Decision
of the Court of First Instance of the Unified Patent Court
Local Division Munich
concerning European Patent 3 669 828
issued on 4 April 2025
HEADNOTES
1. Art. 33(1)(b) UPCA allows multiple defendants to be sued at the domicile, principal
place of business or, failing that, at the place of business of one of the defendants,
provided that the defendants have a commercial relationship, and the action concerns
the same alleged infringement. In the context of a European patent without unitary effect,
the term "the same infringement" addresses situations where multiple defendants are
accused of infringing the relevant national designations of the same European patent by
the same product or process. Another interpretation would undermine the purpose of
the Agreement on a Unified Patent Court to overcome the fragmented patent litigation
landscape in Europe (preamble 2 of the UPCA).
2. For assessing whether an invention shall be considered obvious having regard to the
state of the art, the problem-solution approach developed by the European Patent Office
shall primarily be applied as a tool to the extent feasible to enhance legal certainty and
further align the jurisprudence of the Unified Patent Court with the jurisprudence of the
European Patent Office and the Boards of Appeal.
3. A cease-and-desist declaration without a penalty clause by one or two but not all
defendants being members of a group of companies jointly infringing a patent cannot
secure the patentee's interest in defending the exclusive nature of its right in the same
way as a court order. The risk remains that the members of the group will re-organise their
business around such isolated cease-and-desist declarations and thus continue to
infringe the patent in the relevant territories without the risk of having to pay a penalty.
Local Division Munich
UPC_CFI_501/2023
UPC_CFI_501/2023
2
4. If a decision is immediately and directly enforceable from the date of service in each
of the Contracting Member States pursuant to Rule 354.1 RoP no security must be lodged
beforehand and there is no condition under Rule 118.2.a RoP. However, Rule 118.8 RoP
must be complied with.
KEYWORDS
Jurisdiction; multiple defendants; commercial relationship; same infringement; cease
and desist declaration without a penalty clause; danger of repetition; danger of first
infringement; immediately enforceable; assessment of inventive step; problem solution
approach.
CLAIMANT
Edwards Lifesciences Corporation
1 Edwards Way - 92614 - Irvine – US
represented by: Boris Kreye, Elsa Tzschoppe, Ioana Hategan
(Bird & Bird)
supported by: Bryce Matthewson, Siddharth Kusumakar, Daniel Down
(Powell Gilbert)
Bernhard Thum, Jonas Weickert
(Thum & Partner)
DEFENDANTS
1) Meril Gmbh Bornheimer Straße 135-137 - 53119 - Bonn – DE
2) Meril Life Sciences Pvt Ltd.
M1‐M2, Meril Park, Survey No 135/2/B & 174/2 Muktanand Marg, Chala, Vapi - 396 191
Gujarat - Vapi - IN
3) Meril Italy S.r.l.
Piazza Tre Torri 2 - 20145 - Mailand - IT
represented by: Andreas von Falck, Lukas Wollenschlaeger, Felipe Zilly
(Hogan Lovells)
UPC_CFI_501/2023
3
PATENT AT ISSUE
European patent n° 3 669 828 B2
PANEL/DIVISION
Panel 1 of the Local Division Munich
DECIDING JUDGE/S
This decision was adopted by the Presiding Judge, Dr Matthias Zigann, acting as Judge-
Rapporteur, the legally qualified Judge, Margot Kokke, LLM MSc, the legally qualified
Judge, Tobias Pichlmaier, and the technically qualified Judge, Dr Stefan Wilhelm, LL.M.
LANGUAGE OF THE PROCEEDINGS
English
SUBJECT-MATTER OF THE PROCEEDINGS
Infringement action (ACT_597277/2023) with counterclaim for revocation
(CC_23112/2024) and application to amend the patent (App_39429/2024).
Preliminary objections (APP_8004/2024; APP_9990/2024).
DATE OF THE ORAL HEARING
11 February 2025
DATE OF THE ANNOUNCEMENT OF THE DECISION
4 April 2025
SUMMARY OF THE DISPUTE
The infringement action was filed by Edwards Lifesciences Corporation ("Edwards")
against Meril Life Sciences PVT Ltd, Meril GmbH and Meril Italy S.r.l. (collectively "Meril")
in the Local Division Munich on 27 December 2023 (ACT_597277/2023). Edwards alleges
that Meril's “Myval” THV and its “Navigator” THV delivery device infringe independent
claims 1 and 12 and dependent claims 2-11 and 13-14 of EP 3 669 828 ("the patent") titled
"Prosthetic Heart Valve" and granted on 5 May 2021 (B1) and published in amended form
(B2) on 26 June 2024.
UPC_CFI_501/2023
4
Meril filed preliminary objections (APP_8004/2024; APP_9990/2024). The Judge-
Rapporteur informed the parties pursuant to Rule 20.2 of the Rules of Procedure that the
preliminary objections would be dealt with in the main proceedings.
Meril contests the alleged infringement and filed a counterclaim for revocation on 26 April
2024 (CC_23112/2024), invoking Arts. 76(1) and 123(2), 83, 54 and 56 EPC as grounds for
revocation and argued that the patent was invalid in its entirety.
Edwards filed an application to amend the patent on 2 July 2024 (App_39429/2024),
submitting AR 1-9, AR 3'-9' and AR 3''-9''.
An interim conference was held on 19 December 2024 at which various procedural
motions of the parties were decided. Among other things, the ARs as filed by Edwards
were admitted into the proceedings. Romania was also added to both the infringement
action and the counterclaim (App_56822/2024).
The Court also invited the parties to submit physical objects or drawings to further
illustrate the technical arguments, in particular with respect to the way in which parts of
the leaflets are folded according to the patent, the contested embodiments and the
relevant prior art cited in the counterclaim. The parties then produced various physical
objects (App_4996/2025 - EDW-M-1-9 and App_4953/2025 - HL-CC-17-20).
The oral hearing before the Division took place on 11 February 2025 in Munich.
The patent at issue
The patent at issue (or patent in suit) is owned by Edwards. The patent is a first-generation
divisional application of EP 2,624,785 (appl. No. 11831542.3). EP 2,624,785 is derived
from PCT/US2011/054,973 filed on 5 October 2011 and published as
WO2012/048,035A2 (referred to as "WO035") claiming priority from US 61/390,107 filed
on 5 October 2010 ("P1") and US 61/508,513 filed on 15 July 2011 ("P2"). It should be
noted that the specification of the divisional application underlying the patent (EP
19206328.7) is identical to the description of the original parent application (WO035)
except that original claims 1-32 have been added at the end of the description of EP
19206328.7. Therefore, when the original disclosure is discussed below in relation to the
disclosure of the earlier parent applications, reference is made only to the parent
application (WO035).
The patent (in the B2 version as maintained by the Opposition Division of the EPO, see
below) contains two independent claims, claim 1 and claim 12. Claim 1 is directed to an
implantable prosthetic heart valve and claim 12 is directed to an assembly for implanting
a prosthetic heart valve in a patient's body comprising a delivery device and an
expandable prosthetic heart valve of any of claims 1-11.
UPC_CFI_501/2023
5
An opposition to the patent was filed on 4 February 2002 by a third party, Abbott
Cardiovascular Systems, Inc. of Santa Clara, USA. Oral proceedings were held before the
Opposition Division (OD) on 28 September 2023. As a result, the patent was maintained
in amended form with independent claims 1 and 12 as originally granted:
•Claim 1 of the claims maintained by the OD is the same claim as granted originally
•Dependent claim 9 as originally granted was deleted.
•The remaining claims were renumbered
•Claim 9 was amended to read as follows:
The prosthetic valve (10) of claim 1, wherein the prosthetic heart valve (10) further
comprises an inner fabric skirt (1) positioned along an inner surface of the frame
(12), wherein the inner skirt (16) is secured to the frame (12) via sutures (70).
As no appeal was filed against the decision of the OD, this decision became final. A
patent specification consistent with the OD decision was published on 6 June 2024 as EP
3 669 828 B2. Accordingly, the proceedings before the UPC must be based on the B2
specification.
The parties and the court refer to the separate features of claim 1 as follows:
UPC_CFI_501/2023
6
The attacked embodiments
The action is directed against Meril`s implantable prosthetic heart valve “Myval” and the
delivery apparatus “Navigator” as described in the Product and Process Description
“PPD” (K25):
The leaflet structure of the prosthetic heart valve is made up of three leaflets (p. 5 of the
K25).
Fig. 4 below (reproduced from K25) shows one leaflet:
UPC_CFI_501/2023
7
SUMMARY OF THE PARTIES’ REQUESTS
Meril requests
to allow the preliminary objection to the extent requested and dismiss the action in part
as inadmissible on the grounds of
– lack of jurisdiction of the Court (Rule 19.1(a) RoP) with regard to all requests insofar as
the Claimant seeks a Decision with effect ‘in the scope of the Agreement on a Unified
Patent Court as of the date of the oral hearing, with the exception of Malta’;
- the Court's lack of jurisdiction (R. 19.1(a) RoP), insofar as the requests, in particular the
requests under points IV., V., VI., IX. and X., relate to periods prior to 1 June 2023;
- concerning the jurisdiction of the Local Division Munich (Rule 19.1 b) RoP) insofar as the
Claimant brings an action against the third Defendant.
