Moderna is disputing some claims by the National Institutes of Health that it was behind the invention of the company's mRNA coronavirus vaccine, raising the stakes in the debate over the government's ability to exert influence over the availability and price of the vaccine in the future.
At the core of the dispute is the contribution of NIH-funded scientists who worked closely with Moderna at the dawn of the pandemic to develop the groundbreaking vaccine.
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The dispute was revealed in patent applications filed by Moderna that were reviewed by researchers for the consumer advocacy group Public Citizen.
Some of Moderna's applications excluded government-funded scientists.
The dispute between Moderna and NIH was first reported Tuesday by the New York Times.
The NIH had asserted in documents filed at the U.S. Patent and Trademark Office that three scientists, including Barney Graham, a leading vaccine researcher at the National Institute for Allergies and Infectious Disease, were inventors of key elements of the vaccine, Moderna acknowledged in the documents.
"However, (Moderna has) reached the good-faith determination that these individuals did not co-invent the mRNAs and mRNA compositions claimed in the present application," Moderna said in the documents.
Vaccines and drugs typically are covered by multiple patents. In the case of the mRNA vaccine, Moderna has recognized the contribution of NIH scientists in just one of four patents that Public Citizen examined.
Public Citizen urged NIH to take action to assert the role of government-backed scientists in the invention of the coronavirus vaccine.
Moderna has come under fire from global health leaders and advocates for not making its vaccine and know-how more widely available to address the vaccination gap among rich and poor countries. Advocates also have pushed the government to exercise its licensing rights over the vaccine to force Moderna to share technology.
"We urge you to publicly clarify the role of NIH in the invention of the vaccine, and to explain the steps you intend to take to ensure the contributions of federal scientists are fully recognized, including any legal remedies," Public Citizen wrote to NIH Director Francis Collins.
NIAID said Tuesday that it disagrees with Moderna's position after a thorough review and that its scientists should be named as inventors. Citing a four-year history of investigating potential vaccines with Moderna for other coronaviruses, including MERS, the agency said in a statement that "NIH and Moderna agreed to collaborate and jointly develop a COVID-19 vaccine" last year.
"Omitting NIH inventors from the principal patent application deprives NIH of a co-ownership interest in that application and the patent that will eventually issue from it," it said.
The Times quoted an unnamed government official as saying NIH was surprised by Moderna's patent filings.
Moderna said in a statement Tuesday: "Moderna has all along recognized the substantial role that NIH has played in developing Moderna's coronavirus vaccine. That includes acknowledging that scientists from NIH made inventive contributions during the course of developing the vaccine, and including them as co-inventors on patent applications that have also published recently with claims to the use of mRNA-1273," the technical name of its vaccine.
But, it said, "only Moderna's scientists designed mRNA-1273 itself."
The NIH said last year that it granted nonexclusive licenses to a number of companies to use the spike protein that government-funded scientists engineered in January 2020, almost as soon as China published the gene sequence of the novel and deadly virus. In Moderna's case, the government also subsidized research and development and manufacturing and made guaranteed advanced purchases.
The dispute between Moderna and NIH has its root in a dramatic weekend in January 2020, as government and government-funded researchers and Moderna scientists worked together to nail down the gene sequence for a stable copy of the distinctive coronavirus spike protein that would be used in the vaccine to trigger an immune response.
"It all comes down to that weekend where this sequence work was done," said Zain Rivzi, research director at Public Citizen. "The vaccine itself would not exist without the massive contribution of the federal government at every step of the way."
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