NIH sues Moderna over COVID-19 vaccine patent

by mcardinal

Chris Lange, FISM News


A dispute over patent rights to the Moderna COVID-19 vaccine is headed to court.

The U.S. National Institutes of Health (NIH) claims Moderna failed to include three NIH scientists who played a role in developing the vaccine from its patent application filed in July, according to a New York Times report. The NIH asserts three of its scientists who played “a major role” in designing the genetic sequence used in Moderna’s vaccine should be given co-ownership of its patent.

“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,” NIH Director Dr. Francis Collins told Reuters on Wednesday.  

According to a June 2020 Axios report, while the NIH typically funds outside research, its scientists frequently develop technologies which are then licensed out and used in the development of pharmaceuticals and sold for profit. It is atypical for the agency to seek patent rights. In the case of the COVID-19 vaccine, however, co-ownership of the patent by the federal government allows it to provide free or low-cost vaccine distribution to the public.

Moderna, a pharmaceutical and biotechnology company based in Cambridge, Mass., admitted that NIH scientists Dr. John Mascola, Dr. Barney Graham, and Dr. Kizzmekia Corbett played a “substantial role” in the development of its COVID-19 vaccine but disputes the agency’s patent claims, according to a statement issued to Reuters.

The company projects that its 2021 vaccine sales will reach between $15 and $18 billion and up to $22 billion next year. The COVID-19 vaccine is Moderna’s first commercial product of the company since it was founded in 2010.

According to Collins, the NIH has been attempting to reach a resolution with Moderna concerning the patent for some time, to no avail, which ultimately prompted the legal action. “Clearly this is something that legal authorities are going to have to figure out,” he said. “It’s not a good idea to file a patent when you leave out important inventors, and so this is going to get sorted as people look harder at this.” 

Moderna and the NIH have collaborated on research on other coronaviruses, including MERS, for years. A December contract between the two states that “mRNA coronavirus vaccine candidates [are] developed and jointly owned” by both parties. The novel coronavirus, however, was not mentioned in this contract, the execution of which predates sequencing of the virus.

A Nov. 2  letter from advocacy group Public Citizen, which was obtained by the Times, outlines NIH’s contributions to the development of the Moderna vaccine and urges the NIH “to publicly reclaim the foundational role of the NIH…and use your leverage to champion global vaccine access.” The letter points to a “lack of transparency” on the part of Moderna concerning its patent applications for the vaccine, which heretofore “precluded us from identifying additional patent applications specific to mRNA-1273.”

Zain Rizvi, a health law and policy researcher at Public Citizen, said in June that “the government and the public have a stake” in the vaccine which, he said, “would not exist without the intellectual contributions of federal scientists.”