At the Unified Patent Court (UPC), the Hamburg Local Division rules that defendants must take effective steps to ensure compliance with injunctions by third-party service providers and platforms acting on their behalf. The Düsseldorf Local Division confirms that a patentee need not practice its own invention to obtain injunctive relief and rejected a patient-interest defense in circumstances where alternative products were available on the market.
From the Court of Justice of the European Union (CJEU), the questions referred by the Danish Maritime and Commercial Court seeking clarification on the scope and notification requirements for the Supplementary Protection Certificate (SPC) Manufacturing Waiver Regulation’s export exemption are published.
In Germany, the Federal Patent Court grants an SPC for safinamide by distinguishing single-agent use claims from combination product claims, a ruling with potentially significant implications for holders of use patents that recite one active ingredient in a combination therapy context.
In France, the Paris First Instance Court provides a ruling confirming that even a non-exclusive licensee can have standing to sue for patent infringement under French law, rejecting arguments that U.S. law should apply.
Turning to the United States, the U.S. Supreme Court rules in a unanimous decision that a generic manufacturer’s skinny label and associated marketing materials did not constitute active inducement of patent infringement. In addition, the Food and Drug Administration (FDA) issues draft guidance on leveraging prior knowledge in the development of human gene therapy products incorporating genome editing, which sets out recommendations for streamlining regulatory submissions across chemistry, manufacturing, and controls (CMC), nonclinical, and clinical data.
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Krystyna Szczepanowska-Kozlowska and Tom Edwards
Our June edition includes updates from the following jurisdictions. Click below to jump to any of these sections.
UPC | CJEU | Germany | France | United States
UPC
Defendants must ensure compliance with UPC injunctions by third-party service providers and platforms acting on its behalf
On May 20, 2026, the UPC Hamburg Local Division (the Court) issued a penalty payment order in a dispute between Occlutech (the Applicant) and Lepu Medical (the Defendant) over compliance with a previous preliminary injunction order. The Defendant had been prohibited from offering, placing on the market, importing or storing implantable occlusion devices in Germany, France, Italy, the Netherlands, and Ireland, under threat of a penalty payment of up to EUR250,000.
The Applicant claimed non-compliance based on continued online offer of injuncted products on the Defendant’s own website, product listings on the MedicalExpo B2B platform, and follow-up commercial emails confirming availability in Europe. The Court held that an obligation to refrain requires full, uninterrupted, and permanent compliance, including effective measures to ensure that compliance is maintained.
It further held that the Defendant must control third parties to whom it assigns tasks, or whom it permits to make changes on its behalf, such as website service providers. It also found that implementation of geo-blocking solutions to prevent products being purchased is not sufficient as offering and placing on the market are independent prohibited acts under the preliminary injunction.
Finally, the Court held that disclaimers do not excuse non-compliance where it is contradicted by other website content, such as German-language product descriptions and invitations to request pricing, or by subsequent communications confirming commercial availability.
The Court ordered the Defendant to pay EUR58,800.00 in penalties, imposed a daily penalty of EUR1,500 for further non-compliance, and ordered the Defendant to bear the costs, with the order taking immediate effect and being immediately enforceable.
LD Hamburg, May 20, 2025, Occlutech GmbH v. Lepu Medical Technology (Beijing) Co., Ltd, Lepu Medical (Europe) Cooperatief UA
Contributors: Francoise Billen, Marie Barani, Jarne Jacobs and Krystyna Szczepanowska-Kozlowska
UPC Düsseldorf Local Division grants permanent injunction in mammography patent dispute
On June 10, 2026, the UPC Düsseldorf Local Division (the Court) granted Hologic (the Claimant) a permanent injunction in France and Germany against different Siemens Healthineers and Siemens Healthcare entities (Siemens) (the Defendants) for the infringement of EP 2 352 431 B1. The patent protects a method and system for controlling x-ray focal spot characteristics in breast tomosynthesis and mammography imaging.
The Court also ordered Siemens to provide information and to recall and destroy the infringing products. It dismissed Siemens’ counterclaim for revocation and ordered the publication of the decision in five medical industry journals of Hologic’s choice, as well as on Hologic’s website for three months.
On the proportionality of granting the permanent injunction, the Court confirmed that Hologic’s lack of a competing product on the market was not a bar to obtaining injunctive relief: a patentee may use its patent as a protective tool without itself practicing the patented technology.
The Court also rejected Siemens’ patient-interest defense as a patient’s interest justifies an exception to injunctive relief only where it is established that the infringing embodiment is the sole available treatment or represents an improvement upon the available treatment methods, resulting in notable enhancement of patient care. On the facts, Hologic had identified several comparable 3D tomosynthesis systems already available on the market, including systems supplied by Siemens.
With respect to the orders for recall and destruction, the Court held that the possibility of modifying products already sold so as to avoid infringement does not preclude a recall order. Further, it found that purely software-based deactivation is an insufficient remedy where reactivation is technically possible, in particular as Siemens, as manufacturer, retained full control over firmware and updates.
