EPO revokes Amgen antibody patent amid ongoing battle with Sanofi

In first-instance proceedings, biopharmaceutical company Amgen has lost a patent at the European Patent Office. EP 26 41 917 protects aspects of PCSK9 antibodies, which are used in Amgen’s drug Repatha via active ingredient evolocumab. Sanofi’s competing drug, which also uses PCSK9 antibodies, is sold under the brand name Praluent.

Doctors use the drug to reduce blood fat levels in patients with high cholesterol, and to reduce the risk of heart problems in patients with atherosclerosis (thickened arterial walls) who have experienced circulatory system problems.

Amgen had sought to enforce EP 917 against Sanofi, which in turn sought revocation of EP 917 via opposition proceedings at the EPO. Amgen had defended its patent via requests for claim amendments. However, at the end of February the EPO Opposition Division revoked the patent for added matter. On 27 February, Amgen appealed the verdict.

Sanofi and Amgen at odds

While proceedings over divisional patent EP 917 began in 2021, Sanofi and Amgen have been battling it out since 2016. EP 917 is part of the EP 22 15 124 patent family, which has been subject to multiple proceedings. In July 2019, the Regional Court Düsseldorf condemned Sanofi and Regeneron for violation of EP 124, issuing an injunction (case ID: 4c O 39/26), which Amgen executed against a security deposit of almost €20 million. Sanofi and Regeneron were unable to obtain a compulsory licence for their product, meaning they could no longer sell and produce Praluent in Germany.

However, in opposition proceedings in 2020, the Technical Boards of Appeal maintained EP 124 but in drastically amended form. Thus, the changes to the Amgen patent meant it no longer covered Sanofi’s Praluent product, making a German relaunch possible. Furthermore, the restrictions meant that the Düsseldorf infringement action which followed was baseless.

Distribution and deliberation

In 2020, the Higher Regional Court Düsseldorf then overturned a first-instance judgment in favour of Amgen. As such, the company was not entitled to injunctive relief, provision of information, accounting, recall, destruction and damages for infringement of the German part of EP 124, which it claimed Sanofi’s offering, marketing, use, importation and possession of Praluent had caused. The ruling meant that Sanofi could again distribute its product in Germany.

Now Sanofi and Regeneron are pursuing damages proceedings at the Regional Court Munich (case nos. 44 O 8179/21, 44 O 8184/21, 44 O 3725/22), on the basis of the original enforced injunction. However, as a counterclaim, in March 2022 Amgen also filed infringement suits against Sanofi and Regeneron in Munich over EP 917. The EPO is close to granting another Amgen patent, EP 36 66 797, also part of the EP 124 family. There is a chance that Amgen could enforce this against Sanofi and Regeneron within the next year.

Jörk Zwicker

Stay in the family

Parallel proceedings concerning EP 917 are also ongoing in Japan and the US. In the former, the Supreme Court of Japan (Saikō-Saibansho) revoked the patent for lack of written description. In the US, a case is currently pending before the Supreme Court in Washington, D.C., which will examine the patent for lack of sufficiency.

Further proceedings are also ongoing in Düsseldorf, where Sanofi and Regeneron are asserting EP 27 56 004 against Amgen. The two parties allege infringement of the patent by Amgen, which then initiated opposition proceedings.

However, in June 2022 the EPO Opposition Division maintained the patent in amended form. All parties appealed the decision to the Technical Board of Appeal, but no hearing has yet been scheduled.

German teams in charge

So far, for Sanofi, Munich-based patent attorney firm Zwicker Schnappauf & Partner has worked on all EPO Opposition Division cases in the dispute with Amgen. Jörk Zwicker has led all patent opposition proceedings. While Regeneron was not involved in the proceedings concerning EP 917, representatives from Carpmaels & Ransford were present at the hearing, having worked closely on the team with Zwicker.

Patent law firm df-mp regularly files patents for Amgen. Due to the significance of the case, the team around df-mp partner Ulrich Dörries works with IP boutique Bardehle Pagenberg, including partners Johannes Heselberger and Axel Berger. Both were present at the EPO Opposition Division hearing concerning EP 917, as well as for the infringement proceedings in Germany.

Ulrich Dörries

Bernhard Arnold, partner at German firm Arnold Ruess, is currently pursuing the damages claims in Düsseldorf for Sanofi.

For Amgen
df-mp Dörries Frank-Molnia & Pohlman (Munich): Ulrich Dörries, Michael Eder (both partners); associate: Markus Prägert (all patent attorneys)
Bardehle Pagenberg (Munich): Johannes Heselberger, Axel Berger (both partners, both patent attorneys)

For Sanofi
Zwicker Schnappauf & Partner (Munich): Jörk Zwicker (partner, patent attorney), associate: Timo Kanzleiter
Carpmaels & Ransford (London): Daniel Wise (partner); associate: Emily Nikolic

EPO Opposition Division, Munich
Antonin Tuynman (chair); Ivo Galli, Gabriele Patti (members)