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UPC CFI 189/2024

May 1, 2024·EP4151181 +2 more: PROSTHETIC HEART VALVE

Case details
Status
Case Closed
Action
Revocation
Category
Main Revocation Action
Parties
Claimants
Reps: Emmanuel Larere (Cabinet Gide Loyrette Nouel AARPI); Jean-Hyacinthe de Mitry (Cabinet Gide Loyrette Nouel AARPI); Jonathan Stafford (Marks & Clerck LLP); Gregory Carty Hornsby (Marks & Clerck LLP)
Respondents
Reps: Siddharth Kusumakar (Powell Gilbert (Europe) LLP); Bryce Matthewson (Powell Gilbert (Europe) LLP); Jonas Weickert (Thum & Partner); Bernhard Thum (Thum & Partner)
Division
Paris CD
Technology
Medical Devices · Implants · Pharmaceutical & Medical
Language
English
First decided
Oct 20, 2025
Claims
At issue1, 4, 6, 7, 8, 9, 10, 11, 12
Amended1, 4, 6, 7, 8, 9, 10, 11, 12
Infringed1, 4, 6, 7, 8, 9, 10, 11, 12
Notes: Paris Central Division rejected revocation of EP4151181 (prosthetic heart valve); patent maintained as amended per Auxiliary Request 2; Meril entities found to infringe claims 1, 4, 6-12 as amended, with injunction granted except for XL-size valves.
Decisions
  • 2025-10-20
    Patent amendedInjunction grantedRevocation meritsRevocation Action

    Decision of the Paris Central Division (Paris Seat) dated 20 October 2025 in the revocation action by Meril entities against Edwards Lifesciences Corporation and the counterclaim for infringement by Edwards regarding EP 4 151 181 B1 (prosthetic heart valve technology). The revocation action was rejected; however, the patent was maintained only in the form of Auxiliary Request 2 (amended). The infringement counterclaim was granted: Meril entities were found to infringe claims 1, 4, 6–12 as amended. Edwards was granted an injunction preventing Meril from all infringing acts with products according to those claims in Contracting Member States, with an exception for XL-size valves (exceeding 30 mm) which was denied on proportionality grounds. Meril was ordered to provide information on infringing products, recall and destroy infringing products, and publish the decision in five media. Damages are to be determined in separate proceedings. Costs of the counterclaim were borne by Meril jointly and severally; costs of the revocation action were shared (each party bears own costs given the patent amendment dynamic).

    Legal issues:Inventive step assessment using holistic approachRevocation action versus patent amendmentInfringement counterclaimProportionality of injunction for XL-size medical devicesPublic interest exception to injunctive relief under Art. 63(1) UPCARecall and publication orders
  • 2025-01-08
    Costs onlyGeneric application

    Order from the Paris Central Division dated 8 January 2025 on Meril entities' application for costs (App_56782/2024) seeking reimbursement of EUR 15,000 from respondents (SWAT Medical AB and others) incurred in defending a rejected public-access-to-register application. The order clarifies that a 'decision on the merits' under R. 150 RoP means a decision concluding litigation proceedings with res judicata effect; proceedings on a public access application are not 'litigation' in that sense. The court dismissed the costs application on the basis that a public access proceeding does not produce a 'decision on the merits' that triggers the costs provisions.

    Legal issues:Definition of 'decision on the merits' under R. 150 RoPCosts in public access to register proceedingsNature of R. 262 proceedings (administrative vs. litigation)
  • 2024-09-17
    Generic application

    Central Division (Paris) order dismissing Meril's application to reject Edwards' counterclaim for infringement as inadmissible. The court retrospectively extended the two-month deadline under Rule 49 RoP by one week to 23 July 2024, finding the counterclaim timely. The court declined to hold a hearing before deciding.

