Irides: Weekly global patent litigation update

This edition features updates from: Germany, China, EU/Germany, Denmark, The United Kingdom (UK) and the Unified Patent Court (UPC).

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

Germany

Regional Munich Court grants Regeneron Preliminary Injunction against further Bx in Eylea Case.

On 8 January 2026, it was reported that the Munich Regional Court granted a Preliminary Injunction (PI) in Germany against Stada, Hexal, Celltrion and Advanz Pharma preventing them from marketing their EYLEA® biosimilar products containing the active ingredient aflibercept. For Advanz Pharma, the PI extends to 21 countries, with the Court applying the CJEU's reasoning in BSH v Electrolux. This follows on from the same Court granting a permanent injunction against Formycon in 20 Member States, previously reported here, for which the written decision is now available. 

Like the Formycon decision, Regeneron and Bayer had sued all four biosimilars alleging that they had infringed claim 1 of EP 2364 691 relating to ophthalmic formulations of a VEGF antagonist for intravitreal administration on the basis of the doctrine of equivalents. This patent has been key in Regeneron and Bayer's ongoing worldwide litigation relating to EYLEA®, following expiry of the SPC on 23 November 2025. 
 

China

Supreme Court of China upholds the validity of the semaglutide compound patent.

On 26 December 2025, the Supreme People's Court of China (SPC) handed down a decision upholding the validity of Novo Nordisk’s patent to the compound semaglutide, the sole active ingredient in the successful medicines Ozempic®, Rybelsus® and Wegovy® used to treat diabetes (Ozempic® and Rybelsus®) and obesity (Wegovy®).

Novo Nordisk’s patent had originally been held invalid in 2022 by the Chinese National Intellectual Property Administration (CNIPA). The CNIPA had ruled that the teaching of the patent was not sufficient to establish the claimed technical effect of GLP-1 agonists with a prolonged duration of action. Moreover, it had refused to take into consideration evidence from after the filing date of the patent which demonstrated unequivocally that compounds within the claim possessed the claimed property.

On appeal, the Beijing Intellectual Property Court overturned the CNIPA’s ruling holding that there was sufficient general teaching in the patent about the prolonged duration of action of the claimed compounds to act as a hook to bring in the post-filed evidence. This decision was appealed to the SPC. Following a hearing in September 2024, the SPC issued a ruling in late December 2025 which aligned with the Beijing IP Court and affirmed the validity of the semaglutide compound patent in China. In a landmark decision which will have general applicability to many patents in the life sciences arena, the SPC ruled that as long as (1) the disclosure of the patent sets out a method by which the skilled person can evaluate the claimed technical effect; (2) the claimed technical effects to be proven by the post-filed data are superiority over the prior art (rather than achieving the technical effect); and (3) the description of the application enables the skilled person to reasonably ascertain that the claimed technical effects are present, the patentee should be allowed to rely on post-filed data to support its case of inventiveness.
 

EU/Germany

German Federal Patent Court refers Art. 3(d) SPC questions to the CJEU. 

On 12 December 2025, the German Federal Patent Court referred a question to the CJEU for a preliminary ruling on the interpretation of Art. 3(d) of Regulation (EC) No 469/2009 concerning the Supplementary Protection Certificate (SPC) for medicinal products. The question it referred was:

Is Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products to be interpreted as meaning that the marketing authorisation for a product as a veterinary medicinal product in accordance with Directive 2001/82/EC is the first marketing authorisation for that product as a medicinal product, even if a marketing authorisation for the same active substance as a medicinal product for human use has previously been granted in accordance with Directive 2001/83/EC? 

The patentee had filed a patent application EP 2 934 479 at the EPO for ciclesonide for treating asthma in horses and later marketed the product Aservo® EquiHaler® following veterinary authorisation on 28 January 2020. This was the first authorised veterinary medicinal product containing the active substance ciclesonide, however, this active ingredient had already been approved in 2005 for use in human medicine for the treatment of asthma. It was for this reason that the German Patent and Trade Mark Office (DPMA) rejected the application for an SPC based on the Aservo marketing authorisation. The DPMA argued it was precluded under Art. 3(d) from granting the SPC, especially considering the CJEU's judgment in C-673/18 Santen where it was held that the "first authorisation" must be examined in relation to the active ingredient rather than the therapeutic use of the product. The DPMA therefore considered it irrelevant whether the authorisation was related to human or veterinary use. The applicant argued that there is a strict regulatory distinction between the authorisations for products for veterinary and human use. Furthermore, it put forward policy arguments such as the fact that new, comprehensive and independent clinical studies are required for the marketing authorisation under the different Directives, as well as arguing that the CJEU's judgment in Santen was limited to products where the previous use was also human use such that the CJEU's previous interpretation of Art. 3(d) in C- 130/11 Neurim Pharmaceuticals should be upheld in the present case. 
 

