Sanofi and Regeneron overturn key Amgen patent at UPC

Sanofi and Regeneron have achieved a significant win. Before the Unified Patent Court was launched, it was a key fear of many patent holders that the court could destroy an important patent for all UPC states. This fate has now befallen Amgen. Today, the Munich central division declared Amgen’s EP 3 666 797 invalid for the entire UPC area.

EP 797 is a divisional belonging to the EP 124 patent family. EP 797 covers active ingredient evolocumab, which uses “antigen binding proteins to proprotein convertase subtilisin Kexin type 9 (pcsk9).”

The court under presiding judge Ulrike Voß, András Kupecz and TQJ Casper Struve found EP 797 invalid for lack of inventive step.

First revocation case in Munich

The Munich central division heard Amgen vs Sanofi on 4 June 2024 – the central division’s first ever revocation case. Today’s ruling also constitutes the UPC’s first ever revocation judgment.

The Europe-wide dispute concerns cholesterol-lowering drugs Praluent and Repatha. Amgen sells its product under the Repatha brand, while Sanofi and Regeneron are on the market with Praluent.

On the first day of the UPC’s launch a year ago, Sanofi and Regeneron challenged Amgen’s patent EP 797 at the Munich central division. The court heard both the central revocation claim and the counterclaim for revocation, which the Munich local division had referred to the central division (case ID: ACT_459505/2023 and CC_586764/2023).

Today’s judgment removes the basis for the infringement action filed by Amgen against Sanofi last year at the Munich local division. However, Amgen can still appeal.

According to JUVE Patent information, the local division will hear the parties this year to decide whether it will continue with the infringement proceedings or wait for a final revocation decision from the Court of Appeal.

In view of the commercial significance of the dispute between the two pharmaceutical giants, and the intensity of the dispute to date, it is highly likely that Amgen will appeal today’s judgment.

Sanofi and Amgen battling since 2014

Amgen and Sanofi and the latter’s partner company Regeneron have been battling over Praluent and Repatha since 2014. Initially, the battle was fought in national patent courts. Both companies then escalated their dispute to the UPC.

Then, in early 2024, Sanofi also sued Amgen at the UPC for infringement of EP 3 536 712 (case ID: ACT_597355/2023).

Amgen had already suffered a setback in 2019. At that time, the US company first successfully enforced an infrindgement judgment of the Düsseldorf Regional Court against Sanofi regarding infringement of another patent. However, after the companies ceased sales of Praluent, the EPO Technical Boards of Appeal maintained Amgen’s EP 22 15 124 in a drastically amended form. These changes to the Amgen patent meant it no longer covered Sanofi’s Praluent product.

Short deadlines, large teams

At the oral hearing in Munich in early June, neither Amgen nor Sanofi spared any expense when it came to their legal teams. Amgen hired six law firms to defend EP 797. Koen Bijvank and Daan de Lange from Brinkhof and Bardehle Pagenberg’s Johannes Heselberger and Axel Berger took the lead.

Teams around Ulrich Dörries from df-mp, Will James from Osborne Clark and Lauren Martin from Quinn Emanuel also contributed to the defense of the patent.

The size of the teams defending patents against central revocation claims at the UPC is mainly due to the tight deadlines. The team attacking the Amgen patent in Munich on behalf of Sanofi and Regeneron appeared comparatively small. Daniel Wise, Emily Nikolic and Agathe Michel-de Cazotte from Carpmaels & Ransford took the lead, supported by Nils Hölder and Mike Gruber from Hoffmann Eitle.

Shortly before the trial, both plaintiffs also drew on the pharmaceutical expertise of Gregor König from the Düsseldorf law firm König Szynka Tilmann von Renesse. In addition, Jörg Zwicker from the Munich patent attorney firm ZSP has advised Sanofi in the dispute for years.

July whirlwind

July is a key month for UPC judgments. The two local divisions in Düsseldorf and Paris have already issued the court’s first infringment judgments, and further judgments are set to come.

The Paris central division’s first revocation judgment is expected on 19 July. The hearing in Meril Life Sciences vs Edwards Lifesciences took place in early June.

Meril Italy had filed its own isolated nullity action against EP 3 646 825 with the Paris central division. The Munich local division then referred the counterclaims to Paris and the court heard all attacks against Edwards’ patent together on 7 June (case IDs: ACT_551308/2023, ACT_584916/2023 and ACT_585030/2023).

The Munich local division will probably announce its first substantial judgment at the end of July. The court heard an infringement action between Dexcom and Abbott on 4 June and intends to decide quickly. It recently heard another action between Avago and Tesla. The Hamburg local division also heard an action between the same parties in mid-June. Generally, the courts hand down rulings six weeks after the hearings.