    Legal issues:Admissibility of counterclaim for infringement (Rule 49 RoP)Retrospective extension of time period (Rule 9(3) RoP)Timing of counterclaim
Documents
Document titleDatePublic
action.phaseChange.caseClose2026-01-28Not public
Cover sheet2025-12-09Not public
Application document Claimant2025-12-09Not public
Exhibit document Claimant2025-12-09Not public
Exhibit document Claimant2025-12-09Not public
Receipt2025-12-09Not public
action.publishOrderDecision.decision2025-10-21Not public
action.issueDecision.decision2025-10-21Not public
Decision2025-10-21Public
action.phaseChange.oralPhaseClose2025-10-21Not public
Hearing Reference2025-09-12Not public
Hearing Reference2025-09-12Not public
Outcome of the Order2025-09-03Not public
closing workflow2025-09-03Public
Interim-Procedure-Closure2025-09-03Not public
Summon-Oral-Hearing2025-09-03Not public
rule 1082025-09-03Public
Receipt2025-07-29Not public
Outcome of the Order2025-07-28Not public
closing workflow2025-07-28Public
closing workflow2025-07-28Not public
EDW-122025-07-23Not public
R. 9 application2025-07-23Not public
EDW-132025-07-23Not public
Receipt2025-07-03Not public
Application2025-07-02Not public
Exhibit2025-07-02Not public
Order 17.04.2025 anonymized2025-04-22Not public
Hearing-Dates2025-04-17Not public
rule 1052025-04-17Not public
rule 1052025-04-17Public
Hearing Reference2025-04-14Not public
Hearing Reference2025-04-14Not public
Fix-Interim-Conference-Date2025-04-04Not public
rule 352025-04-04Public
Interim-Conference-Decision2025-04-04Not public
Written-Procedure-Closure2025-04-04Not public
Outcome of the Order2025-04-04Not public
closing workflow2025-04-04Public
Outcome of the Order2025-04-03Not public
rule 3332025-04-03Public
Receipt2025-03-10Not public
05 03 2025 Written comments concerning Edwards Application to review the case management order2025-03-06Not public
Meril response to Edwards request to review the case management order2025-03-05Not public
Meril response to Edwards request to review the case management order2025-03-05Not public
Meril response to Edwards request to review the case management order2025-03-05Not public
rule 3332025-02-28Not public
Acknowledgement-of-lodging2025-02-27Not public
Exhibit EDW-REV-022025-02-26Not public
Exhibit EDW-REV-012025-02-26Not public
R. 333 RoP Application for review of case management order2025-02-26Not public
Hearing-Dates2025-02-24Not public
rule 282025-02-11Public
64037-2024 - 08-01-20252025-01-09Not public
Order 56782-2024 - 08.01.20252025-01-09Not public
Response to the Order of the Judge-rapporteur regarding the dates2024-12-30Not public
Response to the Order of the Judge-rapporteur regarding the dates2024-12-30Not public
Response to the Order of the Judge-rapporteur regarding the dates2024-12-30Not public
Submission on hearing dates2024-12-30Not public
Outcome of the Order2024-12-27Not public
closing workflow2024-12-27Public
closing workflow2024-12-27Not public
preliminary order2024-12-24Not public
Receipt2024-12-12Not public
Response to the Order of the Judge-rapporteur regarding the dates2024-12-12Not public
2024.12.10 (UPC PCD) (EP 181) Submission on hearing dates2024-12-10Not public
Formal response to the order of the Judge-Rapporteur issued on 4 December 20242024-12-09Not public
Formal response to the order of the Judge-Rapporteur issued on 4 December 20242024-12-09Not public
Formal response to the order of the Judge-Rapporteur issued on 4 December 20242024-12-09Not public
rule 282024-12-04Not public
Hearing-Dates2024-12-04Not public
Outcome of the Order2024-11-21Not public
closing workflow2024-11-21Public
Outcome of the Order2024-11-21Not public
closing workflow2024-11-21Public
Receipt2024-11-18Not public
Gide Exhibit 1012024-11-15Not public
Meril s Rejoinder to the Reply to the Defence to the Application to amend - 15 11 20242024-11-15Not public
Receipt2024-11-12Not public
Gide Exhibit 62024-11-12Not public
Gide Exhibit 52024-11-12Not public
Gide Exhibit 6bis2024-11-12Not public
Gide Exhibit 12024-11-12Not public
12 11 2024 Rule 9 Application to comment on Edwards' rejoinder2024-11-12Not public
