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

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).

Hoyng ROKH for Regeneron

As in the previous case against Formycon, Bayer and Regeneron are relying once more on a team from Hoyng ROKH Monegier, led by Düsseldorf-based partner Christine Kanz. Sebastian Kratzer, Valentin Wagner, Max von Leitner and Clara Martinez Berrisch assisted while patent attorneys Tung-Gia Du and Claudia Hertzsch provided technical support.

They worked with patent attorney Gregor König, who moved to Hoffmann Eitle after the former outfit König Szynka Tilmann von Renesse dissolved last year. His former colleague Hertzsch joined the mixed team of Hoyng ROKH Monegier as counsel. The European IP firm has maintained a close client relationship with Regeneron for many years and now also represents Bayer.

Pentarc represents Stada and Sandoz/Hexal with the former relying on a team led by Anja Lunze and including Julia Fischer and Verena Brusius. Patent attorney Sandra Lepthien of Munich-based firm Graf von Stosch provided advice on technical matters.

Same advisor, new outfit

Jan Philip Rektorschek advised Hexal, with support from Julius Zacharias. Stada has had a long-standing relationship with the team from when it was still part of the German patent practice of Taylor Wessing. For example, Rektorschek advised the pharma company in its dispute with Bayer over Xarelto. Both Lunze and Recktorschek are two of the five equity partners who left Taylor Wessing in October last year to launch Pentarc.

Bird & Bird acted for Advanz Pharma and Alvotech with Düsseldorf-based partner Oliver Jüngst and Annika Lückemann from the Hamburg office in the lead. The team included partner Moritz Schröder as well as the partners and patent attorneys Daniela Kinkeldey and Andreas Obermeier.

While Bird & Bird had represented Celltrion at the UPC in the dispute with Novartis over Xolair, a team from Maiwald took over the representation of the US pharma company in the PI proceedings concerning Eylea. Litigators Marco Stief and Christian Meyer led the case.