Context: In August 2023, GlaxoSmithKline (GSK) initiated patent infringement actions against Pfizer in both the District of Delaware and the Unified Patent Court (UPC) (ip fray LinkedIn post), alleging that the defendant’s respiratory syncytial virus (RSV) vaccine infringed several of GSK’s patents related to antigen technology. Pfizer denied the allegations and argued that GSK’s patents were invalid. GSK’s RSV vaccination, also known as Arexvy, is responsible for two-thirds of U.S. RSV shot sales (May 2024, GSK press release). The vaccine helps treat a condition that typically causes cold-like symptoms but can also lead to pneumonia in toddlers and older adults. In a decision last October, and a huge win for Pfizer, the UK High Court invalidated two of GSK’s RSV-related patents, EP3109258 and EP2222710.
What’s new: GSK and Pfizer have settled their dispute, according to a filing in the District of Delaware. The companies stated in the filing that they would dismiss the case with prejudice, which means it cannot be refiled.
Direct impact and wider ramifications: This filing also brings an end to the parties’ pending litigation in the UPC. However, GSK and Pfizer’s patent infringement dispute over the latter’s COVID-19 vaccine, Comirnaty, is still pending.
This is the stipulation of dismissal:
GSK initiated its UPC prong of the dispute last August, by filing an infringement action over EP4183412 (“Rsv f protein compositions and methods for making same”) with the UPC’s Dusseldorf Local Division between the decision by the European Patent Office (EPO) to grant the patent and the official publication of its issuance. Pfizer then filed a revocation action in the UPC’s Milan seat of the Central Division (CD), 9 seconds after midnight on the date on which the grant was (foreseeably) published by the EPO.
In a decision issued in December, the Milan CD decided against GSK’s objection to the revocation action and agreed with Pfizer that the infringement filing was premature (December 13, 2024 ip fray article).
In 2023, Pfizer also sought a so-called “Arrow Declaration” from the UK High Court, arguing that the declaration would serve a “useful purpose” because there was a clear public health interest in having Pfizer’s vaccine made available in the UK. A decision handed down by Judge James Mellor in October sided with Pfizer, allowing the company to continue to market its RSV vaccine in the UK.
Counsel
In the U.S., GSK was represented by Sara M. Metzler, Frederick L. Cottrell III, and Kelly E. Farnan, at Richards, Layton & Finger, PA, while Pfizer was represented by Megan E. Dellinger and Jeremy Tigan at Morris, Nichols, Arsht & Tunnell LLP.
In the UPC, counsel for GSK was Bird & Bird’s Oliver Jan Jüngst, Luca Brons, Dr. Daniela Kinkeldey, and Dr. Anna Schadel, and counsel for Pfizer was Marks & Clerk’s Gareth Williams, and Clifford Chance’s Dr. Claudia Milbradt and Dr. Tobias J. Hessel.
In the UK, counsel for GSK was a team at Gowling, including Paul Inman, Huw Evans, Christopher Freeth, Felicity Wade-Palmer, and Ollie Carpenter. Pfizer was represented by Marks & Clerk’s Mike Gilbert, Dan McGrath, Marcus Riby-Smith, Mari Brace, and Caitlin Ahern.
Last April, GSK also sued Pfizer and BioNTech in the District of Delaware over the latter’s COVID-19 vaccine, Comirnaty, seeking damages for the infringement of five of its patents (April 26, 2024 ip fray article). That case is still pending.