Denmark

Supreme Court sets out presumption of validity and evidentiary burden in Preliminary Injunction cases.

Readers will be aware of the ongoing international litigation relating to Bayer’s patent, EP 1 845 961 (EP 961) and the anticoagulant rivaroxaban. On 8 January 2026, the Supreme Court (SC) handed down its landmark decision following appeals filed by Teva, Sandoz and Glenmark in relation to a decision of the Danish High Court to grant Bayer Preliminary Injunctions on EP 961. In affirming the High Court’s decision, the SC set out the requirements for obtaining a PI in Denmark, including the evidentiary burden.

Presumption of validity

The SC set out that, as EP 961 was maintained by the Technical Board of Appeal (TBA), there is a strong presumption that it is valid. Therefore, in order to avoid a PI, it would be necessary for the generic manufacturers to show gross or blatant deficiencies in the TBA’s decision, or that the TBA’s assessment is clearly incorrect in light of new and significant information. The generics were deemed not to have satisfied this standard, notwithstanding that they submitted several prior art documents that were not considered by the TBA.

Redundant patent claims

A further point of note is the SC’s approach to construction. The SC asserted that the claims of EP 961 should be interpreted in a holistic manner and given a technically meaningful interpretation. The SC emphasised that the TBA had found a feature of the claim relating to half-life not to have an independent technical function. Therefore, half-life was deemed an inherent feature of rivaroxaban and thus the generic products infringed EP 961.

Relevance of foreign judgments

In relation to decisions from foreign jurisdictions, although it was noted that EP 961 has been declared invalid in a number of countries (notably Germany, France, the UK and Norway), the fact that the patent had on the other hand been held valid in different foreign jurisdictions meant that the foreign decision in the generics’ favour were not persuasive.
 

UK

Court of Appeal overturns the High Court’s decision and finds Mira’s patent invalid for sufficiency and not infringed by Triton.

In December 2024, the High Court handed down a decision finding that Kohler Mira Limited’s (Mira) patent GB 2 466 504 (GB 504), which related to instantaneous water heaters, was valid and infringed by Norcros Group (Holdings) Limited (Triton). This first instance decision was notable as the Judge was critical of Triton’s expert evidence, including the approach of Triton’s solicitors to instructing Triton’s expert. Having accepted Mira’s construction of the claim, HHJ Melissa Clarke, at first instance, held that Triton’s range of showers infringed GB 504. The claims were also deemed sufficient, novel and inventive.

Triton appealed this decision, and the Court of Appeal handed down its Judgment in December 2025. Triton’s appeal was on the basis that: (i) the judge had misconstrued the claims; (ii) Triton’s products do not infringe GB 504 (on the correct construction); (iii) the claims were invalid for uncertainty and excessive claim breadth; and (iv) the claims were obvious over the common general knowledge.

In its decision, the Court of Appeal (with Lord Justice Arnold giving the leading judgment) highlighted the fact that the claims of the patent were not limited to water heaters for showers, and thus the water heater could be incorporated into other appliances. Therefore it must be possible to determine whether or not a potentially infringing heater falls within the claims without reference to any larger apparatus within which the heater may be incorporated. It was not possible for infringement to depend on the use, or intended use, of the water heater, as that would mean that the same water heater could be both infringing and non-infringing.

In terms of the language in the claim, there was a dispute regarding what was meant by the wording “wherein the diverter valve is configured so that flow rate is substantially unchanged”. Mira argued that the purpose of the language “substantially unchanged” was to specify that the claimed water heater avoided the risk of scalding the user. However, the Court viewed, in line with established case law, that if general language is used in a claim, then it is not normally legitimate to restrict the claim to a preferred embodiment. In the case at issue, the language of claim 1 was very general and there was no basis for restricting it to the specific embodiment described in the specification. The claimed heater might be incorporated into various devices where scalding was not necessarily a concern and even in the context of showers, the purpose described in the specification was not limited to avoiding scalding but included avoiding any sudden unexpected change in temperature.

