This edition highlights notable developments at the UPC, France, and the Netherlands.
Two recent UPC decisions provide further guidance on the validity of second medical use claims targeting patient subgroups, claim construction, remedies following infringement, and claims extending beyond UPC territory (including the UK).
In France, the Paris Court of Appeal considers SPC protection for combination products, applying the CJEU’s latest guidance on Article 3(a) SPC Regulation. It confirmed that expressly claiming a combination is not, by itself (and without substantive support showing that the combination forms part of the invention), sufficient to satisfy Article 3(a).
In the Netherlands, the District Court of The Hague applied the CJEU’s BSH v. Electrolux judgment and granted cross-border injunctive and declaratory relief, despite pending foreign revocation actions.
UPC | France | The Netherlands
Milan Central Division clarifies validity requirements for second medical use claims targeting patient subgroups
In what we believe to be the first Central Division revocation action in a generic vs innovator pharmaceutical dispute brought by Biogaran, the UPC’s Milan Central Division upheld in amended form Lundbeck’s European Patent EP 4 223 296, concerning the use of nalmefene to reduce alcohol consumption in a specific subgroup of alcohol-dependent patients.
Lundbeck had unconditionally deleted two dependent claims to align the claim set with that submitted in parallel EPO opposition proceedings. The court provided useful guidance on the validity of second medical use claims directed to patient subgroups.
On added matter, the court held that the challenger must specifically identify the subject-matter said to extend beyond the original disclosure. The mere existence of numerous embodiments and possible combinations does not establish added matter where the claimed subject-matter remains directly and unambiguously derivable from the application as filed. Nor can the court cure an insufficiently substantiated invalidity attack without compromising its impartiality.
On novelty, it held that identifying a subset of patients is not sufficient: the subgroup must be physiologically or pathologically distinct and its defining characteristics functionally linked to the therapeutic effect, so as to provide a distinct therapeutic teaching. The claimed subgroup satisfied that test because the patent showed a more pronounced reduction in alcohol consumption in patients meeting the claimed criteria.
On sufficiency, where the contribution lies in identifying a distinct patient subgroup, the patent must provide sufficient technical information to identify that subgroup and make it credible that the medicinal product is suitable for the claimed therapeutic use. The precise dosage need not appear in the independent claim where the skilled person can select a safe and effective dose without undue burden based on the patent, prior art and common general knowledge.
Finally, the court rejected Biogaran’s inventive-step case as hindsight-driven. An obviousness attack assembled from more than ten disclosures addressing different technical questions, none supplying the missing pointer or a reason to combine their teachings, was indicative of an ex post facto reconstruction rather than the path the skilled person would have followed at the priority date.
Milan Central Division, Biogaran v. Lundbeck, October 9, 2026, UPC_CFI_1587/2025
Contributors: Charles Tuffreau and Martin Coumau
Paris Local Division clarifies claim construction and the scope of remedies following infringement
Align Technology brought an infringement action against Angelalign based on EP 2 237 738, which concerns clear aligners incorporating ridge-shaped features designed to control tooth movement. Angelalign counterclaimed for revocation on the grounds of insufficiency, added matter and lack of inventive step. The Paris Local Division rejected those challenges and found that Angelalign’s “Select” and “Pro” systems incorporating its “Torque Ridge” feature infringed the patent.
On claim construction, applying the UPC’s established approach, including the principle that a patent may serve as its own lexicon, the court interpreted the claim language in the context of the patent as a whole, including the description and drawings.
Angelalign argued that “buccal” was limited to cavities receiving posterior teeth. The court disagreed, holding that, in the context of the patent, “buccal” was synonymous with “facial” and therefore covered cavities receiving both anterior and posterior teeth. Angelalign’s Torque Ridge consequently fell literally within the claims.
The court granted a permanent injunction together with recall, removal and destruction measures, reiterating that such remedies are generally the rule rather than the exception following a finding of infringement. In assessing proportionality, it took into account Align’s limitation of the injunction to patients whose treatment had not yet begun or had been interrupted, and its acknowledgement that appliances already delivered to patients would not be subject to corrective measures.
By contrast, the court dismissed Align’s claims concerning acts in the UK. It held that a party alleging infringement outside UPC territory must substantiate the applicable national law. Align’s submissions on UK law were late and insufficient, and it had also failed to establish that the relevant defendants had committed infringing acts in the UK. The decision is therefore a useful reminder that claims extending beyond UPC territory require both the applicable national law and the alleged territorial acts to be properly pleaded and proved.
Paris Local Division, Align Technology v. Angelalign Technology, October 16, 2026, UPC_CFI_684/2025 and UPC_CFI_2279/2025
Contributors: Charles Tuffreau and Martin Coumau
SPCs for combination products: Paris Court of Appeal applies the CJEU’s December 2024 ruling and refuses an SPC for dapagliflozin/metformin
On July 10, 2026, the Paris Court of Appeal dismissed AstraZeneca AB’s appeal against the French Patent Office’s refusal of an SPC for the combination of dapagliflozin, or a pharmaceutically acceptable salt thereof, and metformin, or a pharmaceutically acceptable salt thereof.
