A calm legal battle lasting several months between the U.S. National Institutes of Health and drugmaker Moderna over the COVID-19 vaccine patents recently burst to the public. The outcome of the battle has important implications, not only for efforts to contain the pandemic, but more broadly for drugs and vaccines that could be essential for future public health crises.

I teach drug regulation and patent law at the University of Saint Louis Center for Health Law Studies.

Moderna recently offered to share the property of its main patent with the government to settle 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 in get permission of 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 “Moderna vaccine”That a crucial element in the history of its development risks being eclipsed: Moderna was not the only developer vaccine.

Unlike many other pharmaceutical companies involved in the COVID-19 vaccine race, Moderna is a newcomer to the marketing 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 $ 2 billion in funding pharmaceutical companies and other investors. It has become public in 2018.

Same before the pandemic, research on both coronaviruses and candidate vaccines against emerging pathogens was a priority for agencies operating in the public health space. In 2015, the National Institute of Allergies and Infectious Diseases, an institute within the NIH, signed an R&D cooperation agreement with Moderna on basic research, including the development of new vaccines. The agreement resulted in a undisclosed funding amount and help with research.

In addition, after the start of the COVID-19 epidemic, Moderna also received nearly a billion dollars in funding of Advanced Biomedical Research and Development Authority, which operates within the Department of Health and Social 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 towards 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 peak proteins which are a key component of the vaccine manufactured 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 US government has spent money on Vaccines against covid-19manufactured by other companies, his close involvement in Moderna’s R&D stages sets him apart.

How it became a patent litigation

As vaccine development progressed, Moderna asked several patents, each covering different components of the vaccine. U.S. law allows inventors to file patents on products or methods that are new, not obvious and useful. While some of the earliest modern vaccines – such as polio vaccine developed by Jonas Salk’s team – were not covered by patents, from the end of the 20th century it has become very common for one or more patents to 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 she 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, known as mRNA-1273.

Moderna’s position was that Moderna scientists alone had selected the sequence. The informed business 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 failed 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 scientists from NIAID – Kizzmekia Corbett, Barney Graham and John Mascola – contributed significantly to the invention, however they declined To state publicly 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 a significant amount of control on the technology covered – in this case, the main component of the vaccine 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, the federal patent law allows each of the co-owners to engage in a variety of actions – from the manufacture and sale of the vaccine to its authorization – 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 capacity to enable more manufacturers to produce vaccines using mRNA-1273 technology. In addition, he could direct the vaccine doses wherever he sees fit, including for low-income countries that have received few vaccines so far.

Wider implications

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 both in the realization and in the financing of fundamental 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 though the business projects achieve between $ 15 billion and $ 18 billion in revenue from vaccine sales in 2021 alone, and much more in 2022.

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 settle the Other problems that currently affect 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 numerous problems built into how vaccines are made and delivered in the US And it shows that when taxpayers fund basic research for a drug, they deserve more scrutiny – and rewards – when that drug succeeds.

Moderna explains its mRNA technology.Modern

This article is republished from The Conversation under a Creative Commons license. Read the original article here: https://theconversation.com/why-moderna-wont-share-rights-to-the-covid-19-vaccine-with-the-government-that-paid-for-its-development-172008.



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