CC 585030/2023
—·EP3646825: A SYSTEM COMPRISING A PROSTHETIC VALVE AND A DELIVERY CATHETER
Verletzungs-Hauptverfahren:UPC CFI 15/2023
- Verfahrensdetails
- Status—VerfahrensartWiderklage NichtigkeitKategorieWiderklage auf Nichtigkeit
- Parteien
- KlägerVertreter: Emmanuel Larere (Cabinet Gide Loyrette Nouel AARPI); Raphaëlle Dequiré-Portier (Cabinet Gide Loyrette Nouel AARPI); Jean-Robert Callon de Lamarck (Regimbeau); Anne Seibel (Regimbeau); Andreas von Falck (Hogan Lovells International LLP)BeklagteVertreter: Boris Kreye (Bird & Bird LLP); Elsa Tzschoppe (Bird & Bird LLP); Bernhard Thum (Thum & Partner); Jonas Weickert (Thum & Partner); Siddharth Kusumakar (Powell Gilbert (Europe) LLP); Tessa Waldron (Powell Gilbert (Europe) LLP); Bryce Matthewson (Powell Gilbert (Europe) LLP)
- Division
- Paris CD
- Richter
- Paolo Catallozzi · Presiding judge and judge-rapporteur
- Tatyana Zhilova · Legally qualified judge
- Stefan Wilhelm · Technically qualified judge
- Technology
- Medical Devices · Implants · Pharmaceutical & Medical
- Sprache
- —
- Erste Entscheidung
- 19. Juli 2024
- 2024-07-19Patent geändertNichtigkeit (Hauptsache)Counterclaim for revocation
Decision of the Paris Central Division rejecting the revocation action by Meril Italy Srl and the counterclaims for revocation by Meril GmbH and Meril Life Sciences Pvt Ltd against Edwards Lifesciences Corporation's EP 3 646 825 (prosthetic heart valve). The patent is maintained as amended in auxiliary request II, which limits claims to a frame made up entirely of hexagonal cells. The revocation claimants (60%) and defendant (40%) share costs.
Rechtsfragen:Revocation actionAuxiliary requestsInventive step problem-solution approachPatent maintenance in amended formHexagonal cell prosthetic heart valve
- 522A19D4B7650E80F70E3892FA79C1F6_en.pdf2024-07-19EN
Meril Italy Srl and affiliated Meril entities brought revocation proceedings against Edwards Lifesciences Corporation's EP 3 646 825 (prosthetic heart valve system with hexagonal frame cells and delivery catheter) before the Paris Central Division. The court rejected revocation of the patent as amended by Edwards' Auxiliary Request II, which limited the frame to being made entirely of hexagonal cells in a specific alloy; this amendment was found novel and inventive over the closest prior art Levi and the Fontaine article. The patent was maintained in amended form, with costs split 60% (Meril parties) / 40% (Edwards) because the limitation was filed during proceedings.
Patent EP 3 646 825 is valid as amended by Auxiliary Request II, which limits the frame to being made up entirely of hexagonal cells
BeklagterRechtsgrundlage: Art. 138 EPC; validity under EPCHinweis: Court found that the grounds of invalidity raised against the patent as amended by AR II were unfounded; the Levi prior art did not disclose or render obvious a frame made entirely of hexagonal cells.
Fontaine's article does not teach that the reduced crimping profile derives from the use of a frame made up entirely of hexagonal cells
BeklagterRechtsgrundlage: Inventive step / obviousnessHinweis: Court accepted that the specific technical effect (reduced crimping profile) from using all-hexagonal cell geometry was not taught by Fontaine's article, supporting non-obviousness.
Revocation of EP 3 646 825 as granted (main request) on grounds of lack of novelty and/or inventive step
KlägerRechtsgrundlage: Art. 138 EPCBegründung: The patent as granted was found invalid (not stated explicitly — Edwards ultimately amended the patent), but the revocation of the patent in the amended form (AR II) was rejected because the all-hexagonal-cell frame limitation was novel and inventive over Levi and Fontaine.
Lack of inventive step of AR II claims over Levi (closest prior art) in combination with teachings about hexagonal cells in heart valves
KlägerRechtsgrundlage: Inventive step / problem-solution approachBegründung: Court identified Levi as the closest prior art but found that the skilled person would not be motivated to combine teachings about hexagonal cell geometry to arrive at a frame made entirely of hexagonal cells; the same Fontaine analysis applied.
Weitere Fälle zu diesem Grundsatz ansehen.
- LeviErfindungsmüh-Kombination
- Fontaine articleErfindungsmüh-Kombination
- WO 2013/012801 (WO '801 / grandparent application)Hintergrund
The key claim construction issue was the meaning of 'frame comprising a plurality of rows of hexagonal cells' in EP 3 646 825 as granted versus 'frame made up entirely of hexagonal cells' in Auxiliary Request II. The amendment in AR II added the limitation that (i) the frame is made of a nickel-cobalt-chromium-molybdenum alloy, (ii) the frame is made up entirely of hexagonal cells, and (iii) each hexagonal cell is defined by exactly six struts with specified geometry. The court treated the 'entirely of hexagonal cells' limitation as the critical distinguishing feature that avoided the prior art.