EPO decision clears way for Sanofi blockbuster drug Praluent

The Higher Regional Court Düsseldorf is allowing Sanofi to sell its competing cholesterol-lowering drug Praluent in Germany again, following yesterday's waiver decision. A week prior, the EPO had decisively restricted Amgen's patent, which has implications for Amgen's lawsuits in other European countries. In Germany, Sanofi and Regeneron can now claim damages from Amgen for the period during which the parties were subject to an injunction.

6 November 2020 by Mathieu Klos

Praluent The Higher Regional Court Düsseldorf decision means Sanofi can once agian distribute Praluent in Europe ©New Africa/ADOBE STOCK

The market for cholesterol-lowering drugs is dominated by two products. Amgen sells its active ingredient under the brand name Repatha. Sanofi markets its drug under the trade name Praluent.

Since 2016, Amgen has been trying to stop Sanofi from selling Praluent in six european countries – and other countries such as the US and Japan – on the grounds of patent infringement. In some cases, the courts have found in Amgen’s favour. However, yesterday afternoon the battle for Praluent in Germany took a dramatic turn for both parties.

The Higher Regional Court of Düsseldorf dismissed Amgen’s application at second instance. This means that the first-instance judgment of 2019 is without object (case ID: I-2 O 35/19). Therefore, Amgen is not entitled to injunctive relief, provision of information, accounting, recall, destruction and damages for infringement of the German part of European patent EP 22 15 124, by Sanofi’s offering, marketing, use, importation and possession of Praluent.

As a result, proceedings are now closed. Once again, Sanofi can distribute Praluent in Germany.

French company Sanofi is cooperating with US company Regeneron. While Sanofi possesses sole rights for Praluent outside the US, Regeneron has sole rights for Praluent inside the US. Both companies were on the defendant’s side in the Düsseldorf proceedings.

EPO plays a role

The Düsseldorf ruling was preceded by a decision of the Technical Boards of Appeal at the European Patent Office, handed down last week. The Boards of Appeal had granted, but substantially limited, Amgen’s patent for the active ingredient evolocumab for EP 22 15 124 (case ID: T0845/19-3.304).

The EPO judges confirmed the patent. Therefore, the patent continues to protect Amgen’s active ingredient. However, the judges restricted the patent so drastically, due to lack of inventive step, that the basis for the Düsseldorf infringement action was missing. Many experts consider it likely that the Boards of Appeal decision will have a similar effect on proceedings in other European countries.

Jörk Zwicker

Jörk Zwicker

Compensation for injunction

In July 2019, the Regional Court of Düsseldorf condemned Sanofi and Regeneron for violation of EP 124. The court had issued an injunction (case ID: 4c O 39/26), which Amgen executed against a security deposit of almost 20 million euros. As a result, Sanofi and Regeneron were no longer able to sell and produce in Germany.

In reaction to the infringement claim in Düsseldorf, Sanofi asked the Federal Patent Court for a compulsory licence. However, Sanofi’s request failed.

Bernhard Arnold, Varta

Bernhard Arnold

Furthermore, Sanofi and Regeneron still have the possibility to claim damages from Amgen. Observers consider it certain that the company will take this step.

Sanofi had submitted several comments in the course of the reform of the German patent law. It had called for a stronger proportionality test for the automatic injunction and the consideration of third-party interests.

Amgen launched the Praluent battle in 2016 with an attack on Sanofi. Sanofi and Regeneron had attacked Amgen’s patent with an opposition at the EPO. Eli Lilly and various strawmen joined the attack on the patent.

However, in December 2018 the EPO Opposition Division in The Hague upheld Amgen’s patent. Both sides appealed the decision.

Pharmaceutical experts

Almost all firms involved have represented their clients in the previous proceedings. 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 called in patent attorneys from Hamburg boutique Uexküll as reinforcements in the opposition case. Bardehle partner Johannes Heselberger was present in the EPO, as well as for the infringement proceedings.

Across Europe, Amgen relies on mix of different national patent litigation teams. For example, public sources state that the UK team of Osborne Clarke and an Amsterdam IP boutique firm work for Amgen on the dispute.

Niels Hölder, Hoffmann Eitle, patent litigation

Niels Hölder

ZSP partner Jörk Zwicker frequently works for Sanofi. Zwicker was present at the EPO, as well as the Düsseldorf cases. For the opposition proceedings, Regeneron also retained patent attorneys from mixed London IP boutique Carpmaels & Ransford. In the latest EPO proceeding, Carpmaels partner Daniel Wise led the charge.

Three-firm strong

In the Düsseldorf cases, Sanofi and Regeneron relied on Hoffmann Eitle, Arnold Ruess and Linklaters. Each firm was responsible for a specific aspect of the defence.

Hoffmann Eitle’s team has represented Sanofi and its Regeneron in litigation since 2011. On the other hand, the relationship between Arnold Ruess und Sanofi is relatively young.

UK infringement proceedings for Sanofi are handled by Linklaters’ London partner Yohan Liyanage. The firm also works for the French pharmaceutical company in France, alongside Hoyng ROKH Monegier. The international boutique also works for Sanofi in other countries on the case.

Eli Lilly was also an opponent in the opposition case. Here, assistant general patent counsel Stephen Ingham represented the company. (Co-author: Christina Schulze)

Ulrich Dörries

For Amgen
df-mp Dörries Frank-Molnia & Pohlman (Munich): Ulrich Dörries, Michael Eder, Markus Prägert (all patent attorneys)
Uexküll & Stolberg (Hamburg): Albrecht von Menges, Fabian Müller (both patent attorneys)
Bardehle Pagenberg (Munich): Johannes Heselberger, Axel Berger (patent attorney)
In-house: Tanja Kroth (Associate General Counsel IP, Munich), Steven Tang (Associate General Counsel IP, Thousand Oaks)

For Sanofi
Zwicker Schnappauf & Partner (Munich): Jörk Zwicker, Timo Kanzleiter (both patent attorney)
Hoffmann Eitle (Munich): Niels Hölder (lead), Esther Pfaff, Mike Gruber
Arnold Ruess (Düsseldorf): Bernhard Arnold (lead), Tim Smentkowski, Tobias Weigand
Linklaters (Frankfurt): Julia Schönbohm (lead), Bolko Ehlgen, Natalie Ackermann-Blome
In-house: Jiang Lin (Bridgewater), Nicole Parsons (Cambridge), Stephanie Donahue (New York), Carin Ribard (Paris)

Johannes Heselberger

For Regeneron
Carpmaels & Ransford (London): Daniel Wise (patent attorney)
In-house (New York): Larry Coury, Lynda Nguyen, Shohta Ueno (London)

European Patent Office, TBA 3.304
Gabriele Alt (presiding judge), Ashok Chakravarty, Lukas Buhler, Renate Morawetz

Higher Regional Court Düsseldorf, Civil Senate 2
Thomas Kühnen (presiding judge)