Based on this construction, Triton was deemed not to infringe GB 504. Regarding uncertainty, the specification of GB 504 was deemed not to provide any criterion for determining whether the flow rate is “substantially unchanged”. Therefore, the claims were ruled to be insufficient because the boundary of the claim was impossible to determine. The Court of Appeal stated: “Is a 1% change in flow rate within the claim? 5%? 25%? 50%? The skilled person would have no idea”.
 

UPC

Paris Central Division rejects inadmissible Auxiliary Requests in Microsoft v Suinno.
[UPC_CFI_433/2024]

In the dispute between Microsoft Corporation and Suinno Mobile & AI Technologies Licensing Oy, the admissibility and handling of auxiliary requests to amend the patent became the central issue after the patent as granted was found invalid for added subject-matter.

Suinno had sought to safeguard the patent by filing a series of auxiliary requests. These ranged from targeted corrections to specific claims (Auxiliary Request I), to proposals such as deleting dependent claims (Auxiliary Request II), and reformulating claim 1 by combining it with various dependent claims (Auxiliary Requests III–XVII).

The Court, applying r. 30 RoP (Application to amend the patent), distinguished between objective and discretionary requirements for patent amendments in revocation proceedings. Objectively, amendments must be filed within the prescribed deadline, in the language of the patent, and must include at least one clear amendment. Discretionary factors include the clarity and comprehensibility of the amendments, the sufficiency of the explanation for their validity, and the reasonableness of the number of requests given the complexity of the case. The Court emphasised that, except for simple claim deletions, amendments generally require the submission of a full set of amended claims, enabling both the Court and the counterclaimant to immediately understand the scope and content of the changes without needing to reconstruct the applicant’s intent.

On the facts of the case, only Auxiliary Request I (amending claims 6, 10, and 12) was found to be properly filed and accompanied by the necessary documentation. However, this amendment did not address the fundamental defect in claim 1, meaning the patent remained invalid. The other auxiliary requests were found inadmissible: Auxiliary Request II was too vague, as it proposed deletions “as needed” without specifying which claims or providing supporting documents, while Auxiliary Requests III–XVII lacked clarity and were not accompanied by the required reformulated claim sets at the time of filing.

The Court emphasised that the responsibility for drafting clear and intelligible amendments lies solely with the applicant, and that neither the Court nor the opposing party should be required to interpret or reconstruct the proposed changes.
 

UPC

Paris CD Upholds Mandatory Requirements for Unitary Patent Protection. 
[UPC_CFI_1771/2025]

On 30 December 2025, the Paris CD confirmed that the unitary effect of a patent is not linked to the designation of countries in the patent application, but to the grant of the European Patent (EP) and to the date of the request for unitary effect. This affects whether unitary effect is available, as the EP must have been granted with the same set of claims in respect of all countries participating in the UPCA.

The case concerns the “Malta issue” that many commentators had identified prior to introduction of the Unitary patent regime (the same concern would also apply in relation to Croatia should that country ever join the Unitary patent regime). In this case, PAPST filed an application for the unitary effect of EP 3 327 608 (EP 608) in April 2025. The parent application of EP 608 was filed on 31 July 2005, at a time when Malta was not a member of the EPC. EP 608 was granted 20 years later, after Malta had ratified the UPCA. The Court agreed with the EPO's refusal to grant the patent as a Unitary Patent. The inability to designate a specific state at the date of filing due to it not being an EPC member was not a "regulatory gap" as argued by the applicant. The purpose of the phrase "for all participating Member States" in r. 5(2)(a) of the Rules relating to Unitary Patent Protection, as amended (RUPP) was to ensure the unitary character of the unitary patent. The Court also clarified that r. 7(2) RUPP was not a discretionary power. If the conditions for registering for unitary effect are not met, the EPO must reject the application. The decision will have broader effect, at least in the short term, as it will apply to all patent applications filed before Malta acceded to the EPC on 1 March 2007. 

New episodes: You, Me and the UPC: Case by case

Episode 21: Court of Appeal Upholds First Instance Decision Ruling on Inadmissible Broadening

Episode 22: Paris Central Division Rejects Joinder Application Under r. 340.1 and Maintains Separate Proceedings for Both Infringement and Revocation

View all episodes here