Edwards requests
to reject the preliminary objections in the main proceedings; and to
I. order Defendants to cease and desist with respect to
1) an implantable prosthetic heart valve, comprising: an annular frame comprising a
plurality of leaflet attachment portions; and a leaflet structure positioned within the
frame and secured to the leaflet attachment portions of the frame, the leaflet structure
comprising a plurality of leaflets, each leaflet comprising a body portion, two opposing
primary side tabs extending from opposite sides of the body portion, and two opposing
secondary tabs extending from the body portion adjacent to the primary side tabs;
characterized in that the secondary tabs are folded about a radially extending crease
such that a first portion of the secondary tabs lies flat against the body portion of the
respective leaflet, and the secondary tabs are folded about an axially extending crease
such that a second portion of the secondary tabs extends in a different plane than the
first portion,
(claim 1 of the Patent-in-Suit)
from offering, placing on the market, using, or importing or storing it for the said purposes
within the territory of the Agreement on a Unified Patent Court at the time of the oral
hearing (except in Malta),
in the alternative
in Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia,
Lithuania, Luxembourg, the Netherlands, Portugal, Romania, Slovenia or Sweden,
UPC_CFI_501/2023
8
especially when
the second portion of each secondary tab is sutured to a respective primary tab,
(dependent claim 2 of the Patent-in-Suit)
and/or
the secondary tabs are positioned inside of the frame,
(dependent claim 3 of the Patent-in-Suit)
and/or
the first portion of each secondary tab pivots about the axially extending crease and lays
flat against the second portion of the secondary tab when the prosthetic heart valve is
collapsed to a radially collapsed configuration,
(dependent claim 4 of the Patent-in-Suit)
and/or
the first portion of each secondary tab comprises an inner edge spaced radially from an
inner surface of the frame, and the body portion of the leaflet articulates about the inner
edges of the two secondary tabs of the leaflet in response to blood 17.10.2024 Page 4
flowing through the prosthetic heart valve when the prosthetic heart valve is in operation
within a patient's body,
(dependent claim 5 of the Patent-in-Suit)
and/or
the plurality of leaflet attachment portions comprises window frame portions each
comprising an enclosed opening between first and second axially oriented side struts,
and wherein the primary side tabs extend radially outwardly through respective
commissure window frame portions to a location outside of the frame and are sutured to
the secondary tabs to secure the leaflets around the side struts,
(dependent claim 6 of the Patent-in-Suit)
and/or
the prosthetic heart valve further comprises an annular outer skirt positioned around an
outer surface of the frame, the outer skirt comprising an inflow edge secured to the frame
at a first location, an outflow edge secured to the frame at a second location, and an
intermediate portion between the inflow edge and the outflow edge; wherein when the
prosthetic heart valve is in the expanded configuration, the intermediate portion of the
outer skirt comprises slack in the axial direction between the inflow edge of the outer skirt
UPC_CFI_501/2023
9
and the outflow edge of the outer skirt, and when the prosthetic heart valve is collapsed
to the collapsed configuration, the axial distance between the inflow edge of the outer
skirt and the outflow edge of the outer skirt increases, reducing the slack in the outer skirt
in the axial direction,
(dependent claim 7 of the Patent-in-Suit)
and/or
the outflow edge of the outer skirt of the prosthetic valve of claim 7 comprises a plurality
of alternating projections and notches, the projections being secured to the frame at the
second location, the outer skirt being unsecured to the frame at the notches,
(dependent claim 8 of the Patent-in-Suit)
and/or the frame is made of a nickel-cobalt-chromium alloy, preferably a nickel-cobalt-
chromium-molybdenum alloy,
(dependent claim 11 of the Patent-in-Suit as granted / dependent claim 10 of the Patent-
in-Suit as upheld)
and/or each of the plurality of leaflets further comprises: a free outflow edge portion
extending between the primary side tabs adjacent to an outflow end of the frame; and an
inflow edge portion extending between the primary side tabs adjacent to an inflow end of
the frame, the inflow edge portion comprising opposing axial edge portions that extend
from the primary side tabs toward the inflow end of the frame in a generally axial direction
and an intermediate curved edge portion that extends between the axial edge portions,
the intermediate edge portion comprising a curved apex portion adjacent to the inflow
end of the frame and a pair of oblique portions that extend between the axial edge
portions and the apex portion,
(dependent claim 12 of the Patent-in-Suit as granted / dependent claim 11 of the Patent-
in-Suit as upheld)
especially when
the implantable prosthetic heart valve is a transcatheter prosthetic valve called "Myval"
as shown below:
UPC_CFI_501/2023
10
2) an assembly for implanting a prosthetic heart valve in a patient's body, comprising: a
delivery apparatus comprising an elongated shaft; and a radially expandable prosthetic
heart valve of any one of claims 1 to 12 (as granted), respectively to 11 (as upheld), the
prosthetic valve adapted to be mounted on the shaft in a radially collapsed configuration
for delivery into the body,
(claim 13 of the Patent-in-Suit as granted / claim 12 of the Patent-in-Suit as upheld)
from offering, placing on the market, using, or importing or storing it for the said purposes
within the territory of the Agreement on a Unified Patent Court at the time of the oral
hearing (except in Malta),
in the alternative
in Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia,
Lithuania, Luxembourg, the Netherlands, Portugal, Romania, Slovenia or Sweden,
especially when the shaft has an inflatable balloon and the prosthetic heart valve is
mounted over the balloon,
(dependent claim 14 of the Patent-in-Suit as granted / dependent claim 13 of the Patent-
in-Suit as upheld)
especially when
the assembly comprises a delivery apparatus called "Navigator" and a prosthetic heart
valve called "Myval" as shown below:
UPC_CFI_501/2023
11
II. order the Defendants to each pay penalty payments to the Court for each instance of
non-compliance with the Order under Clause I. The penalty payments shall be set by the
Court at an appropriate rate relative to the significance of the Order to be enforced,
whereby an amount of EUR 20,000 is suggested for each instance of non-compliance and
per defendant;
III. declare that the Defendants have infringed the Patent-in-suit with respect to the
products identified in paragraph I above;
IV. the Court order Defendants, under penalty of a periodic fine of EUR 1,000 for each day
of delay, within a period of three weeks from the date of service of the decision, to provide
Claimant with information on the extent to which Defendants have committed the acts
referred to in item I. since 24 June 2020, specifying:
1) the origin and distribution channels of the infringing products,
2) the quantities produced, manufactured, delivered, received or ordered, as well as the
prices paid for the infringing products, and
3) the identity of any third person involved in the manufacture or distribution of infringing
products;
whereby the list with the data has to be additionally transmitted electronically in a form
that can be evaluated by means of EDP (e.g. Excel table), and copies of the relevant
purchase documents (namely invoices, alternatively delivery bills) are to be submitted by
Defendants as proof of the information, whereby confidential details outside the subject
of the disclosure information may be redacted;
UPC_CFI_501/2023
12
V. order the Defendants, under threat of a penalty payment of €1,000 for each day of
delay, to take the following actions within one week of service of the Decision with regard
to the products referred to in Section I. placed on the market since 5 May 2021, with
reference to the legally established patent-infringing nature of the products, and with the
binding commitment to take back the products and to bear any fees as well as necessary
packaging and transport costs and customs and storage costs associated with the
return, and to take back the products, with the proviso that these are then permanently
removed from the distribution channels;
VI. order the Defendants, under threat of a recurring penalty payment of EUR 1,000 for
each day of delay, within a period of one week after service of the Decision, to
immediately disclose and hand over the products and/or the relevant materials
described in Section I. above and/or the relevant materials (including any products
and/or materials that come into its direct and/or indirect possession and/or ownership
pursuant to Clause IV or otherwise) or, at its option, to surrender them to a bailiff to be
named or appointed by the plaintiff for the purpose of destruction;
VII. order the Defendants to allow the Plaintiff to publish the Court's decision in whole or
in part, including the publication of the decision in five public media and trade journals
of its choice;
VIII. order the Defendants to publish the operative part of the Court's Decision on their
websites;
IX. declare that the Defendants are obliged to compensate the Plaintiff for the damage
(including interest) that the Plaintiff has suffered and will suffer as a result of the acts
described in Section I above, committed since 5 May 2021;
X. order the Defendants to pay provisional damages to the Claimant, the amount being
left to the discretion of the Court, but covering at least the foreseeable costs of the
Claimant's claim for damages and compensation, and in any event an amount of at least
EUR 663,000.00;
XI. order the Defendants to pay the costs of the action, including the costs of the
measures sought under I. to VIII. above;
XII. include an Order of immediate enforcement in the Decision;
in the alternative, in the event that the plaintiff is ordered to provide security,
allow the plaintiff to provide this in the form of a bank or savings bank guarantee and to
determine the amount of the security separately for each claim granted and for the basic
decision on costs,
in the alternative,
UPC_CFI_501/2023
13
allow the plaintiff to avert the enforcement of costs by providing security;
XIII. issue a default judgment in the event that the Defendants fail to act within the time
limit provided for in these Rules of Procedure or set by the Court or fail to appear at an
oral hearing after having been duly summoned.
Meril requests
that the patent in suit (EP 3 669 828 B2) be revoked in its entirety;
in the alternative:
that the patent in suit (EP 3 669 828 B2) be revoked in its entirety for all Contracting
Member States in which EP 3 669 828 B2 has effect;
in the alternative:
that the patent in suit (EP 3 669 828 B2) be revoked with effect in the territories of the
Contracting Member States for which the European Patent has effect at the time of the
decision on the counterclaim for revocation, namely Austria, Belgium, Bulgaria,
Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, the
Netherlands, Portugal, Romania, Slovenia and Sweden;
in the alternative:
that the patent in suit (EP 3 669 828 B2) be revoked with effect in the territories of the
Contracting Member States for which the European Patent had effect at the time of the
counterclaim for revocation, namely Austria, Belgium, Bulgaria, Denmark, Estonia,
Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, the Netherlands,
Portugal, Slovenia and Sweden;
2. that Claimant and Counterclaim Defendant bear the costs of the proceedings.
3. the decision be put under the condition subsequent pursuant to Article 56(1) UPCA
that the patent in suit is not held to be wholly or partially invalid by the final decision in
respect of the counterclaim for revocation (in particular, if referred to the Central Division)
(R. 118.2 lit. a) RoP);
4. in the event that Claimant fails to perform any action within the time limit provided for
in the Rules of Procedure or set by the Local Division or fails to appear at an oral hearing
after having been duly summoned, to issue a default judgment against Claimant.
UPC_CFI_501/2023
14
5. the proceedings be stayed until the Court of Justice of the European Union has given a
preliminary ruling pursuant to Article 267 para. 2 TFEU in accordance with Rules 295 lit.
i), 266.5 sentence 1 RoP.
Edwards requests
I. the Counterclaim for revocation be dismissed;
in the alternative,
II. the patent in suit EP 3 669 828 B2 be maintained based on one of the proposed
amendments (Auxiliary Requests 1 to 9, 3’ to 9’ and 3’’ to 9’’) within the scope of the
territory of the Agreement on the Unified Patent Court at the time of the oral hearing -
except in Malta - or, in the alternative, in Belgium, Bulgaria, Denmark, Germany, Estonia,
Finland, France, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Austria, Portugal,
Romania, Sweden and Slovenia, and the Counterclaim for revocation be dismissed
insofar as the patent in suit is maintained as such; and in the further alternative,
III. the patent in suit EP 3 669 828 B2 be maintained within the scope of the territory of the
Agreement on the Unified Patent Court at the time of the oral hearing - except in Malta -
or, in the alternative, in Belgium, Bulgaria, Denmark, Germany, Estonia, Finland, France,
Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Austria, Portugal, Romania,
Sweden and Slovenia, based on the independent validity of one or more of its dependent
claims in combination with independent claim 1 or independent claim 12 of EP 3 669 828
B2 according to the dependencies of the claims of EP 3 669 828 B2 and the Counterclaim
for revocation be dismissed insofar as the patent in suit is maintained as such;
IV. the Defendants be ordered to bear the costs of the proceedings;
V. in the event that the Defendants or any of them fail(s) to perform any action within the
time limit provided for in the RoP or set by the Local Division or fail(s) to appear at an oral
hearing after having been duly summoned, to issue a default judgment against such
Defendant.
Meril requests
1. The patent be revoked in its entirety.
2. Auxiliary requests 1, 2, and 3 to 9, 3’-9’, 3’’-9’’ be declared inadmissible.
3. Claimant to pay the costs of proceedings.
UPC_CFI_501/2023
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SUMMARY OF THE PARTIES’ SUBMISSIONS
In its preliminary objections, Meril argues that the UPC lacks jurisdiction for actions
directed to "the territory of the Agreement on a Unified Patent Court at the time of the oral
hearing (except Malta)" and for actions relating to acts of infringement before 1 June
2023. Furthermore, the UPC does not have jurisdiction over Meril Italy.
Meril also argues that feature 2.b.aa (leaflet comprising a body portion) must be
interpreted as requiring a V-shaped tip of the body portion. The "Myval" heart valve
prosthesis does not infringe because the leaflets do not have a V-shaped but a rounded
tip of the body portion.
Meril also argues that features 3a and 4a (radially and axially extending crease) are not
restrictive. Thus, the prior art references are novelty destroying and render the subject
matter of the patent claims at least obvious. Furthermore, the invention is not disclosed
sufficiently clearly and completely for it to be carried out by a person skilled in the art.
In any event, corrective measures would not be proportionate because there is a public
need for the Meril devices.
Edwards argues that the Unified Patent Court in general and the Local Division Munich in
particular have jurisdiction over all claims and all defendants. The claim construction
proposed by Meril is not convincing and must be rejected. Consequently, the patent is
valid and infringed. Corrective measures would be proportionate, since sufficient
alternative devices are available. Any remaining public need for XL devices continues to
be adequately met by the existing medical request portal for the Myval valve prosthesis.
For further details reference is made to the grounds for the decision and to the parties'
written pleadings.
GROUNDS FOR THE DECISION
In summary: the preliminary objections are widely rejected. The counterclaim is
dismissed. The contested embodiment makes direct and literal use of the patent as
upheld by the OD. Consequently, the relief sought is widely granted. The defence of
proportionality is almost entirely rejected.
Preliminary objections
The preliminary objections are widely rejected.
UPC_CFI_501/2023
16
1. Meril contended that the Court lacked jurisdiction (Rule 19.1(a) RoP) in respect of all
the claims because the claimant sought a decision "within the area of application of the
Unified Patent Court Agreement as of the date of the hearing, excluding Malta".
a. Meril understands the above cited wording in claimant's request as meaning that if,
between the filing of the Statement of Claim on 1 June 2023 and the date of the hearing,
additional member states in which the patent in question is validated ratify the UPCA,
there will be an "automatic" extension of the action, which Meril considers inadmissible.
b. This question can remain unanswered because Edwards' request is improperly drafted
and therefore invalid. It is the responsibility of the claimant to specify the exact territories
for which relief is sought. This can be done either by including a list with the names of the
Contracting Member States (CMS) for which relief is sought or by referring to the territory
of those CMS for which the European patent has effect (UPC_CoA_523/2024
APL_51115/2024CoA - Sumi Agro/Syngenta, mn. 103-109). Although there are no
transitional provisions in Art. 34 UPCA with the effect that upon ratification and accession
by a UPC signatory state Art. 34 UPCA extends to that CMS from day one
(UPC_CoA_523/2024 APL_51115/2024CoA - Sumi Agro/Syngenta, mn. 107), the relevant
date for determining the relevant territories covered by the patentee's request is the date
of filing of the statement of claim and not the date of the last oral hearing. Otherwise, the
defendant would not have a clear picture of the territories for which he needs to prepare
a defence and, in particular, file a counterclaim. Since Edward's main request relates to
the date of the last oral hearing, it does not serve that purpose and is therefore
inadmissible. However, the auxiliary request, which expressly mentions the territories in
question (Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy,
Latvia, Lithuania, Luxembourg, the Netherlands, Portugal, Romania, Slovenia or
Sweden), is admissible.
2. Meril also contended that the Court lacked jurisdiction (R. 19.1(a) RoP) with respect to
the claims, in particular those in Sections IV, V, VI, IX and X, relating to periods prior to 1
June 2023.
a. Meril's request is to be understood as meaning that the Unified Patent Court does not
have jurisdiction to decide on acts of infringement committed prior to the entry into force
of the Agreement on a Unified Patent Court on 1 June 2023.
b. This interpretation is incorrect. Reference is made to the decision of the Court of
Appeal of 16 January 2025 (UPC_CoA_30/2024 APL_4000/2024).
