Moderna ( MRNA ) announced Friday that it is suing Pfizer and BioNTech ( PFE/BNTX ), alleging the rival drugmakers infringed on three patents for the technology it used for its COVID-19 mRNA vaccine.
In two lawsuits filed in U.S. federal court and in Germany, where BioNTech is based, Moderna said it is seeking monetary damages for the alleged use of Pfizer/BioNTech’s technology in countries where it enforces its patents — which excludes 92 low- and mid- income countries. Moderna is only seeking damages related to alleged infringement that occurred after March 7.
Pfizer and its biotech partner, BioNTech, say they were caught off guard by the lawsuit.
“Pfizer/BioNTech has not yet fully reviewed the complaint, but we are surprised by the litigation given that the Pfizer/BioNTech vaccine for COVID-19 was based on BioNTech’s proprietary mRNA technology and was developed by both BioNTech and Pfizer ,” the companies said in a statement.
Moderna — the first company to select a drug candidate for clinical trials in the U.S. — argues that Pfizer had several options it could have chosen for its vaccine and chose the one most similar to Moderna. The company also claims that Pfizer and BioNTech copied the technology used to carry the vaccine formula into the hands so that the agency would not attack it as a foreign invader.
The lawsuit could signal a more contentious phase in the post-pandemic world. In 2020, Moderna—then just 10 years old—pledged not to enforce its mRNA patents during the pandemic as much of the world scrambled to get vaccinated. While Pfizer said it was surprised by the lawsuit, Moderna said in March this year that it announced it expected drugmakers to “respect” its intellectual property.
“Moderna refrained from asserting its patents earlier so as not to distract from efforts to end the pandemic as quickly as possible,” Moderna said in its lawsuit.
In its lawsuit against Pfizer, Moderna claims that other drug candidates that Pfizer investigated before approval did not include Moderna’s technology. “However, as Pfizer and BioNTech moved further into their clinical development, they ultimately focused exclusively on vaccine designs that used Moderna’s patented technologies,” Moderna said in its lawsuit.
Moderna claims to have discovered mRNA technology years before the COVID-19 pandemic. The research and development, Moderna said, took place in 2011 and 2016 while it worked on a vaccine candidate in response to Middle East respiratory syndrome (MERS).
In its complaint, Moderna cited a Science article that quoted a former top 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 winning full FDA approval, Moderna has released its COVID-19 vaccine as Spikevax, and Pfizer/BioNTech has released its own vaccine as Comirnaty.
Moderna’s chief legal officer, Shannon Thyme Kilinger, said in a statement that it “expects Pfizer and BioNTech to indemnify Moderna for Comirnaty’s continued use of Moderna’s patented technologies.”
In addition to our surprise, Pfizer/BioNTech noted, “We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the lawsuit’s allegations.”
Many claim credit for mRNA technology
This isn’t Moderna’s first patent battle over its COVID-19 vaccine.
In the midst of the pandemic, Moderna found itself in a bitter battle over ownership rights to one of its mRNA patents with the National Institutes of Health (NIH), which claimed its scientists should have been registered on the patent. Moderna eventually relented, withdrawing an application for the patent at issue.
Moderna and BioNTech — also a new company, founded in 2008 — weren’t 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 claims about the LNP technology. Some reports indicate that Alnylam had reached a breakthrough in LNP delivery by 2010.
The fight to demonstrate the potential of mRNA technology has been a long road and hit a wall because the body will attack the formula as a foreign invader. In fact, two scientists at the University of Pennsylvania have also been credited with work published in 2005 that contributed to Moderna’s and BioNTech’s platforms.
Decades of research, roadblocks and mini-breakthroughs highlight the complexity of the world of science and research — and the narrow-minded pharmaceutical companies that covet more than patents.
The effort to identify or identify a single source, seeking awards and recognition, has been the focus of dozens of reports and journal publications throughout the pandemic.
The list of contributions to address the struggle to safely import mRNA into the body is long. But Moderna, through its lawsuit against Pfizer and BioNTech, claims it was first in clinical trials and therefore copied.
“Pfizer and BioNTech chose to promote BNT162b2 as the lead vaccine candidate, knowing that it used the same target antigen as Moderna’s patented Spikevax. Defendants continued to use the invention claimed in the… patent in willful infringement of Moderna’s patent rights.” Moderna claims in the lawsuit.
Wall Street analysts expect Pfizer/BioNTech to file its own lawsuits.
“While the timing of any legal response is unclear, we expect PFE/BNTX to arm its own patent portfolio in response,” Mani Foroohar of SVB Securities Research said in a note on Friday.
“Ultimately, although each case is unique, the history of intellectual property rights disputes between oligopoly companies suggests that the most likely outcome would be modest royalties paid by both companies, with little net favorable economic impact for anyone but the law firms involved,” he added.
Follow Anjalee Twitter @AnjKhem
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