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Scientists question Moderna invention claim in COVID-19 vaccine dispute

One of the three inventions claimed by Moderna in a legal battle that has erupted over the messenger RNA (mRNA) vaccines against COVID-19 was actually patented years earlier by two university scientists.

In a complaint filed on 26 August in a U.S. district court in Massachusetts, Moderna accuses Pfizer and its partner BioNTech of “co-opting Moderna’s patented inventions” covering different aspects of the two COVID-19 vaccines, which have already earned the companies billions of dollars. Both vaccines rely on mRNA that codes for the spike protein of SARS-CoV-2.

BioNTech issued a statement insisting its COVID-19 vaccine work was “original” and said it “will vigorously defend against all allegations of patent infringement.” In a statement to Science, Pfizer said it had “not yet fully reviewed the complaint but we are surprised by the litigation,” adding that the company is “confident in our intellectual property supporting the Pfizer/BioNTech vaccine.”

The two vaccines were the first authorized for COVID-19 in the United States and the first to show the mRNA platform worked, for any pathogen, in people. Moderna said in 2020 it would not enforce patent claims while the pandemic was ongoing. Jacob Sherkow, a patent attorney at the University of Illinois College of Law, suspects the company has changed its tune because it and Pfizer-BioNTech will soon have new markets for formulations of their vaccines that target coronavirus variants. Regulators are expected to authorize these updated vaccines shortly. Moderna and Pfizer-BioNTech initially sold most of their doses to the U.S. government but are now selling the shots globally on the open market, with even larger profits at stake. Moderna’s filing “makes sense now that these are goods,” Sherkow says.

At the heart of Moderna’s patent infringement claim are the steps that opened the door for mRNA as a vaccine. Drew Weissman and Katalin Karikó, both at the University of Pennsylvania (Karikó now also works for BioNTech), published the fundamental discovery in 2005: They showed that altering one of the fundamental building blocks of mRNA, the nucleotide uridine, made the molecule less toxic and also more capable of dodging immune destruction.

Moderna, which was founded to develop medicines based on mRNA, has a patent for a specific modification known as 1-methylpseudouridine. “Moderna’s scientists made the groundbreaking discovery that replacing uridine in the mRNA molecule with 1-methylpseudouridine resulted in surprisingly superior protein production—a severalfold increase over chemically-modified mRNAs studied before—with a significantly reduced immune response against the mRNA itself,” the complaint argues. “This work became the foundation of Moderna’s mRNA platform.”

Weissman and Karikó noted in separate emails to Science that they have an issued patent, filed 6 years earlier than Moderna’s, that explicitly includes the 1-methylpseudouridine modification. Moderna’s attorneys and press office did not respond to Science’s request for comment. Kevin Noonan, a patent attorney in Chicago who specializes in biotechnology, says their 1-methylpseudouridine claim likely will be weakened, but not completely invalidated, by the earlier patent.

Moderna’s complaint alleges two other patent/intellectual property infringements. The company “further discovered that packaging that chemically-modified mRNA in a lipid nanoparticle formulation allowed for the efficient delivery of the mRNA to cells,” it says. Moderna also claims it invented the specific use of mRNA vaccines to protect against betacoronaviruses, the genus that includes SARS-CoV-2. Noonan, who knows the details of these claims, characterizes them as “incredibly broad.”

Industry watchers say that in trying to bolster its claims, Moderna is likely eyeing profits from future mRNA vaccines. “Our mission to create a new generation of transformative medicines for patients by delivering on the promise of mRNA science cannot be achieved without a patent system that rewards and protects innovation,” Moderna CEO Stéphane Bancel said in a press release announcing the lawsuit.

Noonan says the complaint may well wind up in a simplified inter partes review, which could lead to a relatively quick decision by the U.S. patent office as to whether the claims have merit. Or, in keeping with other patent battles over billion-dollar biomedical inventions, this one could drag on for years.

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