UPC_CFI_501/2023
17
3. Finally, Meril argued that the Local Division Munich does not have jurisdiction over
Meril Italy.
a. Edwards argued that the Local Division Munich also had jurisdiction over Meril Italy
under Art. 33(1)(b) UPCA. As already stated in the statement of claim (recital 301), the
first and third defendants are wholly owned subsidiaries of the second defendant. As the
"European headquarters", defendant 1 is responsible, inter alia, for the distribution of the
infringing products in Europe, while defendant 3 is responsible for distribution in Italy,
which is also part of the European market. In addition, defendant 2 supplies the infringing
products to defendant 1 and, where appropriate, to defendant 3.
b. Art. 33(1)(b) UPCA allows multiple defendants to be sued at the domicile, principal
place of business or, failing that, at the place of business of one of the defendants,
provided that the defendants have a commercial relationship, and the action concerns
the same alleged infringement. In the context of a European patent without unitary effect,
the term "the same infringement" addresses situations where multiple defendants are
accused of infringing the relevant national designations of the same European patent by
the same product or process. Another interpretation would undermine the purpose of
the Agreement on a Unified Patent Court to overcome the fragmented patent litigation
landscape in Europe (preamble 2 of the UPCA).
c. In the present case, all three defendants are accused of infringing the respective
national designations of the same European patent with the same attacked
embodiments. Therefore, the requirement that the same infringement is concerned, is
met. Furthermore, there is a sufficient commercial relationship between the three
defendants. Defendant 2 is the parent company of Defendants 1 and 3 and the
manufacturer of the attacked embodiments. Defendant 1 serves as the European
headquarters of the group and is as such also responsible for Defendant 3, which is
based in Italy.
The patent at issue and claim construction
1. Legal standard for claim construction
The principles of claim construction under Art. 69 EPC and the Protocol on its
interpretation have already been explained by the Court of First Instance and the Court
of Appeal in many decisions. However, with regard to the arguments presented in this
case, it must be emphasised that a narrowing construction of a broader claim language
(" Auslegung unterhalb des Wortlauts") on the basis of the description or drawings should
only be allowed in exceptional cases (UPC_CFI_355/2023).
UPC_CFI_501/2023
18
2. Background of the patent
The human heart can suffer from various valvular diseases. These valvular diseases can
lead to significant dysfunction of the heart and ultimately require replacement of the
native valve with an artificial valve. According to the patent specification, there are a
number of known artificial valves and a number of known methods of implanting these
artificial valves in humans ([0002] of the patent).
3. Prior art
There are several surgical techniques that can be used to replace or repair a diseased or
damaged native heart valve ([0003] of the patent). One option is to replace the defective
native valve with a prosthetic valve. Another less drastic method of treating defective
valves is repair or reconstruction, which is typically used for minimally calcified valves. If
the native valve is replaced, surgical implantation of the prosthetic valve usually requires
open-chest surgery, during which the heart is stopped, and the patient is placed on
cardiopulmonary bypass (a so-called "heart-lung machine"). In a common surgical
procedure, the diseased native valve leaflets are removed, and a prosthetic valve is
sutured to the surrounding tissue at the valve annulus ([0004] of the patent).
Due to the disadvantages associated with conventional open-heart surgery,
percutaneous and minimally invasive surgical approaches are receiving considerable
attention. In one technique, a prosthetic valve is configured to be implanted via
catheterisation in a much less invasive procedure. For example, US Patent Nos.
5,411,522 and 6,730,118 describe collapsible transcatheter heart valves that can be
delivered percutaneously in a compressed state on a catheter and expanded to the
desired position by balloon inflation or by using a self-expanding frame or stent. Further
examples of percutaneously deployable heart valves can be found in US 2009/240320,
WO 03/047468 and US 2006/259136 ([0005] of the patent).
4. Underlying problem
The problem with surgical therapy is the significant risk it poses to these chronically ill
patients, with high morbidity and mortality rates associated with surgical repair ([0003] of
the patent). Due to the trauma associated with the procedure and the associated
duration of extracorporeal circulation, some patients do not survive the surgical
procedure or die shortly thereafter. It is well known that the risk to the patient increases
with the duration of extracorporeal circulation. Because of these risks, a significant
number of patients with defective native valves are considered inoperable because they
are too frail to survive the procedure. It is estimated that more than 50 percent of patients
UPC_CFI_501/2023
19
over the age of 80 with valve stenosis are ineligible for valve replacement surgery ([0004]
of the patent). Due to the disadvantages of conventional open-heart surgery,
percutaneous and minimally invasive surgical approaches have been developed ([0005]
of the patent).
An important design parameter of a transcatheter heart valve is the diameter of the folded
or crimped profile. The diameter of the crimped profile is important because it directly
affects the physician's ability to advance the transcatheter valve through the femoral
artery or vein. In particular, a smaller profile allows a larger patient population to be
treated with improved safety ([0006] of the patent).
Against this background, the invention aims to provide an implantable prosthetic heart
valve with a smaller crimped diameter on the one hand and sufficient safety, product
reliability, security and longevity on the other hand as explained in [0018] of the general
disclosure and with view to an exemplary embodiment in paragraph [0056] of the patent-
in-suit.
5. Skilled person
Both parties agree that the skilled person is a team. While Edwards suggests that the
team consists of a medical device engineer and an interventional cardiologist, Meril
wants to add a cardiac surgeon to the team. The Court considers that the addition of a
cardiac surgeon to the team is unnecessary since an implantable prosthetic heart valve
is usually delivered via a catheter and an interventional cardiologist is familiar with
catheter-based cardiac procedures. However, it should be noted that this in no way
affects the outcome of the decision.
6. Solution
As a solution, the patent and the underlying patent application WO035 disclose several
inventions such as heart valves including the respective frame geometry, delivery
systems and assemblies comprising both delivery systems and heart valves. Claim 1 of
the patent-in-suit is directed to an implantable prosthetic heart valve having the following
features
UPC_CFI_501/2023
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The invention as claimed in the patent-in-suit can best be understood with view to the
exemplary embodiment disclosed in paragraphs [0049] - [0056] and Figs. 21 – 35.
The valve comprises a number of leaflets. A tricuspid configuration mimicking the
construction of a natural heart valve is illustrated. The figure is reproduced from Edwards'
statement of claim (German version), p. 29 SoC (with the term “leaflet attachment
portion” and the corresponding arrows being added by the court).
UPC_CFI_501/2023
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“Fig. 2” indicates that it is a figure of the description of the patent. “Abbildung 7” refers to
the numbering added by Edwards when displaying the figure in the SoC. Same applies to
further figures.
An individual leaflet is shown below. It has a body portion (yellow), two opposing primary
side tabs (116) (red) and two opposing secondary side tabs (112) (grey). The illustration is
reproduced from Edwards' statement of claim, p.33 [German version].
The leaflet structure 14 (= all three interconnected leaflets) is secured to the frame of the
valve by the primary tabs 116 (red) and the secondary tabs 122 (grey) of the leaflets.
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The operation of the primary tabs (red) in combination with the secondary tabs (grey) is
described in the detailed description and the figures but is not part of the claims. The
following passage relating thereto is reproduced from [0054], wherein the secondary tab
is referred to as upper tab portion 112:
The secondary tab 112 (grey) comprises a first (inner) portion 142 and a second (outer)
portion 144. The first and second portions 142, 144 are subject to folding as required by
features 3 and 4 of claim 1 (see below), mentioned after 'characterised in that' in the
published version of the claims. The folding of the secondary tab thus constitutes the
core of the invention.
Fig. 26 shown above provides for illustration purposes a vertically extending broken line
running through secondary tab 112 depicted on the top right-hand side, illustrating the
first (inner) and second (outer) portions (142, 144, respectively) of the secondary tab.
The folding of the secondary tab is carried out in two steps:
First, the secondary tab is creased longitudinally (vertically, in the direction of its length)
so that it is folded about a radial axis.
Then, the second portion 144 is folded so as to obtain an L-shape of the secondary tab
112; this is obtained by folding the second portion 144 of the secondary tab 112 about an
axial (vertical) axis.
This is shown in the following two versions of Figure 30, which are reproduced from
Edwards’ statement of claim, pages 34 and 35 (German version). Figure 30 depicted on
the left shows the first folding step and the right Figure 30 shows the second folding step.
Both versions of Figures 30 illustrate the body portions of two leaflets (yellow) abutting
each other. A perspective view of the body portion of only one of the two leaflets is shown.
UPC_CFI_501/2023
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The second leaflet is located behind the leaflet shown in the foreground. The second
leaflet in the background also comprises primary and secondary tabs.
In the left-hand Figure 30, the first portion 142 of secondary tab 112 is folded
longitudinally (vertically) in the first folding step about a radial axis shown in the left-hand
Figure 30 as a dashed blue line. As a result of the first folding step, the first portion 142 of
the secondary tab (light grey) lies flat on the body portion 40 of the leaflet (yellow).
The second folding step of the secondary tab is shown at the right-hand Fig. 30 above.
The second (outer) portion 144 of the secondary tab 112 is folded radially towards the
first portion about an axially extending axis shown in the right-hand Figure 30 as a dashed
blue line. As a result of the second folding step, the secondary tab has an L-shape
comprising the second portion 144 of the secondary tab (dark grey) arranged
perpendicularly to the first portion 142 of the secondary tab (light grey). The right-hand
FIG. 30 thus shows two L-shaped secondary tabs belonging to the front and rear leaflets,
respectively.
The manipulation of the primary tabs 116 is not part of claim 1 of the patent. The following
is, however, mentioned for better understanding of the invention:
As shown in Figure 24 below, the primary tabs 116 of two adjacent leaflets are connected
by a flexible connector 124. The resulting structure is also referred to as a commissure
tab assembly (see [0054] cited above and Fig. 31):
UPC_CFI_501/2023
24
When the third leaflet is fitted, the three leaflets of the valve are joined together as shown
in Figure 25 below:
According to [0054] cited above, the commissure tab assemblies (primary tab 116 plus
flexible connector 124) are inserted through the commissure windows 20 so that the
leaflet structure of Fig. 25 is secured to the frame.
In practice, the leaflet structure of Fig. 25 is first secured to the commissure windows 20
of the frame via the primary tabs 116 and corresponding commissure tab assemblies
before the secondary tabs are folded as described above and as claimed in claim 1.
The result of all the folding operations is shown below in a perspective view (Fig. 30) (left)
and a corresponding cross-sectional view (Fig. 29) (right) (both figures taken from
Edwards' claim):
UPC_CFI_501/2023
25
The primary tab 116 (red), inserted through the commissure window 30, sits opposite the
second portions 144 of the secondary tabs (dark grey). The primary tab is positioned on
the outside of the frame of the valve and is covered by the flexible connector 124.
The first portions 142 of the secondary tabs (light grey) are folded over and lie flat on the
body portions of the leaflets (yellow). The second portion 144 of the secondary tab (dark
grey) abuts the first portion 142 vertically. It should be noted that the second portion 144
of the secondary tab is located on the inside of the frame of the valve, opposite the
primary tab that is located on the outside of the frame.
The advantages of this construction are summarised in [0018] and [0056]:
Thus, the above-mentioned problem, to provide an implantable prosthetic heart valve
with a smaller crimped diameter on the one hand and sufficient safety, product reliability
and longevity on the other hand is solved.
UPC_CFI_501/2023
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7. Some features require further explanation and construction.
a. Feature 2.b.aa "comprising a body portion"
aa. Meril's Interpretation
Meril submits in the context of the infringement test that the overall object of the patent
is to provide a small(er) crimp profile and refers in that regard to paragraph [0006]:
This object is obtained by providing a tapered shape of the frame to make room for the
attachment of an outer skirt according to paragraph [0008]:
In view of this, Meril argues that the objective problem of the patent requires leaflets
having a "substantially V-shaped intermediate edge portion” 120 (red line) and a vertical
edge portion (blue line):
UPC_CFI_501/2023
27
Meril submits that the shape is defined in paragraph [0049] in the sense of a legal
definition using the patent as its own dictionary:
Meril further submits that this is also required on the basis of a functional claim
construction because the V-shaped shape of the body portion ensures, according to
paragraph [0060], that less leaflet material is present in the inflow portion of the valve,
which supports a tapered shape of the valve ("can be at least partly due to"):
UPC_CFI_501/2023
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This is illustrated in the below modified version of Fig. 21 of the patent taken from p. 22 of
Meril’s statement of defence where “.... a more rounded, U-shaped leaflet has been
added for comparison purposes - see the green dashed line....” (sentence bridging from
the bottom of p. 21 to top of p.22).
