CC_585030/2023

A SYSTEM COMPRISING A PROSTHETIC VALVE AND A DELIVERY CATHETER

Parent infringement case:UPC_CFI_15/2023

RevocationCounter Claim for RevocationParis CDCounterclaim for revocation—

Overview Decisions Reasoning Citations Documents Timeline

Plain-English summary

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.

Accepted arguments

What the court agreed with — by party.

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
RespondentLegal basis: Art. 138 EPC; validity under EPC
Note: 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
RespondentLegal basis: Inventive step / obviousness
Note: 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.

Rejected arguments

What the court did not agree with — and why.

Revocation of EP 3 646 825 as granted (main request) on grounds of lack of novelty and/or inventive step
ClaimantLegal basis: Art. 138 EPC
Reason: 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
ClaimantLegal basis: Inventive step / problem-solution approach
Reason: 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.

Key legal principles

Doctrines and rules cited in the reasoning.

Problem-solution approach — court noted it is not mandatory under EPC but would not change the outcome if applied Patent maintenance as amended — court can maintain patent in limited form pursuant to auxiliary request Closest prior art identification Costs apportioned where patent is maintained only because defendant (patentee) filed a limitation during proceedings

Browse other cases on this principle.

Prior art relied on

References cited and the role they played.

LeviObviousness combination
Fontaine articleObviousness combination
WO 2013/012801 (WO '801 / grandparent application)Background

Claim construction notes

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.