GlaxoSmithKline Expands Patent Dispute with Pfizer to Unified Patent Court

Overview:

GlaxoSmithKline (GSK) has escalated its ongoing patent dispute with Pfizer by filing a lawsuit at the Unified Patent Court (UPC). This development marks a notable instance of pharmaceutical intellectual property (IP) litigation being pursued in the UPC, which has seen relatively few pharmaceutical cases since its inception.

Details of the Case:

GSK has accused Pfizer of infringing on European Patent EP 4 183 412, titled “RSV-F protein compositions and methods for their production.” The European Patent Office (EPO) announced its intention to grant this patent in May 2024. Initially opted out of the UPC’s jurisdiction in May 2023, the patent was brought back under UPC’s ambit on April 18, 2024. The patent was officially granted and published in the European Patent Bulletin on August 14, 2024, just nine days before GSK initiated its lawsuit.

Background:

The legal battle centers on Pfizer’s respiratory syncytial virus (RSV) vaccine, Abrysvo, which GSK contends infringes its patent rights. Both Abrysvo and GSK’s rival product, Arexvy, were approved by the US Food and Drug Administration (FDA) last year and launched in the EU and UK in 2023. The two products have already achieved significant revenue; for instance, Abrysvo generated $201 million globally in the first half of 2024 and is projected to be a billion-dollar drug, contributing to a market expected to reach $10 billion annually by the end of the decade.

Legal Proceedings: • US Litigation: In August 2023, GSK filed a patent litigation lawsuit against Pfizer in the District of Delaware. The lawsuit began with claims based on four US patents (nos. 8,563,002, 11,261,239, 11,629,181, and 11,655,284) and was later expanded in November to include two additional US patents (nos. 11,820,812 and 11,827,694). The suit seeks a permanent injunction against Pfizer’s product for use in adults over 60 and unspecified monetary damages.

• European Actions: In June 2022, Pfizer began revocation actions against several GSK RSV patents in the High Court for England and Wales, and similar actions were subsequently launched in the Netherlands and Belgium. GSK has counterclaimed for infringement in these jurisdictions.

UPC Involvement:

GSK’s decision to file at the UPC is part of a broader strategy to enforce its patents across 17 UPC member states through a single lawsuit. This approach offers potential cost efficiencies, especially given that Abrysvo’s revenue outside the US was only $29 million in the first half of 2024.

Pharma-Related UPC Cases:

Despite a spike in drug patent disputes at the UPC, pharmaceutical cases have been relatively rare. Since the court’s opening in June 2023, there has been only one significant pharma-related dispute—a clash between Amgen and Regeneron/Sanofi over PCSK9 inhibitors, consisting of two infringement cases and one revocation case. In the first nine months of the UPC’s operation, 96 infringement actions and 20 revocation cases were filed across all technology sectors.

Recent Developments:

• Biosimilar Disputes: In March and April 2024, the UPC saw its first biologic versus-biosimilar cases, including Alexion’s injunction requests against Amgen and Samsung Bioepis, and Novartis/Genentech’s actions against Celltrion over biosimilar omalizumab.

• Branded-versus: Generic Disputes: May 2024 witnessed traditional branded versus-generic disputes, including Sanofi’s lawsuit against several generic producers of cabazitaxel.

Outlook: The UPC’s handling of pharmaceutical cases is still evolving. Early decisions have not yet prompted a surge of pharma patentees to file cases at the court. Recently, the UPC denied Alexion’s claims for injunctions and invalidated Amgen’s patent. The next significant update will come from Novartis/Genentech’s injunction proceedings against Celltrion, with a decision expected on September 6, 2024. GSK’s latest move in the UPC underscores the complex and high-stakes nature of pharmaceutical patent disputes, highlighting the significant role of the court in global IP enforcement.