Moderna Says Pfizer and BioNTech Infringed Vaccine Patent

30.08.2022 - BioNTech and Pfizer are facing another lawsuit claiming that their Comirnaty-branded Covid-19 vaccine infringes another company’s patent. The latest to sue is US rival Moderna, which claims the German-American duo copied the original mRNA technology it used for its first-generation shot Spikevax.

Like similar charges levied by BioNTech’s German rival CureVax, the Moderna lawsuit, which is seeking unspecified financial damages, was filed both in a US district court in the state of Massachusetts and in a German regional court in Düsseldorf.

Moderna claims that BioNTech (which developed and patented the technology for Comirnaty) and Pfizer copied two key elements of its technology.

The first alleged violation pertains to a chemical modification that avoids an undesirable immune response to the vaccine. The Maryland-based biotech asserts that its own scientists were the first to demonstrate the feature in human trials in 2015.

While Pfizer and BioNTech originally tested four candidates, the one they chose for advancement has the "exact mRNA chemical modification" as Spikevax, Moderna says.

The US rival’s second charge relates to the way both vaccines target the distinctive spike protein on the outside of the virus. Here, it says its rivals encoded a full-length spike protein in a lipid nanoparticle formulation for a coronavirus, copying technology developed by Moderna several years earlier.

In a statement, Moderna CEO Stéphane Bancel said the US company is filing the lawsuits “to protect the innovative mRNA technology that we pioneered, invested billions of dollars into creating, and patented during the decade preceding the Covid-19 pandemic."

Pfizer said it was "surprised" by the lawsuit but remains confident in the intellectual property supporting the Pfizer/BioNTech vaccine and will vigorously defend against the allegations of the lawsuit.” In a statement of its own, BioNTech said, “our work is original, and we will vigorously defend against all allegations of patent infringement.”

In another parallel to the CureVac suit, Moderna said it was not seeking to remove Pfizer and BioNTech’s vaccine from the market, nor was it targeting Comirnaty sales in low- and middle-income countries covered by the global Covax initiative.

In developed markets, both companies said they expect their mRNA rivals to respect their intellectual property rights and would consider a “commercially reasonable license." Pfizer and BioNTech have "failed to seek such a license, ” Moderna asserted.

With the pandemic seen, at least psychologically, to be receding from its acute phase, market watchers expect more lawsuits. In July, Alnylam Pharmaceuticals sued both Pfizer and Moderna, accusing them of violating a patent that covers a “breakthrough class of cationic biodegradable lipids used to form lipid nanoparticles” for mRNA-based vaccines.

Alnylam is seeking royalties from the vaccine makers’ sales.

In February this year, US biotechs Arbutus Biopharma and Genevant Sciences sued Moderna in the district court for the District of Delaware seeking damages for allegedly infringing several of their US patents in the manufacture and sale of Spikevax. The patents relate to nucleic acid-lipid particles and lipid vesicles, as well as compositions and methods for their use.

In late 2021, the US National Institutes of Health said it would fight it out in court with Moderna over the vaccine manufacturer’s refusal to list US government scientists on the patents it has won for Spikevax. This, it said, was despite the scientists’ considerable contribution and the $10 billion in government money the company received.

Reacting to the news, SVB Securities analysts said they expect Pfizer and BioNTech to "weaponize their own patent portfolio" in response to Moderna's lawsuit. The SVB team expects the disputes to take years to play out in court.

"While each case is unique, the history of [intellectual property] disputes among oligo companies suggests the most likely outcome would be modest royalties paid by both companies, with little net favorable impact for anyone but the law firms involved," the investment bank noted. 

Author: Dede Williams, Freelance Journalist