Pharma — European UPC Patent Cases
76 decisions indexed
Page 1 of 3 · 76 total
Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe S.A., and Sanofi Winthrop Industrie S.A. v.Amgen, Inc
This decision from the UPC Court of Appeal concerns procedural matters, specifically the withdrawal of applications for rehearing in a complex dispute involving Sanofi and Amgen over patent EP 3 666 797. Following earlier proceedings where the Central Division had revoked the patent, both parties engaged in appeals and subsequent requests for rehearing. Ultimately, the Court permitted the withdrawal of these procedural actions upon consent from all involved parties. This case highlights how UPC courts manage complex litigation pathways when parties agree to terminate specific stages of the legal process.
Sanofi Biotechnology SAS v.Amgen N.V.
This UPC Court of Appeal decision concerns the withdrawal of an appeal in a pharmaceutical infringement case (Sanofi/Regeneron v. Amgen). Although the parties successfully withdrew the proceedings, citing an agreement and consent from all parties, the court strictly ruled on the financial aspects. The request for reimbursement of court fees was dismissed because the withdrawal occurred after the written procedure had been closed, demonstrating the Court's adherence to procedural timelines.
Neurocrine Biosciences, Inc. v.Spruce Biosciences, Inc.
In this UPC cost decision concerning EP 3 784 233, the Court confirmed that once a patent has been definitively revoked by the EPO's Opposition Division, any parallel revocation action before the UPC becomes redundant. The panel ordered the disposal of the proceedings and ruled on costs, awarding Neurocrine substantial compensation for its legal efforts. This case underscores the importance of monitoring opposition proceedings when pursuing invalidity claims in the UPC.
GlaxoSmithKline Biologicals SA v.C.P. Pharmaceuticals International C.V., Pfizer Export B.V., Pfizer B.V., and associated entities (collectively PBNT)
This procedural order in the GSK v. Pfizer case focused on managing the complexity and volume of submissions within the UPC proceedings. The defendants requested limitations on Auxiliary Requests (ARs) and an extension for their rejoinder, citing excessive length and number of ARs from the claimant. The court acknowledged the high volume but did not limit the ARs; instead, it required GSK to provide a detailed tabular overview of its claims to improve judicial clarity. This ruling underscores the UPC's commitment to balancing procedural fairness with the need for expeditious case management.
Gowling WLG v.Merz Therapeutics GmbH, Merz Pharmaceuticals LLC, Merz Pharma France-Viatris Santé
This procedural order addressed a request by Gowling WLG, a third-party firm of UPC representatives, seeking access to the case file in an ongoing provisional measures dispute between Merz and Viatris. The Court balanced the need for transparency with the protection of confidential information. Access was granted selectively, allowing the applicant to review extracts relevant to the legal issue of 'unreasonable delay,' while ensuring personal data was anonymized.
Samsung Bioepis NL B.V. v.Alexion Pharmaceuticals, Inc.
This UPC Court of Appeal decision concerns the procedural withdrawal of appeals in a dispute between Samsung Bioepis and Alexion Pharmaceuticals regarding EP 3 167 888. The case, which had previously involved provisional measures and cost disputes, was ultimately closed when both parties agreed to withdraw their respective applications for leave to appeal. The court confirmed that consent from the opposing party negates any legitimate interest in the continuation of the proceedings.
Sanofi-Aventis Deutschland GmbH v.Amgen, Inc.
This Court of Appeal decision addressed an application by Sanofi and Regeneron seeking suspensive effect on a ruling that rejected their request for patent revocation. The court ruled against the applicants, emphasizing that applications for rehearing do not inherently possess suspensive effect under UPC rules. The decision underscores the high threshold required to suspend proceedings based on procedural defects in the UPC.
Merz Pharmaceuticals LLC v.Viatris Santé
This UPC Court of Appeal decision clarifies the strict procedural requirements for maintaining confidentiality in proceedings. The court ruled that merely requesting confidentiality under R. 262.2 RoP is insufficient to restrict disclosure by opposing parties; a formal application under R. 262A RoP must be made simultaneously with lodging confidential evidence. This ruling emphasizes that unrestricted access is the default, and procedural compliance is mandatory for any restriction.
