Success for Pfizer and Marks & Clerk as UK High Court revokes GSK patents

Pfizer had sued for revocation of two patents owned by GlaxoSmithKline, EP 3 109 258 and EP 2 222 710. EP 258 is a divisional application of EP 710. Both cover recombinant RSV antigens used in a vaccine against respiratory syncytial virus. RSV commonly causes lower respiratory tract infections in infants, young children, the elderly and immunocompromised people, leading to bronchiolitis and pneumonia.

Pfizer receives Arrow declaration

Judge James Mellor found both patents invalid for obviousness over all the prior art. Furthermore, he granted Pfizer an Arrow declaration, which is rare. The court also found that, even if the two patents were valid, Pfizer’s RSV vaccine product would not infringe them (case ID: HP-2022-000016). JUVE Patent is not aware of whether GSK will appeal the decision.

The judgment is the latest in a string of important judgments in the pharmaceutical sector that the UK High Court has handed down in recent weeks. Judge Mellor, for example, lately ruled on the nullity suit brought by several generics manufacturers against Astellas concerning Xtandi.

Ongoing actions between the parties in the current case concerning patents in the same families as EP 710 and EP 258 are taking place at other European national courts, as well as the UPC. The latter deals with EP 4 183 412, which covers an RSV F protein compositions and methods for making them (case ID: ACT_45928/2024).

Unlike the original EP 710, the divisional EP 258 had faced an opposition at the EPO. Initially, the Opposition Division revoked EP 258. The Technical Boards of Appeal upheld this decision in October 2023, resulting in the complete revocation of the European patent. Pfizer was one of the opponents.

Gowling for GSK

In the UK nullity case, plaintiff Pfizer relied on a team from mixed firm Marks & Clerk. London-based partner and litigator Mike Gilbert took the lead. He focuses on life sciences litigation and has represented Pfizer in the past. For example, in the dispute with MSD over pneumococcal vaccines and against GSK over a patent concerning meningococcal B vaccines. Dan McGrath, Marcus Riby-Smith, Mari Brace, Caitlin Ahern assisted him in the current case.

The barristers Tom Moody-Stuart KC of 8 New Square and Katherine Moggridge of Three New Square also represented Pfizer.

A team from Gowling defended GSK’s patent. Lead partner Paul Inman worked on the case with London-based partner and head of patent litigation Huw Evans. They had assistance from associates Christopher Freeth, Felicity Wade-Palmer, and Ollie Carpenter.

Paul Inman has represented the pharma company and its predecessor companies for two decades, for example in the dispute against Vectura over inhalers. Gowling is also assisting GSK in coordinating the international actions. The firm instructed barristers Justin Turner KC of 8 New Square and Thomas Lunt of Three New Square.

In the UPC dispute over EP 412, Marks & Clerk is also representing Pfizer while a team from Bird & Bird is acting for GSK.