Gide Exhibit 32024-11-12Not public
Gide Exhibit 3bis2024-11-12Not public
Gide Exhibit 42024-11-12Not public
Gide Exhibit 22024-11-12Not public
Outcome of the Order2024-10-25Not public
closing workflow2024-10-25Public
Receipt2024-10-17Not public
Reply to Defence to Amendment Application2024-10-16Not public
Acknowledgement-of-lodging2024-10-16Not public
PM-22024-10-16Not public
EDW-082024-10-16Not public
EDW-11bis2024-10-16Not public
EDW-072024-10-16Not public
PM-12024-10-16Not public
Rejoinder2024-10-16Not public
EDW-062024-10-16Not public
EDW-112024-10-16Not public
EDW-092024-10-16Not public
EDW-102024-10-16Not public
EDW 052024-10-16Not public
PM-32024-10-16Not public
Outcome of the Order2024-10-08Not public
closing workflow2024-10-08Public
Outcome of the Order2024-10-08Not public
closing workflow2024-10-08Public
Headnote-and-Keywords2024-10-08Not public
Outcome of the Order2024-10-08Not public
rule 92024-10-08Public
Receipt2024-10-01Not public
Edwards reply to response to its request to align deadlines2024-09-30Not public
Receipt2024-09-25Not public
Application to comment on the request to align procedural deadlines 24 09 242024-09-24Not public
Gide Exhibit 62024-09-24Not public
Gide Exhibit 52024-09-24Not public
Gide Exhibit 22024-09-24Not public
Gide Exhibit 12024-09-24Not public
Gide Exhibit 32024-09-24Not public
Gide Exhibit 42024-09-24Not public
Gide Exhibit 72024-09-24Not public
Receipt2024-09-23Not public
2024.09.20 Edwards Request to Align Procedural Deadlines2024-09-21Not public
Outcome of the Order2024-09-17Not public
closing workflow2024-09-17Public
Outcome of the Order2024-09-17Not public
time extension2024-09-17Public
Acknowledgement-of-lodging2024-09-16Not public
Gide Exhibit CL.602024-09-16Not public
Gide Exhibit CL.572024-09-16Not public
Gide Exhibit CL.562024-09-16Not public
Gide Exhibit CL.672024-09-16Not public
Gide Exhibit 952024-09-16Not public
Gide Exhibit CL.582024-09-16Not public
Gide Exhibit CL.642024-09-16Not public
Gide Exhibit CL.542024-09-16Not public
Gide Exhibit CL.64bis2024-09-16Not public
Meril s Reply to Defence to revocation and Defence to Application to amend 16 09 2024 signed2024-09-16Not public
Gide Exhibit 982024-09-16Not public
Gide Exhibit CL.632024-09-16Not public
Gide Exhibit CL.612024-09-16Not public
Gide Exhibit CL.592024-09-16Not public
Gide Exhibit 1002024-09-16Not public
Gide Exhibit CL.662024-09-16Not public
Gide Exhibit 972024-09-16Not public
Gide Exhibit 992024-09-16Not public
Gide Exhibit CL.652024-09-16Not public
Gide Exhibit 942024-09-16Not public
Gide Exhibit 962024-09-16Not public
Gide Exhibit CL.552024-09-16Not public
Gide Exhibit CL.622024-09-16Not public
Gide Exhibit CL.58bis2024-09-16Not public
Receipt2024-09-13Not public
Application to comment the response to the request to reject Edwards counterclaim for infringement of EP 181 signed2024-09-13Not public
Outcome of the Order2024-09-11Not public
closing workflow2024-09-11Public
Receipt2024-09-11Not public
EDW-APP-072024-08-20Not public
EDW-APP-052024-08-20Not public
Edwards Response to Meril Request regarding Counterclaim for Infringement2024-08-20Not public
EDW-APP-032024-08-20Not public
EDW-APP-042024-08-20Not public
EDW-APP-062024-08-20Not public
EDW-APP-092024-08-20Not public
EDW-APP-082024-08-20Not public
EDW-APP-012024-08-20Not public
EDW-APP-022024-08-20Not public
preliminary order2024-08-08Not public
Receipt2024-08-07Not public
Gide Exhibit 102024-08-05Not public
Gide Exhibit 42024-08-05Not public
Gide Exhibit 92024-08-05Not public
Gide Exhibit 62024-08-05Not public
Gide Exhibit 8bis2024-08-05Not public
Gide Exhibit 32024-08-05Not public
Gide Exhibit 82024-08-05Not public
Gide Exhibit 52024-08-05Not public
Gide Exhibit 72024-08-05Not public
Gide Exhibit 22024-08-05Not public
Request to reject Edwards counterclaim for infringement of EP 181 05 08 20242024-08-05Not public
Gide Exhibit 12024-08-05Not public
Acknowledgement-of-lodging2024-07-17Not public
Formal-checks_Notification-of-positive-outcome2024-07-17Not public
Exhibit EDW-042024-07-17Not public
Exhibit EDW-012024-07-17Not public
