The Düsseldorf local division of the Unified Patent Court (UPC) has ruled that Amgen may continue selling its PCSK9 inhibitor Repatha (evolocumab) in Belgium, France, Germany, Italy, and the Netherlands, dismissing an infringement suit brought by Sanofi and Regeneron.
The judgment, delivered on May 10, 2025, under presiding judge Ronny Thomas, represents a significant victory for Amgen in the ongoing legal battle over cholesterol-lowering medications. Sanofi and Regeneron had sought an injunction against Repatha sales, claiming the drug infringed their European patent EP 3 536 712 B1, which protects methods for reducing lipoprotein(a) levels by administering a PCSK9 inhibitor.
First UPC Ruling on Second Medical Use Patent
The Düsseldorf judgment marks the first UPC decision concerning a second medical use patent, establishing important precedent in pharmaceutical patent law. In detailed headnotes, the court clarified that "in the case of a second medical use claim, a substance or composition within the meaning of Art. 54(4) EPC is used for any specific use which is not comprised in the state of the art."
For infringement of such patents, the court stated that "the alleged infringer must offer or place the medical product on the market in such a way that it leads or may lead to the claimed therapeutic use of which the alleged infringer knows or reasonably should have known." The judges emphasized that determining such behavior "requires an analysis of all relevant facts and circumstances of the patent claim in question."
While the court rejected Amgen's counterclaim for revocation and upheld the validity of EP 712, it found that Amgen's marketing of Repatha as pre-filled pens and mini-dosers did not constitute infringement of Sanofi and Regeneron's patent claims.
Technical Aspects of the Dispute
The patent at issue, EP 3 536 712 B1, derives from a divisional application branched off from EP 2 756 004 and is in force across the five countries involved in the case. Regeneron's second medical use patent specifically claims the effects of PCSK9 inhibitors on lipoprotein(a), known as Lp(a).
During the hearing on February 25, 2025, much of the technical discussion focused on how standard it was to measure Lp(a) levels in clinical research and patient treatment. This technical point proved crucial in the court's assessment of whether Amgen's product infringed on the specific therapeutic use claimed in Sanofi's patent.
The European Patent Office (EPO) Opposition Division had previously found EP 712 to be valid in late April, a decision that Amgen has directly appealed. The Düsseldorf local division's panel, which included Bérénice Thom as judge-rapporteur, András Kupecz as third legally qualified judge, and Xavier Dorland-Galliot as technically qualified judge, aligned with the EPO on the patent's validity but reached a different conclusion on infringement.
Decade-Long Battle Between Pharmaceutical Giants
The dispute between Amgen and Sanofi/Regeneron over their competing PCSK9 inhibitors—Repatha and Praluent, respectively—dates back to 2014. Initially fought in national patent courts, both companies escalated their dispute to the UPC following its launch.
The legal battle has seen contradictory rulings across different jurisdictions. In July 2024, the Munich central division declared Amgen's EP 3 666 797 invalid for the entire UPC area, a decision Amgen has appealed. Notably, the EPO Opposition Division later upheld this same patent as valid in April 2025, creating a significant divergence between UPC and EPO rulings.
This inconsistency highlights ongoing questions about the harmonization of patent law across European institutions. The UPC Court of Appeal is scheduled to hear Amgen's appeal regarding EP 797 on August 12, 2025, having postponed the original hearing to give both parties more time to argue their cases.
Current Legal Landscape
The pharmaceutical giants now have multiple cases pending before the UPC. Sanofi and Regeneron have two infringement suits against Amgen (over EP 712 and EP 4 252 857) and a revocation case against Amgen's EP 797. Amgen has one infringement case and two counterclaims for revocation.
Prior to the UPC's launch, the companies were engaged in litigation over Amgen's basic patent EP 2 215 124, to which EP 797 belongs. After the EPO Boards of Appeal limited EP 124 in late 2020, the Düsseldorf Higher Regional Court lifted an injunction that had prevented Sanofi and Regeneron from selling Praluent in Germany for over a year.
Legal Representation
In the current proceedings, Amgen relied primarily on teams from Bardehle Pagenberg and Brinkhof. Bardehle partner Johannes Heselberger led the oral hearing, with support from Brinkhof partner Koen Bijvan, patent attorney Axel Berger, and lawyers Nadine Westermeyer and Dominik Woll from Bardehle.
Sanofi and Regeneron were represented by Hoffmann Eitle and Carpmaels & Ransford. Hoffmann Eitle lawyer and partner Niels Hölder led the oral hearing, supported by Mike Gruber, Michael Pfeifer, and Melanie Schain. The Carpmaels team was led by Daniel Wise, with additional support from several colleagues.
Market Implications
The ruling allows Amgen to continue marketing Repatha across five major European markets without interruption. Both Repatha and Praluent represent significant advancements in cholesterol management, particularly for patients with familial hypercholesterolemia or those who cannot achieve adequate LDL-cholesterol reduction with statins alone.
PCSK9 inhibitors work by blocking the PCSK9 protein, which normally reduces the liver's ability to remove LDL cholesterol from the blood. By inhibiting this protein, these medications help lower LDL cholesterol levels significantly.
Both parties are expected to appeal today's judgment, ensuring that this high-stakes pharmaceutical patent battle will continue to evolve in the coming months.
