-invented the mRNA technology, and then noting Moderna’s “good-faith determination that these individuals did not co-invent the mRNAs and mRNA compositions claimed in the [patent] application.” NIH apparently did little in response, so in early November, Public Citizen called on the agency to “publicly reclaim the foundational role of the NIH, and use [its] leverage to champion global vaccine access.” A few days later, NIH Director Francis Collins told Reuters, “Clearly this is something that legal authorities are going to have to figure out,” suggesting that the agency could resort to litigation if its inventors are not recognized. Moderna’s stock price sank and, in mid-December, Moderna announced that it would delay issuance of its mRNA patent until it could sort out the dispute with NIH. The parties currently appear to be at a standoff.

Myriad Parallels

For those familiar with the history of biotech patents, the inventorship dispute between Moderna and NIH bears a striking resemblance to a dispute that played out between Myriad Genetics and NIH a quarter century ago.

As I discuss in my recent book, The Genome Defense, an international race to isolate and sequence the BRCA genes associated with breast and ovarian cancer began in 1990. The “winner” of the race was Myriad Genetics, which identified the first of these genes in 1994.

Two NIH researchers in North Carolina, Roger Wiseman and Andrew Futreal, contributed DNA sequences from cancer-affected families to the effort. These contributions confirmed that the Myriad team were on the right track, eventually leading to their discovery and sequencing of BRCA1. As a result, both Wiseman and Futreal were listed among the 45 co-authors of the Science paper that announced the BRCA1 sequence, and were the primary authors of a companion paper identifying four BRCA1 mutations strongly linked with cancer.

Despite these contributions, Myriad failed to list Wiseman and Futreal as co-inventors on the BRCA1 patents that it filed soon after the discovery was made. Myriad’s CEO, Peter Meldrum, explained to the New York Times that, in his view, Wiseman “merely pulled out fragments of genetic DNA once he was told where to look” — hardly the makings of an inventor. Not surprisingly, NIH disagreed with Myriad’s characterization and filed its own competing patent applications on BRCA1.

The existence of dueling patent applications eventually led Myriad and NIH to the bargaining table. They settled the inventorship dispute in 1995. Under the terms of the settlement, NIH withdrew its BRCA1 patent application, and in return Myriad amended its own application to include Wiseman and Futreal as inventors, giving their employer, NIH, partial ownership of the patent.

The settlement entitled NIH to royalties from Myriad’s patent earnings (which were paid not by Myriad, but by the owner of the patent, the University of Utah Research Foundation), as well as shares of Myriad’s stock. But in return, NIH granted Myriad the exclusive right to operate under the patent, thereby ceding full control over the commercialization of the BRCA1 gene.

That concession enabled Myriad to monopolize the BRCA testing market for years to come and to limit access to testing for many in need. It was not until 2013, nearly two decades later, that the American Civil Liberties Union and Public Patent Foundation succeeded in striking down Myriad’s BRCA patents, and all patents on human genes. Had NIH, back in 1995, insisted on exercising greater control over the licensing of these patents, or at least on the prices that could be charged for BRCA testing, lives might have been saved.

Beyond Recognition

Today, it appears that NIH’s inventorship dispute with Moderna is motivated by similar concerns — the recognition of NIH researchers as inventors on a prominent patent. As NIH Director Collins told Reuters, “I think Moderna has made a serious mistake here in not providing the kind of co-inventorship credit to people who played a major role in the development of the vaccine that they’re now making a fair amount of money off of.”

While recognition is important to scientific careers and agency prestige, there is more at stake than egos in this dispute.

Specifically, NIH should take to heart the lessons that it learned from its inventorship dispute with Myriad. That dispute, too, resulted in NIH researchers getting inventorship credit on a commercially significant patent. However, NIH squandered its opportunity to achieve other public benefits when settling the dispute, such as greater public access to BRCA testing or controls on Myriad’s pricing of BRCA tests.

Admittedly, Moderna has already pledged not to assert its mRNA patents against other COVID-19 vaccine makers. However, Moderna’s pledge is valid only during the COVID-19 pandemic, at least on a royalty-free basis, and applies only to COVID-19 and not to other diseases that might benefit from an mRNA vaccine. Most importantly, Moderna’s pledge does not make available the complex manufacturing know-how or technology necessary to produce mRNA vaccines, as evidenced by its recent refusal to lend technical assistance to the WHO’s African vaccine technology transfer hub.

Accordingly, in settling the inventorship dispute with Moderna, NIH should not focus solely on the prestige at stake. The agency should instead seek concessions from Moderna to advance legitimate public health goals.

Jorge Contreras

Jorge L. Contreras is a Presidential Scholar and Professor of Law at the University of Utah with an adjunct appointment in the Department of Human Genetics. His research focuses on intellectual property, technical standards and science policy, and he is one of the co-founders of the Open COVID Pledge, a framework for contributing intellectual property to the COVID-19 response. Professor Contreras is the editor of six books and the author of more than 100 scholarly articles and chapters appearing in scientific, legal and policy journals including Science, Nature, Georgetown Law Journal, NYU Law Review, Iowa Law Review, Harvard Journal of Law and Technology and Antitrust Law Journal. He has served as a member of the National Institutes of Health (NIH) Council of Councils, the Advisory Councils of the National Human Genome Research Institute (NHGRI) and the National Center for Advancing Translational Sciences (NCATS), and as the Co-Chair of the National Conference of Lawyers and Scientists. He is a graduate of Harvard Law School (JD) and Rice University (BSEE, BA).

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