Exhibit EDW-032024-07-17Not public
Defence to Statement for Revocation2024-07-17Not public
Exhibit EDW-022024-07-17Not public
Defence to Statement for Revocation2024-07-17Not public
Acknowledgement-of-lodging2024-07-17Not public
Formal-checks_Notification-of-positive-outcome2024-07-17Not public
Formal-checks_Request-for-correction2024-07-17Not public
EDW-CC-132024-07-17Not public
EDW-CC-082024-07-17Not public
Counterclaim for Infringement2024-07-17Not public
EDW-CC-162024-07-17Not public
EDW-CC-022024-07-17Not public
EDW-CC-042024-07-17Not public
EDW-CC-072024-07-17Not public
EDW-CC-032024-07-17Not public
EDW-CC-152024-07-17Not public
EDW-CC-122024-07-17Not public
EDW-CC-062024-07-17Not public
EDW-CC-142024-07-17Not public
EDW-CC-012024-07-17Not public
EDW-CC-052024-07-17Not public
EDW-CC-112024-07-17Not public
EDW-CC-092024-07-17Not public
EDW-CC-102024-07-17Not public
Exhibit EDW-032024-07-16Not public
Exhibit EDW-012024-07-16Not public
Application to Amend2024-07-16Not public
Exhibit EDW-022024-07-16Not public
Acknowledgement-of-lodging2024-07-16Not public
Exhibit EDW-042024-07-16Not public
Defence to Statement for Revocation2024-07-16Not public
Exhibit EDW-012024-07-16Not public
Exhibit EDW-032024-07-16Not public
Exhibit EDW-022024-07-16Not public
Acknowledgement-of-change-of-a-representative2024-06-19Not public
Application-RoP293-Receipt2024-06-18Not public
Formal-checks_Notification-of-positive-outcome2024-06-18Not public
Application-RoP2932024-06-18Not public
Change of Representative2024-06-18Not public
Panel-Appointment2024-06-17Not public
epoUploadDocumentsWorkflow2024-05-21Not public
Document from EPO2024-05-20Not public
Acknowledgement of access to case2024-05-16Not public
Notification Of Service2024-05-16Not public
Panel-Appointment2024-05-16Not public
EPO-Request-for-case-pending2024-05-16Not public
Acknowledgement-of-lodging2024-05-16Not public
Formal-checks_Notification-of-positive-outcome2024-05-16Not public
Gide Exhibit CL. 102024-05-15Not public
Gide Exhibit CL. 402024-05-15Not public
UPC Statement for revocation EP 181 30 04 2024 - amended version 15 05 2024 signed2024-05-15Not public
Gide Exhibit 232024-05-15Not public
Gide Exhibit 252024-05-15Not public
Gide Exhibit CL. 45bis2024-05-15Not public
Gide Exhibit CL. 112024-05-15Not public
Gide Exhibit CL. 272024-05-15Not public
Gide Exhibit 552024-05-15Not public
Gide Exhibit CL. 9bis2024-05-15Not public
Gide Exhibit 662024-05-15Not public
Gide Exhibit CL. 122024-05-15Not public
Gide Exhibit 272024-05-15Not public
Gide Exhibit 132024-05-15Not public
Gide Exhibit 122024-05-15Not public
Gide Exhibit 672024-05-15Not public
Gide Exhibit CL. 7bis2024-05-15Not public
Gide Exhibit CL. 372024-05-15Not public
Gide Exhibit CL. 382024-05-15Not public
Gide Exhibit 882024-05-15Not public
Gide Exhibit CL. 302024-05-15Not public
Gide Exhibit 322024-05-15Not public
Gide Exhibit 532024-05-15Not public
Gide Exhibit CL. 10bis2024-05-15Not public
Gide Exhibit 192024-05-15Not public
Gide Exhibit CL. 282024-05-15Not public
Gide Exhibit 742024-05-15Not public
Gide Exhibit CL. 41bis2024-05-15Not public
Gide Exhibit CL. 312024-05-15Not public
Gide Exhibit 932024-05-15Not public
Gide Exhibit CL. 42bis2024-05-15Not public
Gide Exhibit CL. 15bis2024-05-15Not public
Gide Exhibit CL. 32bis2024-05-15Not public
Gide Exhibit 712024-05-15Not public
Gide Exhibit CL. 162024-05-15Not public
Gide Exhibit CL. 422024-05-15Not public
Gide Exhibit 162024-05-15Not public
Gide Exhibit 752024-05-15Not public
Gide Exhibit 612024-05-15Not public
Gide Exhibit 442024-05-15Not public
Gide Exhibit CL. 172024-05-15Not public
Gide Exhibit 212024-05-15Not public
Gide Exhibit CL. 25bis2024-05-15Not public
Gide Exhibit 92024-05-15Not public
Gide Exhibit 372024-05-15Not public
Gide Exhibit 642024-05-15Not public
Gide Exhibit 302024-05-15Not public
Gide Exhibit CL. 222024-05-15Not public
Gide Exhibit 452024-05-15Not public
Gide Exhibit 682024-05-15Not public
Gide Exhibit 382024-05-15Not public
Gide Exhibit 182024-05-15Not public
Gide Exhibit CL. 33bis2024-05-15Not public
Gide Exhibit 22024-05-15Not public