The application was based on European patent EP 1 506 211, entitled “C-aryl glucosides as SGLT-2 inhibitors and corresponding method”, and the EU marketing authorisation for Xigduo. The judgment is noteworthy both for its treatment of new grounds on appeal and for its application of Article 3(a) of Regulation (EC) No 469/2009 to combination products.
AstraZeneca relied for the first time before the Court of Appeal on paragraphs [0056] and [0066] of the patent. The court held that reliance on those paragraphs amounted to new grounds which were inadmissible in the annulment proceedings. The fact that they immediately followed paragraph [0055], which had been relied on before the French Patent Office, did not alter that conclusion.
On Article 3(a), the court applied the two-limb test established in Teva (C-121/17), as subsequently clarified in Royalty Pharma (C-650/17) and in the CJEU’s joined judgments of December 19, 2024 (C-119/22 and C-149/22). The court held that, under that case law, an express reference to a product in the claims is not sufficient: the product must also necessarily fall within the invention covered by the patent and be specifically identifiable by the skilled person.
Although claim 7 expressly listed dapagliflozin and metformin, the court found that the technical solution disclosed by the patent was the provision of new SGLT2 inhibitors, rather than a new combination treatment. Metformin was only one of many possible antidiabetic agents, with no particular teaching or incentive favouring that combination. Paragraph [0054], which stated that “it is believed” that combinations could produce superior results, was no more than an unsubstantiated hypothesis and did not explain how the combined effect differed from the additive effects of the individual active ingredients.
The combination also failed the specific-identification limb. The skilled person would have had to select biguanides from 13 classes in claim 6 and then metformin from 31 compounds in claim 7, while the patent’s examples concerned only the synthesis of the SGLT2 compounds and their intermediates.
The decision confirms that expressly listing a combination in a claim may not, without substantive support showing that the combination forms part of the invention, be sufficient to satisfy Article 3(a).
Paris Court of Appeal, July 10, 2026, AstraZeneca AB v. Director General of the INPI, RG No. 24/18803.
Contributors: Charles Tuffreau and Léa Richier
Dutch District Court applies BSH/Electrolux and grants cross border injunction and declaratory relief despite pending foreign revocation actions
The case concerned Halozyme’s patent EP 2 797 622 B1, which protects a modified PH20 polypeptide with increased stability in the presence of phenolic preservatives. MSD sought revocation of the Dutch part of the patent on several grounds: lack of novelty, lack of inventive step (based on multiple documents), insufficiency and added matter.
Halozyme counter claimed cross-border relief for infringement concerning MSD’s sub-cutaneous version of Keytruda in Belgium, Denmark, France, Ireland, Italy, the Netherlands, Sweden, and Switzerland. The court rejected all the validity attacks and found that MSD’s product falls within the patent’s scope of protection.
On infringement, the court acknowledged that under Article 8 Rome II Regulation, infringement must be assessed under the law of each country for which Halozyme claims protection. The court however held that “given the far-reaching (informal) harmonisation of the rights conferred by a European patent in the Contracting States of the [EPC], the court will proceed on the basis that the rights in the other countries concerned are the same as under Dutch law”.
It then found that MSD threatened to infringe the patent in and outside the Netherlands based on i.a. MSD’s communications about its market plans and given that group companies had already launched the relevant product in Sweden and Denmark. It also held that MSD offers and distributes Keytruda SC in the relevant countries, considering i.a. its role in the distribution system of the product and information on its website.
The court further held that MSD, as a central MA holder, acts unlawfully because it knowingly facilitates or induces infringement by MSD group companies. The court therefore granted a cross-border infringement injunction extending to all the countries that Halozyme sought protection for.
It also granted a cross-border facilitating infringement injunction, limited to Belgium, Denmark, France, Ireland and Italy, and limited to facilitating infringement by MSD group companies. The court further granted the requested cross-border declaration that Keytruda SC falls within the patent's scope of protection.
The court refused MSD’s request to stay the proceedings until parallel foreign nullity actions were decided. Referring to CJEU BSH v. Electrolux, it held that there was no reasonable, non-negligible chance that the foreign designations at issue would be declared invalid that might warrant a stay.
The court came to this conclusion based on its own judgment on validity, the Bundespatentgericht’s preliminary opinion on validity, the Landgericht München’s rejection of invalidity arguments in interim proceedings, and the fact that it is unaware of validity arguments or evidence in the foreign actions that are not considered in these proceedings.
The court added that the approach under the earlier Dutch Supreme Court’s decision in Roche v. Primus II, where a stay was in principle granted, now appears outdated. It said a practical solution like the orders made in this case is desirable because it avoids many stayed cases.
The injunctions stop applying in a country if that country’s competent court revokes the relevant foreign designation in whole or in part. They revive if a higher court later upholds the designation. The granted declaratory relief stops applying only once the foreign designation has (partially or wholly) been revoked by a final decision.
Contributors: Frits Gerritzen and Sara Swinkels
District Court of The Hague October 7, 2026, ECLI:NL:RBDHA:2026:29643 (Merck Sharp & Dohme B.V. v. Halozyme Inc.)