LD Düsseldorf, June 10, 2026, Hologic v. Siemens Healthcare/Siemens Healthineers, UPC_CFI_758/2024, UPC_CFI_259/2025
Contributors: Francoise Billen, Marie Barani, Jarne Jacobs and Krystyna Szczepanowska-Kozlowska
CJEU
Clarification sought on the scope and notification requirements of the SPC Manufacturing Waiver Regulation’s export exemption
The questions referred by the Danish Maritime and Commercial Court to the CJEU in the dispute between Janssen and Samsung Bioepis concerning ustekinumab and relating to the interpretation of the SPC Manufacturing Waiver Regulation (Regulation 2019/933) have now been published.
The underlying dispute covered:
(i) whether the storing of ustekinumab manufactured by Samsung Bioepis in Denmark between January 24, 2024 and July 20, 2024 for later export to the UK is covered by the SPC Manufacturing Waiver Regulation’s export exemption and
(ii) whether, with respect to the export exemption, the notification served by Samsung Bioepis was valid.
Janssen contended that the notification was invalid on the grounds that (a) it did not include the reference number of a foreign marketing authorization (MA), and this should have been granted at the time the notification was initially made and provided in the notification and (b) the export exemption is only intended to apply to third countries in which there are no relevant IP rights in force and in light of the UK SPC, the UK was not such a country at the time the notification was given.
The Danish Court has referred four questions to the CJEU, which in substance cover the following:
- Must the export waiver in the SPC Manufacturing Waiver Regulation be interpreted as excluding storage of product ultimately intended for export for an indefinite period and without any restriction?
- Must the reference to the waiver covering “any related act that is strictly necessary… for the actual export” be interpreted as not covering storage of a product intended for export where the export does not take place immediately following manufacture of the product, for example if storage is necessary pending expiry of IP rights or the grant of a marketing authorization in the third country?
- Must the SPC Manufacturing Waiver Regulation be interpreted as meaning that a maker cannot rely on the exemption for export if at the time of the notification the maker has not yet obtained a marketing authorization in the third country to which export is intended?
- Must the SPC Manufacturing Waiver Regulation be interpreted as meaning that a maker cannot rely on the exemption for export if at the time of the notification the maker cannot place the product on the market in the third country of export without infringing IP rights in that third country?
Janssen & Ors v. Samsung Bioepis NL BV & AGC Biologics A/S - Case – C-371/26 – Request for preliminary ruling
Contributors: Tom Edwards and Rafi Allos
Germany
German Federal Patent Court grants SPC for safinamide, distinguishing single-agent use claims from combination product claims
On April 27, 2026, the 14th Senate of the German Federal Patent Court (Bundespatentgericht) overturned a decision of the German Patent and Trademark office (DPMA) and granted a supplementary protection certificate (SPC) for safinamide (marketed as Xadago), a dual-mechanism MAO-B inhibitor used as add-on therapy in the treatment of Parkinson's disease.
The central issue was whether safinamide as a single active ingredient is protected by basic patent EP 1 613 296, whose claim 1 recites safinamide “in combination with levodopa/PDI.” The Court held that claim 1 relates to the use of safinamide in a combination therapy, not to a combination of active ingredients within the meaning of Article 1(b) of the SPC Regulation, and that the product therefore satisfies Article 3(a).
The Court distinguished the CJEU's Yeda and Santen rulings, finding them inapplicable to single-agent use claims. The SPC runs from April 8, 2024 to April 7, 2029. Based on the SPC, the Regional Court Munich I has since issued ex parte preliminary injunctions against Vivanta Generics (21 O 3953/26), Stadapharm (21 O 3955/26) and Aliud Pharma (21 O 3954/26). A hearing in the preliminary injunction proceedings against Vivanta Generics is scheduled for July 1, 2026.
The decision is noteworthy for pharmaceutical companies holding use patents that recite a single active ingredient in a combination therapy context: the Court's distinction between a use claim directed to a single agent administered alongside another drug and a claim to a combination of active ingredients (Article 1(b) SPC Regulation) suggests that SPC protection may be available in scenarios where its availability was previously uncertain.
BPatG, 14 W (pat) 23/24 – "Safinamid"
Contributors: Caroline Bley and Stephan Neuhaus
France
France says yes to licensee standing in bortezomib patent fight
On May 6, 2026, the Paris First Instance Court delivered two partial judgments in infringement proceedings over formulations of bortezomib—the active ingredient of Velcade® —protected by EP 2 251 344 and EP 3 078 667 (both expired January 25, 2022). The claimants were Millennium Pharmaceuticals (licensee), Janssen (sub-licensee) and Cilag (sub-sub-licensee), with the United States (patent owner) intervening voluntarily.
The Court dismissed every inadmissibility plea raised by the generic defendants, Zentiva and Stragen. The defendants argued that Millennium’s license from the U.S. government distinguished between an exclusive field (bortezomib per se) and a non-exclusive field (secondary patents, including those in suit), and that the reservation of march-in rights negated any exclusivity. They submitted that U.S. law governed standing and that, under 35 USC §281, only a licensee holding all substantial rights may sue.
