This month’s life sciences newsletter highlights several significant developments from the Unified Patent Court (UPC) and national courts across Europe.
A recurring theme within the UPC is the continuing Abbott v SiBio saga, with the UPC Court of Appeal upholding Abbott’s glucose sensor patent on the merits and the Milan Local Division granting a PI against SiBio-related entities. Together, those decisions provide further guidance on added matter, the admissibility of late-filed arguments, and patent infringement in the medical devices sector.
The UPC also continued to shape the law on liability of EU Authorised Representatives, with a series of decisions addressing intermediary liability under Article 63(1) UPCA and the specific circumstances in which the acts of a third party may be attributed.
Beyond the UPC, national courts across Europe delivered notable rulings on a range of topics. In the United Kingdom, the High Court provided important guidance on the meaning of an “active ingredient” for Supplementary Protection Certificates (SPC) purposes in the context of pro-drugs. In addition, in France, the courts issued noteworthy rulings on standing to sue and the limits of pre-priority evidence-gathering in patent litigation, while the courts in the Netherlands clarified the scope of the patent-law pharmacy exemption and reaffirmed the difficulties of obtaining SPC protection for second medical use inventions.
Our September edition includes updates from the following jurisdictions. Click below to jump to any of these sections.
UPC | United Kingdom | France | The Netherlands
Court of Appeal upholds Abbott’s glucose sensor patent and confirms approach to added matter (specifically intermediate generalisations)
The UPC Court of Appeal has dismissed SiBio’s appeal against the Paris Central Division’s decision upholding the validity of Abbott’s patent for an on-body glucose monitoring device (EP 3 831 283). Both SiBio’s added-matter and inventive-step challenges failed. The decision follows a series of proceedings between the parties across multiple forums.
On added matter, the Court of Appeal provided important guidance on specifically the assessment of intermediate generalisation:
- Added matter may arise when subject matter is claimed by importing one or more features from a certain embodiment in the application into a claim, while omitting one or more other features of this same embodiment. This is generally considered to be unallowable if there is a clearly recognisable functional or structural relationship between the omitted feature(s) and the claimed feature(s). This is also referred to as an "extricable link" between the omitted feature(s) and the claimed feature(s).
- In the assessment of added matter, the technical effect that the invention aims to achieve, and whether an omitted feature contributes to that technical effect is relevant. It matters when the skilled person would understand from the application as a whole that there is a structural or functional relationship between the omitted feature and the other features of the claimed embodiment. Put differently: the question is whether the omitted feature is essential to the invention.
- When assessing added matter, the application as a whole must be considered. The assessment shall not be restricted to the description of the embodiments that fall within the scope of the claim: the context must be assessed as well. Passages of the application that do not directly relate to the claimed embodiment may also be relevant.
In applying these principles to the case and assessing the application in detail, the Court of Appeal concludes that the application does not teach the skilled person that the use of any particular type of sealing (a feature omitted in the claim) is essential for achieving the technical effects of the invention and therefore does not constitute added matter. Applying the inventive step principles of its earlier decision in Amgen v Sanofi & Regeneron the Court rejected Sibio’s inventive step attacks as well.
UPC Court of Appeal, Sibio Technology v. Abbott Diabetes Care, August 14, 2026, UPC-CoA-884/2025
Contributors: Frits Gerritzen and Sara Swinkels
Milan LD grants PI for glucose monitoring devices and provides guidance on late-filed arguments and attributable infringement EU Authorised Representatives
The Milan Local Division granted Abbott a PI against Shenzhen SiSensing and SiBio related entities, ordering them to stop offering, importing and marketing GS3-R continuous glucose monitoring devices across multiple UPC Contracting Member States.
A notable procedural issue concerned new arguments on the interpretation and infringement of a feature of the claim, submitted by the respondents for the first time in their final written submissions, one month before the oral hearing. The Court admitted those arguments, emphasizing that:
- Claim construction is a matter of law, and the Court can elaborate on it ex officio.
