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

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.

Hoyng ROKH for Bayer

Two large teams faced each other at Munich Regional Court, and numerous foreign lawyers were also involved.

In the pan-European litigation series, Bayer and Regeneron are relying on an international team from Hoyng ROKH Monegier, which is also coordinating the cross-border work with other law firms. The mixed European IP firm has maintained a close client relationship with Regeneron for many years and has now also been retained by Bayer. In other proceedings, the German corporation also relies on other teams, for example A&O Shearman in the Xarelto case.

In Germany, Düsseldorf Hoyng ROKH partner Christine Kanz is leading the infringement proceedings. The patent attorneys from König Szynka Tilmann von Renesse provided support in the nullity proceedings.

After the dissolution of the renowned patent law firm in the summer, the majority of König Szynka’s Düsseldorf team around Gregor König moved to Hoffmann Eitle. Patent attorney Claudia Hertzsch, however, joined the mixed team of Hoyng ROKH Monegier as counsel and, together with patent attorney Tung-Gia Du, advised on technical issues in the proceedings at the Regional Court Munich. The two Hoyng ROKH lawyers Sebastian Kratzer and Valentin Wagner as well as senior associate Max von Leitner also assisted in the German proceedings.

Hoyng ROKH partners Benoit Strowel, based in Brussels and Paris, Steven Cattor from the Brussels office, Marta Mendez, Agathe Caille and Florence Jacquon from Paris, Peter van Schijndel from Amsterdam, and Natalie Rodriguez from Madrid are also active in parallel proceedings in France, the Netherlands, Belgium and other European countries. In the UK, the team is working with the A&O Shearman team that represents Regeneron and Bayer there.

Bonabry and Hamm & Wittkopp for Formycon

IP boutique Bonabry represented Formycon as well as its distributors and co-plaintiffs in the declaratory judgement action, Klinge and Teva. The team, which split off from Preu Bohlig at the beginning of the year, had already worked with Formycon in the past.

In addition to lead partner Daniel Hoppe and counsel Sarah Salaschek, the team included partners Carl-Alexander Dinges and Konstantin Schallmoser, as well as counsel Yasmine Azzaoui, who moved from Schertenleib in July. Teva, which regularly works with Bird & Bird in Germany, this time retained Bonabry, which was already active for Formycon and Klinge.

Patent attorneys Alexander Wittkopp and Malte von Seebach from Hamm & Wittkopp advised Formycon on technical issues. The litigators from Bonabry and patent attorney Wittkopp are a well-established team in pharmaceutical proceedings. They acted together for Abdi Pharma and Polpharma in the Xarelto case, for example, with Wittkopp as lead counsel for both generic companies, as well as Genepharm in the nullity proceedings.

The team cooperates closely with Christopher Sharp from Pinsent Masons in London, who represents Formycon and Klinge in the UK proceedings.

Samsung Bioepis relied on a team from Quinn Emanuel Urquhart & Sullivan. Bayer withdrew the PI application shortly before the start of the trial. However, litigator Marcus Grosch, together with counsel Andreas Hahne, played a leading role in the nullity action.

Unlike many law firms, Quinn Emanuel’s litigation team regularly represents clients in nullity actions and EPO oppositions, which is usually the remit of patent attorneys. Counsel Michael Krenz, Marlen Yan and associates Sebastian Scholz, Katharina Peters, and Kai Mütze provided support.