Pfizer ‘surprised’ by Moderna COVID-19 vaccine patent lawsuit

Moderna (MRNA) said Friday it is suing Pfizer and BioNTech (PFE/BNTX), alleging the rival drug makers infringed three patents on the technology it used for its mRNA COVID-19 vaccine.

In two lawsuits filed in U.S. federal court, and Germany where BioNTech is based, Moderna said it is seeking monetary damages for Pfizer/BioNTech’s alleged use of its technology in countries where it is enforcing its patents — that excludes 92 low- and middle-income countries. Moderna is only asking for damages tied to alleged infringement that occurred after March 7.

Pfizer and its biotech partner, BioNTech, say they were caught off guard by the litigation.

“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,” the companies said in a statement.

Moderna — the first company to select a drug candidate for clinical trials in the U.S. — contends that Pfizer had multiple options it could have chosen for its vaccine and opted for the one most similar to Moderna. The company also claims Pfizer and BioNTech copied the technology used to deliver the vaccine formula into arms, so that the body does not attack it as a foreign intruder.

The lawsuit could mark a more litigious phase of the post-pandemic world. In 2020, Moderna — then only 10 years old — pledged not to enforce its mRNA patents during the pandemic as much of the world struggled to get inoculated. While Pfizer said it was surprised by the litigation, Moderna said in March of this year it announced that it expected drug makers to “respect” its intellectual property.

“Moderna refrained from asserting its patents earlier so as not to distract from efforts to bring the pandemic to an end as quickly as possible,” Moderna said in its lawsuit.

In its lawsuit against Pfizer, Moderna contends other drug candidates that Pfizer explored prior to approval didn’t include Moderna’s technology. “However, as Pfizer and BioNTech got further along in their clinical development, they ultimately focused exclusively on vaccine designs that used Moderna’s patented technologies,” Moderna said in its lawsuit.

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Moderna contends it explored mRNA technology years before the COVID-19 pandemic. The research and development, Moderna said, took place during 2011 and 2016, while it worked on a vaccine candidate in response to the Middle East Respiratory Syndrome (MERS).

In its complaint, Moderna cited a Science article that quoted a former top vaccine official at the U.S. Food and Drug Administration who called one of Moderna’s mRNA innovations “the most important thing that people have done with mRNA vaccines.”

Since gaining full FDA approval, Moderna has marketed its COVID-19 vaccine as Spikevax, and Pfizer/BioNTech have marketed theirs as Comirnaty.

Moderna’s chief legal officer, Shannon Thyme Kilinger, said in a statement that it “expects Pfizer and BioNTech to compensate Moderna for Comirnaty’s ongoing use of Moderna’s patented technologies.”

In addition to being surprised, Pfizer/BioNTech noted, “We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.”

Many claim credit for mRNA technology

This isn’t Moderna’s first patent fight over its COVID-19 vaccine.

In the middle of the pandemic, Moderna found itself in a bitter fight over ownership rights to one of the mRNA patents with the National Institutes of Health (NIH), which claimed its scientists should have been listed on the patent. Moderna eventually backed down, withdrawing an application for the patent at issue.

Moderna and BioNTech — also a new company, having been founded in 2008 — were not the only companies to have worked 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’s existence. The company is separately suing Moderna and Pfizer over similar allegations about its LNP technology. Some reports show that Alnylam had arrived at a breakthrough in LNP delivery by 2010.

The struggle to showcase the potential of mRNA technology was a long road, and hit a wall because the body would 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, which contributed to Moderna and BioNTech’s platforms.

The decades of research, road blocks, and mini-breakthroughs highlights the complexity of the science and research world — and the close hold pharmaceutical companies desire over patents.

Trying to trace or credit a single source, in pursuits of prizes and recognition, has been the focus of dozens of reports and journal publications throughout the pandemic.

The list of contributions to work around the struggle to safely get mRNA into the body is long. But Moderna, through the lawsuit against Pfizer and BioNTech, claims it was first to clinical trials and therefore was copied.

“Pfizer and BioNTech chose to advance BNT162b2 as their lead vaccine candidate knowing that it utilized the same target antigen as Moderna’s patent-protected Spikevax. Defendants continued to use the invention claimed in the…patent in deliberate disregard for 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 weaponize their own patent portfolio in response,” said SVB Securities Research’s Mani Foroohar, in a note Friday.

“Ultimately, while each case is unique, the history of IP disputes among oligo companies suggests the most likely outcome would be modest royalties paid by both companies, with little net favorable financial impact for anyone but the law firms involved,” he added.

Follow Anjalee on Twitter @AnjKhem

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