The Court disagreed. Standing to bring infringement proceedings before the French Courts is governed by French procedural law, not U.S. law. Applying Article L. 615-2(3) of the French IPC, even a non-exclusive licensee may sue for infringement provided:
(i) the license expressly authorizes it and
(ii) the patent owner has been informed in advance.
Both conditions were satisfied here—through clause 11.02 of the license agreement and written notices to the National Institute of Health’s Technology Transfer Office (NIH TTO). The Court also confirmed that the license’s expiry (following the patents’ expiry) does not extinguish the right to pursue infringement committed while the license was in force.
This outcome contrasts with Germany, where on February 17, 2026 the Düsseldorf Regional Court dismissed parallel claims, finding the patentee’s march-in rights incompatible with an exclusive license under German law and denying standing on that basis.
Paris FIC, May 6, 2026, Millennium Pharmaceuticals, Janssen Products, Cilag International and the United States of America (voluntary intervener) v. Zentiva (Docket No. 25/01858) and v. Stragen (Docket No. 25/01859)
Contributors: Morgan Torchy and Charles Tuffreau
United States
U.S. Supreme Court holds generic manufacturer’s “skinny label” and marketing did not induce patent infringement
On June 4, 2026, the U.S. Supreme Court issued a unanimous decision in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24–889), holding that Amarin, the manufacturer of brand-name Vascepa (icosapent ethyl), failed to plausibly allege that—based on the totality of Hikma’s skinny label, patient leaflet, website, and press releases—Hikma actively induced physicians to prescribe its generic version of Vascepa for Amarin’s patented cardiovascular use.
The Court explained that the central question is not whether Hikma’s statements could be read as instructions to infringe, but rather whether Hikma plausibly took “active steps” to encourage infringement. Reaffirming that induced infringement requires “purposeful, culpable expression and conduct,” the Court held that “ordinary acts incident to product distribution” are insufficient. Metro-Goldwyn-Mayer Studios Inc. v. Grokster, Ltd., 545 U.S. 913, 937 (2005).
Applying that standard, the Court first concluded that several of Hikma’s challenged statements had “obvious alternative explanation[s],” including compliance with federal law and standard industry practice. Generally, a generic label must mirror the branded label except for carved-out uses.
The Court further held that Amarin could not rely on “mere omissions,” such as the label’s omission of the patented cardiovascular use indication or the press releases’ failure to mention that Hikma’s approved use was limited to a particular off-patent indication, i.e., treating severe hypertriglyceridemia.
Finally, the Court held that Hikma’s remaining statements, including information in the patient leaflet, website descriptions, AB-rating references, and sales figures contained in investor-focused press releases, were too vague and speculative to plausibly constitute affirmative encouragement of infringement. Because Amarin failed to plausibly allege affirmative steps, the Court reversed and remanded for further proceedings.
The decision significantly strengthens the position of generic manufacturers marketing skinny-label products and curtails the Federal Circuit’s recent trend of permitting inducement claims based on speculative inferences about how providers might react to ambiguous statements.
Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., 608 U.S. (2026)
Contributors: Thomas Makin and Jessica Rivilis
FDA issues draft guidance on leveraging prior knowledge for genome-editing products
In early June, the FDA’s Center for Biologics Evaluation and Research (CBER) issued draft guidance entitled “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing.”
The guidance is directed at manufacturers, applicants, and other stakeholders developing human gene therapy products that incorporate ex vivo or in vivo genome editing of human somatic cells. It sets out the FDA’s current thinking on the types of “prior knowledge”—defined to include both publicly available scientific knowledge and proprietary platform knowledge derived from developing and manufacturing similar products—that may be scientifically appropriate to leverage in order to streamline regulatory submissions, increase review efficiency, and accelerate product development. And, it provides guidance on how to submit such information for proposed leveraging.
The guidance provides specific recommendations for leveraging prior knowledge across three key areas:
(1) Chemistry, manufacturing, and controls (CMC), including analytical methods, lot release specifications, stability data, comparability data, and process validation
(2) Nonclinical studies, including biodistribution, toxicology, and bioinformatics-based, off-target analyses
(3) Clinical data, including trial design, trial conduct, and long-term follow-up
While the guidance focuses specifically on genome-editing products, the FDA notes that certain recommendations may also be applicable to other cell- and gene-therapy products, such as adeno-associated viral (AAV) vectors, nanoparticle-based, gene-therapy products, and ex vivo-modified, cell-based therapies.
Importantly, the guidance does not establish legally enforceable requirements; rather, it reflects the FDA’s recommendations, and sponsors are encouraged to engage with the FDA early in the product development lifecycle, such as through INTERACT or pre-IND meetings, to discuss any proposals for leveraging prior knowledge. The draft guidance is open for public comment.
Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing – Draft Guidance
Contributors: Thomas Makin, Eric Lucas, and Mia Baijnath
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