Bayer and Regeneron secure market exclusivity of Eylea with PI in Munich

For now, Formycon cannot launch its biosimilar of the macular degeneration treatment Eylea in various European markets. Munich Regional Court yesterday granted Regeneron and Bayer a preliminary injunction spanning 22 countries, thus preserving market exclusivity for their blockbuster drug.

Regeneron and Bayer are embroiled in a global battle against several generic companies over their ophthalmic drug Eylea. Along with Xarelto, it is one of Bayer’s most important revenue drivers and is used to treat neovascular (wet) age-related macular degeneration and diabetic macular oedema.

According to patent holder Regeneron, the drug achieved global sales of around $9 billion in 2023. Bayer and Regeneron are fighting hard to retain market exclusivity. The dispute spans numerous European countries as well as the US and countries in the Asia-Pacific region. However, the SPC (DE 12 2013 000 041.4) for a key substance patent expires in November.

Market approval

After various biotech companies, including Samsung Bioepis and Formycon, received approval from the European Medicines Agency (EMA) for their biosimilars containing the active ingredient aflibercept in recent months, they are poised to launch their products as soon as the SPC of the substance patent expires. Aflibercept inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina that impairs vision.

Patent holder Regeneron and its European licensee Bayer argue that Eylea is still protected by Regeneron’s EP 2 364 691. The formulation patent covers a certain formulation of the active ingredient aflibercept, including certain toning agents, stabilisers, buffers and co-solvents, and could guarantee patent protection and thus market exclusivity for Eylea until June 2027.

Declaratory action to clear the way

To clear the way for its biosimilar, Formycon and its distribution partner Klinge filed a negative declaratory action against Regeneron at Munich Regional Court in December 2024 (case ID: 7 O 16055/24), later including Bayer in the claim. The biotech company asked the court to declare that its aflibercept biosimilar FYB203 does not infringe EP 691 in Germany, Spain, Portugal, Austria, Switzerland, and the Netherlands. In summer this year Teva and Ratiopharm joined the action as co-claimants.

Regeneron and its European licensee Bayer responded in August with a counterclaim for infringement regarding Germany and 19 other European countries. They argue that Formycon infringes EP 691 by equivalence.

Patent upheld in Germany

Previously, Samsung Bioepis, which has also developed a biosimilar containing aflibercept, had challenged EP 691 in a nullity action before the German Federal Patent Court. In the summer, the patent court upheld the property right for the greatest part of the patent claims (case ID: 3 Ni 15/23).

Following the decision of the Federal Patent Court, Bayer in July applied to the 7th Civil Chamber of the Munich court for two preliminary injunctions against Formycon — one for Germany (case ID: 7 O 9382/25) and the other for 30 other European countries, among them Austria, Belgium, France, Ireland, Italy, the Netherlands, Poland, Portugal, Spain, Switzerland, as well as Turkey and Hungary (case ID: 7 O 9383/25 ).

The plaintiff based the latter claim on the CJEU judgement BSH vs Electrolux, according to which a national court can also issue cross-border preliminary injunctions.

The discussion centred on the question of equivalent patent infringement by the biosimilar. The plaintiff withdrew another application for a preliminary injunction that Bayer had filed against Samsung Bioepis shortly before the hearing. After a full-day hearing yesterday, the 7th Civil Chamber under presiding judge Oliver Schön granted the preliminary injunctions for Germany and a total of 22 countries. The court intends to announce the judgment in the declaratory action on 9 October.

The dispute spans numerous countries with proceedings in the US, UK, Italy, Belgium, the Netherlands, and France. In the UK, judge Richard Meade heard the question of equivalence over several days in June (case ID: HP-2024-000015). The judgment is still pending.