Vaccine maker Moderna sued Pfizer and BioNTech on Friday, claiming rival Covid-19 shots copied a breakthrough technology Moderna developed years before the pandemic.
Patent infringement allegations have sparked a long-term strife among the companies behind the coronavirus vaccine that has saved millions of lives worldwide and raised hopes for future medical products using similar messenger RNA (mRNA) technology. set up what can be a dramatic and costly legal battle.
Experts said the Moderna lawsuit, regardless of its outcome, is unlikely to impede access to a Covid vaccine or delay the development of mRNA products. It could determine which side dominates the powerful and profitable medical technology and gains more.
Ameet Sarpatwari, a pharmaceutical policy and legal expert at Harvard Medical School, said: As for Moderna, “establishing ownership and dominance in this space will set the stage for the future royalties they will earn,” he said.
In Friday’s two lawsuits, Moderna alleges that Pfizer and its development partner BioNTech infringed three patents related to mRNA technology that Moderna filed between 2011 and 2016. One lawsuit was filed in the United States District Court in Moderna’s home state of Massachusetts, and his other lawsuit was filed in BioNTech’s home state of Germany.
Pfizer spokeswoman Jerika Pitts said Pfizer and BioNTech were “surprised by the lawsuit” and “confident” in the intellectual property supporting the vaccine. BioNTech said in a statement: Its “works are original and we will vigorously defend against all claims of patent infringement.”
Moderna has cut royalties and lost profits the company has incurred since March when it begins enforcing Covid-related patents in wealthier countries, after previously pledging not to do so during the pandemic emergency. We are seeking damages that may include: Moderna’s lawsuit says it will not seek damages from Pfizer for selling its injectables to the world’s poorest countries. They also said the company would not pursue damages for which the U.S. government, which purchased hundreds of millions of doses of Pfizer and Biontech’s vaccines, would be held responsible.
Moderna spokesperson Christopher Ridley said: The company said it would leave the amount of damages to the court’s determination and would not provide an estimate. But Jacob S. Scherkow, a biotechnology patent law expert at the University of Illinois Law School, said Pfizer could be forced to pay tens of millions of dollars in damages if Moderna’s lawsuit succeeds. I estimate.Covid Vaccine Reaches Record $36.8 billion in 2021.
Christopher Morten, an expert in pharmaceutical patent law at Columbia Law School, said: It tops the billions of dollars that Moderna itself earns. “
Messenger RNA is a genetic molecule that helps cells make proteins. Both Pfizer-BioNTech and Moderna’s vaccines use this technology to order small fragments of the virus into cells that strengthen the immune system to protect against the coronavirus that causes Covid-19.
Moderna has been working on other infectious disease technologies for years before the emergence of COVID-19. While the company invested billions of dollars raised from investors in developing the technology, it also received significant government support. The US has provided the company with more than $10 billion to develop and test a Covid vaccine and purchase dosages.
Moderna’s lawsuit alleges that Pfizer and BioNTech copied key features of their patented technology. This involves making the same chemical modifications to mRNA that target the same type of protein known as the spike protein that scientists at Moderna developed a few years ago.
Moderna has actively pursued intellectual property claims related to mRNA technology.
The company has spent months in a bitter dispute with the National Institutes of Health, a collaborator on a project that led to the development of a Covid vaccine. (It is not related to the intellectual property created in it.) Moderna has since dropped the dispute with the NIH, but the two continue to discuss a solution.
Moderna said it was not seeking to remove Pfizer and BioNtech’s vaccines from the market, nor was it seeking an injunction to prevent future sales given the need for access to the coronavirus vaccine.
“No court in this country will ever issue an injunction barring Pfizer from making or selling a vaccine as long as the virus continues to spread and kill hundreds of Americans a day.” Morten said. “It’s a clear assessment by Moderna’s attorneys, and you won’t get an injunction anyway.”
Moderna is represented by Wilmer Hale, a leading law firm. Its lead attorney is his William Lee, one of the country’s most experienced patent litigators.
Analysts at investment bank SVB Securities said in an investor note on Friday that the history of similar intellectual property disputes between companies meant that “the most likely outcome would be modest royalties paid by both companies. , suggesting little favorable financial impact for other firms.” Relevant Law Firm. “
Sarpatwari of Harvard University said:
Pfizer-BioNTech and Moderna’s Covid vaccines were approved and deployed within a week of each other in December 2020. These account for the majority of coronavirus injections administered in the United States. Now, the Biden administration is preparing to roll out next-generation coronavirus shots developed by Pfizer-Biontech and Moderna shortly after Labor Day.
Both developers completed submissions this week to the Food and Drug Administration seeking emergency approval for modified shots targeted at the Omicron variant that is causing most new coronavirus cases in the United States. ordered 105 million doses of Pfizer-BioNTech improved shots and Moderna’s 66 millionwith the option to buy hundreds of millions more.
Officials say the fall booster campaign could be the last government-funded Covid vaccination campaign for many Americans. said this month The government will likely stop buying vaccines this fall, which means future Covid booster shots, like the annual flu vaccine, will be paid for and distributed primarily through the private healthcare system. To do.
Noah Wayland contributed to the report.