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ACT 459987/2023

—·EP3646825 +1 more: A SYSTEM COMPRISING A PROSTHETIC VALVE AND A DELIVERY CATHETER

Case details
Status
—
Action
Infringement
Category
Main Infringement Action
Parties
Claimants
Reps: Boris Kreye (Bird & Bird LLP); Elsa Tzschoppe (Bird & Bird LLP)
Respondents
Reps: Andreas von Falck (Hogan Lovells International LLP); Roman Würtenberger (Hogan Lovells International LLP); Lukas Wollenschlaeger (Hogan Lovells International LLP)
Division
Munich LD
Judges
  • Matthias Zigann · Presiding Judge / Judge-Rapporteur (Munich Local Division)
Technology
Medical Devices · Implants · Pharmaceutical & Medical
Language
—
First decided
Sep 6, 2024
Last decision
Nov 15, 2024
Claims
At issueall
Infringedall
Notes: Munich Local Division found infringement of EP 3 646 825 by Meril transcatheter heart valve products; no specific claim numbers enumerated in the operative part of the excerpt.
Decisions
  • 2024-11-15
    InfringedInjunction grantedInfringement meritsInfringement Action

    Munich Local Division full merits decision finding that Meril Life Sciences Pvt Ltd and Meril GmbH infringed Edwards Lifesciences Corporation's patent EP 3 646 825 (a heart valve technology patent). The court ordered a permanent injunction to cease and desist from the infringing acts (transcatheter heart valve products) across all UPC contracting states where the patent has effect, recall of infringing products from commercial channels (excluding devices already scheduled for patient implantation by 15 November 2024), destruction of infringing stock, disclosure of information about distribution and quantities, publication of the decision, and an obligation to pay damages (quantum to be determined separately). The defendant's counterclaim for revocation was dismissed, the patent being upheld as valid. Costs were addressed separately.

    Legal issues:UPC jurisdiction over pre-June 2023 infringement actsCompetence of chosen German local divisionBifurcation / referral of revocation counterclaim to Central Division and subsequent stayScope of injunctive relief under Art. 34 UPCA across all contracting statesThird-party interests in corrective measures (Art. 64(4) UPCA)Medical device / patient safety carve-out in recall/destruction ordersDamages liability and quantum proceedings
    Damages: Liability declared, amount deferred
  • 2024-09-06
    Infringement Action

    The Munich Local Division judge-rapporteur issued a procedural order in Edwards Lifesciences v. Meril concerning EP 3 646 825, addressing defendants' arguments that the Central Division Paris first-instance decision on the patent amendment application had failed to consider key invalidity arguments. The judge-rapporteur referred the matter to the full panel, noting that the appeal proceedings before the Court of Appeal would address the alleged deficiencies in the Paris decision.

    Legal issues:Sufficiency of reasoning in first-instance decision (right to be heard)Referral to full panel (R. 102.1 RoP)Invalidity arguments not addressed in Paris Central Division decisionCounterclaim for revocation
Documents
  • 683C206C93F0A3F34B2181F1F2BF5622_en.pdf2024-09-06EN
  • 8302EF6857AD1EB45EBA058622E7843A_en.pdf2024-11-15EN
Coverage: Partial.Reasoning extracted with partial coverage — some sections may be incomplete.
Plain-English summary

Edwards Lifesciences Corporation sued Meril GmbH and Meril Life Sciences for infringement of EP 3 646 825, a heart valve technology patent, before the Munich Local Division. Following bifurcation and the Central Division Paris upholding the patent in amended form, the Munich Local Division found infringement of transcatheter heart valve products, granted a permanent injunction across all UPC contracting states, ordered recall and destruction (with a carve-out for XL devices already scheduled for patient implantation), and awarded EUR 663,000 in preliminary damages. The counterclaim for revocation was dismissed.

Accepted arguments
What the court agreed with — by party.

  • UPC has jurisdiction over acts of infringement committed before 1 June 2023

    ClaimantLegal basis: Art. 3(c) and 32(1)(a) UPCA

    Note: The Munich Local Division held that the UPC's jurisdiction extends to pre-UPCA infringement acts, in the absence of conflicting intertemporal provisions.

  • Infringement action may proceed and be decided despite referral of counterclaim for revocation to the Central Division

    ClaimantLegal basis: Art. 32(3b) UPCA; R. 295(c)(i) and (m) RoP

    Note: Following bifurcation and the Central Division Paris upholding the patent (in amended form), the local division found it was required to proceed with the infringement decision; a stay post-central division decision is limited to exceptional circumstances (manifestly prima facie erroneous decisions).

  • Injunctive relief and corrective measures may be ordered across all contracting member states where the patent has effect

    ClaimantLegal basis: Art. 34 UPCA

    Note: The court confirmed that pan-European relief is available once infringement is proven for at least one contracting member state, which Edwards established.

  • Third-party interests (patient safety) must be considered in scope of corrective measures

    RespondentLegal basis: Art. 64(4) UPCA

    Note: The court partially accepted this argument, carving out XL devices already scheduled for patient implantation by 15 November 2024 from the recall and destruction orders.

Rejected arguments
What the court did not agree with — and why.

  • Stay of infringement proceedings warranted because Central Division Paris decision was manifestly and prima facie erroneous for failing to consider key invalidity arguments

    RespondentLegal basis: R. 295(c)(i) RoP

    Reason: The local division held that a stay post-central division decision is only available in exceptional circumstances where the decision is manifestly and prima facie erroneous; the alleged failure to address certain arguments did not meet this threshold, and appeal proceedings were already pending.

  • Patent EP 3 646 825 is invalid (counterclaim for revocation)

    RespondentLegal basis: Art. 65 UPCA

    Reason: The counterclaim for revocation was dismissed; the patent had been upheld (in amended form) by the Central Division Paris Section and was held valid for purposes of the infringement action.

Key legal principles
Doctrines and rules cited in the reasoning.
UPC jurisdiction over pre-UPCA infringement actsbifurcation and referral of counterclaim for revocation to Central Divisionstay of infringement proceedings post-central division decision limited to exceptional circumstancespan-UPC injunctive relief under Art. 34 UPCA upon proof of infringement in one contracting member statethird-party and public interests considered in scope of corrective measures under Art. 64(4) UPCAclaimant's choice among competent German local divisions determines competence

Browse other cases on this principle.

Prior art relied on
References cited and the role they played.
  • Levi (Exhibit HLNK 39)Obviousness combination
  • Alon (Exhibit HLNK 49)Obviousness combination
  • Fontaine (Exhibit HLNK 25)Obviousness combination
  • EP 3 583 920 B1 (family member)Background
Claim construction notes

The excerpt references that the patent was upheld by the Central Division Paris in its auxiliary request 2 form, meaning the infringement decision was based on amended claim scope. Meril argued the Paris Central Division failed to address added-matter resulting from omission of 'sealing device' feature, novelty attacks based on specific embodiments of Levi, and inventive step starting from Alon alone or combined with Fontaine — but these were appeal points rather than claim construction issues resolved in the infringement judgment itself.