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Moderna Patent Strike on Pfizer Sets Up Post-Covid Vaccine Feuds

Aug. 29, 2022, 9:30 AM

Moderna Inc.’s Covid-19 vaccine lawsuit against Pfizer Inc. tees up an intellectual property fight that could secure the biotech company’s place as a major player in medical innovations—but also carries risk.

Moderna sued Pfizer Aug. 26 for allegedly infringing three of its patents related to messenger RNA, the genetic material at the heart of their vaccines. Attorneys and academics say the move heralds a shift in the future of mRNA technologies.

The company’s patents may cover technology that proves important in future vaccines as well. If it prevails against Pfizer, Moderna will be in a stronger position to license its innovations to pharmaceutical companies pursuing other medical breakthroughs.

“Moderna wants to be sure people don’t use this technology,” as it could end up being “the secret sauce” in future mRNA vaccines for various purposes, said Kevin Noonan, co-chair of McDonnell Boehnen Hulbert & Berghoff LLP’s Biotechnology and Pharmaceuticals Practice Group.

Its goal “may be to have the ability to choose their licensees and get a royalty they think is fair,” Noonan said. “If it works, they’ll get royalties until these patents expire.”

Covid vaccines aside, Pfizer may pose a particular threat to Moderna’s goal. The pharmaceutical giant has the resources to pursue biotech innovations related to Covid and other diseases.

“Pfizer has know-how but should be rightly concerned about blocking patents on mRNA platform technologies,” said Brook Baker, a professor at Northeastern University School of Law and a senior policy analyst at Health GAP.

Moderna wants “to control the platform as much of it as they can for adaptations to other diseases and Pfizer has made a big deal about their intentions to develop multiple messenger RNA vaccines,” Baker said.

Moderna and Pfizer’s partner in developing its vaccine, BioNTech, stand out as “early pioneers” in mRNA use, said Daniel Shores, a partner at Rothwell Figg specializing in biotech and IP law. The mRNA platform instructs cells in the body to make proteins that fight off or prevent disease.

Big Pharma has taken a different road than Moderna toward such innovations, entering the space toward moves like collaboration agreements and acquisitions. Sanofi, for example, has acquired biotech outfit Translate Bio. Pfizer got into the mRNA game via its collaboration with BioNTech.

When it comes to mRNA delivery and vaccines, “it appears that Moderna’s patents are definitely influential,” said Daniel Takash, policy fellow at the Niskanen Center.

“For future treatments and drugs that utilize mRNA but don’t necessarily involve the pandemic, Moderna has a very strong incentive to make it abundantly clear they are a gatekeeper to develop mRNA vaccines,” Takash said.

Pfizer declined to comment on its litigation strategy.

Future Fights

By enforcing its patents, Moderna also opens itself up to attacks on their validity.

Companies have been making certain adjustments to mRNA for medical purposes “for a while,” Noonan said. That means a company wanting to invalidate some of Moderna’s IP protections could argue the technology was obvious and thus unpatentable, then ask a federal court or the US Patent and Trademark Office to declare it invalid.

Georgetown University O’Neill Institute for National and Global Health Law director Lawrence Gostin expects Pfizer to “try and invalidate Moderna’s patents,” but notes the company will “have to be careful.”

“It might set a precedent or principle for their own patents to be invalidated. They’re going to have to walk a tightrope,” Gostin said.

But Gostin warned that the lawsuit foreshadows a “much more important issue” that’s “bad for global health.” That issue is a future where mRNA technology—which will impact vaccines for influenza, ebola and other health risks—is “more monopolistic.”

“We’re now at the point where we want next generation technology, and we want as many innovators including, Pfizer and BioNTech, being able to produce those,” Gostin said.

The lawsuit “sets the stage for patent gamesmanship for the next generation of Covid vaccines, for influenza and all the future health scourges we’re going to face,” Gostin said. “And there will be many. mRNA should be our savior. It should be the penicillin of the 21st century.”

Protecting Its Platform

Pharmaceutical companies have been launching legal attacks against Covid-19 vaccine makers since 2020, looking to cash in on profits accrued from a pandemic response they believe their technology helped make possible.

Prior patent infringement lawsuits against the vaccine giants were brought by companies including Alnylam Pharmaceuticals Inc. They allege that the drugmakers infringed patents protecting things like lipid nanoparticle technology, or tiny balls of fat protecting genetic material as it travels the body to enter cells to deliver drugs.

Moderna is alleging Pfizer infringed three patents on its vaccine “payload,” which gets the drug inside a recipient’s cells and generates a subject protein.

As mRNA technology grows more popular, the companies involved in Covid-19 patent spats may find themselves behind more lawsuits.

“Moderna, BioNTech, and Curevac—each one of those entities has a tremendous patent estate,” Shores said. What’s more, “each one of those companies was founded and grew based on messenger RNA technology.”

And the “scope of possibilities” with mRNA technologies, Shores said, is vast, touching on other infectious diseases and oncology.

“It’s quite possible we will see additional lawsuits for different advancements in the mRNA space moving forward,” Shores said. “It’s a dawn of a new era in therapeutics.”

The case is ModernaTX, Inc. v. Pfizer Inc., D. Mass., No. 1:22-cv-11378, Complaint filed 8/26/22.

To contact the reporter on this story: Ian Lopez in Washington at ilopez@bloomberglaw.com

To contact the editors responsible for this story: Keith Perine at kperine@bloomberglaw.com; Alexis Kramer at akramer@bloomberglaw.com