Sanofi and Regeneron successful against Amgen over compensation for Praluent

The chance of Sanofi and Regeneron obtaining compensation from Amgen for the temporary halt in sales of cholesterol-lowering drug Praluent is increasing. The Munich Regional Court has now ordered Amgen to provide information on profits, while simultaneously dismissing a counterclaim for infringement by the US biopharmaceutical manufacturer.

Amgen and Sanofi have been fighting over the market share of their cholesterol-lowering drugs since 2016. Amgen sells its product under the Repatha brand, while Sanofi and Regeneron are on the market with Praluent.

The dispute, which is also being fought at the Unified Patent Court, reached a peak in 2019 when Amgen enforced a PI judgment against Sanofi. In July of that year, the Regional Court Düsseldorf found Sanofi and Regeneron had infringed Amgen’sEP 22 15 124with the Praluent drug. Amgen enforced the preliminary injunction.

However, after the companies ceased sales of Praluent, the EPO Technical Boards of Appeal maintained EP 124 in a drastically amended form. These changes to the Amgen patent meant it no longer covered Sanofi’s Praluent product, making a relaunch in Europe possible. As a result, the Higher Regional Court Düsseldorf overturned the PI decision. The ruling meant that Sanofi could once again distribute its product in Germany.

Sanofi and Regeneron demand compensation

As a result, Sanofi and Regeneron are now claiming both damages and compensation from Amgen for unjust enrichment for the period during which Praluent was not available for sale. Three different proceedings and several hundred million euros are said to be at stake.

In the latest proceedings, the Regional Court Munich has now ruled that Amgen must provide information on and account for the profits made with its drug between March 2018 and February 2022. Sanofi and Regeneron are therefore entitled to compensation for Amgen’s profits during the period in which the Düsseldorf PI judgment was enforced (case ID: 44 O 8184/21).

As soon as Amgen has provided information about its profits, Sanofi and Regeneron can call for new proceedings to determine the amount of compensation. However, actions for compensation due to unjust enrichment are rare in German patent law. A similar case was decided by the Higher Regional Court in autumn in the dispute between Viatris and Teva over MS drug Copaxone.

Amgen counterclaim dismissed

At the same time, the Munich judges dismissed a counterclaim by Amgen, finding Praluent does not infringe Amgen’sEP 26 41 917. This patent protects aspects of PCSK9 antibodies, which are used in Amgen’s drug Repatha via the active ingredient evolocumab.

EP 917 is a partial invention of EP 124 and was declared invalid by the EPO’s Opposition Division in March 2023.Amgen has since appealed this decision to the Boards of Appeal.

In view of the fierceness with which the manufacturers of Praluent and Repatha are battling on a global scale, it is highly likely that Amgen will appeal against the judgment of the Regional Court Munich. However, JUVE Patent so far has no information regarding whether Amgen will take this step.

High amounts at stake

A large amount of money is also at stake in two other proceedings at the Regional Court Munich. Sanofi and Regeneron are claiming damages from Amgen due to the enforcement of the PI judgment from Düsseldorf .

In May 2022, the court ordered Amgen to make a smaller monetary payment (case ID: 44 O 8179/21). According to JUVE Patent information, the second of the two damages cases is about a significantly higher amount of money. Here, Sanofi and Regeneron are demanding the lion’s share of the damages (case ID: 44 O 3725/22). According to the court, the hearing will take place in February 2024.

Battle reaches UPC

The dispute has now also reached the Unified Patent Court. On the first day of the UPC’s launch, a new battle played out when Sanofi and Amgen raced to file a revocation and infringement action, respectively.

The actions are based on Amgen patentEP 36 66 797, which is the third divisional enforced by the biopharmaceutical company belonging to the EP 124 patent family. EP 797 covers active ingredient evolocumab, which uses “antigen binding proteins to proprotein convertase subtilisin Kexin type 9 (pcsk9).”

After the EPO granted EP 797, Amgen chose not to op-out the patent. Sanofi and Regeneron filed a revocation action at the UPC central division in Munich (case ID:ACT_459505/2023). Just a few hours later, Amgen filed an infringement suit against Sanofi at the Munich local division (case ID:ACT_464985/2023). EP 767 is also subject to an EPO opposition.

Counterstrike by Sanofi

Sanofi and Regeneron also accuse Amgen of infringing a patent with its product. According to JUVE Patent information, both companies sued Amgen for infringingEP 27 56 004at Düsseldorf Regional Court. The patent was recently subject to an appeal hearing at the EPO Boards of Appeal.The court upheld the patent.