The US administration is finally putting its foot down on the appropriation of public research by drug firms
A public health advocacy group has helped blow the lid off a brazen heist — the attempt by a United States drug company to corner the intellectual property rights (IPRS) on a novel coronavirus disease (COVID-19) vaccine it developed in collaboration with the government.
The company is Moderna, Inc, the darling of both Wall Street (because of its ability to garner huge funds) and public health campaigners (because of its promise of sharing its technology). But corporate greed has seen the unravelling of a model partnership that would bring new drugs quickly to the market and ensure fair pricing.
It is an egregious appropriation because the vaccine is the result of a four-year collaboration between Moderna and the US National Institutes of Health (NIH); the government described it as the “NIH-Moderna COVID-19 vaccine" in its documents.
Although the company had not brought a single product into the market previously, the government poured billions into the research project, which accelerated after the pandemic struck.
Most estimates have put the funding it received from various government agencies at $2.5 billion, but a recent New York Times (NYT) report said Moderna has received nearly $10 billion in taxpayer funding “to develop the vaccine, test it and provide doses to the federal government”.
The dream of a “people’s vaccine”, as it was dubbed last year by public health campaigners, is fading fast as the controversy over who should be credited with developing the vaccine heads for the courts. That is because the government is finally saying enough is enough and is contesting Moderna’s claims of having developed the vaccine on its own.
NIH is, in a surprising and heartening turn, insisting that its scientists who developed the technology be credited in the patent application made by the company.
The Moderna story is a good illustration of what is wrong with the American system of promoting innovation. The US law gives patents from government-funded research to universities and small businesses, which in turn partner with private entities to make profitable products. Such a huge giveaway is considered the price of fostering innovation.
Thanks to a campaign by Public Citizen, an advocacy group that takes on corporate interests and their cronies in the government to protect the interests of ordinary people, details of a year-long effort by NIH to stop the appropriation of patent rights on the COVID-19 vaccine has become public.
In a letter to the director of NIH in November, Public Citizen asked him to publicly clarify the role of the institute in the invention of the vaccine and to explain how he intended “to ensure the contributions of federal scientists are fully recognised”. The letter detailed the seminal work underpinning coronavirus vaccine development and how nearly all the leading COVID-19 vaccines use NIH's stabilised spike protein technology, starting with mRNA-1273 (the NIH-Moderna vaccine).
But unlike other companies, Moderna benefited uniquely from federal support. Public Citizen's letter quotes Barney Graham, who has just retired from NIH’s Vaccine Research Centre (VRC) as saying: We did the front end. They did the middle. And we did the back end.
Graham was referring to the whole process of designing the spike protein sequence, manufacturing the vaccines and running clinical trials. Public Citizen has urged NIH to publicly reclaim its foundational role and to use its leverage to champion global vaccine access.
And in a move designed to increase public awareness and drum up support for such campaigns, it said NIH should make people aware of the critical role played by federal scientists in the invention and development of the vaccine.
When Moderna announced in November 2020 that the vaccine was successful, a simultaneous NIH press release had called mRNA-1273 the NIH-Moderna COVID-19 vaccine. Anthony S Fauci, the public face of the US fight against the pandemic, had at the time said, “The vaccine was actually developed in my institute’s VRC by a team of scientists led by Graham and his close colleague Kizzmekia Corbett.”
Fauci is the director of NIH’s Allergy and Infectious Diseases Institute. NIH credits three of its scientists, the third being VRC director John Mascola, as co-inventors. How, then, did Moderna claim the vaccine as its own?
Moderna has filed for four patents and lists several of its employees as the sole inventors, claiming the company was working on a parallel track when it got all the data from NIH. Only one application cites the contributions of NIH and that is not the critical patent.
It transpired that NIH has been trying to resolve the dispute amicably but has not succeeded since the company went ahead and filed the claims in July. NYT said scientists familiar with the situation see it “as a betrayal by Moderna”.
But it is not just about scientific integrity and ethics; there are more pivotal issues involved. As co-owner of the patent, the US government will have a clear say in licensing the drug to other companies, which in turn will have an impact on access to these vaccines globally. Besides, it would help recoup some of the millions the government poured into the research.
Moderna has said that it will not enforce its COVID-19 related patents, but has shown no willingness to share the technology. This leaves the company free to set its own price — a steep one that will enable it to rake in revenues of $35 billion till the end of 2022.
Hopefully, NIH will, in a break from the past, pursue the case legally because it is important to set a precedent. Media reports from the US that quoted NIH director suggest this would be the case.
The issue is being closely watched because it has significant — and global — ramifications. As Public Citizen pointed out, co-inventorship creates a presumption of co-ownership. Joint ownership by the US government should ensure authorisation of additional manufacturers to use the patents, including through the UN-backed Medicines Patent Pool.
At home, too, there is a similar case, where the Council of Scientific and Industrial Research (CSIR) institutes have been involved in developing Bharat Biotech’s Covaxin vaccine. The terms of the deal remain opaque.
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