As COVID vaccine patent dispute drags on, Moderna forks over $400M to NIH

Image of a syringe in front of the Moderna logo.

Vaccine maker Moderna forked over $400 million to the National Institutes of Health to use molecular stabilization technology borrowed from government and academic researchers for its mRNA-based COVID-19 vaccine. to the New York Times.

Moderna referred to the payment in the company’s latest earnings report, describing the amount as a “catch-up payment” negotiated with the NIH as part of a new royalty-bearing licensing agreement in December. The deal would also give the NIH “low-single-digit royalties on future COVID-19 vaccine sales.” The company expects he will have about $5 billion in sales for its COVID-19 vaccine in 2023.

The molecular technology at the heart of the agreement is designed to stabilize the SARS-CoV-2 spike protein to facilitate potent immune responses after vaccination. An mRNA-based vaccine provides the genetic code for the spike protein, which is translated into protein by human cells. Researchers at the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and collaborators at the Scripps Research Institute in Dartmouth and La Jolla, Calif. have fine-tuned the mRNA code so that the protein spikes at translation time, triggering the immune response. It remains locked into a specific conformation that is best suited to generate. We published that in a 2017 study involving the spike protein from the syndrome coronavirus. Moderna said in 2016 he began working with his NIAID on the general design of mRNA-based vaccines, although none of the scientists were authors of his 2017 paper.

The Times reported that the NIH will share catch-up payments from Moderna with Dartmouth and Scripps.

While the deal appears to have settled some of the rights to a life-saving, multi-billion dollar vaccine, a bigger battle still looms. That battle centers around a major patent filed by Moderna over the entire mRNA sequence used in the vaccine. Moderna says the scientist came up with the sequence on its own, but the NIH says researchers came up with it and provided it to the company. The agency asked Moderna to list her three NIH researchers as co-inventors on the patent they filed. But Moderna ruled them out, as Nature reported in 2021.

“not finished yet”

At the time, NIH Director Francis Collins told Reuters that the NIH spent time trying to resolve the dispute with Moderna amicably, but failed. “I think Moderna made a grave mistake in not offering credit as a co-inventor to the people who played a major role in the development of the vaccine and are now making significant amounts of money,” Collins said. Stated. .

“But we’re not done yet,” he added. “Obviously, this is something that law enforcement agencies have to figure out.”

It is unclear how that dispute will be resolved, and such patent disputes could take years to unfold. Not sure how aggressive it will be. As Nature noted earlier, the agency sees its role as basic research, and has therefore tended to let its industry partners handle intellectual property. But as drug prices continue to soar in the United States, the political will is changing for governments to become more involved in the outcome of early-stage efforts.

As noted by The Times, Moderna not only generated about $36 billion in sales from COVID-19 vaccines worldwide, but also received $10 billion in funding from taxpayers to help develop and test the vaccine. But this year, the company signaled it would raise the price of its vaccine by 400% as it moves from government distribution to the commercial market. At Moderna last week, Moderna issued a commitment statement that Americans “can access Moderna’s COVID-19 vaccine regardless of their ability to pay.” How it works is still unknown.

Commenting on the agreement with the NIH announced yesterday, Moderna spokesperson Chris Ridley said in a statement to the Times, “We will continue to pursue productive licensing of certain patents related to the COVID-19 vaccine from 2020 onwards. We’ve had a lot of discussions,” he said. He added, “It has always been our intention to reach an agreement and we are pleased that we did so last December.”

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