First UPC Court of Appeal decision clarifies deadline for defendants

The global patent dispute between Amgen, Sanofi and Regeneron over the cholesterol-lowering drugs Repatha and Praluent is increasingly becoming a lead case at the Unified Patent Court. The dispute is based on Amgen’s divisional patent EP 3 666 797 covering active ingredient evolocumab.

In August, the UPC central division in Munich clarified questions regarding the bifurcation of infringement and revocation actions in the dispute. Now, the UPC Court of Appeal in Luxembourg has clarified details concerning the deadline for the statement of defence (case ID: UPC_CoA_320/2023).

Previously, the Munich local division had decided by order that the deadline for the defendant to file a statement of defence begins when the claim has been served on the defendant, even if this does not include the attachments. However, the statement of claim must state that there will be a subsequent submission of attachments.

According to lawyers, this would be in line with practice at the patent chambers of the Regional Court Munich in national proceedings. According to JUVE Patent information, the Munich central division and the local division in Milan had also taken different views on the beginning of the deadline for defendants.

All documents required

In the UPC dispute between Amgen and its two opponents Sanofi and Regeneron, this initially meant that the three-month deadline for the statement of defence would have begun on 11 July 2023, even though Amgen did not upload its attachments to the UPC CMS system until 10 August.

However, the Court of Appeal has now confirmed that Amgen’s complaint was validly served even without the attachments. But unlike the Munich local division, the appeals court is granting defendants an extension.

UPC Court of Appeal in Luxembourg ©UPC

According to JUVE Patent information, the Court of Appeal ruled that the deadlines specified in rules 19.1 and 23 of the UPC Rules of Procedure are to be extended by the period during which the attachments were not available contrary to rule 13.2. Unless the plaintiff demonstrates special circumstances to the contrary in the individual case.

In effect, the deadline does not begin until the plaintiff has submitted all documents.

Defendants breathe easy

Following the order from the Munich local division, Sanofi’s and Regeneron’s lawyers might have had only two months left to respond to Amgen’s attachments. However, the UPC Court of Appeal has now stipulated that the deadline for Sanofi and Regeneron began on 10 August. As a result, their lawyers now have until 10 November to complete their statement of defence.

The current decision is likely to take pressure off defendants, which are already struggling with a very short three-month deadline. Patent experts in Europe agree that defendants need large teams and a good deal of effort to meet the short deadline.

In the future, plaintiffs will now take care to serve all attachments with their statements of claim to the defendant. However, the separation of documents could still be an option if a claimant wants to serve the claim quickly and effectively.

Everlasting battle

The patent in the UPC case between Amgen, Sanofi and Regeneron is the third divisional patent belonging to the EP 124 patent family that the biopharmaceutical company has enforced. The active ingredient evolocumab uses “antigen binding proteins to proprotein convertase subtilisin kexin type 9 (pcsk9)”.

The ruling in the Amgen case is the Court of Appeal’s first ever decision. However, the court recently received a second case, namely the dispute between 10x Genomics and NanoString.

Read more information about the battle between Amgen and Sanofi/Regeneron and their representatives here.

For Amgen
Bardehle Pagenberg (Munich): Johannes Heselberger (lead), Axel Berger (patent attorney, both partners); associate: Ronja Schregle (lead), Dominik Woll

For Sanofi
Hoffmann Eitle (Munich): Niels Hölder (lead), Mike Gruber (both partners); associates: Michael Pfeifer, Melanie Schain
Carpmaels & Ransford (London): Agathe Michel-de Cazotte
Zwicker Schnappauf & Partner (Munich): Jörk Zwicker (patent attorney)

Unified Patent Court, Court of Appeal, Luxembourg
Rian Kalden (presiding judge and judge rapporteur), Ingeborg Simonsson, Patricia Rombach