- It is essential that the opposing party is always given the opportunity to be heard in accordance with the adversarial principle and the right of defence.
- The new argument was introduced one month before the oral hearing, without relying on any additional factual elements or documents.
- The conduct of applicant is considered relevant: the applicant merely objected to the late filing, and did not request, even in the alternative, a short time limit to file a reply on that specific issue.
- The applicant was given adequate opportunity to respond to the argument during the oral hearing.
- A different conclusion would amount to an overly rigid application of the front-loaded character of UPC proceedings, at least in the context of provisional measures, with an excessive and disproportionate impairment of the right of defence.
The patent was nevertheless found more likely than not valid and infringed.
The Court then examined each defendant’s role in distributing the system. With respect Shanghai International (respondent 5) in particular, it held that in its capacity as EU Authorised Representative of the manufacturer (one of the other respondents) under the MDR, the company was not a mere passive intermediary because, by accepting the mandate to act on the manufacturer's behalf for regulatory purposes, it enabled the lawful placement of the devices on the EU market. The Court held that under these circumstances, the infringing acts are attributable to Shanghai International, which therefore qualifies as an infringer within the meaning of Article 25 UPCA and 63 UPCA.
LD Milan, Abbott Diabetes Care v. Shenzhen SiSensing and others, September 7, 2026, UPC_CFI_1086/2026
Contributors: Frits Gerritzen and Sara Swinkels
UPC further clarifies the role of the EU Authorised Representative as an infringing “intermediary” (Article 63(1) UPCA)
The Düsseldorf Local Division has granted an injunction on the merits extending to Germany, France, and the UK against Shanghai Limited in favour of Aesculap AG. The Court addressed the liability of the EU Authorised Representative (MDR)5 under Article 63(1) UPCA in detail. The patent concerned a surgical instrument, and the defendants were alleged to infringe it with their “Bojin” instruments.
After establishing technical infringement, the Court turned to the infringing acts. Regarding the second defendant, Shanghai Limited, the Court first held that being named in the CE declaration of conformity of the instruments - a legal prerequisite for marketing the alleged infringing products in the EU - did not make it a co-infringer or an accessory to infringement per se. The CE declaration was characterised as a mere preparatory act for a subsequent patent infringement.
However, in its capacity as EU Authorised Representative, Shanghai Limited was found to be an intermediary within the meaning of Article 63(1) UPCA:
- Liability of an intermediary presupposes that the intermediary is capable of influencing the infringement. There are no additional requirements that need to be met, such as a breach of a duty of care.
- The term "intermediary" is not limited to providers of digital intermediary services. It covers a party that does not itself use the patent but provides a service that is used to infringe and thereby creates a condition necessary for the infringing act.
- An EU Authorised Representative under Article 11 MDR plays an indispensable role in the marketing of medical devices. Referring to UPC_CFI_387/2025 (Dyson v DREAME), the Court held that without that appointment, lawful marketing of a non-EU manufacturers products in the EU is not possible. Also, the EU Authorised Representative is in a position to stop the further distribution of infringing products by terminating its services. In other words, it is capable of influencing the infringement.
The injunction (and other measures) against the intermediary extended to Germany and France. The Court also assessed in detail whether the EU Authorised Representative could be held liable under “joint tortfeasorship” in UK. It held that it could and extended the injunction to the UK subject to the condition that the patent would not be declared invalid by the competent national institutions; the orders beyond the injunction were however rejected.
The Court declined to stay the proceedings pending the CJEU reference in Dyson v Dreame (concerning the requirements of liability as an intermediary, C-196/26), as that reference concerned different EU regulations and summary proceedings rather than a main action or the MDR.
