Pharma — European UPC Patent Cases
76 decisions indexed
Page 2 of 3 · 76 total
Alexion Pharmaceuticals, Inc. v.Samsung Bioepis NL B.V.
This UPC cost decision addressed the financial claims following a preliminary measures application concerning the pharmaceutical product Epysqli®. The court meticulously reviewed the claimed costs, distinguishing between reasonable expert fees and disproportionate legal representation expenses. While recognizing the necessity of certain travel and expert costs, the court struck down excessive charges from UK solicitors that did not demonstrate efficiency in the proceedings.
Novartis AG v.ZENTIVA PORTUGAL, LDA; ZENTIVA K.S.
This UPC decision on costs addressed the compensation sought by Novartis following a dismissed application to intervene in a related main proceeding. The court emphasized that while legal costs must be proportionate under Art. 69 UPCA, the applicant bears the burden of proof for detailed cost substantiation. By failing to provide sufficient evidence justifying the extensive legal fees incurred across multiple firms, Novartis' claim was significantly reduced.
N.V. Nutricia v.Nestlé Health Science (Deutschland) GmbH
In this UPC decision, N.V. Nutricia and Nestlé Health Science reached a settlement leading to the withdrawal of the infringement action concerning EP 2 359 858 B1. The court confirmed that an estimated assessment is sufficient for valuing actions in settled cases. Although the infringement claim was dropped, the counterclaim for revocation was disposed of, with both parties ultimately bearing their own costs.
Sanofi SA (as successor of Sanofi Mature IP, Sanofi-Aventis France) 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 sets the stage for a complex pharmaceutical patent infringement case involving Sanofi against multiple defendants, including Accord Healthcare and STADA. The court confirmed the dates for the final interim conference and the subsequent oral hearing, indicating that the case is moving toward substantive arguments. A key focus remains on assessing obviousness, requiring parties to prepare expert testimony regarding industry knowledge at the priority date.
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 a major pharmaceutical patent dispute between Sanofi and various generic competitors (Accord, STADA, Reddy, Zentiva) sets the stage for the final stages of litigation. The court confirmed the dates for the final interim conference and the oral hearing, focusing heavily on complex issues like obviousness related to clinical trial data. Furthermore, the judge addressed procedural concerns raised by defendants regarding the drafting style of claimant's briefs.
Sanofi SA and associated entities (including Sanofi Winthrop Industrie, Sanofi-Aventis GmbH, etc.) v.Accord Healthcare S.L.U., STADAPHARM GmbH, Reddy Pharma SAS, Zentiva France, etc.
This procedural order addresses multiple infringement actions concerning European patent EP 2 493 466, involving Sanofi as the claimant and various generic manufacturers (Accord Healthcare, Zentiva, etc.) as defendants. The court confirmed key dates for the final interim conference and the subsequent oral hearing in October 2025. Furthermore, the judge addressed procedural concerns raised by the parties regarding the review of EPO decisions and the standardization of legal briefs across different defendant groups.
Sanofi SA (and related Sanofi entities) v.STADA Nordic ApS, STADA Arzneimittel AG, Accord Healthcare S.L.U., etc.
This procedural order addresses multiple infringement actions involving Sanofi and various defendants, including STADA and Accord Healthcare. The court confirmed the schedule for the final interim conference and the subsequent oral hearing, which will focus heavily on complex issues of obviousness related to clinical trial data (Phase III TROPIC study). Practitioners should note the court's proactive approach in managing expert evidence and procedural fairness across multiple related proceedings.
Sanofi SA v.Zentiva, k.s.
This procedural order addressed a dispute between Sanofi and Zentiva regarding the timeline and scope of written submissions in an infringement action concerning EP patent 2 493 466. Zentiva sought to amend the case management schedule, arguing that the existing deadlines were insufficient or unclear. The UPC Panel dismissed these requests, upholding the judge-rapporteur's procedural order. This decision reinforces the strict application of the Rules of Procedure in managing complex infringement litigation within the UPC.
Alexion Pharmaceuticals, Inc. v.Samsung Bioepis NL B.V.
