Vaccine maker Moderna sued Pfizer and BioNTech on Friday, claiming that their rivals’ Covid-19 shots copied groundbreaking technology Moderna developed years before the pandemic.
The patent infringement allegation sets off what could turn into a lengthy and costly legal battle between the companies behind the coronavirus vaccine that has saved millions of lives worldwide and raised hopes of future developments. future medical products using the same messenger RNA, or mRNA, technology.
Experts say Moderna’s lawsuit, whatever its outcome, is unlikely to impede access to a Covid vaccine or chill the development of mRNA products. But the results could decide whether Pfizer or Moderna control and profit more from a powerful and lucrative medical technology.
“The real battle is over who will be the source of access that other companies may have to license in the future,” said Ameet Sarpatwari, an expert in pharmacy policy and law at Harvard Medical School. For Moderna, he said, “establishing their ownership and their dominance in this space sets the stage for the future royalties they will receive.”
In two lawsuits on Friday, Moderna alleges that Pfizer and its development partner, BioNTech, infringed on three patents Moderna filed between 2011 and 2016 related to their mRNA technology. One lawsuit was filed in US District Court in Massachusetts, where Moderna is headquartered, and the other in Germany, BioNTech’s home country.
Jerica Pitts, a spokeswoman for Pfizer, said Pfizer and BioNTech are “surprised by the litigation” and “remain confident” in their intellectual property that supports the vaccine. BioNTech said in a statement that “its work is original and we will vigorously defend against any allegation of patent infringement”.
Moderna is seeking damages, which could include royalties and lost profits, incurred since March, when the company said it would begin enforcement of Covid-related patents in richer countries after previously pledging not to do so during the pandemic emergency. Moderna’s lawsuits say the company will not seek damages from Pfizer’s gun sales to the world’s poorest countries. They also said the company would not pursue any damages for the responsibility of the US government, which has purchased hundreds of millions of doses of the Pfizer-BioNTech vaccine.
Christopher Ridley, spokesman for Moderna, says the company will leave the amount of damages to the court to decide and they will not give an estimate. But Jacob S. Sherkow, an expert in biotechnology patent law at the University of Illinois Law School, estimates that if Moderna’s lawsuit is successful, Pfizer could be forced to pay tens of millions of dollars in damages. – a fraction of its total sales for its Covid vaccine, which has hit a record $36.8 billion in 2021.
Christopher Morten, an expert in 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 others. its shareholders a fraction of the billions that Pfizer is making. billions of dollars that Moderna herself is making. “
Messenger RNA is the genetic molecule that helps cells make proteins. Vaccines from Pfizer-BioNTech and Moderna both use technology commands cells to make tiny virus fragments that boost the immune system to protect against the coronavirus that causes Covid-19.
Moderna had been working on technology for other infectious diseases for years before Covid appeared. The company has invested billions of dollars raised from investors to develop the technology while receiving substantial government support. The United States has given the company more than $10 billion to develop and test a Covid vaccine and buy dosages.
Moderna’s lawsuits allege that Pfizer and BioNTech copied key features of its patented technology, including making the same chemical modifications to their mRNA and targeting it. into the same protein, called a mutant protein, that the Moderna scientists had pioneered years earlier.
Moderna has been very active in making claims about its intellectual property rights to mRNA technology.
The company has spent many months locked in a bitter dispute with the National Institutes of Health, its collaborator on a project that led to the development of a Covid vaccine, see who deserves credit for a key component of that shot. (None of the patents mentioned in Friday’s lawsuit relate to intellectual property created during that partnership.) Moderna has since then. balk in the dispute with the NIH, although the two sides still discussed a solution.
Moderna said it is not seeking to remove Pfizer and BioNTech’s vaccines from the market and is not requesting an injunction to prevent its future sale, given the need for access to a coronavirus vaccine.
“There is no way any court in the country will issue an injunction banning Pfizer from making or selling vaccines as long as the virus continues to circulate and kill hundreds of Americans every day,” Morten said. “It is a clear assessment by Moderna’s attorneys that they will not receive an injunction.”
Moderna is being represented by WilmerHale, a large and well-connected law firm. Its lead attorney is William Lee, one of the most experienced patent litigators in the country.
Analysts at investment bank SVB Securities wrote in a note to investors on Friday that the history of intellectual property disputes between similar companies “reveals the most likely outcome.” would be modest royalties paid by both firms, with little net financial impact in favor of anyone but the law firms involved.”
“These two companies will be entangled in lawsuits for years to come,” said Harvard’s Sarpatwari.
The Covid vaccines from Pfizer-BioNTech and Moderna were both authorized and deployed within a week of each other in December 2020. They make up the majority of coronavirus shots in the United States. Now the Biden administration is preparing deployed, right after Labor Daynext generation of coronavirus shots developed by Pfizer-BioNTech and Moderna.
Both developers this week completed their submissions to the Food and Drug Administration for urgent authorization of retooled injections aimed at the Omicron sub-variants that cause most cases. new coronavirus cases in the United States. The federal government has ordered 105 million doses of Pfizer-BioNTech’s improved shooting and 66 million of Moderna’swith options to buy hundreds of millions more.
Officials say the fall-intensity campaign could be the last government-subsidized Covid vaccination campaign for many Americans. Ashish Jha, White House Covid-19 Coordinator, said this month that the government is likely to stop buying vaccines as soon as this fall, meaning future Covid boosters will be paid for and distributed largely through the private healthcare system, same as for the annual flu vaccine.
Noah Weiland contribution report.