Regional Court Munich grants PI to Regeneron against generics in Eylea case

Once again, Regeneron and Bayer have successfully defended their ophthalmic drug Eylea on the German market and beyond. Munich Regional Court yesterday granted a preliminary injunction against Stada, Hexal, Celltrion and Advanz Pharma.

Like Formycon, generics manufacturers Stada, Hexal, Celltrion and Advanz Pharma are now also prohibited from marketing their biosimilar containing the active ingredient aflibercept. This forms the basis of Regeneron’s ophthalmic drug Eylea, used to treat neovascular (wet) age-related macular degeneration and diabetic macular oedema. Late yesterday evening, the Regional Court Munich issued a PI against the four manufacturers, ordering the defendants to cease distribution and recall the products already on the market.

The US patent holder and its European licensee Bayer are vigorously defending EP 2 364 691. The patent covers a specific formulation of the active ingredient aflibercept, including certain toning agents, stabilisers, buffers and co-solvents. After the SPC (DE 12 2013 000 041.4) for a key substance patent expired last November, EP 691 could guarantee patent protection and thus market exclusivity for Eylea until June 2027.

In September last year, Munich Regional Court granted Regeneron and Bayer a preliminary injunction spanning 22 countries based on this patent against Formyon. This thus preserved market exclusivity for their blockbuster drug. Formycon appealed the decision. Previously, in the summer of 2025, the German Federal Patent Court upheld EP 691 in limited form in the parallel nullity proceedings (case ID: 3 Ni 15/23). Both parties appealed the decision to the Federal Court of Justice.

Further actions

The two plaintiffs are now taking action against other competitors, namely Celltrion (case ID: 7 O 15537/25), Stada (case ID: 7 O 15538/25), Advanz Pharma (case ID: 7 O 15539/25) as well as Hexal (case ID: 7 O 15541/25). While the PIs for Celltrion, Hexal and Stada concern only Germany, in the case of Advanz Pharma the judges panel, consisting of presiding judge Oliver Schön and judges Katalin Tözsér and Florian Schweyer, issued a PI for 21 countries.

In the case against Formycon, the 7th Civil Chamber had also granted the preliminary injunction for multiple countries. The judges based their decision in this case on Article 24 No. 4 of the Brussels Ibis Regulation, thus deriving their jurisdiction primarily from the domicile of the defendant. However, in the case against Advanz Pharma the cross-border PI was issued based on Article 24 No. 8 of this regulation, which defines the competence of the court to rule on the factual connection.

Both decisions rely on the CJEU judgement BSH vs Electrolux.

It is not yet known if the generics companies will appeal the decision, but it is likely that they will follow the example of Formycon, which appealed the PI decision from last year.

Global battle

The PI proceedings in Munich form part of a global battle against several biosimilar producers concerning the ophthalmic drug Eylea. Along with Xarelto, it is one of Bayer’s most important revenue drivers. The dispute spans numerous European countries as well as the US and Asia-Pacific region.

In October last year, in a nullity suit launched by Formycon and Samsung Bioepis, the London High Court found EP 691 valid but not infringed.

Prior to this decision, the District Court The Hague had dismissed the nullity suit filed by Samsung Bioepis against EP 691. The court not only upheld the patent in full but also found that Samsung Bioepis’ biosimilar Opuviz falls within the scope of claim 6 of the patent and thus infringes it. The judges enjoined Samsung Bioepis from marketing the product in the Netherlands. At the same time, the Dutch court partially revoked another formulation patent, EP 2 944 306 (case ID: C/09/675547 / HA ZA 24-972).