A month-long legal battle between the US National Institutes of Health and drugmaker Moderna over a COVID-19 vaccine patent recently went public. The outcome of the fight has important implications, not only for efforts to contain the pandemic but more broadly for drugs and vaccines that could be critical to future public health crises.
I teach drug regulation and patent law at St. Louis University’s Center for Health Law Studies.
Moderna recently offered to share ownership of its core patents with the government to settle the dispute. Whether this is enough to satisfy the government’s claims, I believe, the controversy points to serious problems with the way American companies bring drugs and vaccines to market.
America was a major funder of Moderna Vaccine
Vaccines have played an important role in the response to the pandemic.
In December 2020, Moderna became the second pharmaceutical company after Pfizer to receive authorization from the Food and Drug Administration to market a COVID-19 vaccine in the United States. Since then people have become so used to talking about the “Modern Vaccine” that a key element in the history of how it was developed was minimizing the risk: Moderna was not the only developer of the vaccine.
Unlike many other pharmaceutical companies in the race for a COVID-19 vaccine, Moderna is a newcomer to drug and vaccine commercialization. Founded in Massachusetts in 2010, the company never brought a product to market until the FDA authorized its COVID-19 vaccine last year.
During 2010, Moderna focused on the development of mRNA technology, attracting more than US$2 billion in funding from pharmaceutical companies and other investors. It went public in 2018.
Even before the pandemic, research on both coronaviruses and vaccine candidates against emerging pathogens was a priority for agencies working in the public health sector. In 2015, the National Institute of Allergy and Infectious Diseases, an institute within the NIH, signed a cooperative R&D agreement with Moderna on basic research, including the development of new vaccines. The agreement resulted in an undisclosed amount of funding and assistance with research.
In addition, after the COVID-19 outbreak began, Moderna received nearly $1 billion in funding from the Biomedical Advanced Research and Development Authority, which works within the Department of Health and Human Services. This funding was specifically targeted towards the development of a COVID-19 vaccine candidate.
Researchers have calculated that, collectively, the US government has provided $2.5 billion for the development and commercialization of Moderna’s COVID-19 vaccine.
America, Modern scientists working side by side
In addition to providing financial support, the federal government was instrumental in the development of Moderna’s vaccine for other reasons. Namely, federal scientists worked with Moderna scientists on the various components of the vaccine.
These contributions included work on the dosing mechanism, and the NIH said federal scientists created the stable spike protein that is a key component of the vaccine made by Moderna.
The importance of the role played by federal scientists in their work with Moderna will soon become clear. A 2019 agreement with a third party explicitly acknowledged this, pointing to mRNA vaccine candidates “developed and jointly owned by NIAID and Moderna.” And by the end of 2020, the US government was calling it the “NIH-Moderna COVID-19 Vaccine.”
While the US government has spent money on COVID-19 vaccines made by other companies, its close involvement in Moderna’s R&D phases sets it apart.
How It Became a Patent Dispute
As vaccine development progressed, Moderna applied for several patents, each covering different components of the vaccine. US law allows inventors to apply for patents on products or methods that are new, obvious and not useful. While some early modern vaccines – such as the polio vaccine developed by Jonas Salk’s team – were not covered by patents, from the late 20th century it became very common for one or several patents to cover a newly developed vaccine.
Applying for some patents related to its vaccine, Moderna named scientists from the National Institute of Allergy and Infectious Diseases as co-inventors along with Moderna scientists. This was the case, for example, in a May 2020 patent application for a relatively minor component of the vaccine.
However, in July 2021, Moderna made it clear that it would not name government scientists as co-inventors in a patent application covering a much more important component of the vaccine: the mRNA sequence used to produce the vaccine. which is known as mRNA-1273.
Modern’s position was that only Modern scientists had chosen the sequence. The company made its position known to the Patent and Trademark Office in a 2020 statement.
In November 2021, government officials publicly challenged the company’s decision after months of unsuccessful negotiations with the company. modern then took to social media To defend his position, tweeting:
“Just because someone is an inventor on a patent application related to our COVID-19 vaccine, doesn’t mean they are an inventor on every patent application related to the vaccine.”
In contrast, the National Institutes of Health argued that three NIAID scientists – Kizmekia Corbett, Barney Graham and John Mascola – had made meaningful contributions to the invention, although they declined to publicly specify how. If true, patent law states that they must be named co-inventors.
But this controversy is not just about scientific principles or technical aspects of law. While patents are also regarded as proxies for measuring scientific reputation, their most immediate and powerful effect is to give patent holders a significant amount of control over the technology covered – in this case, the core of the vaccine made by Moderna. Constituent.
From a practical standpoint, excluding federal scientists from the application means Moderna alone has to decide how to use the vaccine, whether or not to license it, and for whom. If, by contrast, the government co-owns the vaccine, federal patent law allows each of the joint owners to engage in a variety of actions – from manufacturing and selling the vaccine to licensing it – without the consent of the other owners.
This is particularly relevant in cases of product shortages or potential pricing issues in relation to the commercialization of vaccines. For example, the US would have the ability to allow more manufacturers to make vaccines using mRNA-1273 technology. In addition, it can direct the dosage of the vaccine wherever it prefers, including in low-income countries that have received some vaccines so far.
The ongoing battle between the government and a rising star in the pharmaceutical industry is yet another link in the complex relationship between actors with complementary but distinct roles in the production of drugs and vaccines.
On the one hand, the federal government has long played a key role in both performing and funding basic research. On the other hand, it does not have the resources and capacity to market most types of new drugs and vaccines on its own.
The pharmaceutical industry thus plays an important and essential role in pharmaceutical innovation, which I think should be rewarded – though not infinitely.
If the NIH is correct about vaccine co-ownership, Moderna is inappropriately using a legal tool to gain market control status—an award it doesn’t deserve. This position of sole control becomes even more problematic in light of the significant amount of public funding funding the development of this vaccine. This offset some of Moderna’s financial risk, even as the company plans to generate $15 billion to $18 billion in revenue from vaccine sales in 2021 alone, with much expected in 2022.
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However, even if the NIH prevails in a patent dispute, it is important to understand the limitations of such a “win.” For example, the US would be in a position to license the vaccine, and could do so should the licensees agree to an equitable distribution of vaccine doses.
But co-ownership will not enable the government to fix any other problems that currently affect the manufacture and distribution of COVID-19 vaccines, such as production or building infrastructure to deliver vaccine doses.
In my view, the controversy is a reminder of many of the problems inherent in how vaccines are made and distributed in the US, and shows that when taxpayers fund basic research on a drug, they deserve more control. – and rewards – when that drug is successful.