The V-shape would be necessary to achieve the overall aim of the patent, i.e. a smaller
crimping profile. Meril submits that, in view of this, feature 2 b) (aa) (=body portion) must
be interpreted as "V-shaped body portion", i.e. limiting its literal meaning.
UPC_CFI_501/2023
29
bb. Edwards' interpretation
Edwards argues that paragraph [0049] is in the example section of the patent and refers
to the specific embodiment shown in Figure 21, which is referred to in paragraph [0049]
as "the illustrated configuration" (see [0049] line 4 as reproduced above).
Claim 1, however, contains no such limitation. Edwards points out that it is settled case
law in Germany that exemplary embodiments are generally not intended to limit or
broaden the scope of an independent claim. A limitation is only possible in exceptional
cases, e.g. if the technical teaching of the patent is only possible if the teaching of the
narrower exemplary embodiment is applied. Insofar as Meril relies on the case law of the
German Federal Court of Justice according to which a patent is to be regarded as "its own
dictionary", such case law only applies if the claim uses a term which differs from its
usual understanding in the CGK. This is not the case here, as the term "body portion" used
corresponds to the terminology used by the person skilled in the art. Also, from a
functional point of view, the patent does not require that the term "V-shaped leaflets" as
used in paragraph [0060] reproduced above means that the leaflets have a strictly
geometrical V-shape. This would be inconsistent with Figure 21 and paragraph [0049] and
other passages of the specification summarised by Edwards as follows:
Edwards concludes that a precise V-shape of the body portion of a leaflet is not relevant
to the function of the invention. The shape of the leaflets is referred to in dependent claim
11, which does not use the term "V-shape" but states that the intermediate portion of the
edge portion of the leaflet has a curved apex portion (119) adjacent the inflow end of the
frame (12) and a pair of oblique portions (121) that extend between the axial edge
portions (118) and the apex portion (119): (based on [....] of the patent)
UPC_CFI_501/2023
30
In view of this, a limitation of the term "body portion" of the leaflet, as suggested by Meril,
cannot be inferred from the wording of the claims and/or the specification and the
drawings.
cc. The Court's interpretation
The presence of V-shaped leaflets is optional and not mandatory. Claim 1 does not
further specify the shape of the body portion of a leaflet, so that claim 1 broadly refers to
valves with leaflets of any shape.
Paragraphs [0017] and [0018] of the general part and paragraphs [0049] - [0056] of the
example part of the specification relate to the invention as claimed.
The term "V-shape" is only referred to in paragraph [0049] of this group of paragraphs:
UPC_CFI_501/2023
31
The substantially V-shaped shape of the body portion of the leaflet is referred to in [0049]
as "in the illustrated configuration" and is therefore exemplary and not mandatory. It is
true that a "generally V-shaped leaflet" is shown in Figs. 21-28 of the set of Figs. 21-31
relating to the claimed invention, but this is stated, for example, in [0024]:
Such a subtantially V-shaped shape of the body portion of the leaflet is claimed in claim
11 that is dependent on claim 1, although the term “V-shaped” is not used in the claim
language:
UPC_CFI_501/2023
32
This underlines that a substantially V-shaped format of the leaflet is not a mandatory
requirement for independent claim 1.
The technical considerations put forward by Meril do not justify a narrow interpretation of
the term either.
Meril states on p. 21 of its defence to Edwards' claim in section 5:
It needs to be noted, however, that the above quoted passage of paragraph [0060] (yellow
highlighting added by the Court) clearly states: "The tapering of the frame can be at least
partially due to the V-shaped leaflets" (emphasis added).
The Patent discloses various ways of achieving a tapered configuration of the frame in the
crimped state of the frame. An example is disclosed in paragraph [0012] of the general
part of the specification as follows
The technical effect of this frame design is described in paragraph [0036] and illustrated
in Figures 53 and 54:
UPC_CFI_501/2023
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UPC_CFI_501/2023
34
In addition, the patent specification discloses another way of providing a tapered shape
of the frame, e.g. in paragraph [0014] of the general part of the description as follows
Thus, the presence of V-shaped leaflets is only optional and not mandatory.
b. Features 3.a and 4.a "folded about a radially extending crease" and "folded about an
axially extending crease"
aa. Meril`s interpretation
Meril argues in the context of the validity attack that the terms “radially extending” and
“axially extending” are relative terms without a precise meaning at least in claim 1 as
there is no indication in claim 1 that the leaflets are secured to the frame by the tabs.
Also, in Figure 21, for example, both the radially and axially extending creases are inclined
against the x- and y-directions respectively, i.e. not aligned with the flow axis of the valve
and the radial axis which is perpendicular to the flow axis.
.
As a result, the terms "radially extending" and "axially extending" include orientations that
are tilted relative to the x- and y-directions, so that these terms are not limiting and can
be disregarded.
Meril further points out that the term "folding" describes a process step which, according
to the case law of the EPO, only contributes to the patentability of a product claim if the
process step results in a new constructional feature of the article. In the present case,
the folding step would result in a double-layer structure of the secondary leaflet tabs,
which could also be achieved by other means.
UPC_CFI_501/2023
35
bb. Edwards` interpretation
Edwards argues that the terms "'radially" and "axially" are absolute and not relative. While
relative terms such as thick/thin can have different meanings depending on the context,
the terms "axially" and "radially" both refer to directions relative to the flow axis of the
valve, which is an unambiguous reference axis. As a result, the terms "axially" and
"radially" would describe concrete and specific spatial directions that are essentially
perpendicular to each other.
The terms "axially extending crease" and "radially extending crease" used in the patent
claims do not have a strict geometric meaning as these terms are used in the technical
context of a valve rather than in mathematics. Thus, for example, the term "radially
extending crease" will be understood by those skilled in the art to mean that the crease
extends substantially perpendicular to the axial direction of flow.
The radially extending fold, both in the assembled valve and in the flat-folded leaflet, can
be seen from the following annotated figures provided by Edwards:
Edwards argues that the orientation of the crease is represented by the dashed blue line,
whereas the dashed green line would represent the direction of extension of the top edge
of the leaflet. Therefore, the orientations of the crease and the top edge are not the same.
UPC_CFI_501/2023
36
As to the issue of an alleged process feature in claim 1, Edwards argues that this issue is
irrelevant because claim 1 includes the term "folded" rather than " folding". The terms
"folded about radially or axially extending creases" provide clear structural limitations.
cc. The Court`s interpretation
The Court notes, first, that the terms 'axial direction' or 'axis' are used in the patent to
mean the direction of the length of the frame or the direction of the flow of blood. This is
clear, for example, from the following passages:
The radial direction is the direction in which the valve expands or collapses and is
perpendicular to the axial/blood flow direction; see, for example, the following passage:
These definitions do not appear to be disputed by the parties and are also consistent with
CGK in the field of transcatheter heart valves.
The Court agrees with Edwards that the terms “axial” and “radial” do not require a strict
orientation along the y-axis in a mathematical sense but that a certain deviation from the
x- and y-axis is possible. To the skilled person this is a clear teaching of the Patent-in-suit.
In claim 1 of the patent-in-suit the terms “radial” and axial” are disclosed when specifying
that the secondary tab is folded about a radially and axially extending crease, respectively
(features 3 and 4).
UPC_CFI_501/2023
37
These features need to be considered in conjunction with features 1 and 2
According to feature 1 the implantable prosthetic heart valves comprises an annular
frame. The frame extends between an inflow and outflow end (e.g. [0010] and [0015] that
extends along the axial (flow) direction and is thus (essentially) cylindrical in shape. The
leaflet structure that comprises a plurality of leaflets (feature 2a) is positioned within the
frame and secured to the leaflet attachment portion (commissure windows) of the frame
(feature 2).
It follows from this that features 3a and 4a of claim 1 (folding about radially and axially
extending creases, respectively) refer to the assembled leaflet structure as mounted into
and secured to the frame.
According to [0054] of the Patent features 3a and 4a are illustrated in Fig. 30.
UPC_CFI_501/2023
38
It can be seen that the second portion of the leaflet extends axially along the frame, and
the same is true for the axially extending crease about such portion was folded. Due to
UPC_CFI_501/2023
39
the L-shaped geometry of the folded secondary tab the radially extending crease is
vertical relative to the axially extending crease.
As to Meril's argument that claim 1 lacks an explicit limitation that the leaflets are
secured to the frame by the tabs, this is not correct in view of the clear language of
features 1 and 2 of claim 1. The skilled person appreciates that the leaflet structure of
claim 1 is part of an implantable prosthetic heart valve that is intended to function within
a human heart. It is therefore clear to the person skilled in the art that the body portion of
the leaflets must perform the function of controlling the flow of blood, while the tabs have
the function to secure the leaflets to the frame. Consequently, the Court is satisfied that
the features of "an axially extending crease" and "a vertically extending crease" are clearly
and unambiguously disclosed and have a technical meaning because they characterise
the position and the general direction of the extension of the creases of the assembled
leaflet structure relative to the blood flow direction. They are not relative terms and
cannot be disregarded.
Furthermore, the Court agrees with Edwards that the terms ''folding'' and ''folded'' are
different. The term 'folded' does not describe a folding operation but is a structural
feature describing the position of the creased tabs in relation to the body of the leaflet.
c. Leaflet to be composed of a single, unitary piece of material
aa. Meril's interpretation
Meril argues in the context of the validity attack that the patent does not require the leaflet
to be made of a single, unitary piece of material; the body portion could be made of
material being independent from the material of the tabs.
bb. Edwards' interpretation
Edwards refutes Meril's claim construction in this respect. The language of feature 2b) of
claim 1 is clear and requires that the body portions of the leaflet and the side tabs are
one piece.
cc. The Courts interpretation
The Court agrees with Edwards' claim construction.
Looking at the claim language as a whole, the skilled person will appreciate that each
leaflet comprises a body portion and not a body part.
Furthermore, the primary and secondary side tabs extend from opposite sides of the
body portion. In the case of leaflets with tabs composed of different parts, the skilled
person would refer to the parts forming the side tabs as being attached to the body part.
Not a single embodiment in the specification shows a multi-part leaflet. Consequently,
there is no information as to how the different parts are attached to each other.
UPC_CFI_501/2023
40
Finally, the secondary tabs are folded around a radially extending crease. In the case of a
multi-part leaflet, there would be a place where the multiple parts are joined together.
This location cannot be the crease. The skilled person would only refer to a crease in
relation to a one-piece situation. If the leaflet could be composed of multiple parts,
information would be needed to define the specific relationship between the place where
the parts are joined and the crease. There is no such information in the specification.
Therefore, the patent is directed to a leaflet structure comprising only one-piece leaflets.
VALIDITY
Added matter
1. Legal Standard
Pursuant to Art. 65(2) UPCA and Art. 138(c) EPC, a European patent may be revoked with
effect for a Contracting State on the ground that the subject-matter of the European
patent extends beyond the contents of the application as filed or, if the patent was
granted on a divisional application or on a new application under Article 61 EPC, beyond
the contents of the earlier application as filed.
Thus, in order to determine whether there is added matter, the court must first determine
what the person skilled in the art would deduce directly and unambiguously from the
whole of the application as filed, using his common general knowledge and viewed
objectively and in relation to the date of filing, whereby implicitly disclosed subject-
matter, i.e. matter which is a clear and unambiguous consequence of what is expressly
mentioned, is also considered to be part of the content of the application as filed. Where,
as here, the patent is a divisional application, this requirement applies to each earlier
application. The Court of Appeal notes that the assessment of added matter cannot be
limited to those parts of the original application which the patentee has indicated as the
basis for an amended claim during the examination proceedings before the EPO, since a
proper understanding of those parts also requires an assessment of their content in the
context of the disclosure of the application as a whole (UPC_CoA_382/2024
APL_39664/2024).
2. No added matter objection against claims 1-6
It is undisputed that claims 1-6, as granted and maintained by the OD, correspond to
claims 16-21 of WO035, so there is no added matter issue with respect to these claims.
Meril has not expressly conceded this but has not raised any added matter objections to
these claims.
UPC_CFI_501/2023
41
3. Dependent claims 7 and 8
a. Dependent claims 7 and 8 read as follows:
b. Meril`s argument
Meril submits that original claims 13 and 14 do not provide a basis for claims 7 and 8 of
the patent because original claims 13 and 14 were not dependent on original claim 16
(corresponding to claim 1 of the patent B2) and because the disclosure of WO035 did not
provide any indication that such a combination should be made.
Furthermore, claims 7 and 8 would be an intermediate generalisation with respect to
original paragraphs [0007] and [0008] of WO035. [0008] discloses an assembly
comprising a delivery device having an elongate shaft and a radially expandable
prosthetic heart valve mounted on the shaft in a radially collapsed configuration. [0008]
further discloses that the reduced diameter of the frame at the inflow end portion can
make room for an outer skirt positioned around the inflow end portion. These features are
absent from claim 7 as claimed.