Viatris Santé v.Merz Pharmaceuticals LLC, Merz Therapeutics GmbH, Merz Pharma France
This UPC Court of Appeal decision addresses a procedural appeal concerning the admissibility of exhibits and submissions during infringement proceedings related to a pharmaceutical SPC. The court ultimately dismissed the appeal, ruling that it had become devoid of purpose because the underlying matter—the provisional measures application—had already been decided in favor of the appellant (Viatris). This highlights the importance of assessing legal interest when determining whether an action warrants adjudication under UPC rules.
Sanofi SA as successor of Sanofi Mature IP v.STADAPHARM GmbH a.o.
In a significant ruling, the UPC Local Division Munich revoked European Patent 2 493 466 in its entirety. The patent, which covered a novel anti-tumoral use of cabazitaxel (marketed as JEVTANA), was found invalid across several key member states. Consequently, all associated infringement actions brought by Sanofi against generic manufacturers like STADAPHARM were dismissed. This case highlights the vulnerability of patents facing prior national challenges and underscores the UPC's role in enforcing or nullifying IP rights.
Sanofi SA as successor of Sanofi Mature IP a.o. v.Reddy Pharma SAS
In a significant pharmaceutical case, the UPC Local Division Munich revoked European Patent 2 493 466, which covered a novel anti-tumoral use of cabazitaxel. The revocation was based on prior findings of invalidity concerning the patent's scope and obviousness. Consequently, all associated infringement claims brought by Sanofi against generic manufacturers like Reddy Pharma were dismissed. This decision underscores the powerful impact of national invalidation proceedings on UPC rights.
Sanofi SA as successor of Sanofi Mature IP v.Zentiva France
In a significant pharmaceutical case, the UPC Local Division Munich revoked European Patent 2 493 466 concerning the anti-tumoral use of cabazitaxel. The revocation was based on prior invalidation proceedings in France, which demonstrated how national court decisions can directly impact patent validity within the unified system. Consequently, all associated infringement actions brought by Sanofi against generic manufacturers like Zentiva were dismissed.
Sanofi SA as successor of Sanofi Mature IP a.o. v.Reddy Pharma SAS
In a significant ruling concerning pharmaceutical patents, the UPC Local Division Munich revoked European Patent 2 493 466. This patent covered a novel anti-tumoral use of cabazitaxel, which was marketed under the brand name JEVTANA by Sanofi. The revocation decision immediately dismissed all associated infringement actions brought by Sanofi against generic competitors like Reddy Pharma SAS. This case underscores the powerful effect of successful revocation proceedings within the UPC framework.
Sanofi SA as successor of Sanofi Mature IP v.Zentiva France
In a significant pharmaceutical case, the UPC Local Division Munich revoked European Patent 2 493 466 concerning the anti-tumoral use of cabazitaxel. The revocation decision effectively dismissed the concurrent infringement actions brought by Sanofi against generic manufacturers like Zentiva. This ruling underscores the power of the UPC to enforce patent validity across multiple jurisdictions, even when national court decisions regarding invalidity are involved.
Sanofi SA as successor of Sanofi Mature IP v.STADAPHARM GmbH a.o.
In a significant ruling for the pharmaceutical sector, the UPC Local Division Munich revoked European Patent 2 493 466, which covered a novel anti-tumoral use of cabazitaxel. This decision immediately dismissed the associated infringement actions brought by Sanofi against generic competitors such as Stada and Dr Reddy's. The ruling underscores the vulnerability of patents, even those related to specific medical uses, when challenged successfully on grounds of invalidity.
GlaxoSmithKline Biologicals SA v.Moderna et al.
In a procedural order concerning an infringement and revocation case involving GlaxoSmithKline Biologicals SA and Moderna et al., the UPC Court of First Instance decided to split the combined counterclaim for revocation. The court found that combining the two counterclaims, one for each patent (EP4066856 and EP4226941), was procedurally impractical given the different opposition stages before the EPO. This ruling highlights the UPC's flexibility in managing complex litigation to ensure procedural fairness and proper fee assessment.
Amgen, Inc. v.Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe and Sanofi Winthrop Industrie S.A.
In a significant decision concerning patent validity in the pharmaceutical sector, the UPC Court of Appeal upheld the patent against revocation challenges brought by Sanofi. The ruling not only rejected the requests to invalidate but also established important legal precedents regarding claim interpretation and inventive step assessment within the Unified Patent Court. This case reinforces the rigorous standards for patentability while providing clarity on how therapeutic claims must be interpreted.
Amgen Inc. v.Regeneron Pharmaceuticals Inc.
