Moderna Files Patent Infringement Lawsuits Against Pfizer and BioNTech Over Covid-19 mRNA Vaccines

“Moderna believes that Pfizer and BioNTech’s COVID-19 vaccine, Comirnaty, infringes patents filed by Moderna between 2010 and 2016 covering Moderna’s fundamental mRNA technology. This breakthrough technology was essential to the development of its own COVID mRNA vaccine -19 from Moderna, Spikevax. Pfizer and BioNTech copied this technology, without permission from Moderna, to manufacture Comirnaty”, the Press release said.

Pfizer said the lawsuits were unexpected.

“Pfizer/BioNTech has not yet fully investigated the complaint, but we are surprised by the litigation given that the Pfizer/BioNTech COVID-19 vaccine was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer. We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the lawsuit allegations,” Pfizer said in a written statement to CNN.

In a report, BioNTech said it “will vigorously defend itself against all allegations of patent infringement. BioNTech also 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 was not seeking to remove Pfizer’s vaccine from the market or prevent future sales of its vaccine, nor was it seeking damages for its sale under the circumstances. specific. The company says it won’t seek to cut Pfizer’s sales to the US government and won’t seek money from sales to a list of 92 low- and middle-income countries that have struggled to access to global sourcing. Covid-19 vaccines. He also won’t seek damages for activities prior to March 8, the date the company uses to mark the end of the pandemic.

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

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

Now proven against coronavirus, mRNA can do so much more

Moderna said in October 2020 it pledged not to enforce its Covid-19 related patents “as long as the pandemic continues”.

“In March 2022, when the collective fight against COVID-19 entered a new phase and vaccine supply was no longer a barrier to access in many parts of the world, Moderna updated its He made it clear that while he would never enforce his patents for any COVID-19 vaccine used in the 92 low- and middle-income countries in the GAVI COVAX Advance Market Commitment (AMC 92), Moderna expected that companies such as Pfizer and BioNTech respect its intellectual property rights and would consider a commercially reasonable license should they seek one for other markets Pfizer and BioNTech have failed to do so.

Moderna described specific instances where the company claims Pfizer infringed its patents, saying the company moved forward with “a vaccine that has the exact same chemical modification of its vaccine mRNA as Spikevax. Moderna scientists began to develop this chemical modification that avoids causing an unwanted immune system response when mRNA is introduced into the body in 2010 and were the first to validate it in human trials in 2015.”

Moderna also says “Pfizer and BioNTech copied Moderna’s approach to encoding the full-length spike protein in a lipid nanoparticle formulation for a coronavirus. Moderna scientists developed this approach when they created a coronavirus vaccine which causes Middle East Respiratory Syndrome (MERS) years before COVID-19 emerged.”

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

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

“Instead of looking at mRNA technology as a global public good and being the heroes of the Covid pandemic, you know, Moderna is just playing hardball,” said Lawrence Gostin, professor of global law at public health at Georgetown University, in an interview with CNN. “They’ve played tough with countries and negotiated their contracts. They’ve played tough with not transferring their technology to low-income countries. And now you know, in suing Pfizer, I can tell you one thing the consumer doesn’t 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 is also being sued by two biotech companies, Arbutus Biopharma and Alnylam Pharmamaceuticals, for the same thing it claims Pfizer did – patent infringement. These companies claim that Moderna used the technology they developed to manufacture lipid nanoparticles that are essential for delivering mRNA into cells.

modern ice cream to defend oneself in this case, saying he was granted the right to infringe patents under a legal clause that allows the government to waive patent rights for companies developing goods in times of public emergency. Moderna’s legal filing was obtained through a Freedom of Information Act request filed by the nonprofit organization Knowledge Ecology International, or KEI.

James Love, director of KEI, said on the one hand that Moderna had taken pains to seek a narrow remedy for its grievances, in order to limit the impact that the lawsuit could have on public health.

On the other hand, the fact of the lawsuit and the amount of money it seeks – treble damages – would almost certainly discourage other companies from developing products with mRNA technology.

“This will have a crippling impact on any new mRNA product,” Love wrote in an email to CNN.

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

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

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 vaccines in less than a year, shipping the first doses to healthcare workers in December 2020.

A recent estimated study that Covid-19 vaccines saved nearly 20 million lives in their first year of use.

CNN’s Ben Tinker contributed to this report.

Leave a Comment