UPC_CFI_501/2023
42
c. Edwards` argument
Edwards points out that original claim 16 can be combined with original claims 13 and 14
in view of the overall teaching of WO035 and refers in this respect to Fig. 43 which shows
the arrangement and folding of the primary and secondary side tabs as claimed in original
claim 16, as further illustrated by reference to original Fig. 30.
Fig. 43 is discussed in original paragraph [084], which discloses that the valve has an
outer skirt which bulges outwardly as the frame shortens during radial expansion. It is
also disclosed in [084] that "the slack between the lower and upper edges of the outer
skirt 18 allows the frame 12 to expand axially during crimping without resistance from the
outer skirt, and the outer skirt does not substantially affect the outer diameter of the
prosthetic valve in the crimped position".
d. Meril’s counterargument
Meril argues in its response to the defence that a combination of Figs 43 and 30 together
with [084] does not disclose the subject matter of claims 7 and 8 as maintained by the
OD because Fig 43 comprises several other features such as:
• The outer skirt shown in Fig. 43 has projections 164 and notches 166
• in Fig. 43, each projection 164 being sutured to the second row II of struts 24
• Claim 7 does not include the term "foreshortening" disclosed in [084].
e. The Court`s finding
The Court agrees with Meril that original claim 16 cannot be combined with original
claims 13 and 14 because claims 13 and 14 are not dependent on claim 16.
However, the Court notes that original claim 16 can be combined with original paragraph
[0015], which provides literal support for claim 7, as maintained by the OD. It is clear from
the wording of [0015] that its disclosure can be applied to all valves of the invention,
including the one shown in Figure 43 in combination with Figure 30 and paragraph [0084]:
UPC_CFI_501/2023
43
[0015] does not specify that the outer skirt includes projections and notches, so these
features are not mandatory. [0015] also does not specify the term " foreshortening", but
discloses that when the valve is collapsed to the collapsed configuration, the axial
distance between the inflow and outflow edges of the outer skirt increases (relative to
such distance in the expanded configuration); this appears to be synonymous with the
term "foreshortening" (cf. the definition of the term "foreshortening" as "shortening in
length" in [084] of WO035). Hence this is covered by the term 'collapsable' of claim 1
which is part of claims 7 and 8 by reference. [015] also does not require the outer skirt to
cooperate with an inner skirt, or that the outer skirt does not substantially affect the outer
diameter of the prosthetic valve in the crimped condition. There is, consequently, no
intermediate generalisation.
Since claim 7 was originally disclosed, support for claim 8 can be found in original claim
14.
Thus, claims 7 and 8 are originally disclosed.
UPC_CFI_501/2023
44
4. Dependent claim 9
a. Claim 9 corresponds to claim 10 as granted with the addition of the feature highlighted
in yellow:
b. Merril’s argument
Meril argues that original claim 22 cannot provide a basis for claim 9 of the patent-in-suit
because claims 16 and 22 of WO035 are independent claims which cannot be combined
unless a specific pointer could be identified in WO035. In addition, claim 22 would
include features such as the valve being radially expandable and collapsible which are
not included in claim 9. Also, claim 22 requires that the inner skirt comprises a weave of
a first with a second set of strands, both of which are non-parallel to the axial direction of
the valve. The same comments apply to paragraph [019] of WO035, which therefore also
cannot provide a basis for claim 9 of WEO035.
c. Edwards` argument
Edwards points to the first sentence of paragraph [064] of WO035, reproduced below,
and submits that this would provide literal support for claim 9:
Edwards further argues that the literal disclosure for claim 9 in claim 22 and paragraph
[019] of WO035 could be combined with the exemplary embodiment shown in Figures 43
and 30 of the patent specification.
UPC_CFI_501/2023
45
d. The Court`s finding
The Court notes that the first paragraph of paragraph [064] of WO035 provides literal
support for claim 9, whereas the other features disclosed in [064] are optional (see
reproduction of [064] above).
Figure 39, referred to in [064], shows that the leaflets tabs are folded as required by claim
16 in combination with an inner skirt sutured to the frame with sutures 70 :
The OD had stated in its preliminary opinion on claim 10 as granted as follows
The Court agrees with that statement and considers that the intermediate generalisation
originally identified by the OD has been cured by the inclusion of the words "wherein the
inner fabric skirt (16) is secured to the frame (12) via sutures (70)".
The Court also considers that the feature of a specific composition of the inner skirt
comprising a weave of first and second sets of strands, both of which are not parallel to
UPC_CFI_501/2023
46
the axial direction of the valve, is not intrinsically linked to the feature of the inner skirt
being secured to the frame. It is true that both features are disclosed side by side in
paragraph [019] of the general part of the specification of WO035 and in independent
claim 22. It is also disclosed in [019] that the technical effect of this fabric construction
is to allow the inner skirt "to elongate in the axial direction along with the frame". However,
the Court notes that the specific construction of the fabric of the inner skirt is not
inseparable from the securing of the inner skirt to the frame, since the inner skirt can
alternatively be formed, for example, from woven elastic fibres (see [072]).
For these reasons, the Court concludes that claim 9 is originally disclosed.
5. Dependent claim 10
a. Claim 10 reads as follows:
b. Meril`s argument
Meril argues that a nickel-cobalt-chromium-molybdenum frame is only disclosed in [052]
and [053] of WO035. [052] refers to Fig.4 and requires balloon expansion for frames made
of plastically expandable materials. Similarly, the selection of nickel-cobalt-chromium-
molybdenum represents a selection from several lists that was not originally disclosed.
c. Edwards` argument
Edwards refers to the OD's decision that paragraph [053] of WO035 discloses that the
frame may be expanded by a balloon or equivalent expansion mechanism, i.e. a balloon
is not mandatory. [053] discloses "suitable plastically expandable materials" so that any
material selected from [053] is a plastically expandable material – therefore no selection
is required. Also, the skilled person would understand that a nickel-cobalt-chromium-
molybdenum material can be used for the frames disclosed in WO035 in general and is
not intended to be used exclusively for the frame of Figure 4.
d. The Court`s finding
The Court agrees with the OD and Edwards for the reasons stated.
UPC_CFI_501/2023
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6. Dependent claim 11
a. Claim 11 reads as follows:
b. Meril`s argument
Meril argues that paragraph [010] of WO035 does not support claim 11 of EP828B2
because that paragraph does not specify opposing pairs of primary and secondary tabs.
Paragraph [010] of WO035 is distinguished from paragraph [017] of WO035, which
corresponds to claim 16 of WO035 and thus to claim 1 as maintained. Meril submits that
paragraph [010] of WO035 refers to Figs 57 and 58 of WO035, which show leaflets
comprising only one opposing pair of primary tabs.
c. Edwards` argument
Edwards refers to the decision of the OD that stated in mn. 18.4 of the decision:
UPC_CFI_501/2023
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d. The Court`s finding
The Court agrees that the general disclosure of paragraph [010] can also be used with the
leaflet structure of claim 16 of WO035. Paragraph [010] of WO035 provides literal support
for claim 11:
In addition, the leaflet exemplarily shown in Figure 21 of WO035 has all the features of
claim 11, as shown in the annotated Figure 21 of WO035 provided by Edwards that is
reproduced below:
UPC_CFI_501/2023
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7. Independent claim 12 and dependent claims 13-14
a. These claims refer to an assembly for implanting a prosthetic heart valve and read as
follows.
b. Meril`s argument
Meril argues that claim 12 of EP828B2 is supported only by [0008] of WO035, whereas
claims 1-9 of WO035 cannot provide a basis because the further features of those claims
are not specified in claim 12. Paragraph [0008] requires the valve to be mounted on the
shaft whereas claim 12 specifies that the valve is adapted to be mounted. Also, [0008]
requires that "[t]he outer diameter of the inflow end portion of the frame is smaller than
the outer diameter of the outflow end portion of the frame". This feature is absent from
claim 12.
Meril argues in relation to claim 13 that only paragraph [0085] and Fig. 56 of WO035 cited
therein refer to an elongate shaft bearing an inflatable balloon. Paragraph [0085] requires
the frame of the valve to have a tapered shape, at least in part due to the presence of V-
shaped leaflets. This feature is missing in claim 13, so there is an inadmissible
intermediate generalisation.
UPC_CFI_501/2023
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Finally, with respect to claim 14, Meril argues that this claim depends on claims 12 or 13,
so that the objections raised for those claims apply mutatis mutandis. Meril also argues
that the tapered shape of the frame can result from various effects, such as frames
comprising lower cells with larger openings compared to intermediate cells with smaller
openings (paragraph [061]) or the valve comprising V-shaped leaflets (paragraph [085]).
Neither of these features is present in claim 14.
c. Edwards` argument
Edwards rejects these attacks in a rather general way, as can be seen from its reply to the
reply to the defence of the CC:
The OD addresses the original disclosure of claim 12 of EP828B” by referring to paragraph
[0081] of WO031, which discloses an embodiment of claim 1 shown in Figures 29 and 30.
The OD notes that this paragraph discloses a valve which is compressed and mounted
on a delivery shaft. A tapered design of the frame having a larger diameter at the outflow
end portion of the frame compared to the diameter of the inflow end portion is not
disclosed in [0081], so that such a feature is optional. Therefore, claim 12 is originally
disclosed.
The OD further argues in relation to claim 13 that paragraph [0008] is in the general part
of WO035 and therefore broadly discloses the assemblies defined by claims 12 and 14.
The OD notes that while paragraph [0008] discloses that the outer diameter of the inflow
end of the valve is smaller than that of the outflow end to provide room for the outer skirt,
that paragraph also states that this "may be due to a reduced amount of materials
positioned within the inflow end portion of the frame".
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Therefore, this feature and the effect it provides (making room for an outer skirt) are
optional and need not be included in claim 13. Claim 13 is therefore originally disclosed.
With respect to claim 14, the OD concludes:
Hence, claim 14 is also originally disclosed.
d. The Court`s finding
The Court agrees with the OD on these points.
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52
Novelty
1. Legal Standard
Pursuant to Art. 65 (2) UPCA and Art. 138(a) EPC, a European patent may be revoked with
effect in a Contracting State on the ground that the subject-matter of the European patent
is not patentable under Articles 52 to 57 EPC.
For the purposes of Article 54 EPC, an invention is considered to be new if it does not
belong to the state of the art. According to Article 54(2) EPC, the state of the art is to be
taken to mean everything that has been made available to the public by means of a
written or oral description, by use, or in any other way, before the date of filing of the
European patent application (or, where applicable, the priority date). The assessment of
novelty under Art. 54 (1) EPC requires an examination of the entire content of the prior
publication. It is decisive whether the subject-matter of the claim is directly and
unambiguously disclosed with all its features in the prior art references (UPC_CFI_
252/2023; UPC_CoA_182/2024).
2. Meril mentioned the following references in the counterclaim:
Reference
no. CC
Reference no.
Opposition
Document no. Main inventor
“nick name” used in
pleadings
HL-CC 5 D11 US 2006/259,136
A1published 16 November
2006
Nguyen
HL-CC 6 D2 US 2009/0,157,175 A1
published 18 June 2009
Benichou
HL-CC 7 - US 6,767,362 B2 published
24 July 2004
Schreck
HL-CC 8 D3 US 2004/0,186,563 A1
published 23 September
2004
Lobbi
HL-CC 9 D1 WO 2007/013,999 A2
published 1 February 2007
Jaramillo
HL-CC 10 D4 WO 2009/042,196 A2
published 2 April 2009
Braido
HL-CC 11 D9 US 2006/0,259,137 A1
published 16 November
2006
Artof
HL-CC 12 - Chapters 2, 7, 8, 18, 21 and
Appendices 3, 4 from
-
UPC_CFI_501/2023
53
Serruys, P. W., Piazza,N.,
Cribier, A., Webb, J. G.,
Laborde, J. C., & de
Jaegere, P. (2009).
Transcatheter Aortic Valve
Implantation, informa
healthcare
HL-CC 13 - Feldman, T., & Leon, M. B. (2007). Prospects for
percu-taneous valve
therapies. Circulation,
116(24), 2866-2877.
-
HL-CC 14 D5 US 2010/0036484 A1
(“Hariton”), published 11
February 2010
HL-CC 15 - US 6,730,118 B1 Spenser
HL-CC 16 - Grube et al., JACC vol. 50,
no. 1, 2007:69-76, 3 July
2007
Grube
HL-CC P1 P1 US 61/390,107 (first priority
document)
HL-CC P2 P2 US 61/508,513 (second
priority document)
Prior art references HL-CC 15 and HL-CC 16 were filed late. Meril filed these references
with the reply to the defence dated 2 September 2024, without giving any reason for the
late filing. The Court therefore disregards the late filed prior art references and the
arguments relating to them (Rule 9.2 RoP).
