I teach drug regulation and patent law at the Center for Health Law Studies at the University of Saint Louis.
Moderna recently offered to share ownership of its main patent with the government to resolve the dispute. Whether or not that’s enough to satisfy the government’s claims, I think the dispute highlights serious issues in the way American companies market drugs and vaccines.
The United States has been a major donor of the Moderna vaccine
Vaccines have played a crucial role in the response to the pandemic.
In December 2020, Moderna became the second pharmaceutical company after Pfizer to obtain approval from the Food and Drug Administration to market a COVID-19 vaccine in the United States. Since then, people have grown so used to talking about the “Moderna vaccine” that a crucial piece of the history of its development is in danger of being overshadowed: Moderna was not the only developer of the vaccine.
Unlike many other pharmaceutical companies involved in the COVID-19 vaccine race, Moderna is a newcomer to the commercialization of drugs and vaccines. Founded in Massachusetts in 2010, the company had never put a product on the market until the FDA cleared its COVID-19 vaccine last year.
Throughout the 2010s, 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 operating in the public health space. In 2015, the National Institute of Allergy and Infectious Diseases, an NIH institute, signed an R&D cooperation agreement with Moderna on basic research, including the development of new vaccines. The deal resulted in an undisclosed amount of funding and research assistance.
In addition, after the start of the COVID-19 epidemic, Moderna also received nearly $ 1 billion in funding from the Biomedical Advanced Research and Development Authority, which operates within the Department of Health and Human Services. . This funding was specifically intended for the development of a vaccine candidate against COVID-19.
The researchers calculated that, collectively, the U.S. government provided $ 2.5 billion for the development and commercialization of Moderna’s COVID-19 vaccine.
Scientists from the United States and Moderna work 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 alongside scientists at Moderna on different components of the vaccine.
These contributions included work on dosing mechanisms, and the NIH said federal scientists created the stabilized spike proteins that are a key component of the vaccine made by Moderna.
The importance of the role played by federal scientists in their work with Moderna would soon become evident. A 2019 agreement with a third party explicitly acknowledged this, alluding to mRNA vaccine candidates “jointly developed and owned by NIAID and Moderna”. And at the end of 2020, the US government called it the “NIH-Moderna COVID-19 vaccine.”
While the U.S. government has spent money on COVID-19 vaccines made by other companies, its close involvement in Moderna’s R&D stages sets it apart.
How it became a patent litigation
As vaccine development progressed, Moderna filed for several patents, each covering different components of the vaccine. US law allows inventors to file patents on products or methods that are new, neither obvious nor useful. While some early modern vaccines – like the polio vaccine developed by Jonas Salk’s team – were not covered by patents, by the end of the 20th century it became very common that one or more patents cover a newly developed vaccine.
By filing certain patents related to its vaccine, Moderna appointed scientists from the National Institute of Allergy and Infectious Diseases as co-inventors alongside Moderna scientists. This was the case, for example, in a patent application dated May 2020 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 larger component of the vaccine: the mRNA sequence used to produce the vaccine, which is known to exist. as mRNA-1273.
Moderna’s position was that only Moderna scientists had selected the sequence. The company informed the Patent and Trademark Office of its position in a 2020 statement.
In November 2021, government officials publicly challenged the company’s decision after months of fruitless negotiations with the company. Moderna then caught on social networks to defend his position, tweeting:
“Just because someone is an inventor on a patent application for our COVID-19 vaccine does not mean that they are an inventor on every vaccine patent application. “
In contrast, the National Institutes of Health argued that three NIAID scientists – Kizzmekia Corbett, Barney Graham, and John Mascola – significantly contributed to the invention, although they declined to publicly say how. If this is true, the patent law says they should be named co-inventors.
But this dispute is not just about scientific principles or technical aspects of the law. While patents are also seen as indicators to measure scientific reputation, their most immediate and powerful effect is to give patent holders significant control over the technology covered – in this case, the main component of the vaccine being manufactured. by Moderna.
From a practical standpoint, excluding federal scientists from the app means that Moderna alone decides how to use the vaccine, whether to allow it, and to whom. If, on the other hand, the government is co-owner of the vaccine, federal patent law allows each of the co-owners to engage in a variety of actions -om making and selling the vaccine to licensing – without the consent of the other owners.
This is particularly relevant in the event of product shortages or potential pricing issues related to the marketing of the vaccine. For example, the United States would have the option of allowing more manufacturers to produce vaccines using mRNA-1273 technology. In addition, he could direct vaccine doses wherever he sees fit, including to low-income countries that have received few vaccines so far.
The ongoing battle between the government and an emerging star in the pharmaceutical industry is yet another episode in a complicated 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 an essential role in carrying out and funding basic research. On the other hand, it does not have the resources and the capacity to market most types of new drugs and vaccines on its own.
The pharmaceutical industry therefore plays an important and necessary role in drug innovation, which, in my opinion, should be rewarded, but not without limits.
If the NIH is right about joint ownership of the vaccine, then Moderna is improperly using a legal tool to gain a controlling position in the market – a reward it does not deserve. This position of exclusive control becomes even more problematic in view of the large sums of public money which have financed the development of this vaccine. This offset some of Moderna’s financial risk, even as the company expects to generate $ 15-18 billion in revenue from vaccine sales in 2021 alone, with many more expected in 2022.
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However, even if the NIH prevails in patent litigation, it is important to understand the limitations of such a “winner.” The United States would be able to authorize the vaccine, for example, and could do so by requiring licensees to agree to equitable distribution of vaccine doses.
But co-ownership would not allow the government to solve any of the other issues currently affecting the manufacture and distribution of COVID-19 vaccines, such as increasing production or building infrastructure to deliver vaccine doses.
In my opinion, the dispute is a reminder of the many problems inherent in the manufacture and delivery of vaccines in the United States. And it shows that when taxpayers fund basic research for a drug, they deserve more scrutiny – and rewards – for success.