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

Pfizer said the lawsuits were unexpected.

“Pfizer/BioNTech has not yet fully assessed the complaint, but we were surprised by the lawsuit, as the Pfizer/BioNTech COVID-19 vaccine was based on BioNTech’s mRNA technology and was developed by both BioNTech and Pfizer. We remain confident in our intellectual property support for the Pfizer vaccine. / BioNTech and will vigorously defend against the allegations of the lawsuit,” Pfizer said in a written statement to CNN.

Moderna said in the statement that it has no plans to withdraw the Pfizer vaccine from the market or prevent the vaccine from being sold in the future, nor is it seeking compensation for its sale in certain circumstances. The company says it will not try to cut Pfizer’s sales to the US government, nor will it seek money to sell to a list of 92 low- and middle-income countries struggling to access global supplies. Covid19 vaccines. Nor will it ask for compensation for activities before March 8, the date the company uses to celebrate the end of the pandemic.

What Moderna really wants is some of the competition’s profits, said Christopher Morten, an intellectual property law expert at Columbia University.

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

Moderna said it pledged in October 2020 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 ceased to be a barrier to entry in many parts of the world, Moderna updated its pledge. It clarified that although it is For every vaccine COVID-19 used in 92 low- and middle-income countries In the GAVI COVAX Advance Market Commitment (AMC 92), Moderna expected companies such as Pfizer and BioNTech to respect their intellectual property rights and consider adopting a obtain a commercially reasonable license if they asked for one for other markets, including Pfizer and BioNTech.”

Moderna outlined specific cases where the company claims Pfizer has infringed its patents and says the company has made progress with “a vaccine that contains the same precise chemical modification of mRNA as the vaccine Spikevax. Scientists at Moderna have begun developing this chemical modification that avoids causing unwanted immunity.” response when mRNA is introduced into the body in 2010 and was first validated in human trials in 2015.

Moderna also says: “Pfizer and BioNTech have copied Moderna’s method for encoding the full-length spike protein in a formula of lipid nanoparticles from the coronavirus. Moderna scientists developed this approach when they developed a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS) years ago before COVID showed up. -19 for the first time.”

Vaccines are key.  They also make some people very rich.

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

Lawrence Justin, a 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 a hard ball at failing to bring their technology to lower-income countries. Now you know, now that Pfizer is suing, I can tell you one thing that the consumer is not 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 did: patent infringement. Those companies claim that Moderna used the technology they developed to make the lipid nanoparticles needed to deliver messenger RNA to cells.

Moderna is defending itself In this case, saying that the right to patent infringement was granted by a legal provision that allows the government to waive patent rights to companies that develop goods during public emergencies. Modern’s legal briefing was obtained through a Freedom of Information Act request filed by the nonprofit Environmental Knowledge International, or KEI.

James Love, director of KEI, said Moderna has struggled to find a scary remedy for its grievances, on the one hand, in order to lessen the lawsuit’s impact on public health.

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

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

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

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

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 professionals in December 2020.

New You can study That Covid-19 vaccines saved nearly 20 million lives in the first year of use.

CNN’s Ben Tinker contributed to this report.

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