3. Nguyen
a. Meril`s argument
Meril argues, based on its claim construction discussed above, that the terms "axially
and radially extending creases" are non-limiting relative terms that cannot establish
novelty over Nguyen.
During the oral hearing Meril has shown the slide reproduced below that show a leaflet of
Nguyen in the non-assembled state.
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Meril argues that fold line e is a radially extending crease whereas fold line f is an axially
extending crease although both fold lines extend in parallel to each other. Since the fold
lines would not extend in the axial direction, they would both have a radial and an axial
component. According to Meril it depends on the result of folding what component of the
fold line “prevails”. By folding flap 35 along line e, it lies atop flap 34, forming seam 42
comprising a triple thickness of the tissue (Nguyen, p.4, right col., paragraph [0053]). This
would be functionally equivalent to the folding of the first portion of the secondary tab
112 in claim 1 along a radially extending crease so that it lies flat against the body portion
of the respective leaflet.
Contrary to that, flap 36 of Nguyen is folded along line f so that it extends in a different
plane than flaps 34 and 35 (slide 29 of Meril presented during the oral hearing;
highlighting added). Therefore, line f would qualify as an axially extending fold line
UPC_CFI_501/2023
55
As a result, Nguyen discloses all features of claim 1 of the patent.
b. Edwards’ argument
Edwards refers to its claim construction and argues that Meril's claim construction of
feature groups 3 and 4 is incorrect. Edwards points out that Nguyen has three flaps on
each side which are folded along fold lines d, e and f, all of which are parallel to each
other and extend axially in the assembled valve. Therefore, there is no teaching in Nguyen
that the tabs are folded along radially extending creases. Furthermore, the tabs in Nguyen
are all folded so that they lie on top of each other and thus extend in the same plane of
space.
Edwards also submits that the teaching provided by Nguyen is insufficient. Flaps 36
would extend outwardly in Fig. 4A but inwardly in Fig. 4B. This would be inconsistent, and
it would be completely unclear how the arrangement of Fig. 4B can be obtained.
c. The Court`s finding
The Court notes that Nguyen (FL-CC5) was also on file as D11 in the opposition
proceedings, but didn't play a major role there.
Nguyen discloses a heart valve with three leaflets 22 ([038] of Nguyen). A leaflet is shown
in annotated Figure 3A below (taken from Meril’s counterclaim for revocation, p. 41):
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56
A leaflet comprises three opposite pairs of tabs 34, 35, 36 on opposite sides of the body
33. The tabs are folded (Figs. 3A, 4A) about fold lines d, e and f and inserted into the skirt
21 of the valve to provide the assembly of valve body 14 (Fig. 4B).
This is shown in the following annotated Figures 3A, 3B, 4A and 4B of Nguyen; the
annotated figures are taken from Edwards' defence to the CC:
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Fig. 3A shows a leaflet 22 having a body portion 33 and lateral ends 30, 31 which each
comprise tabs 34, 35 and 36. Three tabs 34, 35, 36 are folded about fold lines d, e and f
that are parallel to each other. Flap 35 is folded along line e so that it lies atop flap 34
forming seam 42 comprising a triple thickness of the tissue ([0053]). Figure 4A shows the
three tabs 34, 35 and 36 in a folded condition.
The seams 43 are formed by folding reinforcing tabs 38 about fold lines g, h and i, and by
fastening together reinforcing end tabs 40 and 41 ([0054] and Fig. 3B).
Figure 3B shows the skirt 21 of the valve. Fig. 4B shows that adjacent leaflets 22 and the
skirt 21 are joined ) along seams 42 and 43 The leaflet assembly is attached to the skirt
21 along the lower edges of the leaflet bodies 33 forming the joint 44. The valve body 14
shown in Figure 4B is closed to form an annular body which is then attached to the frame
12 via the folded tab assemblies.
During the oral hearing, Meril showed a modified version of Fig. 4A that shows the leaflet
in a position with that the leaflet is assembled into the skirt and the valve (modified Fig.
4A below on the right). This can be compared with original Fig. 4A of Nguyen that shows
the leaflet in an arbitrary position (Fig. 4A on the left).
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The parallel folding lines d, e and f are arranged essentially axially when the leaflet is
displayed in the assembled state. The slight deviation from the axial direction is removed
when the valve body 14 shown in a flattened-out configuration in Fig. 4B is closed to a
cylindrical configuration that is inserted into the frame (Fig.6).
Therefore, all tabs of the leaflets of Nguyen are folded about parallel and axially
(vertically) extending fold lines in the assembled valve body 14. There are no secondary
tabs folded about a radially extending fold or fold line.
Thus, Nguyen does at least not disclose a radially extending fold line.
Furthermore, in the assembled state, all tabs 34-36 extend in the same plane (see [0055]
and Figs. 4A and 6).
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Therefore, Nguyen does at least not disclose features 3a, 3b and 4b and the patent-in-
suit is novel over Nguyen.
4. Benichou
Meril has not referred to Benichou as a novelty-destroying reference in its reply to the
defence to the CC for revocation and its presentation in the oral hearing anymore. In case
this argument is nevertheless to be understood to be maintained, the following applies:
a. Meril`s argument
Meril’s argument is based solely on the claim construction according to that the patent does
not require that the leaflets be made of a single, unitary piece of material; they could also be
made of a composite material.
b. Edwards` argument
Edwards again rejects Meril's claim construction. The language of feature 2b) of claim 1 is
clear and requires that the body portions of the leaflet and the side tabs be made of the same
material.
c. The Court`s finding
The Court notes that Benichou is on file in the CC proceedings as HL-CC 6 and
corresponds to D2 in the opposition proceedings.
Benichou generally discloses a two-part foldable frame of a valve with an upper and a
lower portion, each of the two portions being formed with rounded arcuate portions. The
arc portions are separated by a gap 282 which sandwiches the leaflet attachment
portions 314 (see Figs 5 and 6 of Benichou).
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Figure 6, taken from Meril's CC for revocation, p. 50, is taken along line 6-6 in Figure 5.
Figure 6 shows that the leaflet is inserted into the gap between the upper and lower parts
of the frame. The leaflet is attached to the first and second arch portions of the respective
parts of the frame by fabric 304.
Figure 7 of Benichou shows a leaflet 106 (green) having a U-shaped bottom edge line. A
plurality of fabric (or cloth) portions 310 are sutured to the leaflet via suture lines 330. The
fabric portions are folded around the edge of the leaflet as shown in Figure 8 and then
inserted into the gap between the upper and lower portions of the frame as shown in
Figure 6. The upper and lower fabric portions are folded around the first and second arc
portions as shown in Figure 6 above.
This is described in [0053] of Benichou as follows:
It is clear from the highlighted passage that the leaflet 106 and the fabric portions 310 are
separate elements, contrary to what is required by features 2 b), bb) and cc).
This is also recognised by the EPO's OD, which states in mn. 23.1.2: "D2 does not disclose
leaflets with tabs but uses a separate cloth" (D2 corresponds to HL-CC 6 in the present
proceedings).
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61
Furthermore, the pieces of fabric do not have any creases or fold lines but are simply folded
around the edge of the leaflet.
Accordingly, Benichou does not disclose any tab at all.
Consequently, D2 does not disclose features 2(b), 3 and 4. The patent is novel over
Benichou.
5. Jaramillo
a. Meril`s argument
Meril argued in its revocation counterclaim that the upper and lower opposing pairs of
tabs (shown in red and blue in Jaramillo’s Fig. 8 below that was taken from Meril’s CC for
revocation, p. 54) form primary and secondary tabs. The lower tabs, shown in red, are
divided into two portions so that the small inner portions of the tab - together with the
body portion of the leaflet - are folded along a radially extending crease. In this way, the
small inner portions of the lower tabs are folded onto the body of the leaflet. The large
outer portions of the lower tabs are folded along a vertical crease so that the large outer
portions lie in a different plane to the body of the leaflet.
With its reply to the defence to counterclaim and at the oral hearing, Meril provided a
different interpretation of Fig. 8A of Jaramillo as shown below ( slide #32 provided by
Meril):
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62
Meril argues that in modified Fig. 8A of the revised interpretation (shown on the top right)
only the orange portion represents the body portion of the leaflet that is connected to
primary tabs that are white (not coloured). Only the red portion would coapt against other
leaflets in the middle portion of the valve thereby allowing for blood flow in the open state
and preventing blood flow in the closed state. The lower portion of the leaflet would be
composed of two secondary tabs that would seal the valve against the frame. The
secondary tabs have a first portion that is folded onto the white primary tabs and is then
folded together with them about a vertically extending axis. The second portion of the
secondary tab is folded along the radially extending crease and lies flat atop the body
portion of the leaflet. The second portion of the secondary tab thus extends in a different
plane than the first portion.
In view of this interpretation claim 1 of the Patent lacks novelty over Jaramillo.
b. Edwards` argument
Edwards argues that the new construction provided by Meril is artificial because, e.g., the
radially extending crease runs along the edge of the body of the leaflet and not within the
tabs.
Edwards refers to paragraphs [070] and [076] of Jaramillo and submits that the person
skilled in the art could only take from these paragraphs that the body portion of Jaramillo
comprises both portions located on both sides of the central folding line.
Edwards further submitted the following slide in the oral hearing (slide # 28) that shows
the folding line of a leaflet in an unfolded state (Fig. 8A) and in a top view of the valve (Fig.
UPC_CFI_501/2023
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8B). Edwards submits that the folding line is a secant that does not extend through the
centre of the (dotted) circle. Therefore, the fold line would not represent a radially
extending fold line:
Since Jaramillo would not disclose a secondary tab at all and no radially extending fold
line (feature groups 3 and 4 of claim 1) the patent-in-dispute is novel over Jaramillo.
c. The Court´s finding
First, the Court notes that Jaramillo discloses an unusual configuration of a heart valve
which is described in more detail in [0070] and [0076], and is schematically illustrated for
a double coaptation leaflet in Figures 8A, 8B, 12A and 12B below (all taken from Edwards’
defence to CC for revocation, pp. 39 and 40):
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UPC_CFI_501/2023
65
A leaflet for a double coaptation arrangement is shown in Figure 8A. The leaflet is folded
about its horizontal axis (Fig. 8A) shown as a dashed red line (Figs. 8A and B) and forms a
pocket-like structure in the assembled state (marked in yellow in the spherical view of
Fig. 12A). The pockets are formed by plies 14a and 14b (top view of Fig. 8B). The red fold
line of Figure 8A is also shown in the top view of Figure 8B (for another of the three
pockets).
The valve is shown in the closed position in Figure 12A. It can be seen that the valve
comprises three pockets which are centrally aligned with each other and peripherally
aligned with a stent 12. The stent 12 is also of unusual construction.
UPC_CFI_501/2023
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Figure 12B shows the valve in the open position where it can be seen that the pockets are
radially compressed to allow blood to flow both centrally and peripherally in the axial
direction. In Figure 12B the number "1" is covered by one of the red arcs.
When Figures 8A and Fig. 4 are considered side by side (taken from Edwards’ defence to
CC for revocation, p. 40), it can be seen from Figure 8 that the leaflet 38 comprises a body
portion (blue) and tabs (green) extending from the body portion.
The body portion (not a tab) is folded along the horizontal fold line (shown as red dashed
lines in Figure 8A above on the previous page) to form the pocket-like structures shown
in Figure 4.
This was also the position taken by the OD in its decision to maintain the patent in
amended form:
The OD refers to Jaramillo as D1. Features 1.2.3 and 1.2.4 correspond to features 3 and 4
of the feature analysis above. In particular, the OD states that the formation of the
coaptation pockets is achieved by folding the body portion of the leaflet which cannot be
considered as a tab (within the meaning) of the patent.
UPC_CFI_501/2023
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The tabs extending outwards from the pockets (Fig. 4) are used to attach the leaflets to
the frame 12, as can be seen in Figs. 12A and 12B; in this respect they can be folded along
a vertically extending edge line.
The interpretation of Fig. 8A shown by Meril is not convincing. It is explicitly stated in
[0070], 1st sentence that “(E)ach leaflet is both peripherally and centrally coaptable”. In
terms of the double coaptation leaflet 36 of Figs. 8A and 8B it is stated in [0076]:
Thus, Jaramillo explicitly states that the leaflets comprise two plies 14a and 14 b that seal
centrally and peripherally. This is in clear contradiction to the interpretation of Meril
suggesting that the outer ply 14 b is not part of the leaflet body but consists of two
secondary tabs.
The interpretation proposed by Meril bends the disclosure of Jaramillo and attempts to
artificially re-interpret it so that the outer ply 14b of the leaflet corresponds to secondary
tabs in the sense of the patent-in-suit. There is absolutely no hint in this regard in
Jaramillo, and the suggestion that this interpretation would correspond to the
understanding of a leaflet and its function by the person skilled in the art is not
convincing.