Gide Exhibit 822024-05-15Not public
Gide Exhibit CL. 28bis2024-05-15Not public
Gide Exhibit CL. 432024-05-15Not public
Gide Exhibit 762024-05-15Not public
Gide Exhibit 102024-05-15Not public
Gide Exhibit CL. 262024-05-15Not public
Gide Exhibit CL. 8bis2024-05-15Not public
Gide Exhibit CL. 16bis2024-05-15Not public
Gide Exhibit 912024-05-15Not public
Gide Exhibit 892024-05-15Not public
Gide Exhibit 522024-05-15Not public
Gide Exhibit CL. 43bis2024-05-15Not public
Gide Exhibit 592024-05-15Not public
Gide Exhibit CL. 322024-05-15Not public
Gide Exhibit 32024-05-15Not public
Gide Exhibit CL. 192024-05-15Not public
Gide Exhibit 462024-05-15Not public
Gide Exhibit 502024-05-15Not public
Gide Exhibit 312024-05-15Not public
Gide Exhibit 342024-05-15Not public
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Gide Exhibit 542024-05-15Not public
Gide Exhibit 422024-05-15Not public
Gide Exhibit 332024-05-15Not public
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Gide Exhibit CL. 292024-05-15Not public
Gide Exhibit 152024-05-15Not public
Gide Exhibit CL. 152024-05-15Not public
Gide Exhibit 702024-05-15Not public
Gide Exhibit CL. 352024-05-15Not public
Gide Exhibit 68bis2024-05-15Not public
Gide Exhibit 202024-05-15Not public
Gide Exhibit CL. 242024-05-15Not public
Gide Exhibit CL. 212024-05-15Not public
Gide Exhibit CL. 37bis2024-05-15Not public
Gide Exhibit CL. 92024-05-15Not public
Gide Exhibit 112024-05-15Not public
UPC Statement for Revocation EP 181 - 30 04 20242024-05-15Not public
Gide Exhibit CL. 202024-05-15Not public
Gide Exhibit CL. 72024-05-15Not public
Gide Exhibit CL. 332024-05-15Not public
Gide Exhibit CL. 342024-05-15Not public
Gide Exhibit 72024-05-15Not public
Gide Exhibit CL. 26bis2024-05-15Not public
Gide Exhibit CL. 412024-05-15Not public
Gide Exhibit CL. 482024-05-15Not public
Gide Exhibit CL. 132024-05-15Not public
Gide Exhibit 93bis2024-05-15Not public
Formal response to the request for amendments2024-05-15Not public
Gide Exhibit 602024-05-15Not public
Gide Exhibit CL. 19bis2024-05-15Not public
Gide Exhibit 852024-05-15Not public
Gide Exhibit 772024-05-15Not public
Gide Exhibit 262024-05-15Not public
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Gide Exhibit 292024-05-15Not public
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Gide Exhibit 512024-05-15Not public
Gide Exhibit 4bis2024-05-15Not public
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Gide Exhibit 902024-05-15Not public
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Gide Exhibit 472024-05-15Not public
Gide Exhibit CL. 12bis2024-05-15Not public
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Gide Exhibit 492024-05-15Not public
Gide Exhibit 652024-05-15Not public
Gide Exhibit 52bis2024-05-15Not public
Formal-checks_Request-for-correction2024-05-13Not public
Gide Exhibit 472024-05-01Not public
Gide Exhibit CL. 7bis2024-05-01Not public
Gide Exhibit CL. 362024-05-01Not public
Gide Exhibit CL. 152024-05-01Not public
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Gide Exhibit CL. 37bis2024-05-01Not public
Gide Exhibit 452024-05-01Not public
Gide Exhibit CL. 472024-05-01Not public
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Gide Exhibit 122024-05-01Not public
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Gide Exhibit CL. 102024-05-01Not public
Gide Exhibit 682024-05-01Not public
Gide Exhibit 732024-05-01Not public
Gide Exhibit 42024-05-01Not public
Gide Exhibit CL. 122024-05-01Not public
Gide Exhibit 68bis2024-05-01Not public
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UPC Statement for Revocation EP 181 - 30 04 20242024-05-01Not public
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Gide Exhibit CL. 122024-05-01Not public
Gide Exhibit CL. 152024-05-01Not public
UPC Statement for Revocation EP 181 - 30 04 20242024-05-01Not public
Gide Exhibit CL. 29bis2024-05-01Not public
Gide Exhibit 832024-05-01Not public
Gide Exhibit CL. 252024-05-01Not public
Gide Exhibit 322024-05-01Not public
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Plain-English summary

