Setback in UK after victory in Netherlands for Regeneron in Eylea case

Regeneron and Bayer have faced a defeat in the UK in their global dispute against several generic companies over their ophthalmic drug Eylea. The London High Court found the patents-in-suit not infringed and declared one patent invalid. The ruling comes after recent success in the German and Dutch courts.

At the centre of proceedings in the UK and Netherlands are two of Regeneron’s patents from the same family. EP 2 364 691 and EP 2 944 306 cover formulations and a pre-filled syringe containing aflibercept.

The active ingredient inhibits vascular endothelial growth factor (VEGF), which causes excessive formation of blood vessels in the retina that impairs vision. It forms the basis of Regeneron’s drug Eylea, which generated global sales of  $9.5 billion in 2024.

While no opposition against EP 691 was filed within the time frame, the EPO Opposition Division revoked EP 306 at the beginning of the year. An appeal is pending at the Boards of Appeal.

Formycon and Samsung Bioepis have each developed aflibercept biosimilars they plan to launch when the SPC for EP 1 183 353, the patent on aflibercept itself, expires in November 2025. Following recent successes in Germany and the Netherlands, Regeneron and its licensee Bayer have now lost in the UK.

Revocation actions

To clear the way for their products, Formycon and Samsung Bioepis launched nullity proceedings against EP 691 and EP 306 at the UK High Court. They challenged the patents on priority and added matter grounds. Regeneron and exclusive licensee Bayer responded with an infringement counterclaim for both patents. As in the recent German PI proceedings, they argued the biosimilars infringe by equivalence.

Judge Richard Meade found EP 306 not entitled to priority and thus invalid for added matter, while declaring EP 691 valid. However, the court rejected Regeneron’s equivalence infringement claims for both patents. According to the judge, Formycon’s and Samsung’s products do not have all the formulation features of the claims (case IDs: HP-2024-000015 and HP-2024-000036).

An action in the UK concerning the same patents but involving Amgen was discontinued before trial, according to JUVE Patent information.

Dutch victory

Parallel to the UK proceedings, Samsung Bioepis brought nullity suits against EP 691 and EP 306 including an Arrow declaration before the District Court The Hague. Samsung argued both patents were invalid due to added matter and lack of novelty. Regeneron again countered with an infringement claim.

However, the approach differed from other proceedings. While the German dispute focused on heavily claim 1 and the English case mainly on claim 5 of EP 691, the Dutch proceedings centred on claim 6. Regeneron argued Samsung Bioepis’ biosimilar falls within the scope of claim 6, but unlike in Germany and England, did not argue infringement by equivalence.

The judicial panel comprising F.M. Bus, Hugo van Heemstra and S. H. Verrips rejected the nullity suits against both patents and found Samsung Bioepis’ product Opuviz infringes claim 6 of EP 691. The court granted Regeneron an injunction for the Netherlands (case ID: C/09/675547 / HA ZA 24-972).

However, the court denied Regeneron’s request for a cross-border injunction. The patent holder had claimed Samsung Bioepis could make its European marketing authorisation for Opuviz available to third parties and sought a territorially unlimited injunction against the Korean biosimilar producer, excluding Germany and the UK.

It is not yet known if either party will appeal the Dutch and British decisions. In Germany, Formycon has appealed.

Renowned teams at the fore

In both the UK and Netherlands cases, Samsung Bioepis instructed renowned teams from market-leading firms, namely Powell Gilbert and Brinkhof. London partners Zoë Butler and Penny Gilbert led the UK proceedings, alongside associates Callum Beamish-Lacey, Anna Matthew, Charlotte Malley and Gabriella Simon. Meanwhile, a team around lead partners Koen Bijvank and Mark van Gardingen from Brinkhof represented the Korean client in The Hague. Associates Barbara Mooij and Djamo van Lutterveld provided assistance, while patent attorney Atze van Stralen provided support in technical matters.