Irides: Weekly patent litigation update

This edition features updates from: The United Kingdom, Brazil and the Unified Patent Court (UPC).

The Irides Weekly Update is our round-up of patent litigation news highlights from around the world.
 

UK

UK Court finds that two Eylea® formulation patents are not infringed under the doctrine of equivalents. 

On the 8 October 2025, Mr Justice Meade (Meade J) handed down his judgment in Formycon and Samsung v Regeneron and Bayer [2025] EWHC 2527 (Pat) finding neither Formycon nor Samsung (together, the Claimants) infringed European Patents (UK) Nos. 2 364 691 B1 (EP 691) and 2 944 306 B1 (EP 306). EP 691 was found to be valid, but EP 306 was revoked for added matter.

EP 691 and EP 306 were part of the same patent family with the same priority date of June 2006 and substantially similar specifications. They both claimed a specific formulation to aflibercept, the active ingredient for Eylea®, which is used to treat wet age related macular degeneration (wet AMD). Both Formycon and Samsung sought to launch their aflibercept biosimilars upon expiry of the SPC in November 2025. They therefore challenged the validity of the later expiring formulation patents (expiry date in June 2026), and Regeneron, as patentee, and Bayer as exclusive licensee, (together, Regeneron) counterclaimed for infringement.

It was accepted that there was no literal infringement. This was because Formycon’s biosimilar formulation varied from asserted claim 5 as it used 10mM histidine buffer, rather than the claimed 10mM sodium phosphate buffer. Samsung’s formulation differed in two respects – firstly it used 7.78mM sodium phosphate (not 10mM), and secondly it contained 8% sucrose rather than 5%. Regeneron therefore relied on infringement by equivalence, with the decision turning on the inventive concept and question 1 of the established test for infringement by equivalence in Actavis v Lilly [2017] UKSC 48:

1. 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, i.e. the inventive concept revealed by the patent?
2. 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?
3. 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?

The Claimants argued that the inventive concept of claim 5 was narrow – it was the claimed features in the claimed quantities. Regeneron argued that the inventive concept worked at two levels: (1) each of the formulation aspects individually, and (2) how each of the aspects interact to achieve a stable formulation suitable for intravitreal administration. Meade J found in favour of the Claimants, i.e. a narrow inventive concept. Meade J said that assessing the level of generality should be done by reference to the claims, with a relevant factor being that claim 5 was a dependent claim directed to a preferred embodiment of a very specific and narrow formulation.

Having held that the inventive concept was narrow, Regeneron failed on the first Actavis question; the biosimilar formulations achieved a stable formulation but in a different way to the invention, such that there was no infringement by equivalence.
 

BRAZIL

BRPTO upholds Genentech’s antibody patent PI0905733-1, rejecting Organon’s invalidity claims based on novelty, inventive step and enablement.

The Brazilian Patent and Trademark Office (BRPTO) has issued an opinion in favour of validity of a patent to an antibody and its variants. Organon International Services GmbH and Organon Farmacêutica Ltda (Organon) filed an invalidity action against Genentech Inc’s patent PI0905733-1. The patent claims a composition comprising pertuzumab (an anti-HER2 antibody) and specific acidic variants (glycated, reduced disulfide, and non-reducible forms), as well as their use in the treatment of a HER2-positive cancer.

Organon argued that the invention was merely a discovery rather than an invention (Art. 10(I) of the Brazilian IP Statute); that the patented composition was already disclosed in prior art documents, particularly WO2006/033700 (D1) and WO2006/044908 (D2); and that the variants were inevitable by-products of standard antibody production processes. Organon argued alternatively that the patent was obvious and by way of a “squeeze” that it was not enabled (i.e. to the extent the patent is different from the prior art, it is not clear how). Organon also alleged bad faith by Genentech during prosecution, asserting that Genentech misled BRPTO by claiming novelty based on amino acid sequences that were allegedly present in D1.

