Pfizer and BioNTech allege inconsistencies in Moderna’s COVID-19 statements

Pharma giants raise concerns about Moderna’s COVID-19 vaccine patents | Company's statements to the FDA and PTAB contain "inconsistencies" | Appeals Board urged to scrutinise assertions.

Pfizer and BioNTech have submitted two statements to the US Patent Trial and Appeal Board (PTAB), highlighting alleged inconsistencies in language used by  Moderna to protect its COVID-19 vaccines.

In their statement submitted on January 23, the duo called into question the validity of Moderna's patents, accusing the company of making contradictory assertions to the US Food and Drug Administration (FDA) and the PTAB.

“Prior to this IPR [inter partes review], when seeking FDA approval for commercialisation of its COVID-19 mRNA vaccine, as well as previous mRNA vaccine candidates, Moderna candidly represented to the FDA that prior studies for related vaccines supported an expectation of safety and efficacy," the pharma firms outlined in their statement.

“But now, faced with invalidating vaccine prior art Moderna wrongly casts the same vaccine prior art as irrelevant."

The patents in question are US patent numbers 10,933,127 and 10,702,600 which are related to COVID-19 mRNA vaccines.

Pfizer and BioNTech urged the board to not allow Moderna to “opportunistically embrace prior art before the FDA but now distance itself from the same prior art here.”

Inventor's prior art 'irrelevant'

In the statements, Pfizer and BioNTech accused Moderna of inconsistencies related to the prior art of inventor Andrew Geall's work and the use of DNA vaccines.

Moderna, according to the petitioners, previously emphasised the relevance of Geall to mRNA vaccines when seeking FDA approval. However, they now argue that the same work is irrelevant to the PTAB proceedings.

According to Pfizer and BioNTech, Moderna attempted to distinguish Geall's disclosure, but they accused Moderna of inconsistencies related to prior art on the use of DNA vaccines.

They argue that Moderna's FDA statements are at odds with its current stance before the PTAB, and that it is “unable to explain its litigation-driven one-eighty”.

The pair also argued that Moderna's statements regarding the differences between DNA and mRNA vaccines are contradictory.

Pfizer and BioNTech claim that Moderna's attempts to reconcile these inconsistencies fall short, and the board should institute a trial to resolve the factual disputes.

Case background

In August last year, BioNTech and Pfizer filed an inter partes review before the US Patent and Trademark Office (USPTO) concerning the ongoing dispute against Moderna’s COVID-19 vaccine, challenging its patents.

BioNTech and Pfizer alleged that Moderna had attempted to monopolise the entire field of mRNA technology.

As a result, the two companies requested that the claims be found unpatentable and cancelled.

This filing added to several ongoing cases in multiple jurisdictions concerning the three bio-pharma firms.

In August 2022, Moderna sued Pfizer and BioNTech, alleging the pair had copied Moderna’s patented technology when developing their COVID-19 vaccine, Comirnaty.

The suit, filed at the US District Court for the District of Massachusetts, claimed that Comirnaty infringed patents which Moderna filed between 2010 and 2016 over the mRNA technology.

Simultaneously, Moderna filed a suit against the pair at the Regional Court of Düsseldorf in Germany.

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."

In July 2023, Moderna filed two new patent infringement lawsuits against BioNTech and Pfizer at the High Court in Dublin and at the Brussels Commercial Court in Belgium over the mRNA vaccine tech.

BioNTech and Pfizer are represented by Bruce Wexler, Eric Dittmann, Naveen Modi, Chetan Bansal, and Ryan Meuth from Paul Hastings.

Moderna is represented by Emily Whelan, William Lee, Kevin Prussia, Andrew Danford, and Amy Wigmore from WilmerHale.

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