Carpmaels & Ransford represented Sanofi and Regeneron in their win against Amgen in today’s landmark UPC revocation decision. This action was the first to be lodged at the UPC on the day of its launch just over a year ago.

The decision is the latest milestone in the long-running fight for the cholesterol-lowering PCSK9 antibody market, which has been ongoing between Sanofi/Regeneron and Amgen since 2014.

The Carpmaels & Ransford team, comprising partners Daniel Wise (European patent attorney) and Agathe Michel-de Cazotte (French and German attorney at law) and Senior Associate Emily Nikolić led the successful team for Sanofi and Regeneron.

In this family of patents, the US Supreme Court previously held that a corresponding US patent lacked enablement (21-757 Amgen Inc. v. Sanofi (05/18/23) (supremecourt.gov) ). A Japanese patent in the family was also found invalid by the IP High Court for a lack of support, having previously been found valid in other proceedings.  Most recently the Israeli Patent Office decided that Amgen’s inventive contribution was limited to the specific antibodies exemplified in the patent.

In today’s decision, the UPC’s Central Division in Munich indicated that “[t]he Patent is revoked entirely”, in a decision effective for all UPC contracting states. The Court found the patent invalid for lack of inventive step, and did not address the other grounds of invalidity. Summarising the reasons for the lack of inventive step, the Court said:

“The Central Division comes to the conclusion that the Patent as granted is invalid because it does not involve an inventive step over Lagace. Auxiliary Requests 1-17 lack inventive step for the same reasons. The skilled person who was interested in developing a treatment for hypercholesterolemia targeting PCSK9 would, starting from and following the teaching of Lagace, without inventive skill develop antibodies against PCSK9 that block the interaction of PCSK9 with the LDLR and would thereby arrive at the claimed subject matter in an obvious way.”

Following this decision, there will also be a hearing later this year at the UPC’s Munich Local Division to consider whether a parallel infringement action should be stayed.  In addition, a further hearing on the subject of validity is expected to take place in late 2024, this time at the European Patent Office and that decision will apply to countries in addition to those covered by the UPC’s decision.

The Carpmaels & Ransford team was made up of patent attorneys and litigators, including Corey Chapman, Henry Evans, Hadi Godazgar, Andreas Hänsele, Suzy Howat, Ian Kirby, Stephen Michell, Hiske Roos and Elizabeth Taylor, led by the core team members Agathe Michel-de Cazotte, Daniel Wise and Emily Nikolić. This UK-based team worked collaboratively with attorneys from Hoffman Eitle, König Szynka Tilmann von Renesse, and Zwicker Schnappauf & Partner in Germany.

Support from the Carpmaels Team:

Our patent attorneys and litigators have already devised and implemented UPC litigation and opt out strategies for many of our clients’ most important products, giving clients the ability to take a competitor off the market in all 17 (soon to be 18) UPC states in a single UPC action. We are currently actively involved in more than 12 UPC cases.

Our mixed teams of European patent attorneys and litigators are ideally placed to advise on how best to use the UPC as over 90 of our litigators and patent attorneys have full UPC representation rights.