In a significant decision concerning patent validity in the pharmaceutical sector, the UPC Court of Appeal ruled in favor of Amgen against Regeneron. The court successfully defended the patent by affirming that the claims met the requirements for inventive step and sufficiency. Furthermore, the ruling provided detailed guidance on interpreting medical use claims, emphasizing that therapeutic efficacy is an inherent feature of such claims, not a matter to be proven solely from the claim text.
Boehringer Ingelheim International GMBH v.Zentiva Portugal, Lda.
In this preliminary ruling, the UPC confirmed its exclusive jurisdiction over a pharmaceutical patent infringement case involving nintedanib. The Defendant attempted to challenge the Court's competence by arguing that the dispute was administrative, stemming from a national health authority's communication. However, the UPC rejected this objection, clarifying that the core issue is a private enforcement action based on the threat of infringement, not an administrative review. This decision allows the case to proceed to the substantive merits phase.
Organon Heist B.V. v.Genentech, Inc.
This UPC Local Division order addresses the review of prior 'ex parte' orders for evidence preservation and inspection concerning EP 3 401 335 B1. The court provided crucial procedural guidance, outlining a rigorous two-step assessment process for reviewing these types of orders under R. 197.3 RoP. It also clarified the legal standard required to prove 'about to be infringed' in relation to subsequent infringement proceedings. This decision is highly significant for practitioners managing evidence gathering and risk assessment within the UPC framework.
Organon Heist B.V. v.Genentech, Inc.
This UPC Local Division order addresses the procedural framework for reviewing prior 'ex parte' orders related to evidence preservation and inspection in a pharmaceutical patent case (EP 3 401 335 B1). The court detailed a rigorous two-stage review process, ensuring that both initial applications and all subsequent party submissions are considered when assessing the validity of the original order. Crucially, the ruling clarified the legal threshold for 'about to be infringed,' setting a high bar requiring demonstrable risk of future infringement. This decision provides significant guidance on managing evidence gathering in complex UPC litigation.
F. Hoffmann-La Roche AG v.A. Menarini Diagnostics S.r.l.
In a case involving F. Hoffmann-La Roche AG and A. Menarini Diagnostics S.r.l., the Düsseldorf Local Division issued an order to protect confidential information during proceedings related to EP 1 962 668 B1. The court classified detailed manufacturing processes, commercial negotiation records, pricing data, and expert witness statements as trade secrets. This decision underscores the importance of robust confidentiality measures within UPC litigation, allowing parties to safeguard sensitive business intelligence.
Merz Therapeutics GmbH v.Viatris Santé
In a procedural order concerning provisional measures (UPC_CFI_697/2025), the Court addressed the disparity in the length of written submissions between Merz Therapeutics and Viatris Santé. Recognizing that the extensive 473-page objection filed by Viatris was disproportionate to the summary nature of the proceedings, the Judge Rapporteur intervened. The Court imposed strict page limits—70 pages for Viatris's summary objection and 40 pages for Merz's reply—to ensure procedural economy while maintaining fairness.
Sanofi SA (and associated Sanofi entities) v.STADA Nordic ApS, STADA Arzneimittel AG, and other defendants
In this complex pharmaceutical infringement case, Sanofi initiated proceedings against several competitors regarding the validity of EP patent 2 493 466. The court issued a procedural order summoning party experts to address critical questions concerning the inventive step and the reasonable expectation of success in oncological clinical trials (specifically referencing the TROPIC study). This hearing will focus on whether sufficient data existed at the priority date to justify the trial's progression, making it a significant case for pharmaceutical patent practitioners.
Sanofi SA (as successor of Sanofi Mature IP), Sanofi Winthrop Industrie, Sanofi-Aventis GmbH, Sanofi Belgium, Sanofi-Aventis Deutschland GmbH, Sanofi S.r.l., Sanofi B.V., Sanofi - Produtos Farmaceuticos Lda, Sanofi AB, Sanofi A/S v.Accord Healthcare S.L.U., Accord Healthcare GmbH (AT), Accord Healthcare BV, Accord Healthcare GmbH (DE), Accord Healthcare Italia Srl, Accord Healthcare B.V., Accord Healthcare, Unipessoal Lda., Accord Healthcare AB, STADAPHARM GmbH, STADA Arzneimittel AG, STADA Nordic ApS, Reddy Pharma SAS, betapharm Arzneimittel GmbH, Dr Reddy's Srl, Zentiva France, Zentiva Pharma GmbH, Zentiva, k.s.