As was set out above, Jaramillo discloses a leaflet structure in which the body portions
are folded along an axis of symmetry which constitutes a crease. The portions of the
leaflet shown in green in modified Fig. 8A above can be considered as tabs because they
are drawn through the frame 12 and folded around the axially extending edge portion of
the leaflet and the corresponding portions of the frame for attachment. However,
Jaramillo does not disclose secondary tabs having a first and a second portion, the first
portion being folded along a radially extending crease to lie flat on the body of the leaflet
portion, and a second portion being folded along an axially extending crease so that the
second portion of the secondary tab lies in a different plane of space from the first
portion. Thus, Jaramillo does not disclose a secondary tab at all.
Thus, features 2 b), (bb) and (cc) and features 3 and 4 are missing and the patent is novel
over Jaramillo.
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6. Independent Claim 12
Independent claim 12 (former claim 13 in EP828B1), claiming an assembly for implanting
a heart valve according to claims 1-11, is novel over Nguyen, Benichou and Jamarillo at
least for the reasons given above for claim 1.
Inventive Step
1. Legal Standard
a. Pursuant to Art. 65 (2) UPCA and Art. 138 (a) EPC a European patent may be revoked
with effect for a Contracting State on the ground that the subject-matter of the European
patent is not patentable under Articles 52 to 57 EPC. According to Article 56 EPC, an
invention shall be considered as involving an inventive step if, having regard to the state
of the art, it is not obvious to a person skilled in the art.
b. For assessing whether an invention shall be considered obvious having regard to the
state of the art, the problem-solution approach (PSA) developed by the European Patent
Office (EPO) shall primarily be applied as a tool to the extent feasible to enhance legal
certainty and further align the jurisprudence of the Unified Patent Court with the
jurisprudence of the EPO and the Boards of Appeal (BoA).
The Court of First Instance and the Court of Appeal of the Unified Patent Court have
assessed inventive step in various decisions. Some decisions explicitly referred to the
PSA, used by the the EPO, including the BoA, and several national courts; others applied
a different approach, that is similar if not identical to the test of inventive step applied by
the German Federal Court of Justice. Both tests, the 'German' test and the PSA, if
correctly applied, should lead to the same results in the majority of the cases (see
Deichfuss, GRUR Patent 2024, 94) and both tests require a “realistic starting point” and
an “incentive” for the skilled person to do the “next step”, e.g. to amend the technical
solution disclosed by the starting point to arrive at the patented solution. As none of the
tests is enshrined in the European Patent Convention (EPC) and lead basically to the
same results both can be applied as a tool to assess inventive step. However, this Panel
takes the decision to apply the PSA as practiced by the EPO, including and the BoAs, to
the extent feasible and to state this explicitly as there is a need for legal certainty for both
the users of the system and the various divisions of the Unified Patent Court. Applying the
PSA further aligns the jurisprudence of the Unified Patent Court with the jurisprudence of
the EPO and the BoA.
In the present proceedings, the PSA is also the tool applied by the parties in their briefs.
UPC_CFI_501/2023
69
2. Nguyen alone, with CGK or with Jaramillo
a. Meril`s argument
Meril submits that if the Court finds that Nguyen does not disclose features 3 a) and b),
claim 1 would lack inventive step over Nguyen. Nguyen relates to an implantable
prosthetic heart valve having a multitude of leaflets with flaps (tabs) extending therefrom.
The tabs are folded “forming seam 42 comprising a triple thickness of the tissue” (para
[0053] on p.4). The technical effect resulting from this stack of material is according to
[0056] of Nguyen: “Moreover, the use of multiple thicknesses of material along seams 42
and 43 is expected to provide a highly durable valve body which will last for many years
once implanted in a patient.”
Ngyuen thus is in the same field and disclosed a prosthetic heart valve comprising a
frame and a leaflet structure attached to the frame. The primary objective underlying
Nguyen is summarized in [0011] as follows:
Other objects addressed by Nguyen are given in [0012] to [0022]. It is further stated in
[0056] that “the use of multiple thicknesses of material along 42 and 43 is expected to
provide a highly durable valve body which will last for many years once implanted in a
patient”.
Nguyen thus addresses the same object as the patent-in-suit in connection with the
enlarged lateral end regions ([0038]), seams 42 provided by the folded tabs and seams
43 provided by folding reinforcing tabs 38 along fold lines g, h and i ([0051] and Fig. 3B of
Nguyen). Nguyen therefore qualifies as closest prior art (CPA).
Meril claims that there is no technical effect associated with the missing features 3a and
b so that the objective technical problem can be defined as providing an alternative
configuration of the secondary tab. Starting from the Nguyen document and faced with
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70
the objective technical problem defined above, the person skilled in the art would have
been motivated to adapt the configuration of the secondary tabs so that a first portion is
folded around a radially extending fold.
Meril further submits that the CGK comprised leaflets with opposite pairs of tabs of
different configurations, so that it was routine to consider different geometries and
creases for a secondary tab. Meril refers, for example, to a combination of Nugyen and
Jaramillo. For Meril it is obvious to change the position of tab 34 (marked in blue in the
modified Fig. 3A above) and fold line e (marked in red) as shown above.
The claim limitations would be satisfied by this modified embodiment of Figure 3A.
b. Edwards` argument
Edwards submits that the patent-in-suit would distinguish by feature groups 3 and 4 over
Nguyen. A technical effect relating to such distinguishing features is disclosed in
paragraphs [0018] and [0056] of the patent-in-suit that is reproduced above.
Edwards concludes:
Edwards generally argues that the references relied on by Meril in its inventive step
attacks are patent references which are generally not part of the CGK. Meril also fails to
provide any motivation as to why a person skilled in the art would have made the
proposed modifications, which are quite substantial.
These comments also apply when relying on Nguyen. More specifically on Nguyen alone,
Edwards submits that the proposed modification would not be considered by the person
UPC_CFI_501/2023
71
skilled in the art because it is more complex and would require more material so that it
would be more expensive than the original configuration. The proposed radially extending
fold line would be very short and thus exposed to high forces of stress.
Also, the proposed modification would not result in the same configuration as in Fig. 4A
because flaps 36 would extend inwardly rather than outwardly as in Fig. 4A.
c. The Court`s finding
The Court agrees with the parties that Nguyen does not disclose features 3a) and 3b
(folding about a radial crease). Nguyen does also not disclose feature 4b) requiring that
the second portion of the secondary tab extends in a different plane than the first portion.
The technical effect resulting from the missing features is disclosed in [0018] and [0056]
and Figs. 29 and 30 of the patent-in-dispute.
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Radially folding the first portions of the secondary so that they lay flat on the body
portions of the leaflets results in a 4-layer stack of leaflet materials 142. This causes the
leaflets to articulate primarily at inner edges 143 of the folded-down inner portions 142
and thus spaced apart from the frame. As a result, the leaflets avoid contact with and
damage from the frame. In the embodiment of the exemplary portion of the patent-in-suit
the four-layer stack 142 can in addition to that splay apart about longitudinal axis 145
under high forces that occur when the valve is crimped. This allows for a smaller crimped
diameter. High forces also apply during the subsequent balloon expansion. The stress is
dissipated because of the splaying apart of the 4-layer stack thereby protecting the
commissures.
The Court agrees with Edwards that the technical effect resulting from the missing
features is to provide a reliable and durable valve.
The Court agrees with Meril that Nguyen qualifies as a realistic starting point. Nguyen
discloses a prosthetic heart valve comprising a multitude of leaflets having tabs that are
folded over to increase the durability of the commissures. Nguyen also addresses the
technical problem to provide a reliable and durable valve.
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However, the Court finds that the technical solution provided by Nguyen is structurally
completely different from that disclosed in the patent. The tabs of the leaflets of Nguyen
are folded along parallel and axially extending folding lines to create first seams 42 to
increase the durability of the commissures (claim 11 of Nguyen). In the assembled state
all tabs 34-36 are lying on top of each other and on the frame. Additional seams 43
extending axially along the lateral ends of the skirt are obtained when “reinforcing tabs 38
are folded along lines g, h, and i“([0054] of Nguyen). The combination of axially extending
seams 42 and 43 provides a high durability of the valve body through even axial stress
dissipation ([0056]). It is required that the leaflets are fastened together at enlarged
lateral end regions ([0038]) so that the coaptation leaflets are at a distance below the
commissures ([0057]).
Nguyen does not disclose any radial folding lines. Nguyen also does not disclose folding
of portions of the tabs along a radially and longitudinally extending crease, respectively,
so that they extend upon folding in the assembled state in different planes.
This, however, is the core of the technical teaching of the patent-in-suit. Folding of the
first and second portions of the secondary tab about radially and longitudinally extending
creases so that they extend in the assembled state in different planes puts the
articulation point of the leaflets space apart from the frame so that the leaflets are not in
contact with the frame are not damaged by it.
There was no incentive in Nguyen to have flaps 34, 35 and 36 extend in different planes
upon folding in the assembled state. Tab 35 is folded so that it lies atop tab 34 because
Nguyen requires a seam 42 comprising a triple thickness of the tissue. Then flap 36 is
folded along line f and is arranged in the assembled state on top of tabs 34 and 35 to
attach the leaflet structure to the frame and form commissures 24. This means in other
words that the tissues both in seams 42 and 43 form stacks and lay flat on top of each
other and are secured in that configuration to the frame.
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Thus, Nguyen teaches away from using differently oriented folding creases.
The Court agrees with Edwards that there is absolutely no motivation for Nguyen to
modify the tab design as suggested by Meril. The modified construction in changed Figure
3A could have made by the person skilled in the art but no motivation is provided
(“would”) so that this Fig. represents wishful thinking using the wisdom of hindsight.
In addition to that, the Court agrees with Edwards that the changed construction of Fig.3A
had disadvantages (more material required in comparison to the construction of
unmodified Fig.3 because of even further enlarged lateral end regions, high stress at short
folding line) so that the person skilled in the art would have been withheld from using
these constructions.
The same applies when combing Nguyen with the CGK or Jaramillo. Meril claims that the
patent references cited against the patent-in-suit would form CGK so that the tab
geometries disclosed therein could be arbitrarily combined. A motivation would not be
required because no technical effect would be associated with the missing features.
The Court does not find this line of argument convincing. Patent references are generally
not considered as CGK in the first place. Also, the features missing in Nguyen with
respect to the patent-in-suit display a technical effect as was outlined above.
The person skilled in the art starting from Nguyen would not have considered Jaramillo
that discloses a completely different leaflet design and valve construction. Even if such
combination would have been made the person skilled in the art would not have arrived
at the teaching of the patent-in-suit because Jaramillo does neither disclose secondary
tabs nor radially extending folding lines of tabs.
3. Lobbi in combination with Nguyen
a. Merril’s argument
Meril argues that the person skilled in the art, starting from Lobbi, would take Ngyuen into
account. Both documents relate to the durability of the heart valve. Meril submits that
the skilled person would be motivated to combine Lobbi with Nguyen because Nguyen
teaches that the durability of the valve can be improved by using the folded tab
configuration of Figure 4A of Nguyen:
UPC_CFI_501/2023
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Referring to Figure 7 of Lobbi
and confronted with the objective technical problem of providing an alternative leaflet
configuration, the skilled person would, having considered the teaching of Ngyuen in Fig.
3A
have arrived at the leaflet configuration shown below:
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According to Meril, this modified version of the Lobbi leaflet fulfils features 2b) (cc), 3 and
4.
b. Edwards` argument
Edwards submits that the modified Figure 7 has no basis in Nguyen at all because Nguyen
discloses only folding about fold lines d, e and f, all of which extend in parallel and have
an axial orientation in the assembled valve. Thus, a combination of Lobbi with Nguyen, if
made at all, would not provide the features of the patent as claimed.
Edwards also refers to the decision of the OD of the EPO that states in para 24:
T
Reference D3 used as a starting point is Lobbi (HL-CC 8), and the secondary references
referred to by the OD are Benichou (D2 = HL-CC 6), Jaramillo (D1 = HL-CC 9) and Braido
(D4 = HL-CC 10).
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c. The Court`s finding
The Court sides with Edwards and the OD on this issue. Lobbi provides no motivation to
consider Nguyen (could-would test) and even if such a combination had been made, the
missing features of the patent would not have been obtained.
The Court finds that Lobbi generally discloses a valve leaflet frame having three cusp
regions alternating and interposed with three commissure regions (see claim 1 of Lobbi).
