Moderna (MRNA) on Friday said it is suing Pfizer and BioNTech (PFE/BNTX), alleging rival drug makers infringed three patents on the technology used for its COVID-19 mRNA vaccine.
In two lawsuits filed in federal court in the US and Germany, where BioNTech is headquartered, Moderna said it is seeking damages for Pfizer/BioNTech’s alleged use of its technology in countries where it is applying its patents – which excludes 92 companies from low and middle income. countries. Moderna is only seeking damages for alleged infringement that occurred after March 7.
Pfizer and its biotechnology partner, BioNTech, say they were taken by surprise by the litigation.
“Pfizer/BioNTech has not yet fully reviewed 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 BioNTech and Pfizer,” the companies said. in a statement.
Moderna – the first company to select a drug candidate for clinical trials in the US – says Pfizer had several options it could have chosen for its vaccine and opted for the one most similar to Moderna. The company also claims that Pfizer and BioNTech copied the technology used to deliver the vaccine formula into the arms, so the body doesn’t attack it like a foreign intruder.
The lawsuit could mark a more litigious phase of the post-pandemic world. In 2020, Moderna — then just 10 years old — vowed not to enforce its mRNA patents during the pandemic, as much of the world struggled to be inoculated. While Pfizer said it was surprised by the litigation, Moderna said in March of this year that it announced it expected drug makers to “respect” its intellectual property.
“Modern refrained from claiming its patents early so as not to distract from efforts to end the pandemic as quickly as possible,” Moderna said in its filing.
In its lawsuit against Pfizer, Moderna alleges that other drug candidates that Pfizer explored prior to approval did not include Moderna’s technology. “However, as Pfizer and BioNTech advanced their clinical development, they focused exclusively on vaccine designs that used Moderna’s patented technologies,” Moderna said in its filing.
Moderna claims it explored mRNA technology years before the COVID-19 pandemic. The research and development, Moderna said, took place during 2011 and 2016 while working on a vaccine candidate in response to Middle East Respiratory Syndrome (MERS).
In its complaint, Moderna cited a Science article that cited a former senior vaccine official at the US Food and Drug Administration who called one of Moderna’s mRNA innovations “the most important thing people have done with mRNA vaccines.” “.
Since gaining full FDA approval, Moderna has marketed its COVID-19 vaccine as Spikevax, and Pfizer/BioNTech has marketed theirs as Comirnaty.
Moderna’s Chief Legal Officer Shannon Thyme Kilinger said in a statement that he “expects Pfizer and BioNTech to compensate Moderna for Comirnaty’s continued use of Moderna’s patented technologies.”
In addition to being surprised, Pfizer/BioNTech noted, “We remain confident in our intellectual property that supports the Pfizer/BioNTech vaccine and will vigorously defend ourselves against the allegations in the lawsuit.”
Many claim credit for mRNA technology
This isn’t Moderna’s first patent fight over its COVID-19 vaccine.
In the midst of the pandemic, Moderna found itself in a bitter fight over the ownership rights to one of the mRNA patents with the National Institutes of Health (NIH), who claimed their scientists should have been listed on the patent. Moderna eventually backed off, withdrawing a patent application in question.
Moderna and BioNTech – also a new company, founded in 2008 – were not the only companies working on the lipid nanoparticle technology used to develop the COVID-19 vaccine.
Alnylam Pharmaceuticals (ALNY) was on the scene, along with other partners, at least three years before BioNTech existed. The company is separately suing Moderna and Pfizer over similar allegations over its LNP technology. Some reports show that Alnylam made a breakthrough in LNP delivery in 2010.
The struggle to show the potential of mRNA technology has gone a long way and hit a wall because the body would attack the formula like a foreign invader. In fact, two scientists from the University of Pennsylvania were also credited with work published in 2005 that contributed to the Moderna and BioNTech platforms.
The decades of research, roadblocks and mini-revolutions highlight the complexity of the world of science and research – and the desire of pharmaceutical companies towards patents.
Attempting to trace or credit a single source, in search of awards and recognition, has been the focus of dozens of reports and journal publications throughout the pandemic.
The list of contributions to bypassing the struggle to get mRNA safely into the body is long. But Moderna, through its lawsuit against Pfizer and BioNTech, claims that it was the first to do clinical trials and was therefore copied.
“Pfizer and BioNTech chose to advance BNT162b2 as their primary vaccine candidate, knowing that it used the same target antigen as Moderna’s patent-protected Spikevax. Defendants continued to use the invention claimed in the…patent in willful disregard to Moderna’s patent rights,” Moderna alleges in the lawsuit.
Wall Street analysts expect Pfizer/BioNTech to file their own lawsuits.
“While the timing of any legal response is unclear, we expect PFE/BNTX to store its own patent portfolio in response,” Mani Foroohar of SVB Securities Research said in a note on Friday.
“Ultimately, while each case is unique, the history of intellectual property disputes between oligopoly firms suggests that the most likely outcome would be modest royalties paid by both firms, with little favorable net financial impact to anyone but the law firms involved,” he added.
Follow Anjalee on Twitter @AnjKhem
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