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Overview · Filed: May 1, 2024

UPC_CFI_189/2024

PROSTHETIC HEART VALVE

RevocationMain Revocation ActionParis CDRevocationCase Closed
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.