NIH director says the agency will take legal action if necessary in patent fight with Moderna


The National Institutes of Health (NIH) is maintaining its position in a patent dispute over Moderna’s COVID-19 vaccine – and may be prepared to take legal action if necessary.

‘Clearly this is something that legal authorities are going to have to figure out,’ NIH director Dr Francis Collins said in an interview with Reuters on Wednesday.

After a years-long collaboration on the technology underlying Moderna’s Covid vaccine, the NIH and the company disagree on whether NIH scientists should be included as co-inventors on the technology’s patent.

A potential legal battle could end in the U.S. government taking ownership of the vaccine and selling it to manufacturers in other countries, thus increasing global vaccine supply.

Dr Francis Collins, director of the NIH, maintains that NIH scientists have a claim to inventing Moderna's Covid vaccine. Pictured: Collins holds up a model of the coronavirus as he testifies on Capitol Hill, Washington, DC, May 2021

Dr Francis Collins, director of the NIH, maintains that NIH scientists have a claim to inventing Moderna’s Covid vaccine. Pictured: Collins holds up a model of the coronavirus as he testifies on Capitol Hill, Washington, DC, May 2021

Moderna maintains that only its own scientists were involved in inventing the vaccine. Pictured: Vials of Moderna's vaccine, photographed at a clinic in Connecticut, April 2021

Moderna maintains that only its own scientists were involved in inventing the vaccine. Pictured: Vials of Moderna’s vaccine, photographed at a clinic in Connecticut, April 2021

For years prior to the Covid pandemic, NIH scientists worked with Moderna on developing potential messenger RNA (mRNA) vaccines.

The company – which had not brought a commercial product to market prior to 2020 – received billions of dollars in funding from the federal government for vaccine research and production.

This includes about $1.4 billion to develop and test the vaccine and $8.1 billion to provide the U.S. government with millions of doses.

mRNA, a type of genetic material, can be used to teach the human immune system how to respond to a particular virus.

Before the pandemic, NIH scientists helped Moderna with addressing key challenges of mRNA vaccines.

Three NIH scientists at the Vaccine Research Center were particularly crucial to the collaboration, the agency has said.

According to the agency, these scientists – Dr John Mascola, Dr Barney Graham and Dr Kizzmekia Corbett – worked on key aspects of the vaccine’s design, including identifying the genetic material for the coronavirus’ spike protein.

And these scientists should be named on Moderna’s patent application for the vaccine technology, the NIH says.

Yet Moderna maintains that only its own scientists should be listed as inventors of the vaccine.

This dispute – first reported by the New York Times on Tuesday – has garnered national attention, as the vaccine’s ownership could have global ramifications.

In a recent interview with Reuters, Collins made it clear that the agency is not backing down.

Moderna has made over $15 billion from vaccine sales in 2021, and is set to make even more next year. Pictured: Moderna's headquarters in Cambridge, Massachusetts, May 2020

Moderna has made over $15 billion from vaccine sales in 2021, and is set to make even more next year. Pictured: Moderna’s headquarters in Cambridge, Massachusetts, May 2020 

‘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,’ Collins told Reuters.

Indeed, Moderna anticipates that it will make over $15 billion in sales from its Covid vaccine this year, and over $20 billion in 2022.

The company’s founders and CEO have become billionaires during the pandemic.

For over a year, NIH has been working with Moderna to resolve the dispute – yet Moderna filed a patent application earlier in 2021 which only listed its own scientists.

‘But we are not done,’ Collins told Reuters. ‘

‘Clearly this is something that legal authorities are going to have to figure out.’

Collins was referring to government authorities when he said ‘legal authorities,’ a NIH spokesperson told the New York Times.

Still, the NIH director’s statements make clear that the agency is prepared to take further action in order to preserve its claim over the vaccine.

‘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,’ Collins told Reuters.

‘I did not expect that to be the outcome from what had been a very friendly, collaborative effort between scientists at NIH and Moderna over many years.’

Moderna responded to the comments in a statement emailed to Reuters, reiterating the company’s claim that NIH scientists were not co-inventors of the vaccine.

‘We do not agree that NIAID scientists co-invented claims to the mRNA-1273 sequence itself. Only Moderna’s scientists came up with the sequence for the mRNA used in our vaccine,’ Moderna’s statement said.

If NIH scientists are listed on the patent – or if a court eventually decides that the federal agency has a claim to the vaccine – the government could licence the vaccine to manufacturers in other countries.

Such licensing would increase supplies of Moderna’s vaccine around the world.

Currently, Moderna maintains full control of its vaccine production and primarily sells doses to wealthy nations.

NIH could also make money from licensing the patent, to potentially fund further research.

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