“Alexion Pharmaceuticals and Novartis/Genentech File for Preliminary Injunctions in Pharma Patent Disputes at Unified Patent Court”

The Unified Patent Court (UPC) is witnessing its second and third ever pharmaceutical patent disputes, with Alexion Pharmaceuticals and Novartis/Genentech filing for preliminary injunctions. These actions also represent the court’s first ever biosimilar patent disputes.

Alexion has filed two applications for provisional measures at the Düsseldorf Local Division. Both applications concern EP 3 167 888, a patent that claims the treatment of paroxysmal nocturnal hemoglobinuria patients using eculizumab, which is marketed by Alexion as Soliris. The applications target Amgen and Samsung Bioepis, both of which are seeking to market biosimilar versions of eculizumab. The cases were filed on 19 March but have only recently come into public view.

The patent in question was opted out of the UPC in May 2023, but had its opt-out withdrawn in late-January. Following a Board of Appeal decision, the European Patent Office (EPO) announced its intention to grant the patent on 4 March this year.

Novartis and Genentech have also taken action at the Düsseldorf Local Division, seeking a preliminary injunction based on EP 3 805 248, which covers a “process for concentration of antibodies and therapeutics products thereof”, including for rhuMAb E25. This antibody is also known as omalizumab, which is marketed by Novartis and Genentech as Xolair.

The patentees have filed two separate applications for provisional measures, both targeting Celltrion and its various subsidiaries, which are seeking to market a biosimilar omalizumab. These applications were filed on 9 April 2024.

These cases are part of broader biosimilar disputes. While omalizumab has not yet been the subject of US litigation, Celltrion filed a revocation action against a UK patent owned by Genentech and Novartis in July 2023. That action was the subject of a consent order on 3 April, which might indicate that the UK portion of the dispute has been settled, though no announcement has been made in that respect.

The UPC actions were filed after that date, meaning that a pan-European spat has now emerged. European patent ‘248 was also challenged in EPO Opposition proceedings by Celltrion and one other company in October last year.

Soliris has been the subject of a larger and more complicated dispute than Xolair. Alexion has sued Samsung Bioepis in the US under the Biologics Price Competition and Innovation Act, and several of Alexion’s patents are being challenged in inter partes reviews at the USPTO’s Patent Trial and Appeal Board.

In Germany, Alexion is embroiled in national litigation with Amgen regarding the Orphan Drug Exclusivity. The Munich Higher Regional Court was recently persuaded to lift a preliminary injunction based on Alexion’s ODE, which had been imposed by Munich’s lower court in May 2023.

Amgen also initiated UK revocation proceedings against a Soliris patent in May of last year. Now, the UPC preliminary injunction request has broadened this spat into a cross-Europe dispute.

Samsung, despite settling German patent litigation against Alexion in August 2023, is now being targeted across a slew of EU jurisdictions. It is pursuing revocation actions against two Soliris patents at the High Court of England and Wales.

The four recently filed provisional measures applications also end a pharma patent drought at the UPC. A deluge of early cases in the court’s first year have almost entirely avoided one of the patent landscape’s most fertile plains. Previously, the court’s only pharma spat has been the PCSK9 war between Amgen and Sanofi/Regeneron. Just four of the 274 first instance cases filed at the UPC between 1 June 2023 and the end of February related to pharmaceuticals patents. This tally has now doubled in the blink of an eye.