LD Düsseldorf, Aesculap v. Shanghai Bojin Medical Instrument and others, September 1, 2026, UPC_CFI_307/2025
Contributors: Frits Gerritzen and Sara Swinkels
PI granted for battery-powered surgical instruments with guidance on urgency attack based on previous products
The Hamburg Local Division has granted Cilag GmbH International a PI against RiVOLUTION and Shanghai International Holding, prohibiting the sale of battery-powered endoscopic linear cutting staplers (EnDrive Orca and EnDrive Zero) that infringed a patent protecting certain surgical cutting and stapling instruments (EP 2 615 984 B1).
On validity, the Court rejected a notable argument from the respondents that the patent was excluded from patentability under Article 53(a) EPC on grounds of public policy. The Court held in this respect that surgical instruments are subject to the highest sterility requirements and disposable products are common and essential in the surgical environment for patient safety. Furthermore, the controlled discharge of batteries serves a genuine safety purpose.
After establishing the validity and technical infringement of the patent, the Court provided helpful guidance on the assessment of urgency:
- The respondents argued lack of urgency based on a previous version of the products at issue, which was “structurally similar” and had been subject to earlier notice letters and proceedings based on a different patent.
- The Court held that for such attack to succeed, “under the more likely than not standard”, the respondent must demonstrate a prima facie case that (i) the current product is substantially identical to the previous product with respect to the patent at issue, and (ii) the previous product must have provided reasonable grounds for an investigation into the infringement of the intellectual property right now asserted.
- According to the Court, the defendants did not demonstrate that the earlier products employed the same specific discharge mechanism as the successor products (i.e. they were not identical; cf. (i) above).
- Nor was there any reason for the applicant to have investigated the previous product: the earlier proceedings concerned technical aspects of the previous products that are unrelated to the patent at issue (cf. (ii) above).
- The fact that the applicant's notice letter concerning the previous products did not mention the patent in suit also demonstrated that the applicant was not aware of infringement of that patent at the time. Referring to UPC_CoA_19/2026, Guardant v Sophia, the Court held that the applicant can therefore not be held liable for not having already asserted the patent in suit against the predecessor product.
- The Court also considered relevant that the applicant possesses a portfolio of more than 1,000 patents potentially relevant to the product at issue, which makes comprehensive preliminary review difficult, even for a large company with a well-staffed patent department like the applicant.
- The two-month period between receipt of the physical products and the filing of the application was considered reasonable: the applicant took all steps within her power to obtain the products as quickly as possible and to subsequently analyse it.
It is worth noting that also in this case, the EU Authorised Representative (respondent 2) was held liable as an intermediary and was ordered to stop acting as an authorised representative for the allegedly infringing products. A security was provided in case this decision was annulled or amended following the CJEU Dyson v Dreame decision.
LD Hamburg, Cilag v. RiVOLUTION & Shanghai International Holding, August 25, 2026, UPC_CFI_1535/2026
Contributors: Frits Gerritzen, Sara Swinkels and Caspar van Dijk
SPC on pro-drug of previously authorised active moiety found to be valid
On September 24, 2026, the UK High Court issued a decision that Takeda's SPC for its ADHD treatment ‘Elvanse’ was validly granted, dismissing invalidity claims brought by Aristo Pharma and Stada. Elvanse contains lisdexamfetamine (LDX), a pro-drug that is metabolised to release the active moiety dexamfetamine (DEX) upon ingestion. LDX provides an improved treatment to DEX as its mechanism causes slower release of DEX that allows once-daily dosing rather than multiple doses per day.
The claimants argued that DEX, rather than LDX, is the correct ‘active ingredient’ as defined in the SPC Regulation. DEX had already been authorised, so the SPC would be invalid given an SPC must rely upon the first MA for the product specified. HHJ Hacon concluded that a reasonable reader of the MA and the public assessment report would identify LDX as the active ingredient, notwithstanding it being pharmacologically inactive before ingestion. Their understanding would be that LDX had biological activity upon ingestion resulting from its transformation into DEX. HHJ Hacon went on to consider the actual properties of LDX and DEX and whether LDX satisfied the test for being an ‘active ingredient’ for SPC purposes on the facts. Following Forsgren and the Advocate-General's Opinion in Case C-456/24 (Halozyme), he held that 'active substance' under the Medicinal Products Directive is the same as 'active ingredient' under the SPC Regulation. Applying this test, he found that LDX was both an ‘active substance’ and an ‘active ingredient’ because it has a pharmacological and/or metabolic action of its own given its different pharmacokinetic profile to DEX that enables less frequent dosing. Moreover, since LDX is considered a single new substance rather than an earlier active ingredient combined with a non-active carrier, the 'of its own' requirement in the Forsgren test was not really engaged.
