Vaccines were the axis of several conflicts during the Covid pandemic. Now, in a stage of greater control of the disease, a new front appears: a legal dispute involving the innovative messenger RNA platform: Moderna sued Pfizer/BioNtech for the patent.
Moderna filed a complaint against the also American Pfizer and the German BioNtech, partners in the development of the Comirnaty vaccine, and accuses them of having infringed the patent that Moderna filed between 2010 and 2016 as part of the development of messenger RNA technology.
“We are filing these lawsuits to protect the innovative messenger RNA technology platform on which we were pioneersin which we invested billions of dollars for its creation and that we patented during the previous decade to the Covid-19 pandemic,” Moderna CEO Stéphane Bancel said in a statement on Friday.
According to Moderna, the American Pfizer and the German BioNtech, which developed their own vaccine against the coronavirus also using messenger RNA technology, “illegally copied Moderna’s inventions and have continued to use them without permission,” said the drugmaker’s legal director, Shannon Thyme Klinger.
“Moderna believes that Pfizer and BioNTech they copied two key features of Moderna’s proprietary technologies that are critical to the success of messenger RNA vaccines,” the statement said, ensuring that both companies lacked the necessary level of experience for the development of vaccines based on this technology when the coronavirus pandemic broke out.
Pfizer was quick to respond. Company sources said: “Pfizer/BioNTech have not yet fully reviewed the lawsuit, but we are surprised by the litigation given that Pfizer/BioNTech’s vaccine against Covid-19 was based on BioNTech’s proprietary mRNA technology and was developed by both BioNTech and Pfizer. We trust our intellectual property, which supports the Pfizer/BioNTech vaccine, and will vigorously defend against the allegations in the court case.”
A vial of the Pfizer vaccine. Photo: AFP
The company based in Massachusetts (United States), argues that in October 2020 promised not to claim their rights on patents related to Covid-19 while the pandemic continues.
However, it maintains that in March 2022 it updated this commitment so as not to demand any claim in the 92 countries considered low and middle income by the COVAX program of the World Health Organization and by the GAVI foundation.
Moderna argues that as of March “when the collective fight against Covid-19 entered a new phase and the supply of vaccines ceased to be a barrier to access in many parts of the world,” he hoped that Pfizer and BioNTech would “respect his intellectual property rights and consider a commercially reasonable license in case of requesting it for other markets”.
Moderna specified that its claims are limited to period after March 2022but he did not give details of what are the economic compensations that he demands from his competitor. The complaint was filed simultaneously in the United States and Germany.
What does this complaint mean?
Javier Echaide is an expert in International Law and highlights Clarion a first question: “At the beginning of the pandemic, there were requests from Civil Society and from some governments, to release patents, in order to distribute vaccines more equitably. That initiative was not successful and patents succeeded. This lawsuit is a consequence of that: there are cross accusations about who owns the original patent.”
Everything that has to do with patents at an international level, in general, explains Echaide, is negotiated both in the World Intellectual Property Organization (WIPO) and in the World Trade Organization (WTO), where the more active negotiations.
There is no international claims mechanism. Patents are nations, the principle of territoriality is governed. That is why this Moderna lawsuit was filed in the United States and Germany.
“Moderna claims the commercialization of the vaccine from March of this year onwards. It is leaving a void for proprio motu by not claiming anything that was marketed prior to March, which is when the largest number of vaccine sales took place,” he maintains.
For the expert, it is key to see how the accusations continue. In each country. “They are two trials, parallel, that can have two sentenceseven contradictory”, he closes.
Lucas Lehtinen is executive director of the Master’s Degree in Intellectual Property at Universidad Austral and tells Clarion that “without patent law, the state of research that guaranteed a response against Covid in 10 months would not have existed”. He also says that Moderna at the time spoke publicly of release some of your licenses and that “we will have to see how that will be taken in the two trials.”
“So far, according to the official documents of Moderna, it only requests the repair of the damages causedalthough it is important to see if any precautionary measure was also requested on the marketing of the Pfizer vaccine. From the official communications, it does not appear that they have attempted this measure, “he points out.
The messenger RNA revolution
Successful vaccines with messenger RNA is perhaps the great achievement left by the pandemicbecause this platform opens the door to a true revolution in immunology.
Messenger RNA vaccines use only synthesized genetic materialand they have the possibility of being modified much easier and faster in case of virus mutations. This is what Pfizer and Moderna have done with bivalent vaccines adjusted to the Ómicron subvariants that have already begun to be approved by regulatory agencies.
But in addition, this technology can be used in vaccines for other viruses and in fact it is already being tested against influenza and respiratory syncytial virus (RSV). Moderna is conducting trials with messenger RNA for both vaccines at research centers in Argentina. And Pfizer would also start investigating messenger RNA in RSV, after the good results of its protein subunit vaccine candidate.
All these investigations would lead to the messenger RNA platform in the not too distant future, enabling the wanted panvaccinethat allows in a single dose to protect against Covid, flu and RSV.
AS / PS