PTAB grants BioNTech and Pfizer's inter partes review against Moderna

US Patent Trial and Appeal Board sides with the biotech pair in their challenge against Moderna's mRNA vaccine patents | Inter partes review challenges broad claims and monopolisation over mRNA tech. 

The US Patent Trial and Appeal Board has granted BioNTech and Pfizer’s petition for inter partes review (IPR) against Moderna in the ongoing dispute concerning patents related to mRNA vaccines.

Judges Sheridan Snedden, Timothy Majors and David Cotta concluded, on March 19, that there was a reasonable likelihood of BioNTech and Pfizer prevailing on at least one of the challenged claims.

The US patents are 10,702,600 and 10,933,127 and cover the betacoronavirus mRNA vaccine.

IPR allegations

Last August, BioNTech and Pfizer initiated an IPR with the US Patent and Trademark Office (USPTO) against Moderna's COVID-19 vaccine patents, accusing Moderna of trying to monopolise mRNA technology—and requested claims to be invalidated and revoked.

The IPR petition claimed Moderna acquired the patent during the pandemic with “unimaginably broad claims directed to a basic idea that was known long before the asserted priority date of 2015”.

Pfizer and BioNTech submitted two statements to the PTAB, highlighting inconsistencies in Moderna's language regarding its COVID-19 vaccines, in January 2024.

They questioned the validity of Moderna's patents, alleging that the company made conflicting statements to the US Food and Drug Administration (FDA) and the PTAB.

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.”

PTAB’s decision

Moderna requested a denial of the petition, arguing BioNTech and Pfizer presented similar invalidity arguments in ongoing parallel litigation involving the same parties, which is set to be decided before this case is concluded.

Moderna also argued that the prior art had already been considered during the patent application process, without showing any significant error by the examiner when granting the patent.

BioNTech and Pfizer argued, in response, that the examiner failed to properly consider certain references, despite their submission during prosecution.

They also claimed the examiner made errors in evaluating the prior art and that their arguments are not repetitive of those made before.

The board found that the USPTO erred in allowing the challenged claims and ruled that the petition should not be rejected.

The PTAB's decision not to deny the petition was influenced by factors such as the likelihood of a stay in the parallel litigation, the proximity of the trial date to the statutory deadline for a final decision, the investment in the parallel proceeding, the overlap of issues, the identity of the parties involved, and other circumstances impacting the exercise of discretion.

BioNTech and Pfizer had also sufficiently demonstrated a reasonable likelihood of prevailing on at least one of the challenged claims in the petition.

Case background

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

The suit 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 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 and Chetan Bansal from Paul Hastings.

Moderna is represented by Emily Whelan and Wenli Gu from WilmerHale.