This UPC Court of Appeal decision addresses a request for a rehearing based on alleged fundamental procedural defects in a prior ruling. Alexion Pharmaceuticals sought to reopen proceedings concerning its patent EP 3 167 888, arguing that the court applied new standards without proper notice. The Court ultimately rejected the application, clarifying that a rehearing is an extraordinary remedy reserved only for truly fundamental flaws, not mere errors of legal reasoning or disagreement with the outcome.
Alexion Pharmaceuticals, Inc. v.Amgen Technology (Ireland) Unlimited Company; Amgen N.V.; Amgen GmbH; Amgen AB; Amgen S.A.S.; Amgen s.r.l.; Amgen Biofarmacêutica Lda.; Amgen Zdravila D.O.O.
This UPC Court of Appeal decision addresses a request for a rehearing filed by Alexion Pharmaceuticals against Amgen, challenging an earlier ruling. The court clarified the extremely narrow scope of Art. 81(1) UPCA, emphasizing that a rehearing is not a regular appeal mechanism. The court ruled that procedural errors must be 'fundamental'—so severe they are intolerable to the legal system and would have prevented the decision from being reached—and rejected Alexion’s application.
Genentech Inc. v.F. Hoffmann – La Roche AG, Organon & Co., Organon Heist B.V., NV Organon, Shanghai Henlius Biotech Inc
In a significant procedural ruling, the UPC Local Division granted an order to preserve evidence and an order for inspection in the dispute concerning EP 3 401 335 B1. The case involves Genentech/Roche against Organon and Shanghai Henlius Biotech regarding biosimilars of the cancer drug Perjeta®. This decision allows the Applicants to secure critical information necessary for their claims, highlighting the UPC's proactive role in managing complex pharmaceutical litigation.
Genentech Inc. v.F. Hoffmann – La Roche AG, Organon & Co., Organon Heist B.V., NV Organon, Shanghai Henlius Biotech Inc
In this significant pharmaceutical dispute, Genentech and F. Hoffmann-La Roche AG sought urgent procedural measures against Organon and Shanghai Henlius Biotech Inc. The UPC Local Division granted both an order to preserve evidence and an order for inspection concerning the patent EP 3 401 335 B1, which covers the cancer medicine Perjeta®. This decision is a critical step in securing necessary data for the ongoing litigation regarding biosimilar launch (HLX11).
Regeneron Pharmaceuticals Inc. v.Amgen Inc.
This UPC decision addressed a complex infringement and revocation dispute concerning the PCSK9 inhibitor evolocumab (Repatha®). While the case involved detailed arguments regarding second medical use claims, the court ultimately dismissed both the infringement action and the counterclaim for revocation. The ruling served to clarify procedural aspects of patent litigation within the UPC, particularly emphasizing that pleading ignorance is not recognized under the Rules of Procedure.
Sanofi SA (as successor of Sanofi Mature IP) v.Accord Healthcare S.L.U., Accord Healthcare GmbH, Accord Healthcare BV, Accord Healthcare Italia Srl, Accord Healthcare B.V., Accord Healthcare, Unipessoal Lda., Accord Healthcare AB
Sanofi initiated infringement actions against Accord Healthcare and related entities concerning European patent EP 2 493 466, which covers a specific compound combination for treating advanced prostate cancer. The UPC Local Division Munich issued a procedural order confirming the case schedule, including an interim conference in September 2025 and the main oral hearing in October 2025. This ruling moves the litigation into its substantive phase, setting the stage for detailed arguments on infringement and validity.
Boehringer Ingelheim International GmbH v.Zentiva Portugal, LDA
Boehringer Ingelheim sought a preliminary injunction at the UPC against Zentiva Portugal regarding the generic version of nintedanib for treating idiopathic pulmonary fibrosis. Boehringer alleged imminent infringement, but the Court ultimately rejected the application for provisional measures. However, in a notable cost allocation decision, the Court ordered Boehringer to pay the interim legal costs incurred by Zentiva, setting a precedent on how costs are determined even when the main relief is denied.
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.
