Amgen prevails over Sanofi at UPC Court of Appeal with Brinkhof and Bardehle

The European Patent Office ruled in April 2025 that Amgen’s EP 3 666 797 is valid as granted. The UPC central division Munich had invalidated EP 797 in summer 2024. For over a year, Amgen and Sanofi, embroiled in a long-running dispute over their cholesterol-lowering drugs Praluent and Repatha, faced conflicting decisions. The question of whether the Amgen patent was rightfully granted remained unclear.

Yesterday, the UPC Court of Appeal published a landmark decision affecting both this dispute and future revocation actions.

The second panel of the Court of Appeal under presiding judge and judge-rapporteur Rian Kalden ruled that Amgen’s patent is valid (case IDs: UPC_CoA_528/2024 and UPC_CoA_529/2024).

The panel also comprised legally qualified judges Patricia Rombach and Ingeborg Simonsson, with Rainer Friedrich and Cornelis Schüller serving as technically qualified judges.

EP 797 covers the active ingredient evolocumab, which uses “antigen binding proteins that bind to proprotein convertase subtilisin kexin type 9 (PCSK9)”. A divisional of the EP 124 patent family, it protects Amgen’s drug Repatha.

Infringement case can proceed

Amgen filed an infringement suit against Sanofi at the UPC based on EP 797 in June 2023, shortly after the court began operations. On the court’s very first day, Sanofi and Regeneron challenged Amgen’s EP 797 at the Munich central division. The UPC later heard both the central revocation claim and the counterclaim for revocation, which the Munich local division had referred to the central division.

The central division ruled EP 797 invalid. This first-ever UPC revocation judgment removed the basis for Amgen’s infringement action at the Munich local division. However, following Amgen’s successful appeal, the Munich local division can now proceed with the infringement claim.

The bitter battle over Praluent and Repatha thus continues. Sanofi has since sued Amgen at the UPC for infringement of patents protecting its drug Praluent. The rivals were already in dispute before the UPC launched.

BoA ruling expected next April

In June 2023, Regeneron and Sanofi challenged EP 797 at both the UPC and EPO, citing violation of added matter prohibition, insufficiency of disclosure, lack of novelty and lack of inventive step.

The EPO Opposition Division rejected these claims entirely. Sanofi and Regeneron appealed immediately. The Boards of Appeal will hear the appeal in April 2026.

The Opposition Division’s decision contrasted with the UPC central division’s invalidation of EP 797. Following the current judgment, however, both patent institutions now agree: the patent is valid — for now. The Boards of Appeal will have the final say.

35 pages and 22 headnotes

The Court of Appeal judges used this opportunity to clarify fundamental questions in UPC revocation actions. Their 35-page judgment addresses key issues such as claim interpretation, added matter and sufficiency.

The inventive step was central to the hearing, with twelve headnotes devoted to this topic. The “reasonable expectation of success” approach is crucial to assessing inventive step.

Headnote 17 states that “a claimed solution is obvious if the skilled person would have taken the next step in expectation of finding an envisaged solution of his technical problem. This is generally the case when the results of the next step were clearly predictable, or where there was a reasonable expectation of success”.

Experts are currently still divided on whether the Court of Appeal is taking a new approach here. But the judgment likely sets the course for future UPC revocation actions. Experts say the headnotes read like guidelines, potentially harmonising previously divergent rulings by first-instance divisions influenced by national legal traditions.

Whether this leads to European-level harmonisation with the EPO remains to be seen until the EPO Boards of Appeal decide on the case next April.

Costly case

The decisions reveal the significant financial stakes. The court valued the proceedings at €100,000,000 for each appeal regarding the central revocation action and counterclaim for revocation.

The judges ordered Sanofi and Regeneron to each pay Amgen €1,375,000 for first instance costs and to bear appeal costs. This includes Amgen’s legal fees.

Bardehle and Brinkhof sucessful for Amgen

As in other proceedings, Amgen relied mainly on teams from Brinkhof and Bardehle Pagenberg. Brinkhof partner Koen Bijvank, dual-qualified as patent attorney and lawyer, led the UPC appeal proceedings, supported by lawyers Daan de Lange, Rik Lambers, Jonathan Santman, and Roza Rijpkema.

The Bardehle team included lawyer Johannes Heselberger and patent attorney Axel Berger, both partners, alongside lawyers Dominik Woll, Ronja Schregle, and Kerstin Galler.

Amgen also works with Osborne Clarke and df-mp in other proceedings. Quinn Emanuel handles the US litigation.

German-British team for Sanofi

Sanofi and Regeneron retained their usual advisors Carpmaels & Ransford and Hoffmann Eitle, both previously involved in Amgen disputes. The Carpmaels team was led by Daniel Wise. Emily Nikolic, Stephen Michell, Agathe Michel-de Cazotte, Ian Kirby, Hiske Roos, Hadi Godazgar, Andreas Hänsele, Henry Evans and Elizabeth Taylor were also part of the team. Carpmaels & Ransford also represents Regeneron in EPO proceedings.

Hoffmann Eitle partner Niels Hölder led the oral hearing for Regeneron. Hölder will leave the firm at year-end. He and Mike Gruber, who became acquainted through their work with Carpmaels & Ransford for Sanofi, have joined the UK firm’s Munich office.

The dispute continues, with Hoffmann Eitle remaining involved via patent attorney Gregor König. Jörg Zwicker from Munich-based patent attorney firm ZSP is also involved in the dispute.