Pfizer, BioNTech Challenge Moderna’s COVID-19 Patents with USPTO

Pfizer_iStock, Alexandros Michailidis

Pictured: Pfizer's office in Belgium/iStock, Alexandros Michailidis

Pfizer and German partner BioNTech on Monday asked the U.S. Patent and Trademark Office to reconsider, and ultimately invalidate, Moderna’s patents over core technologies of the COVID-19 vaccine, Reuters reported.

In an 87-page document, the partner companies argued that the Moderna patents are “unimaginably broad” and seek to claim ownership of knowledge that had existed long before its asserted priority date of 2015.

Pfizer and BioNTech contend that using injecting mRNA into cells to produce a protein—and in turn leveraging this process to produce vaccines that prime immune protection—had been demonstrated and documented in the scientific literature as early as the 1990s.

Moderna’s patent claims over any mRNA sequence encoding any betacoronavirus spike protein or its subunit, as well as a lipid-based formulation for delivery, is an “attempt to coopt and entire field of mRNA technology,” Pfizer and BioNTech argued in their USPTO filing.

The partners are asking the USPTO to launch an inter partes review of Moderna’s patents and that “the challenged claims be found unpatentable and canceled,” according to their filing.

Moderna started the legal tussle over the COVID-19 vaccines in August 2022, when it slapped Pfizer and BioNTech with lawsuits alleging that their Comirnaty infringes on patents covering the Cambridge biotech’s mRNA technology. The cases were filed in the U.S. and in Germany.

Moderna’s lawsuit focused on two key elements of the vaccine. In particular, the company claims that after conducting tests with a handful of different vaccine candidates, Pfizer and BioNTech “ultimately decided to proceed with the vaccine that has the same exact mRNA chemical modification to its vaccine as Spikevax,” Moderna wrote in its press release at the time.

Spikevax is Moderna’s COVID-19 vaccine, which won the FDA’s full approval in January 2022.

Moderna’s lawsuit also alleges that Pfizer and BioNTech used its process of encoding the full-length spike protein loaded into a lipid nanoparticle for delivery.

According to Moderna, neither Pfizer nor BioNTech “had Moderna's level of experience with developing mRNA vaccines for infectious diseases” and could have only produced their vaccine by following “Moderna’s lead.”

Several other companies have since joined the patent battle over the COVID-10 vaccines. In June 2023, Promosome filed separate lawsuits against Moderna and Pfizer, while Arbutus Biopharma in April 2023 launched a similar legal complaint against Pfizer and BioNTech.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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