This procedural order in the UPC Munich Local Division sets the stage for a complex pharmaceutical patent dispute involving Sanofi and various generic competitors. The court has scheduled detailed expert testimony to address highly technical questions concerning oncological clinical trials, specifically regarding the reasonable expectation of success for the patented drug. This focus on factual evidence related to industry practice is crucial as it will directly inform the panel's decision on whether the patent lacks inventive step (obviousness).
Sanofi A/S, Sanofi-Aventis GmbH, Sanofi S.r.l., Sanofi B.V., Sanofi-Aventis Deutschland GmbH, Sanofi AB, Sanofi Winthrop Industrie, Sanofi - Produtos Farmaceuticos Lda, Sanofi Belgium, Sanofi Mature IP (represented by Sanofi SA) v.Accord Healthcare BV, Accord Healthcare, Unipessoal Lda., Accord Healthcare S.L.U., Accord Healthcare GmbH, Accord Healthcare Italia Srl, Accord Healthcare AB, Accord Healthcare B.V.
This procedural order in a complex pharmaceutical patent dispute between Sanofi and Accord Healthcare (and related defendants) sets the stage for critical expert testimony and oral hearings. The core of the case revolves around the validity of European Patent EP 2 493 466, specifically challenging its inventive step based on clinical trial data (TROPIC study). The court has scheduled detailed sessions to allow experts to address complex factual questions regarding oncological drug development, which will ultimately inform the legal question of obviousness. This case highlights the UPC's structured approach to integrating technical expertise into patent litigation.
Sanofi A/S, Sanofi - Produtos Farmaceuticos Lda, Sanofi B.V., Sanofi Belgium, Sanofi Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis France, Sanofi-Aventis GmbH, Sanofi S.r.l., Sanofi AB v.Accord Healthcare S.L.U., Accord Healthcare GmbH (AT), Accord Healthcare BV, Accord Healthcare GmbH (DE), Accord Healthcare Italia Srl, Accord Healthcare B.V., Accord Healthcare, Unipessoal Lda., Accord Healthcare AB, STADAPHARM GmbH, STADA Arzneimittel AG, STADA Nordic ApS, Reddy Pharma SAS, betapharm Arzneimittel GmbH, Dr Reddy's Srl, Zentiva France, Zentiva Pharma GmbH, Zentiva, k.s.
This procedural order in a complex pharmaceutical infringement case involving Sanofi against multiple defendants sets the stage for intensive litigation. The core dispute revolves around the inventive step of EP 2 493 466, specifically concerning the reasonable expectation of success derived from clinical trials (TROPIC study). The court has scheduled extensive expert testimony and oral hearings to allow the panel to address highly technical factual questions related to oncology drug development before making a final decision on validity and infringement. This case highlights the UPC's capacity to handle deep scientific and medical complexities in patent disputes.
Gilead Sciences, Inc. v.Academy of Military Medical Sciences
This procedural order addressed the validity of service in a revocation action concerning Remdesivir (EP3854403). The claimant sought a default judgment after alleging improper service on the defendant. The UPC ruled that service was validly completed upon receipt by the patent representative, clarifying that foreign headquarters do not invalidate internal CMS service procedures. Consequently, the request for a default judgment was dismissed, and the case remains active.
Boehringer Ingelheim International GmbH v.Zentiva Portugal, LDA.
In a significant decision regarding generic drug competition, the UPC Court of Appeal granted provisional measures in favor of Boehringer Ingelheim against Zentiva. The court held that the completion of national health technology assessments and reimbursement procedures for generics can constitute an imminent infringement threat, even before market launch. This ruling reinforces the proactive nature of the UPC's jurisdiction across all member states, providing a strong deterrent against premature generic entry.
Moderna, Inc. v.Genevant Sciences GmbH
In this complex UPC case involving Moderna and Genevant Sciences, the Court addressed a procedural application seeking an extension of time to file responses following extensive confidentiality proceedings (R.262A). The Judge-rapporteur ruled that while extensions are generally viewed narrowly, the delay in accessing unredacted confidential information justified a limited extension for the claimants. This decision reinforces the balance between maintaining the UPC's swift procedural timeline and ensuring parties have adequate time to prepare their defense against complex claims.
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