Genentech maintained that the patent protects a specific composition comprising pertuzumab and the three defined acidic variants, not the antibody per se. They argued that the patent showed through experimentation that the claimed composition had desired pharmacokinetics, potency, and monomer content (which was not yet known). This offered regulatory and commercial advantages, reducing the chances of regulatory bodies requiring additional testing excluding the variants. Genentech denied any misconduct and emphasized that the claimed invention was not disclosed (explicitly or inherently) in the cited prior art.

The BRPTO upheld validity. The composition protected by the patent was not a mere discovery because it had a practical application (i.e. its therapeutic equivalence to a composition comprising the antibody alone). It was not inherently disclosed as this required that the subject matter is necessarily implicit, not probably so. There must be no doubt that the claimed subject matter derives from the prior art. Further the BRPTO accepted Genentech’s arguments on inventive step, noting the technical contribution of the patent. Finally, it found the claims to be enabled.
 

UPC

Court of Appeal Upholds UPC's Compatibility with EU Law and Judicial Structure 
(UPC_CoA_288/2025).

On the 6 October 2025, the UPC Court of Appeal rejected an appeal filed by Roku International B.V and Roku, Inc (Roku) against several orders issued by the Munich Local Division. This preliminary decision relates to wider patent infringement actions commenced by Dolby International AB (Dolby) and Sun Patent Trust (Sun) (previously reported here).

The Court concluded that the compatibility of the Agreement on a Unified Patent Court (UPCA) and European primary law could be considered at a preliminary stage as part of an objection to jurisdiction. However, jurisdictional objections lodged in this case were nevertheless unsuccessful on the merits.

The lower court had determined that the question of UPC compatibility with primary law of the European Union could not be considered as part of a preliminary objection to jurisdiction. However, the Court adopted a contrary position. It found that the incompatibility of the UPCA with European primary law could be examined in the context of a preliminary jurisdictional objection because the challenge concerned the basis of the UPC’s jurisdiction. The Court noted that the UPC was obliged to examine the validity of European primary law in the same way as national courts of Contracting Member States, and this obligation was not restricted to a review in main proceedings only. The UPC should interpret its own substantive and procedural law in accordance with EU law on an ongoing basis and disregard it where a consistent interpretation could not be achieved.

Having reached this conclusion, the validity of the UPC’s jurisdiction was then substantively considered.

Roku had argued that the competencies of the UPC set out in the UPCA were incompatible and interfered with the respective competencies of the Court of Justice of the European Union (CJEU) and national Courts. As part of its argument, Roku classified the UPC as an international Court, rather than a Court of a Member State. However, the Court drew a parallel with the CJEU decision that found the Benelux Court of Justice could refer questions to it, despite being a common court for several member states. The Court saw no reason to distinguish the position of the Benelux Court from that of the UPC: the UPC had a “sufficient connection” with the Court systems of Contracting Member States to make it a court common to the Contracting Member States. By extension, and pursuant to Art. 71a Brussels Ia Regulation, the UPC should be deemed to be a court of one of the Contracting Member States.

The aforementioned “sufficient connection” arose from a number of factors, the primary one being the express clarification in Art. 1 UPCA that “The Unified Patent Court shall be a court common to the Contracting Member States and thus subject to the same obligations under Union law as any national court of the Contracting Member States.” Having come to this decision, the Court rejected Roku’s request for the issue of compatibility to be referred to the CJEU.

The Court also found as inadmissible Roku’s objection that its right to a lawful judge had been violated. The objection was also unfounded on the merits as Roku had failed to demonstrate that the absence of a London division created legitimate doubts about the independence and impartiality of judges appointed to the UPC. Furthermore, the substitution of Milan for the London division was allowable as it ensured the UPCA could continue to function after the UK failed to ratify it.

Finally, when considering the Court fee of the two appeals, it was stated that the fee must be paid for each infringement proceeding, although they raised the same issues.