Aristo Pharma GmbH v Takeda Pharmaceuticals USA Inc & Anor [2026] EWHC 2414 (Pat) (September 24,2026)
Contributors: Rafi Allos and Jess Jiang
Fraudulent filing of the patent not affecting standing to sue in infringement action
On June 24, 2026, the French Supreme Court (Cour de cassation) dismissed the appeal filed by MMLS and M2I Salin against a decision of the Paris Court of Appeal in patent infringement proceedings brought by Minakem. The patent at issue relates to a process for the preparation of bromomethylcyclopropane, a synthesis intermediate used in the manufacture of active pharmaceutical ingredients. The judgment provides two key findings.
On the standing of the registered owner, the defendants raised a preliminary objection on the ground based on Minakem's alleged lack of standing, arguing that the patent had been filed fraudulently (incorrect designation of the inventor) and that Minakem had no rights to the invention. The Court of Cassation laid down the following principle: the fact that the applicant knows at the time of filing the patent application that he is not entitled to the industrial property right affects neither the patentability of the invention nor the validity of the patent protecting it. The applicant therefore retains standing and a legitimate interest to bring infringement proceedings against any third party until such time as an entitlement action succeeds. In this case, no inventor claimed any right to the invention, and the preliminary objection was accordingly held to be unfounded.
As regards inventive step, the Court of Cassation expressly confirmed the use of the problem-and-solution approach, stating that, among the possible methods for assessing inventive step in accordance with Articles L. 611-10 and L. 611-14 of the French Intellectual Property Code, the courts may apply this approach. In the present case, the Court of Appeal had identified a certain patent as the closest prior art and held that the person skilled in the art would not have been prompted to combine it with any other document to arrive at the patented process. The Court of Cassation upheld this finding on the merits.
French Supreme Court (Cour de cassation), June 24, 2026, MMLS and M2I Salin v. Minakem, Docket No. 24-14.680
Contributors: Sarah Kasbi and Charles Tuffreau
No pre-priority evidence fishing in Janumet® SPC dispute
On June 3, 2026, the case-management judge of the Paris First Instance Court ruled in proceedings brought by Merck/MSD against generic defendants Mylan/Viatris concerning EP 1 412 357 and French SPC No. 08C0033. The SPC covered the sitagliptin/metformin combination marketed as Janumet® until 8 April 2023. The Court rejected the generics’ request for the forced production of pre-priority experimental protocols, laboratory notebooks, regulatory materials and internal documents said to be relevant to the validity of the SPC.
The generics argued that EP 357 did not specifically single out sitagliptin in combination with metformin, that neither sitagliptin nor metformin was presented as preferred, and that MSD had to show that it was in possession of a synergistic effect at the priority date. In their view, only the requested documents could establish whether MSD had generated such data before that date.
The judge recalled that a party seeking forced production must identify documents that are at least likely to exist, are held by the opposing party, are sufficiently specific, and are useful for resolving the dispute. The generics’ request did not satisfy that test: documents proving a pre-priority technical effect for the sitagliptin/metformin combination would tend to support MSD’s case, rather than the invalidity attack. In the judge’s view, the request was therefore aimed less at obtaining relevant evidence than at demonstrating that MSD had no such evidence.
