According to reports, NIH and Moderna have been at loggerheads over the vaccine rights for some time, but NIH was enraged when it belatedly learned that only one of the four US patent applications filed by the biotech for its vaccine listed the government scientists as co-inventors. The most important application, which covers the sequencing to prompt an immune response was not one of them. 

The health institute’s director, Francis Collins, insists that the scientists working for NIH sub-agency National Institute for Allergies and Infectious Diseases (NIAID) headed by US president Joe Biden’s current coronavirus advisor Anthony Fauci “played a major role” in developing the mRNA-1273 vaccine Moderna manufactures and sells as Spikevax.

Collins said the NIH intends to defend its right to co-ownership of the vaccine – in court, if it has to. “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,” he told the Reuters news agency.

Names the NIH wants to see on the patent are John Mascola, Barney Graham and Kizzmekia Corbett. But while Moderna acknowledges that the three NIAID co-collaborators played a "substantial role" in the vaccine’s development, it disputes that they co-invented the sequence that triggers the response.

“Only Moderna’s scientists came up with the sequence,” the company said in comments to US media, adding that it was acting in “good faith” in not listing others. The vaccine maker said it has acknowledged NIH scientists in other patent applications, such as those related to dosing; however, for the core patent it maintains that under strict US patent laws it is required solely to list its own scientists as inventors.

Ownership of the patent could be crucial against the backdrop of the World Health Organization’s (WHO) push to improve global vaccination rates through out-licensing. If the NIH scientists were to be recognized as co-inventors, the institute and the government could be entitled to receive a share of royalties from the use of the patents as well as licensing the technology, something Moderna has said it won’t do.

Some in the scientific and pharmaceutical community are standing with Moderna, some with the government. The NGO Public Citizen recently urged the NIH to try to resolve the patent ownership question quickly, as a decision in its favor could “empower the government to authorize manufacturers in other countries to make the vaccine.” With "huge gaps” in global vaccine access, the need for the government to exercise control over the vaccine technology "only grows more urgent,” it said.

According to the New York Times, which broke the story on the dispute, Moderna collaborated with the NIH and its scientists for four years to develop its vaccine. Altogether, the US taxpayer contributed $10 billion to the Massachusetts biotech’s vaccine effort, a sum that also paid for the government’s advance purchase of 500 million doses, which created a captive market, it said.

As Moderna’s critics have note, thanks to the vaccine, the company is on track to take in as much as $15-18 billion in revenue for 2021.  For 2022, it already has advance purchase deals worth up to $22 billion. The sales of its only product both this year and next are likely to rank among the highest in a single year for any medical product in history.

Even if the NIH should win the patent dispute, it may not win the battle. As has been an issue for months, even with a license manufacturers would not have all the components needed to make Moderna’s vaccine — including the recipe and the company’s technical knowhow.

Still, one patent expert has estimated that through licensing the government could recoup some of the subsidies it has shelled out to vaccine developers including Johnson & Johnson, Novavax, Sanofi and Merck in addition to AstraZeneca. Of that group, only the first has a vaccine approved by the FDA.

Author: Dede Williams, Freelance Journalist