Pfizer, BioNTech Get Legal Pause in Moderna’s COVID-19 Vaccine Patent Lawsuit

Courthouse_iStock, Mariakray

Pictured: Roman columns at the entrance of a U.S. courthouse/iStock, Mariakray

The U.S. District Court for the District of Massachusetts has granted Pfizer and BioNTech’s motion to put on hold Moderna‘s lawsuit against the companies over alleged patent infringement related to their COVID-19 vaccines, pending a review by the Patent Trial and Appeal Board, according to an electric docket order.

In his ruling on Friday, federal judge Richard Stearns wrote that he granted the stay “pending resolution of two inter partes review proceedings recently instituted by the Patent Trial and Appeal Board.” Waiting for the board’s decision would “simplify the issues in this case,” Stearns argued.

If the Patent Trial and Appeal Board (PTAB) ruled to cancel two of Moderna’s patent claims, “there would be no need to litigate infringement with respect to these claims,” Stearns wrote. “And if the PTAB was instead to uphold the claims, Pfizer and BioNTech would be stopped from raising any invalidity arguments.”

Stearns also noted that delaying the case pending the PTAB’s decision should not “prejudice Moderna’s ability to present evidence at trial.”

During the duration of the stay, the parties need to file status reports with the court every 90 days, starting on August 1, 2024.

Moderna kicked off the legal battle in August 2022, when it hit Pfizer and BioNTech with a lawsuit alleging that the partners infringed on patented mRNA technology to develop their COVID-19 vaccine Comirnaty.

At the time, Moderna CEO Stéphane Bancel said that the lawsuits were meant to “protect the innovative mRNA technology that we pioneered, invested billions of dollars in creating and patented during the decade preceding the COVID-19 pandemic.” The company established its “foundational platform” in 2010 and supplemented it with patented work on coronaviruses in 2015 and 2016, according to Bancel.

Moderna’s legal complaint focused on two crucial elements of Comirnaty: the specific chemical modifications to the mRNA molecule—which Moderna says is exactly the same as its vaccine Spikevax—and the overall approach of encoding the full-length spike protein inside a lipid nanoparticle formulation.

Pfizer and BioNTech hit back in August 2023, asking the U.S. Patent Trademark Office to launch an inter partes review of Moderna’s patents, with the ultimate goal of having these patents declared invalid.

The partners argued that Moderna’s patents were too broad and claimed ownership over knowledge that existed before 2015. The injection of mRNA into cells to produce a protein that could be used in a vaccine has been documented for decades, Pfizer and BioNTech contend.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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