Moderna files patent infringement lawsuits against Pfizer and BioNTech over mRNA Covid-19 vaccines

“Moderna believes that the COVID-19 vaccine from Pfizer and BioNTech infringes Moderna’s 2010-2016 patents covering Moderna’s founding mRNA technology. This groundbreaking technology was essential to the development of Moderna’s COVID-19 mRNA vaccine, Spikevax. Pfizer and BioNTech copied this technology, without Moderna’s permission, to make Kommernati. new version He said.

in the current situation, BioNTech . said “It will vigorously defend against all allegations of patent infringement. BioNTech values ​​and respects the valid and enforceable intellectual property rights of others and remains confident in its intellectual property.”

Moderna said in the statement that it does not aim to remove the Pfizer vaccine from the market or prevent its vaccine from being sold in the future, nor does it seek compensation for its sale in certain circumstances. The company says it will not seek to cut Pfizer’s sales to the US government, nor will it seek funds from sales to a list of 92 low- and middle-income countries that have had difficulty accessing global supplies. Covid-19 vaccines. Nor will it seek compensation for activities before March 8, the date the company uses to celebrate the end of the pandemic.

What Moderna really wants is a portion of its competition’s profits, said Christopher Morten, an expert in intellectual property law at Columbia University.

“We have one of the two largest vaccine manufacturers asking the court to award a significant portion of its competitor’s revenue,” Morten said in an interview with CNN. “And that’s a really interesting sort of possibility for Moderna and its shareholders and Pfizer and its shareholders.” .

Moderna said that in October 2020, it pledged not to enforce patents related to Covid-19 “while the pandemic continues.”

“In March 2022, as the collective fight against COVID-19 entered a new phase and the provision of vaccines was no longer a barrier to access in many parts of the world, Moderna updated its pledge. It explained that while it would not apply its patents. For any vaccine COVID-19 used in 92 low- and middle-income countries In the GAVI COVAX Advance Market Commitment (AMC 92), Moderna expected companies like Pfizer and BioNTech to respect their intellectual property rights and would consider obtaining a commercially reasonable license if they requested one for other markets. Pfizer and BioNTech in doing so.”

Moderna outlined specific instances in which the company alleges that Pfizer infringed its patents, saying that the company has moved forward with “a vaccine that contains the same precise chemical modification of mRNA as the vaccine as Spikevax. Moderna scientists have begun developing this chemical modification that avoids triggering unwanted immunity.” response when mRNA is introduced into the body in 2010 and was the first to be validated in human trials in 2015.

Moderna also says: “Pfizer and BioNTech have copied Moderna’s method of encoding the full-length spike protein into a coronavirus lipid nanoparticle formula. Moderna scientists developed this approach when they created a vaccine for the coronavirus that causes Middle East respiratory syndrome (MERS) years before the emergence of MERS-CoV. COVID-19 for the first time.

Legal experts said the lawsuit was an indication that Moderna was trying to control its RNA vaccine technology, despite the company’s assurances it was not trying to restrict access.

Lawrence Justin, professor of global public health law at Georgetown University, said in an interview with CNN. “They played hard ball with countries and negotiated their contracts. They played hard ball with the failure to take their technology to lower income countries. Now you know, suing Pfizer, I can tell you one thing the consumer is not going to be the winner.”

In addition to the lawsuit against Pfizer, Moderna is also in a public dispute with the National Institutes of Health over intellectual property rights.

Moderna has also been sued by two biotech companies, Arbutus Biopharma and Alnylam Pharmaceuticals, for the same thing it claims Pfizer has done — patent infringement. Those companies claim that Moderna used the technology they developed to make the lipid nanoparticles needed to deliver messenger RNA to cells.

James Love, director of KEI, said Moderna has taken some pain on the one hand to seek a narrow remedy for its grievances, in order to reduce the impact of the lawsuit on public health.

On the other hand, the fact of the lawsuit and the amount of money it seeks – triple damages – will almost certainly dissuade other companies from developing products using mRNA technology.

“It would have a chilling effect on any of the new mRNA products,” Love wrote in an email to CNN.

Moderna and Pfizer’s mRNA Covid-19 vaccines have been the backbone of the US vaccination strategy, with Pfizer making up the majority of doses given.

As of Friday morning, 360 million doses of Pfizer’s Covid-19 vaccine have been administered in the United States and 229 million doses of Moderna.

The development of mRNA vaccines for Covid-19 is considered one of the greatest achievements of modern science. In a race against time, scientists created and tested the shots in less than a year, shipping the first doses to health care workers in December 2020.