The United States and Moderna quarrel over the vaccine patent

The United States and Moderna quarrel over the vaccine patent
The United States and Moderna quarrel over the vaccine patent

The National Institutes of Health (NIH), an agency of the US Department of Health, disagrees deeply with the US pharmaceutical company Moderna on the list of researchers to be associated with the patent for the coronavirus mRNA vaccine. NIH believes at least three of its own scientists should be included on the list, while Moderna claims it independently developed core vaccine technologies without their help. The dispute could have numerous legal repercussions and financial implications, negatively impacting the ability to license the vaccine in other countries.

NIH claims that three scientists at its Vaccine Research Center worked with Moderna to design the genetic sequence contained in the vaccine, which causes the body to make certain coronavirus proteins so that the immune system learns to counter them in the event of any real infections in the future. The scientists are the director of the center, John. R. Mascola, virologist Barney Graham and researcher Kizzmekia Corbett, all three indicated by various institutions as the main architects of the success of Moderna’s vaccine and beyond.

Well before the pandemic, Graham had conducted various studies on coronaviruses, working with Corbett and other researchers on the spike protein, used by these viruses to evade cell defenses and inject genetic material into them. One technology in particular, to stabilize the protein, had been patented by the NIH and is the basis of the mRNA vaccines developed so far, both by Moderna and Pfizer-BioNTech.

Moderna had collaborated for several years with groups of scientists in public research centers in the United States, always on projects related to coronaviruses. In January 2020, NIH and Moderna had then decided to collaborate in the development of a specific vaccine against SARS-CoV-2, a virus that from China had begun to spread practically all over the world.

The Vaccine Research Center had identified the gene that causes the SARS-CoV-2 spike protein to be expressed and quickly sent the information to Moderna. However, the company claims that at that stage its scientists had already identified the gene with independent research.

Starting from that information, it was possible to design the mRNA vaccine which a few months later, following the first clinical tests, was found to be highly effective in preventing severe forms of COVID-19. At the time, NIH officials called the newly developed system “the NIH-Moderna vaccine” ƒ, with several agency officials claiming the work done by their colleagues.

Later, Moderna would have repeatedly claimed to have developed the vaccine substantially independently, to the point of wanting to patent some technologies without including the three main NIH scientists who had worked on the project.

How did he reconstruct the New York Times, in July Moderna had filed a first request with the US Patent Office, indicating that it had “concluded in good faith” that the three scientists had not “co-invented” one of the main components of the mRNA vaccine against the coronavirus. The request therefore included only the names of employees of the company, without particular references to external members. The wording of the request in that way surprised those in charge of the NIH, who had been working for about a year to resolve the dispute with Moderna.

According to various experts, the presence on the patent of the three NIH researchers could make a difference, not only for those directly concerned. The government would have more control over the management of licenses, so as to facilitate the production of the coronavirus vaccine by other companies, especially in poor and developing countries, where Moderna has so far delivered very few doses despite repeated requests from of governments and institutions.

In recent months, Moderna has been accused of having favored deliveries of its vaccine to richer countries, where it can sell doses at higher prices without particular problems. The United States government has expressed criticism on the issue, recalling that during the development and testing phase of the vaccine it had financed the company with more than 1.4 billion dollars, not counting the spending of over 8 billion dollars for the hundreds of millions of doses so far purchased by the government itself. This year alone, the coronavirus vaccine will lead to 18 billion in revenues for Moderna, while for the next year the company has already signed agreements for 20 billion dollars.

The company does not believe it has received special treatments or aid in developing the vaccine, and according to some observers it is maintaining this position to have more freedom in deciding its trade policies, which have so far largely excluded the poorest countries. As one expert told the New York Times, «Moderna wants exclusive ownership and full control of this patent. It wants to be the only organization capable of deciding where the mRNA vaccine is produced, how, by whom and at what price it is sold. A shared patent is a threat to this possibility of control ».

When it presented its vaccine, Moderna still pledged not to enforce its patent rights until the end of the pandemic, arguing that in this way other companies could produce vaccines with the same system on their own. In reality, even without the constraints of patents, a recipe for making a vaccine is often not enough, because its production requires special scientific and technological knowledge.

The Patent Office has the task of deciding whether or not to award a patent, but it has no role in resolving any disputes related to the requests. In the event that the two sides do not find a solution in time before the patent is approved, the United States government – which controls the NIH – would have to decide whether or not to sue Moderna, initiating a process that could take a long time and money.

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