Moderna on Friday sued Pfizer and BioNTech, its main rivals in the mRNA Covid vaccine race, for allegedly infringing on its patents, the latest and perhaps most significant in a series of intellectual property disputes over the technology behind the world-changing and astoundingly lucrative shots.
In its complaint, the Cambridge, Mass.-based company said it is not seeking damages prior to March 8, 2022, before which the company said it would not enforce its patents because of the Covid-19 public health emergency. It is also not seeking damages in 92 low- and middle- income countries where Moderna said it would continue to not enforce its patents.
Nevertheless, the result of any lawsuit could have expensive implications as all three companies seek to expand their mRNA technology into new vaccines for infectious diseases and new treatments for cancer, autoimmune disorders, and rare diseases.
It was not entirely unexpected that the pandemic’s pharmaceutical titans would eventually go to war. There have long been competing claims over the central inventions that made mRNA vaccines possible, but for much of the outbreak, there was little incentive for the companies to go to court, said Jacob Sherkow, an intellectual property expert at University of Illinois’s College of Law and College of Medicine.
When supply was constrained and governments were purchasing the vaccine through advance agreements, there was little extra money to be made and a lot of public good will to be lost. But now doses are abundant and companies may soon commercialize their shots.
“The idea that there would be this Westphalian peace among the oligopolies that are the vaccine producers and that would last forever, I think, was just wholly unrealistic,” Sherkow said.
The suit centers on two key parts of the two approved mRNA vaccines: first, a chemical modification on the mRNA itself that assures the body won’t immediately attack and destroy the string of letters before it can coax cells to produce spike proteins.
Moderna also says it pioneered back in 2015 the broader design for mRNA coronavirus vaccines employed in both Covid shots.
“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” Moderna CEO Stéphane Bancel said in a statement.
A Pfizer spokesperson, in a statement, said the company had not fully reviewed the complaint but was “surprised” by Moderna’s decision.
The “Pfizer/BioNTech COVID-19 Vaccine was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer,” the spokesperson said. “We remain confident in our intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.”
BioNTech issued a statement saying its “work is original” and it will “vigorously defend against all allegations of patent infringement.”
“It is an unfortunate but rather regular occurrence that other companies make allegations that a successful product potentially infringes their intellectual property rights, even more so here after witnessing the historic accomplishments of a vaccine like Comirnaty,” the company said, using the official name for its mRNA vaccine.
The two claims focus on aspects of the technology that have already been the center of key patent disputes throughout its short history. In the last couple years, lawsuits have cropped over who owns the IP for lipid nanoparticles, a technology that evolved over more than two decades to solve the tricky problem getting genetic material into cells.
Moderna is currently facing lawsuits from two small biotechs, Arbutus and Genevant, for allegedly copying their lipid nanoparticle recipe. Alnylam, a $25 billion company that developed nanoparticles in the 2000s and 2010s for use in another type of RNA technology, is suing both Pfizer and Moderna for infringement.
The chemical modifications have a similarly rocky history. Vaunted mRNA pioneers Katalin Karikó and Drew Weissman originally devised the idea of modifying the chemistry of mRNA to avoid the body’s immune response in the mid-2000s at the University of Pennsylvania.
Moderna did not originally license their technology. It says it came up with a slightly different modification, but still ultimately paid $76 million to license Karikó and Weissman’s patent. Moderna says that BioNTech, which also licensed the patent and now employs Karikó and has long worked closely with Weissman’s lab, used the exact chemical modification that Moderna devised.
Sherkow said a court’s ruling may ultimately come down to how a judge views Moderna’s pledge in October 2020 to not enforce its patents “while the pandemic continues.” Is Moderna bound by that pledge? And, if so, for how long? The World Health Organization has not declared the pandemic over and the U.S. is still under a public health emergency.
He doesn’t, however, expect the case to drag on, like other high-profile life science suits have; he predicts a resolution by 2024.
“It’s not going to be like the CRISPR interference that just keeps on going on forever,” he said. “It seems like a pretty straightforward patent case.”