Meril Life Sciences entities sought revocation of Edwards Lifesciences' EP 4 151 181 B1 (prosthetic heart valve), which Edwards defended and pursued via a counterclaim for infringement. The Paris Central Division rejected the revocation action but maintained the patent only as amended by Auxiliary Request 2, then granted Edwards' infringement counterclaim against Meril, issuing an injunction covering all UPC member states except for XL-size valves (diameter exceeding 30 mm) where the court found the remedy disproportionate given the absence of an approved alternative for large aortic annuli.

Accepted arguments
What the court agreed with — by party.
  • Holistic approach to inventive step assessment, considering the invention as a whole rather than isolated features

    RespondentLegal basis: Art. 56 EPC

    Note: The court explicitly adopted a 'holistic approach' to non-obviousness and applied it in finding that the amended claims involved an inventive step.

  • Infringement of amended claims 1, 4, 6-12 of EP 4 151 181 by Meril's prosthetic heart valve products

    RespondentLegal basis: Art. 25(a) UPCA; Art. 63(1) UPCA

    Note: Edwards' counterclaim for infringement was granted; Meril entities were found to infringe the patent as amended by Auxiliary Request 2.

  • Injunction should be denied for XL-size valves (diameter exceeding 30 mm) on proportionality grounds given absence of alternative treatment

    ClaimantLegal basis: Art. 63(1) UPCA

    Note: The court refused the injunction for XL-size valves because their exclusion from commerce would harm patients with large aortic annuli where no suitable alternative valve was approved, making the injunction disproportionate until an alternative becomes available.

  • Realistic starting point for inventive step must be a document of interest that addresses the same or similar underlying problem

    RespondentLegal basis: Art. 56 EPC

    Note: Court laid down as headnote that a realistic starting point discloses the main relevant features and has constituted a basis for developing the inventive idea.

Rejected arguments
What the court did not agree with — and why.
  • Revocation of EP 4 151 181 B1 as granted for lack of inventive step

    ClaimantLegal basis: Art. 56 EPC

    Reason: Court dismissed the revocation action, finding sufficient inventive step in the amended claims; patent maintained as amended by Auxiliary Request 2.

  • Edwards' counterclaim for infringement is inadmissible as filed outside the two-month deadline under R. 49 RoP

    ClaimantLegal basis: R. 49 RoP; R. 9(3)(a) RoP

    Reason: Counterclaim was timely; the JR retrospectively extended the time period to 23 July 2024 under R. 9(3)(a) RoP because CMS technical issues beyond the respondent's control prevented proper lodging.

  • Injunction should extend to XL-size prosthetic heart valves (exceeding 30 mm diameter)

    RespondentLegal basis: Art. 63(1) UPCA

    Reason: Court refused the XL-size injunction as disproportionate under Art. 63(1) UPCA: requiring physician compliance mechanisms would be burdensome and inappropriate, and no alternative large-annulus valve is approved, creating a patient-care gap.

  • Costs application for EUR 15,000 arising from rejected public-access-to-register proceedings

    ClaimantLegal basis: R. 150 RoP

    Reason: Public access proceedings do not produce a 'decision on the merits' capable of res judicata effects and therefore do not trigger the costs provisions of R. 150 RoP.