A dispute between Moderna and the National Institutes of Health (NIH) – the US government’s biomedical research agency – has come to light after nearly a year of wrangling behind closed doors.
The dispute centres on which scientists invented the core component of the mRNA vaccine, the genetic sequence that prompts the vaccine to produce an immune response.
The NIH asserts that three of its scientists – who worked with Moderna on the technology for more than four years – should be named on the patent, but the paperwork Moderna filed in July only names its own scientists.
It is clear that the US government – which has spent nearly $10bn on the vaccine partnership – has felt a sense of ownership for some time, even referring to it last year as the ‘NIH/Moderna COVID-19 vaccine’.
The dispute has far-reaching implications for the long-term distribution of the vaccine, not to mention the billions of dollars in future profits.
If the three NIH scientists – NIH vaccine centre director John Mascola, Barney Graham (now retired) and Kizzmekia S Corbett (now at Harvard University) – are named on the patent, the federal government could have more of a say in who manufacture the vaccine, which could influence who gets access to the COVID-19 jab.
US media outlets are reporting on the ‘mounting frustration’ within the US government about Moderna’s ‘limited efforts’ to get the vaccine to poorer countries, despite the company having racked up huge profits.
Moderna has insisted that while it recognises the role the NIH played in developing the vaccine, it isn’t permitted to choose who is listed on the patent application. “Following those rules, as we must, Moderna is required to only list Moderna scientists as the inventors for the patent claims to mRNA-1273,” said the company. “Moderna’s conclusion is driven by nothing other than our obligation to comply with US patent law.”
“NIH disagrees with Moderna’s inventorship determination,” said Kathy Stover, a spokeswoman for the National Institute for Allergy and Infectious Diseases, the branch of the NIH that oversees vaccine research. “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.”
Politics aside, Cornell professor of microbiology and immunology at Cornell University, John Moore, said it was a matter of “fairness and morality at the scientific level”.
The dispute cannot be good news for Moderna. Last week the company downgraded its forecasts for the year, which saw its share price tumble. Previously it had promised to make up to a billion doses this year but now believes this will be closer to 800m doses, although this still represents up to $22bn in sales.