Two lawsuits filed in Massachusetts and Germany claim the Pfizer-BioNTech Covid-19 vaccine violated Moderna’s mRNA patents.
- Aug. 26, 2022
The vaccine manufacturer Moderna sued Pfizer and BioNTech on Friday, claiming that its rivals’ Covid-19 shot copied groundbreaking technology that Moderna had developed years before the pandemic.
The allegation of patent infringement sets up what could become a protracted and expensive legal battle between the companies behind coronavirus vaccines that have saved millions of lives worldwide and raised hopes for future medical products using similar messenger RNA, or mRNA, technology.
Experts said Moderna’s litigation, regardless of its outcome, was unlikely to impede access to Covid vaccines or chill the development of mRNA products. But the outcome could dictate whether Pfizer or Moderna controls and profits more from a powerful and lucrative medical technology.
“The battle really is who is going to be, in the future, the go-to source that other companies may have to license from,” said Ameet Sarpatwari, an expert on pharmaceutical policy and law at Harvard Medical School. For Moderna, he said, “establishing their ownership and their dominance in this space is going to set the stage for future royalties that they’re going to get.”
In two lawsuits on Friday, Moderna claimed that Pfizer and its development partner, BioNTech, had infringed on three patents that Moderna filed between 2011 and 2016 related to its mRNA technology. One lawsuit was filed in U.S. District Court in Massachusetts, where Moderna is based, and the other in Germany, home to BioNTech.
Jerica Pitts, a spokeswoman for Pfizer, said Pfizer and BioNTech were “surprised by the litigation” and “remain confident” in their intellectual property supporting the vaccine. BioNTech said in a statement that its “work is original, and we will vigorously defend against all allegations of patent infringement.”
Moderna is seeking damages, which could include royalties and lost profits, incurred since March, when the company said it would begin enforcing its Covid-related patents in wealthier countries after previously pledging not to do so during the pandemic emergency. Moderna’s lawsuits said the company would not seek damages from Pfizer’s sales of its shot to the world’s poorest countries. They also said the company would not pursue any damages that would be the responsibility of the U.S. government, which has bought hundreds of millions of doses of the Pfizer-BioNTech vaccine.
Christopher Ridley, a spokesman for Moderna, said that the company would leave the amount of the damages for the courts to decide and that it would not give an estimate. But Jacob S. Sherkow, an expert on biotechnology patent law at the University of Illinois College of Law, estimated that if Moderna’s litigation succeeded, Pfizer might be forced to pay tens of millions of dollars in damages — a small fraction of the overall sales for its Covid vaccine, which reached a record $36.8 billion in 2021.
Christopher Morten, an expert on pharmaceutical patent law at Columbia Law School, said, “It seems to me that Moderna is really just looking for a cut of Pfizer’s profits and hoping to share with its shareholders a fraction of the billions that Pfizer is earning on top of the billions that Moderna itself is earning.”
Messenger RNA is the genetic molecule that helps cells make proteins. The vaccines from Pfizer-BioNTech and Moderna both use the technology to command cells to make tiny pieces of viruses that strengthen the immune system to protect against the coronavirus that causes Covid-19.
Moderna had been working on the technology for other infectious diseases for years before Covid emerged. The company invested billions of dollars it raised from investors in developing the technology while also receiving significant government support. The United States has given the company more than $10 billion to develop and test the Covid vaccine and to buy doses.
Moderna’s suits claim that Pfizer and BioNTech copied crucial features of its patented technology, including making the same chemical modification to their mRNA and targeting the same type of protein, known as a spike protein, that Moderna scientists had pioneered years earlier.
Moderna has been aggressive in staking out its intellectual property claims on mRNA technology.
The company spent months locked in a bitter dispute with the National Institutes of Health, its collaborator on a project that led to the development of its Covid vaccine, over who deserves credit for a crucial component of that shot. (None of the patents at issue in Friday’s litigation relate to intellectual property generated during that collaboration.) Moderna has since backed down in the dispute with the N.I.H., though the two sides remain in discussions about a resolution.
Moderna said it was not seeking to remove Pfizer and BioNTech’s vaccine from the market, and was not asking for an injunction to prevent its future sale, given the need for access to coronavirus vaccines.
“There is no way that any court in the land would ever issue an injunction blocking Pfizer from making or selling its vaccine as long as the virus continues to circulate and kill hundreds of Americans a day,” Mr. Morten said. “That’s a cleareyed assessment by Moderna’s lawyers that they just wouldn’t get an injunction anyway.”
Moderna is being represented by WilmerHale, a major and well-connected law firm. Its lead lawyer is William Lee, one of the most experienced patent litigators in the country.
Analysts at the investment bank SVB Securities wrote in a note to investors on Friday that the history of disputes over intellectual property between similar 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.”
“These two companies are going to be locked up in litigation for years to come,” said Mr. Sarpatwari of Harvard.
The Covid vaccines from Pfizer-BioNTech and Moderna were both authorized and rolled out within a week of each other in December 2020. They account for the vast majority of the coronavirus shots administered in the United States. Now the Biden administration is preparing to roll out, soon after Labor Day, the next generation of coronavirus shots developed by Pfizer-BioNTech and Moderna.
Both developers this week completed their submissions to the Food and Drug Administration seeking emergency authorization of retooled shots aimed at Omicron subvariants that are causing most new coronavirus cases in the United States. The federal government has ordered 105 million doses of Pfizer-BioNTech’s revamped shot and 66 million of Moderna’s, with options to buy hundreds of millions more.
Officials have said the fall booster campaign could be the last government-subsidized Covid vaccination campaign for many Americans. Ashish Jha, the White House’s Covid-19 coordinator, said this month that the government was likely to stop buying vaccines as soon as this fall, meaning that future Covid booster shots would be paid for and distributed largely through the private health care system, as is done with annual flu vaccines.
Photo: Moderna said Pfizer and BioNTech had infringed on patents filed between 2010 and 2016.Credit…Bagus Indahono/EPA, via Shutterstock
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