Sanofi initiated multiple infringement actions against various generic manufacturers, including Accord Healthcare and STADA, concerning the use of a specific compound combination for treating prostate cancer (EP 2 493 466). This procedural order confirms the court's schedule, setting key dates for interim conferences and the main oral hearing in October 2025. The case is currently moving through its written phase toward substantive litigation.
Sanofi SA (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
Sanofi initiated multiple infringement actions against Accord Healthcare concerning the use of a specific compound combination for treating prostate cancer (EP 2 493 466). This procedural order confirms the court's schedule, setting key dates for interim conferences and the main oral hearing in October 2025. The parties are now moving into the substantive phase of the litigation after initial filings.
Sanofi SA (and various Sanofi entities) v.Accord Healthcare S.L.U. (and various Accord Healthcare entities, STADA Nordic ApS, Reddy Pharma SAS, Zentiva France, etc.)
Sanofi initiated multiple infringement actions against various defendants, including Accord Healthcare and STADA Nordic ApS, concerning European patent EP 2 493 466. The UPC Local Division Munich issued a procedural order confirming the litigation schedule, setting deadlines for written submissions, and confirming dates for interim and oral hearings in late 2025. This case highlights the complex multi-defendant nature of pharmaceutical infringement suits within the unified patent court framework.
Genevant Sciences GmbH v.Moderna (various entities)
This UPC decision addresses procedural challenges arising from the complex, multinational structure of a corporate group (Moderna). Claimants sought extensions for defendants due to varying service dates across multiple jurisdictions. The Court rejected the blanket extension requests but imposed a single, unified deadline for filing Statements of Defense. This ruling highlights how the UPC manages procedural complexity when dealing with global entities, prioritizing judicial efficiency while ensuring all parties have adequate time.
STADAPHARM GmbH v.ACCORD HEALTHCARE S.L.U., ACCORD HEALTHCARE LIMITED, Novartis AG, ACCORD HEALTHCARE B.V.
This UPC Court of Appeal decision addresses the scope of public access to court documents, specifically written pleadings and evidence. Stadapharm appealed a lower court's denial of access to documents from a withdrawn main infringement proceeding. The Court ultimately granted access, emphasizing that once proceedings are concluded and parties consent or do not object, the general interest in public access prevails. This ruling provides clarity on how confidentiality concerns must be balanced against transparency requirements within the UPC framework.
GlaxoSmithKline Biologicals SA v.Pfizer Europe MA EEIG, Pfizer Manufacturing Belgium NV, Pfizer Pharma GmbH, Pfizer Corporation Austria GmbH, Pfizer SA, Pfizer Aps, Pfizer Oy, Pfizer SAS, Pfizer S.r.l., Pfizer B.V., Laboratórios Pfizer, Lda., Pfizer AB, Pfizer Luxembourg S.a.r.l., Pfizer Service Company S.r.l.
In a case involving GlaxoSmithKline Biologicals SA and various Pfizer entities, the UPC Local Division in Düsseldorf allowed the Claimant to withdraw its patent infringement action against the Defendants. This decision followed the mutual agreement of both parties to terminate the proceedings. Crucially, the court also ruled to reimburse the Claimant 60% of the substantial court fees paid during the litigation. This case highlights how procedural agreements between parties can lead to swift resolution in UPC actions.
Aliud Pharma GmbH v.Novartis AG
In a procedural matter concerning document access, the UPC granted Aliud Pharma GmbH's request to view confidential documents from ACCORD Healthcare and Novartis AG. The Court provided clear guidance on GDPR compliance in digital proceedings, specifically addressing the scope of protection for digital signatures and company email addresses. This decision clarifies how parties must redact personal data when sharing evidence within the UPC framework.
BioMarin Pharmaceutical Inc. v.Ascendis Pharma A/S; Ascendis Pharma Growth Disorders A/S
In this procedural order, the UPC Local Division Munich rejected the preliminary objection raised by Ascendis Pharma against BioMarin Pharmaceutical Inc.'s infringement action concerning European patent EP 3 175 863. The Court ruled that BioMarin had adequately established jurisdiction and competence by demonstrating alleged infringing acts within Germany. Consequently, the proceedings will continue to the main substantive phase, where the legal characterization of the disputed acts will be examined.
