Moderna on Friday filed patent infringement lawsuits against Pfizer and BioNTech “for infringing patents central to (its) mRNA technology platform,” the company said in a news release Friday.
“Moderna believes that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty infringes patents Moderna filed between 2010 and 2016 covering Moderna’s foundational mRNA technology. This groundbreaking technology was critical to the development of Moderna’s own mRNA COVID-19 vaccine, Spikevax. Pfizer and BioNTech copied this technology, without Moderna’s permission, to make Comirnaty,” the news release said.
Pfizer said the lawsuits were unexpected.
“Pfizer/BioNTech has not yet fully reviewed the complaint but we are surprised by the litigation given 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 allegations of the lawsuit,” Pfizer said in a written statement to CNN.
In a statement, BioNTech said it “will vigorously defend against all claims of patent infringement. BioNTech also values and respects valid and enforceable intellectual property rights of others and remains confident in its intellectual property.”
Moderna said in the release that it is not aiming to remove Pfizer’s vaccine from the market or prevent future sales of its vaccine and also is not seeking damages of its sale in specific circumstances. The company says it won’t seek a cut of Pfizer’s sales to the US government, and it won’t seek money from sales to a list of 92 low and middle-income countries that have had a tough time getting access to the world’s supply of Covid-19 vaccines. It also won’t seek damages for activities before March 8, a date the company is using to mark the end of the pandemic.
What Moderna really wants is a cut of its competitor’s profits, said Christopher Morten, an expert on intellectual property law at Columbia University.
“We have one of the two biggest vaccine manufacturers asking a court to award a chunk of its competitor’s revenues. And that’s a really interesting kind of prospect for Moderna and its shareholders and for Pfizer and its shareholders,” Morten said in an interview with CNN.
Moderna said that in October 2020, it pledged not to enforce its Covid-19-related patents “while the pandemic continued.”
“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 pledge. It made clear that while it would never enforce its 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 companies such as Pfizer and BioNTech to respect Its intellectual property rights and would consider a commercially reasonable license should they request one for other markets. Pfizer and BioNTech have failed to do so.”
Moderna outlined specific instances where the company claims Pfizer’s infringed on its patents, saying the company moved foward with “a vaccine that has the same exact mRNA chemical modification to its vaccine as Spikevax. Moderna scientists began developing this chemical modification that avoids provoking an undesirable immune 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 encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus. Moderna scientists developed this approach when they created a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS) years before COVID-19 first emerged.”
Legal experts said the lawsuit was a signal that Moderna was trying to control mRNA vaccine technology, despite the company’s assurances that it is not trying to constrain access.
“Instead of thinking of 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 public health law at Georgetown University, in an interview with CNN. “They played hardball with countries and negotiating their contracts. They played hardball with failing to transfer their technology to lower income countries. And now you know, suing Pfizer, I can tell you one thing of 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 is also being sued by two biotech companies, Arbutus Biopharma and Alnylam Pharmamaceuticals, for the same thing it is claiming that Pfizer did – patent infringement. Those companies claim that Moderna used technology they developed to make lipid nanoparticles that are key to delivering the mRNA into cells.
Moderna is defending itself in that case by saying it was granted the right to infringe on patents under, a legal clause that allows the government to waive patent rights for companies that develop goods during public emergencies. Moderna’s legal brief was obtained by 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 had taken some pains to seek a narrow remedy for its grievances, in order to limit the impact the lawsuit could have on public health.
On the other hand, the fact of the suit and the amount of money it’s seeking – triple damages – would almost certainly discourage other companies from developing products with mRNA technology.
“It will have a chilling impact on any 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 administered doses.
As of Friday morning, 360 million doses of Pfizer’s Covid-19 vaccine have been administered in the US and 229 million doses of Moderna have been administered.
The development of the 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.
A recent study estimated that Covid-19 vaccines saved nearly 20 million lives in their first year of use.