EPO and UPC disagree on validity of Amgen’s patent for cholesterol drug

Amgen’s battle with Sanofi and Regeneron, concerning cholesterol-lowering drugs is arguably one of the pharmaceutical industry’s longest-running and most acrimonious. Amgen sells its product under the Repatha brand, while Sanofi and Regeneron market their product as Praluent.

For years, both sides have received conflicting decisions from different courts in Europe. To date, neither side has gained a decisive advantage. Now, the question is whether a key Amgen patent is valid for the purposes of a UPC action. The UPC and EPO have reached very different conclusions.

EPO upholds patent

Amgen’s EP 3 666 797 is valid as granted, the EPO Opposition Division ruled in early April after four days of oral hearings. EP 797 covers the active ingredient evolocumab, which uses “antigen binding proteins that bind to proprotein convertase subtilisin kexin type 9 (PCSK9)”. It is a divisional belonging to the EP 124 patent family.

Amgen had filed an infringement suit against Sanofi at the UPC based on EP 797. Regeneron and Sanofi had challenged the patent not only at the UPC but also at the EPO, citing violation of the added matter prohibition, insufficiency of disclosure, lack of novelty and lack of inventive step.

But the EPO Opposition Division, under chair Nicole Renggli-Zulliger and members Anastassia Malamoussi and Zoran Cilenšek, rejected the claims entirely. Both companies can now appeal to the EPO Boards of Appeal.

UPC revocation case

The Opposition Division’s decision on validity thus contrasts with that of the UPC central division, which declared EP 797 invalid in summer 2024 for the entire UPC area.

On the first day of the UPC’s launch a year ago, Sanofi and Regeneron challenged Amgen’s EP 797 at the Munich central division. The court heard both the central revocation claim and the counterclaim for revocation, which the Munich local division had referred to the central division.

At the time, this was Sanofi and Regeneron’s first main attack on the patent at the UPC. It was also the UPC’s first ever revocation judgment. The judgment removed the basis for the infringement action filed by Amgen at the Munich local division. However, Amgen appealed the ruling.

Now, at the end of May, the UPC Court of Appeal will decide whether the central division was correct to declare the patent invalid.

Harmonisation of law

The question of how uniformly the UPC and EPO would assess the validity of patents was a hot topic in the run up to the UPC’s launch. The Court of Appeal will likely take an interest in the Opposition Division’s decision and thus the latter must publish the written reasoning quickly.

It appears the UPC is also interested in a harmonised approach in Europe. The Munich local division, under presiding judge Matthias Zigann, recently issued an injunction against Meril based on a heart-valve patent held by Edwards Lifesciences. In the headnotes of the judgement, the court wrote:

“For assessing whether an invention shall be considered obvious having regard to the state of the art, the problem-solution approach developed by the European Patent Office shall primarily be applied as a tool to the extent feasible to enhance legal certainty and further align the jurisprudence of the Unified Patent Court with the jurisprudence of the European Patent Office and the Boards of Appeal.”

The fact that ambition and reality do not always align was recently demonstrated in another case that has already made UPC history. The EPO Opposition Division upheld 10x Genomics’ important spatial profiling patent EP 4 108 782. This is one of the patents-in-suit in 10x Genomics’ high-profile UPC battle with NanoString.

In February 2024, the UPC Court of Appeal had concerns about the validity of EP 782 and denied 10x Genomics a Europe-wide preliminary injunction. Now the Munich local division can resume the main infringement proceedings against NanoString.

Judgment postponed to May

Before the UPC Court of Appeal rules on the validity of Amgen’s EP 797, the Düsseldorf local division under presiding judge Ronny Thomas is expected to announce an infringement judgment in a parallel dispute between Sanofi and Amgen. The case is part of the broader dispute between the two pharmaceutical companies.

Sanofi and Regeneron have sued Amgen for infringement of Regeneron’s second medical use patent EP 3 536 712. Amgen filed a counterclaim for revocation. The Düsseldorf local division heard the case at the end of February. While the court originally planned to hand down a ruling last week, it has now postponed the judgment to 10 May.

The fate of EP 124

Even before the launch of the UPC, the two pharmaceutical giants were locked in a dramatic battle. The subject of the dispute at the time was Amgen’s basic patent for the family, EP 22 15 124, to which EP 797 also belongs. Initially upheld by the EPO Opposition Division, the Boards of Appeal granted — but substantially limited — EP 124 in late 2020.

In July 2019, the Regional Court Düsseldorf found Sanofi and Regeneron had infringed EP 124. Amgen enforced the injunction, meaning Sanofi and Regeneron were unable to sell and produce Praluent in Germany for over a year.

After the Boards of Appeal limited EP 124, Düsseldorf Higher Regional Court lifted the injunction, clearing the way for Sanofi’s Praluent to return to the German market. The companies continue to battle over damages.

The advisors remain

In the EPO proceedings for EP 797, Daniel Wise and Emily Nikolic of Carpmaels & Ransford represented Sanofi, while Jörk Zwicker of the Munich patent attorney firm ZSP advised Regeneron.

Both firms also represent the companies at the UPC alongside other lawyers. In addition, Sanofi and Regeneron rely on a team from Hoffmann Eitle.

Dutch lawyer and patent attorney Koen Bijvank of Amsterdam litigation firm Brinkhof took the lead for Amgen in the EPO proceedings. Patent attorney Axel Berger of Bardehle Pagenberg provided support.

While Bardehle Pagenberg has represented Amgen since the dispute began in Europe, Brinkhof joined later. Both firms, along with additional lawyers, are acting on behalf of the US company in other proceedings. Amgen also relies on teams from df-mp, Osborne Clark and Quinn Emanuel for the UPC cases.