A rift between Moderna and the US government deepened on Thursday after the biotech group dismissed claims by the National Institutes of Health that three of its scientists should be recognised as co-inventors of a patent underpinning the company’s Covid-19 vaccine.
More than any other vaccine maker, Moderna has worked in lockstep with the US government to develop its jab, receiving about $2.5bn of grants and orders while also collaborating on clinical trials.
But now the pair are engaged in a bitter dispute over a patent relating to the genetic sequence in the vaccine: the NIH says its scientists are co-inventors, while Moderna insists they are not.
The disagreement has been simmering for more than a year and the NIH was caught unawares by Moderna’s decision to file a patent in July that did not credit its scientists, Kizzmekia Corbett, Barney Graham and John Mascola.
On Thursday, Moderna escalated the dispute by issuing a public statement insisting it did “not agree” that the trio “co-invented claims to the mRNA (modified nucleotide) sequence of our Covid-19 vaccine”.
The company also hit out at critics of its approach, accusing them of trying to “twist Moderna’s good faith application of US patent law” in a move that threatened to add fuel to a row over the intellectual property rights protecting vaccines that are generating tens of billions of dollars in annual sales.
Moderna’s intervention comes after Francis Collins, outgoing director of NIH told Reuters this week that the agency intended to defend its claims and signalled that if a the pair cannot resolve the matter then it will be up for the courts to decide.
“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,” he said.
Public Citizen, a consumer rights advocacy body, said achieving recognition as the vaccine’s joint inventor could help the US government influence how the vaccine is used and help secure access for low- and middle-income nations. The Biden administration recently urged Moderna to do more to boost supplies for the developing world.
The dispute represents a rare breakdown in relations between Moderna and the US government, which has supported the company since its shortly after it was created in 2011.
The pair were already working together on the Covid-19 jab by the time the outbreak was declared a pandemic and have also collaborated on other projects, such as a jab for Nipah virus, which some scientists have identified as a potential source of a future pandemic.
The company on Thursday said it had offered to resolve the patent dispute with the NIH by making the government a co-owner of patent applications that list only Moderna scientists as inventors.
That would allow the government to license the patents as it saw fit, Moderna said.
But the company insists that said only its scientists can be listed as inventors on the patent claim, as they worked exclusively to select the genetic sequence used in the vaccine without input from government scientists.
Stephen Hoge, Moderna president, told the Financial Times there was “no fundamental disagreement” with the NIH, as they had offered co-ownership of the patent.
“I think there’s been some gross mischaracterisation that’s happened both with what our position is as well as what you can and can’t do from a matter of the law’s perspective of selecting an inventor,” he said.
Moderna has listed the three scientists as co-inventors on a separate, less central patent application. But officials are concerned that by omitting the NIH inventors from the principal patent, there is a risk that the NIH will be deprived of a co-ownership interest in the application and patent that will eventually follow.