Paris FIC, June 3, 2026, Merck Sharp & Dohme LLC and MSD France v. Mylan Ireland Limited and Viatris Santé, Docket No. 22/12518
Contributors: Morgan Torchy and Charles Tuffreau
Ceban cannot validly rely on patent-law pharmacy exemption for its semaglutide nasal spray
The Dutch PI Judge held that Ceban Ziekenhuisfarmacie (Ceban), a Dutch compounding pharmacy, infringed Novo Nordisk’s SPC protecting semaglutide (Ozempic®, Wegovy® and Rybelsus®) by preparing and supplying its semaglutide nasal spray “Semanova”. Ceban argued that the product fell within the pharmacy exemption of Article 53(3) Dutch Patent Act because it was prepared for individual patients, including patients with a fear of needles.
The PI Judge first clarified that the patent-law pharmacy exemption is limited to preparations made for immediate use, on the basis of a medical prescription for individual patients. Structural preparations fall outside the scope of the exemption. The exemption serves public interests and applies only where there is a genuine medical need that cannot be met by the patentee’s own medicinal product. The PI Judge acknowledged that the precise boundary between permitted and non-permitted preparations is not always straightforward and requires an interpretation of the concepts of "immediate use" and "individual cases" in light of the circumstances of the particular case.
Ceban sought to rely on the fact that, under the regulatory pharmacy exemption, preparations for up to 50 patients per month may be permitted and that the same threshold should apply under the patent-law pharmacy exemption. It argued that it had prepared the nasal spray only 44 times.
The PI Judge rejected that argument, finding no basis for assuming that small-scale preparation of up to 50 individual prescriptions per month is automatically permissible under the patent-law pharmacy exemption as well. The PI Judge further noted that several aspects of Ceban's conduct suggested that it intended to prepare the spray on a larger scale. Ceban had promoted the product through presentations, imported 600 grams of semaglutide, sufficient to produce approximately 15,000 bottles, registered the product in the G-Standard, and marketed it under a distinct brand name. Taken together, these circumstances pointed to structural and potentially large-scale use, which, according to the PI Judge, clearly falls outside the scope of the patent-law pharmacy exemption.
The Hague District Court August 5, 2026, ECLI:NL:RBDHA:2026:21938, Novo Nordisk v Ceban
Contributors: Frits Gerritzen, Sara Swinkels, and Caspar van Dijk
Dutch District Court holds: Article 3(d) SPC Regulation is acte éclairé - Dutch Patent Office correctly rejected SPC cladibrine as the Mavenclad® MA is not first MA for cladibrine
Merck Serono’s SPC application for cladribine (Mavenclad®) was rejected by the Dutch Patent Office on the basis of Article 3(d) of the SPC Regulation. Cladribine had previously been authorized as the active ingredient in Leustatin® and Litak® for the treatment of hair cell leukaemia.
Merck Serono challenged that decision before the District Court of The Hague. Mavenclad® represents the first use of cladribine for the treatment of multiple sclerosis, i.e. a new therapeutic indication. The basic patent underlying the SPC is directed to this second medical use. Merck Serono in short argued that the assessment should follow the reasoning of CJEU Neurim rather than CJEU Santen.
The Court rejected that argument. In its view, the CJEU in Santen unequivocally departed from the approach adopted in Neurim. The legal position is therefore acte éclairé: an MA for a new therapeutic application (second medical use) of a previously authorized active ingredient cannot qualify as the first marketing authorization within the meaning of Article 3(d) of the SPC Regulation. The Court therefore saw no reason to refer questions to the CJEU. It was also not persuaded by the fact that the Bundespatentgericht reached a different conclusion on the scope of Santen in parallel Boehringer-proceedings (concerning the situation where the first MA concerned a human drug and the later one a veterinary drug) than the Dutch court (and the Cour d’Appel de Paris), or that the Bundespatentgericht has referred questions on Article 3(d) of the SPC Regulation to the CJEU (Case C-15/26).
The Hague District Court 5 August 2026 ECLI:NL:RBDHA:2026:21645 (Merck Serono v Dutch Patent Office)
Contributors: Frits Gerritzen, Sara Swinkels, and Caspar van Dijk
