EWHC clashes with Munich I Regional Court over doctrine of equivalents: rules no infringement in Bayer, Regeneron v. Formycon, Samsung Bioepis

Context:

• The legal standard for the doctrine of equivalents differs strongly between the UK and Germany. In the UK, there is a three-question test under Actavis v. Lilly (2023 Carpmaels & Ransford update):
  • “Notwithstanding that it is not within the literal meaning of the relevant claim(s) of the patent, does the variant achieve substantially the same result in substantially the same way as the invention, ie the inventive concept revealed by the patent?
  • Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?
  • Would such a reader of the patent have concluded that the patentee nonetheless intended that strict compliance with the literal meaning of the relevant claim(s) of the patent was an essential requirement of the invention?”
• Formycon and Samsung Bioepis are seeking to commercialize a biosimilar of Regeneron’s injectable drug aflibercept, which is used to treat Wet AMD (causes progressive blindness, especially in the elderly). They filed for a declaratory judgment against Regeneron (and through an exclusive licensee relationship, Bayer) in several jurisdictions, including the UK, Germany, the Netherlands, France, Italy, Belgium, the U.S., Canada, and South Korea. Regeneron and Bayer then brought infringement counterclaims.
• Last month, the Landgericht München I (Munich I Regional Court) issued the first-ever BSH-based preliminary injunction (PI) against Formycon, enjoining its medication from 23 countries (September 29, 2025 ip fray article). The finding of a likely infringement was based on the doctrine of equivalents (DOE).

What’s new: In the UK case, Mr Justice Meade of the High Court of Justice for England & Wales (EWHC) yesterday ruled that neither Formycon nor Samsung’s products infringe the patents asserted by Bayer and Regeneron, notably because the arguments based on the doctrine of equivalents failed (October 8, 2025 EWHC judgment). Mr Justice Meade also ordered that one of the two patents be revoked.

Direct impact: Mr Justice Meade’s opinion undeniably diverges from that of the Munich I Regional Court. While the German court based its decision to issue a preliminary injunction on the doctrine of equivalents, the EWHC concluded that Regeneron should have sought a broader patent claim. He used the Actavis test for both Formycon and Samsung’s products, finding that neither met the legal standard.

Wider ramifications: The Munich I Regional Court’s final judgment with the written reasons for the preliminary injunction is due by October 14, 2025. However, it is highly unlikely that the German court will change its mind or agree with the EWHC. Formycon will likely file an appeal in the German case, however.