Moderna COVID-19 vaccine dispute halted by court

A US District Court has granted a motion to stay the company’s lawsuit against Pfizer and BioNTech | Decision pauses proceedings until two inter partes review proceedings are resolved.

Pfizer and BioNTech have successfully paused a Moderna lawsuit over royalties for their COVID-19 vaccine Comirnaty.

The court granted a motion to stay the case on April 12, 2024, pausing it until the resolution of two inter partes review (IPR) proceedings initiated by the Patent Trial and Appeal Board (PTAB).

The decision, issued by US District Court for the District of Massachusetts, involved US patent numbers 10,933,127 and 10,702,600, which cover mRNA technology owned by Moderna.

Stay will ‘simplify’ case issues

Judge Richard Stearns said against the issuing of a stay that despite “substantial progress” being made on the case, “a significant amount of work remains to be done before any trial may occur.”

However, in support of the stay, Stearns explained that “while it is true, as Moderna notes, that one of the asserted patents is not encompassed by the IPR proceedings, the outcome of those proceedings will nonetheless simplify the issues in this case.”

The court argued in support of the stay even when only one patent is under review as it has the potential to simplify the case.

“If the PTAB was to cancel the '600 or '127 patents (or any subset of claims therein), for example, there would be no need to litigate infringement with respect to these claims.

“And if the PTAB was instead to uphold the claims, Pfizer and BioNTech would be stopped from raising any invalidity arguments which could have been presented in the IPR,” said the court docket.

Additionally, despite Moderna's concerns about prejudice, the court found that the delay wouldn't harm its ability to present evidence at trial or affect Moderna financially.

During the stay, the parties must file status reports with the court every 90 days, beginning on August 1, 2024.

Case background

Moderna first filed its suit against Pfizer and its German partner BioNTech in August 2022, alleging the pair had copied Moderna’s technology when developing their COVID-19 vaccine.

The pharma and biotech company claimed that Comirnaty infringed patents Moderna filed between 2010 and 2016 covering its foundational mRNA technology.

Moderna itself used this technology to develop its own mRNA COVID-19 vaccine, Spikevax.

In December 2022, Pfizer and BioNTech hit back at Moderna and accused it of rewriting history in a defence and counterclaim filing in the US.

The two companies asked the Massachusetts court to dismiss Moderna’s suit and to issue an order that Moderna’s patents were invalid and not infringed.

They claimed that Moderna had rewritten history to “eliminate the contributions of many brilliant and dedicated scientists and place itself in the single, starring role”.

In the filing, they added: “Ignoring the contributions of all these others—including defendants’ scientists and those working for the National Institutes of Health—Moderna now alleges that it developed both the Moderna vaccine and the technology behind Pfizer and BioNTech’s vaccine, and that Moderna deserves credit for the hard work and creative experiments performed by an entire field of researchers in the years before COVID-19 emerged.

“Moderna avers that it alone—not BioNTech, not Pfizer, and not the US government holds critical patent rights to both parties’ COVID-19 vaccines."

Duo file inter partes review

The duo then filed an IPR before the US Patent and Trademark Office challenging the patents.

The pair challenged Moderna’s patents arguing it acquired them during the pandemic with “unimaginably broad claims directed to a basic idea that was known long before the asserted priority date of 2015”.

BioNTech and Pfizer alleged that Moderna had attempted to monopolise the entire field of mRNA technology and requested the claims be found unpatentable and cancelled.

The board agreed to review both patents last month, however, due to the length of the board’s proceedings Pfizer and BioNTech requested a motion to stay the Massachusetts trial.

Moderna is represented by William Lee, Emily Whelan, Kevin Prussia, Andrew Danford and Amy Wigmore from Wilmer Cutler Pickering Hale & Dorr.

Pfizer is represented by Thomas Selby, Stan Fisher and Kathryn Kayali from Williams & Connolly.

BioNTech is represented by Bruce Wexler, Eric Dittmann, Young Park and Ashley Mays-Williams from Paul Hastings.

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