American pharma company Moderna and the US government are locked in a row over the patent for the company’s Covid-19 vaccine after it filed an application that left out the names of three government scientists, the New York Times reported on Tuesday.
The dispute could ultimately determine whether the private company alone has intellectual property rights to the dose or if this is shared with the US government’s National Institutes of Health (NIH), which in effect will determine where billions of dollars in future profits go and whether the American government can nudge Moderna to help other companies make its product to address large vaccine access inequities across the world.
According to the NYT report, the vaccine was the culmination of four-year collaboration between Moderna and NIH, the government’s biomedical research agency. In November 2020, when Moderna’s clinical trial results showed significant success, the government called it the “NIH.-Moderna Covid-19 vaccine.”
NIH, according to the NYT report, said three scientists at its Vaccine Research Center — Dr. John R. Mascola, the center’s director; Dr Barney S Graham, who recently retired; and Dr. Kizzmekia S Corbett, who is now at Harvard — worked with Moderna scientists to design the genetic sequence that prompts the vaccine to produce an immune response, and should be named on the “principal patent application” that was filed in July.
In the filing with the United States Patent and Trademark Office, the company said it “reached the good-faith determination that these individuals did not co-invent” the component in question, the report said.
The patent has not yet been issued. The application names several of Moderna’s own employees as the sole inventors.
The report quoted NIH representatives as saying the dispute continued. “NIH disagrees with Moderna’s inventorship determination,” said Kathy Stover, a spokeswoman for the National Institute for Allergy and Infectious Diseases (NIAID). “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.”
A spokeswoman for Moderna, Colleen Hussey, told NYT the company had “all along recognised the substantial role that NIH has played in developing Moderna’s Covid-19 vaccine.” But she said the company was legally bound to exclude the agency from the core application, because “only Moderna’s scientists designed” the vaccine.
If NIH scientists were named as co-inventors, the agency would generally not need Moderna’s permission to license it to other companies or organisations, which could expand the supply of the vaccine at a time when inequity in access is high.
In a statement on Tuesday, the World Health Organization noted that only about 2.5% of the population in low income countries has been fully vaccinated for the coronavirus.
But even with a license, manufacturers would lack crucial components for quickly making Moderna’s vaccine — including the recipe and the company’s technical know-how, the NYT report pointed out.
A similar vaccine development arrangement has been in the spotlight in India where the government’s medical research agency, the Indian Council of Medical Research (ICMR) helped private company Bharat Biotech develop the Covaxin Covid-19 vaccine. Government officials, including the ICMR’s head, said the agency shares the intellectual property rights and gets a 5% royalty, although the company has not made its position clear on the matter.