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

“Moderna believes that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty infringes patents covering Moderna’s basic mRNA technology between 2010 and 2016. This groundbreaking technology is critical to the development of Moderna’s own mRNA Covid-19 vaccine. The technology, without Moderna’s permission, allowed Comirnaty to develop ,” Press release said.

Pfizer said the cases were unexpected.

“Pfizer/BioNTech has not yet fully reviewed the complaint, but Pfizer/BioNTech’s Covid-19 vaccine is based on BioNTech’s proprietary mRNA technology and was developed by both BioNTech and Pfizer. We remain confident in our intellectual property support. Pfizer/BioNTech will vigorously defend the vaccine and the lawsuit’s allegations. protect,” Pfizer said in a written statement to CNN.

In a statement, BioNTech reported It will “vigorously defend against all claims of copyright infringement. BioEntech respects and respects the valid and enforceable intellectual property rights of others and is confident in its intellectual property rights.”

Moderna said in the release that it does not intend to remove Pfizer’s vaccine from the market or prevent future sales of its vaccine and does not under certain circumstances harm its sales. The company says it won’t cut Pfizer’s sales to the U.S. government, and won’t seek money from sales to a list of 92 low- and middle-income countries that have a tough time accessing the world’s supplies. Covid-19 vaccines. It will not seek damages for operations prior to March 8, the date the company uses to mark the end of the pandemic.

What Moderna really wants is to undercut its competitor’s profits, said Christopher Morton, an expert in intellectual property law at Columbia University.

“We have one of the two largest vaccine manufacturers asking the court to give them a portion of their competitor’s revenue. And that’s a very interesting opportunity for Moderna and its shareholders and Pfizer and its shareholders,” Morton said in an interview with CNN. .

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

“In March 2022, when the collective fight against COVID-19 entered a new phase and access to vaccine supplies was hampered in many parts of the world, Moderna renewed its commitment. At the same time it made it clear that it would never exercise its patent. GAVI COVAX ADVANCE MARKET Moderna expected companies like Pfizer and BioNTech to respect its intellectual property rights and consider a commercially reasonable license for any COVID-19 vaccine used in 92 low- and middle-income countries in the Commitment (AMC 92). If they requested one for other markets, Pfizer and BioNTech failed to do so. .”

Moderna outlined the specific cases in which the company claims Pfizer violated its patent, saying the company “advanced a vaccine containing a precise mRNA chemical modification like Spikevax. Modern scientists began to develop this chemical modification to avoid triggering an unwanted immune response. In 2010, when the mRNA was introduced into the body, the response and in 2015 in humans It was first verified in experiments.”

Moderna adds that “Pizer and BioEntech codified Moderna’s approach to full-length spike protein in a lipid nanoparticle formulation several years before the first appearance of COVID-19.”

Vaccinations are important.  They also make some very rich.

Legal experts said the lawsuit is a signal that Moderna is trying to control mRNA vaccine technology, despite the company’s assurances that it is not trying to control access.

“Instead of thinking of mRNA technology as a global public good, instead of being the heroes of the Covid pandemic, you know Moderna is just playing hardball,” Lawrence Kostin, a professor of global public health law at Georgetown University, said in an interview. CNN. “They played hardball with countries and negotiated contracts. They failed to transfer their technology to low-income countries. Now you know, suing Pfizer, and I can tell you one thing the consumer is not going to be a 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 is being sued by two biotech companies, Arbutus Biopharma and Alnylam Pharmamaceuticals, for the same thing it says Pfizer did — patent infringement. The companies say Moderna used the technology they developed to create lipid nanoparticles critical for delivering mRNA to cells.

Modern ice defends itself In that case, the right to infringe patents was granted under a section of the law that allowed the government to waive patent rights for companies making products during public emergencies. Moderna’s legal brief was obtained through a Freedom of Information Act request filed by the nonprofit Knowledge Ecology International, or KEI.

James Love, director of KEI, said on the one hand, Moderna took some pains to find a short-term solution to its grievances, which would minimize the impact the lawsuit could have on public health.

On the other hand, the truth of the suit and the amount of money it seeks — treble damages — will almost certainly deter other companies from developing products with mRNA technology.

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

Moderna and Pfizer’s mRNA Covid-19 vaccines are the backbone of the U.S. vaccine strategy, with Pfizer making up the bulk of the doses administered.

As of Friday morning, 360 million doses of Pfizer’s Covid-19 vaccine had 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 developed and tested the shots within a year, sending the first doses to healthcare workers in December 2020.

A recent The study was evaluated Covid-19 vaccines saved nearly 20 million lives in their first year of use.

CNN’s Ben Tinker contributed to this report.

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