Evolocumab and alirocumab (Repatha, Praluent): the UPC's first revocation, reversed

What was decided

Amgen’s European Patent 3 666 797 claims antibodies that bind PCSK9, the target of both Amgen’s Repatha and Sanofi/Regeneron’s Praluent, two injectable cholesterol-lowering biologics. Sanofi and Regeneron asked the Unified Patent Court to revoke it; Amgen counterclaimed for infringement.

On 16 July 2024 the Munich Central Division revoked the patent in its entirety, for lack of inventive step, in all 17 UPC countries at once: the court’s first revocation decision on the merits. The European Patent Office’s Opposition Division, looking at the same patent in parallel proceedings, rejected the opposition and kept it. On 25 November 2025 the UPC Court of Appeal set the Munich decision aside, dismissed the revocation action and ordered Sanofi and Regeneron to pay Amgen’s first-instance costs. Sanofi and Regeneron applied for a rehearing in January 2026.

Timeline

Date	Event
2023	Sanofi and Regeneron file for revocation at the UPC; Amgen counterclaims
16 July 2024	Munich Central Division revokes the patent across the UPC states
2024–25	EPO Opposition Division maintains the same patent
25 November 2025	UPC Court of Appeal reverses and upholds the patent
26 January 2026	Sanofi and Regeneron apply for a rehearing

What it means if you are…

A generics, biosimilar or launch planner. A first-instance UPC revocation is not a clearance. The Court of Appeal is willing to re-decide inventive step from the ground up, and it did so here sixteen months later. Plans that treated the July 2024 decision as the end of the patent were wrong for a year. Until the Court of Appeal has spoken, or the time for appeal has passed, treat a revoked patent as suspended rather than gone.

A wholesaler or buyer. Biologic prices in this class depend on which of the two products can be sold freely where. A reinstated patent reopens an infringement claim that had been closed, with all that implies for supply of the competing product.

A parallel trader. Little direct effect: both products are originator biologics and the dispute is between them. The general lesson is the one above: at the UPC, a patent’s status is not final until the appeal is.

Status and what to watch

The rehearing application, and any infringement proceedings Amgen now pursues on the reinstated patent. Also the difference between the EPO’s and the UPC first instance’s views of the same patent, which the Court of Appeal has now resolved in the EPO’s direction.