Accord Healthcare Group (Accord) v.Novartis AG
This procedural order addressed an application by ZENTIVA K.S. and ZENTIVA PORTUGAL, LDA to intervene in a main infringement proceeding between Accord Healthcare and Novartis regarding the drug nilotinib (EP2501384). The court dismissed ZENTIVA's request, establishing a strict requirement for direct legal interest when seeking intervention under Rule 313 RoP. This decision reinforces that parallel interests based on similar factual situations are insufficient grounds to join proceedings.
Sanofi (various entities) v.Medac Gesellschaft für klinische Spezialpräparate m.b.H.
This procedural order addressed Medac's attempt to withdraw an application concerning a privileged and confidential document (Exhibit 2) that had been uploaded into the UPC system. The court permitted the withdrawal but issued a strong warning against Medac's representative for negligently breaching the Code of Conduct by uploading the unredacted material. This decision underscores the strict procedural requirements regarding confidentiality and evidence handling within the UPC framework.
GlaxoSmithKline Biologicals SA v.Pfizer Europe MA EEIG, Pfizer Manufacturing Belgium NV, Pfizer Pharma GmbH, Pfizer Corporation Austria GmbH, Pfizer SA, Pfizer Aps, Pfizer Oy, Pfizer SAS, Pfizer S.r.l., Pfizer B.V., Laboratórios Pfizer, Lda., Pfizer AB, Pfizer Luxembourg S.a.r.l., Pfizer Service Company S.r.l.
In this complex pharmaceutical patent dispute, the Düsseldorf Local Division addressed a dual action involving infringement and revocation. Following unanimous requests from all parties, the Court opted to refer the counterclaim for revocation to the Central Division, citing procedural efficiency as a key factor. Crucially, however, the Local Division decided to proceed with the main infringement action itself. Furthermore, the Defendants were granted a necessary one-month extension to ensure they could address all issues related to the infringement proceedings.
Syngenta Limited v.Sumi Agro Europe Limited, Sumi Agro Limited
Syngenta Limited initiated an infringement action against Sumi Agro entities concerning European patent EP 2 152 073, which relates to crop protection technology. The Court of First Instance in Munich issued a procedural order setting the schedule for the case. Both parties are summoned to participate in the Interim Conference and the subsequent Oral Hearing, where the core issues of infringement and potential revocation will be debated.
STADAPHARM GmbH v.Novartis AG, Accord Healthcare B.V., Accord Healthcare S.L.U., Accord Healthcare Limited
This preliminary order addressed a request by STADAPHARM GmbH, an applicant in a non-infringement action, seeking access to the main proceedings documents. The Court clarified the scope of document inspection under Rule 262.1 b), stating that such requests are limited to existing filings and cannot preemptively cover all future submissions. The ruling underscored the importance of maintaining procedural integrity and protecting parties' rights to independent legal defense when balancing public transparency.
STADAPHARM GmbH v.Novartis AG, Accord Healthcare B.V., Accord Healthcare S.L.U., Accord Healthcare Limited
This preliminary order addressed a request by STADAPHARM GmbH, an applicant in a non-infringement action, seeking access to the main proceedings documents. The Court clarified the scope of Rule 262.1 b), stating that such requests are limited to existing filings and cannot preemptively cover all future submissions. The ruling underscored the importance of maintaining procedural integrity over general public visibility when interests conflict, a key principle for transparency in UPC litigation.
Sanofi SA (and various Sanofi entities) v.Zentiva France, Zentiva Pharma GmbH, Zentiva, k.s.
In a procedural order concerning multiple infringement actions, the UPC Local Division Munich set key dates for the litigation between Sanofi and Zentiva. The court scheduled an Interim Conference via videoconference on July 17, 2025, followed by in-person oral hearings from October 14 to 17, 2025. This decision moves the complex pharmaceutical patent dispute closer to a substantive hearing, allowing both parties time to prepare their arguments and counterclaims.
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