Figure 3A shows a perspective view of the valve construction and Figure 3B is a plan view
of the valve:
A leaflet like disclosed by Lobbi is shown below (Figure 7):
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The leaflet comprises only primary tabs 100 (shown in green in annotated Figure 10
below) which are inserted through the commissure windows 106,108 (blue) in the
assembled valve as shown in Figure 10 below:
Annotated Fig. 10 as provided by Edwards in its defence to the CC
It is disclosed in paragraph [0084] of Lobbi that the folded leaflet tabs 100 are secured to
the commissures provided by attachment flanges 106 and assembly holes 108 (see Fig.
5 of Lobbi) via cloth layers including fabric cover 114, cloth flange 114 and cloth covers
54 (marked in red in Fig. 10 above):
Thus, Lobbi does not disclose secondary tabs. The pair of opposing single tabs 100 is
attached to the frame via various clothes that are folded around and sutured to the
commissure strut. The single tabs are folded around an axially extending fold line.
UPC_CFI_501/2023
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Thus, Lobbi fails to disclose features 2. b) (cc), 3 and 4.
This is supported by the OD in its decision to maintain the patent where D3 is Lobbi:
In view of that, the Court does not consider Lobbi as a promising springboard for an
inventive step attack.
Meril has argued that the folding of the first and second portion of the secondary tab
would not have any technical effect so that the objective problem underlying the patent-
in-suit would be to provide an alternative configuration. Based on a similar argument by
the opponent Abott in the EPO opposition proceedings the OD has considered that the
person skilled in the art may be motivated to simplify the construction of the leaflets in
Lobbi and use a folded extension of the leaflet rather than a separate cloth.
Nguyen does not use a separate cloth but three leaflets that are fastened together at
enlarged lateral end regions to form commissural joints ([0038] of Nguyen). Lobbi does
not comprise extended lateral end regions of the leaflets so that the design of the leaflets
and the overall design of the valve of Lobbi would have had to be changed considerably
when combining Lobbi with Nguyen. Even if the person skilled in the art would have made
that change and omit the cloth portions there is no disclosure in Nguyen of folding the
two portions of a secondary tab about a radial and an axial crease line. In other words,
even if the combination would have been made, the person skilled in the art would not
have arrived at the invention as claimed. Nguyen discloses that the three leaflets are
folded along parallel folding lines that all extend axially in the assembled configuration.
The Court does not agree, however, with the assumption that there is no technical effect
associated with the features of folding the two portions of the secondary tab about a
radially and an axially extending crease line, respectively. The technical effect associated
with this is disclosed both in [0018] of the general portion and in [0056] of the exemplary
portion of the patent-in-suit:
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Starting from Lobbi the person skilled in the art would not have considered Nguyen that
does not address the object of spacing apart the articulation point of the leaflets from the
frame. Nguyen does not even disclose folding two portions of a secondary tab about a
radially and an axially extending fold line.
Meril has not provided any motivation for the skilled person to combine Lobbi with
Nguyen. Even if the skilled person would have combined the two references the resulting
valve would not show all features of claim 1. As Nguyen only discloses folding around
folding lines d, e and f that all extend in parallel an axial orientation of creases in the
assembled valve as claimed in the Patent will not be obtained.
Enablement
1. Pursuant to Art. 65(2) UPCA and Art. 138(b) EPC, a European patent may be revoked
with effect for a Contracting State on the ground that the European patent does not
disclose the invention in a manner sufficiently clear and complete for it to be carried out
by a person skilled in the art (Article 83 EPC).
The subject-matter of a patent must be sufficiently disclosed on the basis of the patent
as a whole, including the examples, and taking into account the common general
knowledge of the person skilled in the art. It is up to the patentee to demonstrate the
practicability of the claimed subject-matter. However, as the patent is directed to the
person skilled in the art, the CGK of the skilled person must also be taken into account
when considering the question of sufficiency. Evidence of such knowledge may include,
for example, scientific textbooks. Sufficiency of disclosure means that the patent
enables the skilled person to obtain substantially all embodiments falling within the
scope of the claims. The disclosure in the patent must enable the claimed invention to
be carried out in the whole range claimed ("whole range sufficiency"). To define the whole
range claimed, all technically reasonable claim constructions must be considered.
Specifying one way of carrying out the claimed invention may be sufficient to satisfy the
description requirement of R. 42.1(e) EPC, but it is not necessarily sufficient to satisfy the
sufficiency requirements of Art. 83 or Art. 138(1)(b) EPC. Rather, the person skilled in the
art within the meaning of these articles must be enabled by the patent and his common
knowledge to use the claimed invention to its full extent without having to embark on a
research programme (i.e. without unreasonable effort). The requirement that the
disclosure must enable the implementation of the claimed invention to its full extent is
consistent with the concern that the right of exclusion conferred by a patent with respect
to its scope of protection should in principle be commensurate with the actual
contribution of the patent to the state of the art. Thus, the disclosure of only one way of
carrying out an invention is sufficient only if it enables the invention to be carried out in
UPC_CFI_501/2023
81
the entire scope claimed and not only in some embodiments of the claimed subject
matter (UPC_CFI_355/2023).
2. Meril`s argument
Meril argues that it is essential that the folded tab regions are attached to the frame. This
is particularly true for the second portion of the secondary tab, which might otherwise be
moved by blood flow to lie flat on the leaflet body and the first portion of the secondary
tab. The attachment of the folded tab regions to the frame is shown, for example, in Figure
30. As such feature is not mentioned in claim 1, the invention is not disclosed in a manner
sufficiently clear and complete for it to be carried out by a person skilled in the art.
This objection would apply to all claims because the feature is missing from claim 1 and
all other claims are dependent on claim 1.
Meril further submits that dependent claim 4 lacks crucial features such as the material
of the leaflets and the exact construction of the tabs to allow folding around the axially
extending crease. Applying the teaching of claim 4 without including these features
places an undue burden on the person skilled in the art and/or constitutes an invitation
to a research programme.
A similar objection is raised by Meril in respect of dependent claim 5.
3. Edwards‘ argument
Edwards points out that
(i) the absence of an allegedly missing mandatory feature in claims 1-12 is a matter of
clarity which is not a ground for opposition (Art. 100 EPC), and
(ii) "the detailed description and the figures, in particular paragraphs [0054] to [0057]
together with Figs. 29 and 30, provide sufficient information on the design of the leaflets
and their attachment to the frame to undoubtedly enable the skilled person to provide a
valve with the features specified in claim 1" (p. 55, para. 190 of Edwards' defence to the
CC).
4. The Court`s finding
Edwards' position is in line with the OD's decision (paras 25-26.4). The Court sides with
the OD and Edwards on this issue. Applying the correct claim construction as set out
above, the skilled person will understand that the leaflets are secured to the frame by the
UPC_CFI_501/2023
82
tabs. This is implicitly disclosed in claim 1; another reading does not make technical
sense. With respect to claim 4, the skilled person can rely on the specification and the
CGK to select the correct material for the leaflets and to construe the leaflets to permit
folding about the axially extending crease.
Infringement
1. Legal test
The scope of protection is determined by Art. 69(1) EPC that is directly applicable under
the UPCA (see Art. 24(1) c UPCA). Art. 69(1) EPC stipulates that “[T]he extent of the
protection conferred by a European patent or a European patent application shall be
determined by the claims. Nevertheless, the description and drawings shall be used to
interpret the claims.” This provision is further clarified in the Protocol on the
Interpretation of Article 69 EPC requiring that courts should interpret the claims adopting
an approach that combines a fair protection for the patentee with a reasonable degree of
certainty for third parties. Reference is made to the claim construction above.
2. Literal infringement of feature 2.a.aa “body portion” of claim 1
a. Meril`s argument
Meril only has one non-infringement argument. It argues on the basis of its claim
construction that the leaflets used in its Myval prosthetic heart valve are U-shaped and
not V-shaped.
A leaflet of the attacked embodiment is shown below (bottom of p.5 of K25):
UPC_CFI_501/2023
83
Meril illustrates this argument by referring to an annotated Figure 21 of the patent. The V-
shaped edge line of the inflow section of the body portion of the leaflet is highlighted in
red. A U-shaped edge line is also shown as a dashed line in green for comparison:
Meril concludes that its Myval heart valve therefore does not infringe claim 1 or any other
claim.
b. Edwards` argument
Edwards argues, based on its claim construction, that the attacked embodiment
includes leaflets with a body portion and thus infringes the patent.
c. The Court`s finding
The Court refers to the claim construction set out above. As stated above, the patent
broadly claims an implantable prosthetic heart valve comprising a leaflet structure
having a plurality of leaflets comprising a body portion and side tabs. The shape of the
body portions of the leaflets is not specified. The valves may consist of leaflets of any
shape. For the claimed invention of the patent, it is not essential that the leaflets have a
body portion which is generally V-shaped. Meril's Myval comprises leaflets with a body
portion and thus literally infringes feature 2.b) (.aa) of claim 1.
3. Literal infringement of the other features of claim 1
Meril does not dispute the infringement of the other features of claim 1. The Court
considers that Meril is right:
UPC_CFI_501/2023
84
From the image of the leaflet shown above, it can be concluded that the leaflet has
- a body portion;
- two opposing primary side tabs (= the lower side tabs) extending from opposite sides of
the body portion; and
- two opposing secondary side tabs (= upper side tabs) extending from the portion
adjacent to the primary side tabs
- wherein the first portion of the secondary side tab is folded around a radially extending
crease so that it lies flat atop the body portion of the leaflet, and
- the second portion of the secondary tab is folded around an axially extending crease so
that the second portion extends in a different plane than the first portion. A leaflet is
connected to an adjacent leaflet by attaching pieces of fabric (connectors 124) to the
lower tabs (=primary tabs). This is illustrated in the PPD (K25) created by Meril and filed
by Edwards. The PPD uses an enlarged cardboard model to visualise the construction of
Meril's Myval THV using primary and secondary tabs to attach the leaflets to each other
and to the valve frame.
The sequence of figures reproduced below from K25 shows the attachment of the fabric
pieces (=connectors 124, green) to the lower tabs (=primary tabs).
The assembly is carried out in a sequence of 4 steps.
1st Step
A leaflet as shown at the bottom of p.5 of K25 is provided.
UPC_CFI_501/2023
85
The leaflet has
• a body portion;
• two opposing primary side tabs (=the lower side tabs) extending from
opposite sides of the body portion; and
• two opposing secondary side tabs (=upper side tabs) extending from the
portion adjacent to the primary side tabs
(feature 2 b))
2nd Step
In a second step (Fig. 10), a piece of supporting fabric (green) is attached to part of the
lower (primary) tab of a leaflet (step not disclosed in EP828B2). Then, in Figures 11 and
13, a piece of fabric (=connector 124, green) is sutured to the fabric support. The step is
repeated with another leaflet so that two leaflets are connected (Figs 14 and 15). By
attaching the remaining leaflet, all three leaflets are connected in a leaflet attachment
element (leaflet structure 14) (right, unlabelled figure above).
(feature 2a))
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86
3rd Step
The next step is to assemble the leaflet structure to the frame. The frame comprises
commissure windows 20, which are represented in the cardboard model exercise by
clear polymer pieces (bottom left). A perspective view of the frame (Figure 8, right) shows
that the frame has commissure windows.
The lower (primary) tabs are inserted through the commissure windows as shown in
Figures 23-25 below:
(features 1. and 2.)
UPC_CFI_501/2023
87
4th Step
The upper (secondary) tab is then first folded (i) along a radial crease and then (ii) the
outer (second) portion connected to the inner (first) portion of the upper (secondary) tab
by a broken line is folded along such a broken axial line to provide an L-shaped form of
the outer (secondary) tab.
A spherical and a cross-sectional view of the joint are shown below. Both are taken from
the PPD (K25).
The leaflet is highlighted in yellow in the sectional view. The lower (primary) tab is marked
in red. The upper (secondary) tab is marked in grey, with the first portion in lighter grey
and the second portion in darker grey.
(features 3 and 4)
As a result, Meril's Myval THV literally infringes claim 1.
4. Literal infringement of claim 12
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Meril does not contest the infringement of the other features of claim 12. The Court
considers that Meril is right:
It is generally stated in mn.3 of K25's PPD:
The Navigator THV delivery system is shown in Fig. 38 of the PPD:
The Navigator comprises an elongate shaft referred to as the "outer shaft" in Figure 38.
Meril's Myval THV is a radially expandable prosthetic heart valve (10) according to any
one of claims 1-11, as shown in detail above for claim 1. It is described in mn. 32 of the
PPD of K25:
UPC_CFI_501/2023
89
Therefore, claim 12 is also literally infringed by an assembly comprising the Navigator
THV delivery system and the Myval THV.
5. Literal infringement of the other claims
Meril rightly does not contest the literal infringement of the other claims with other
arguments as already dealt with.
Infringing Acts and Liability of the three Meril defendants
All three Meril defendants have committed infringing acts within the scope of the UPCA.
And all Meril defendants are cumulatively liable because they acted in a close and
interdependent commercial relationship based on their structure as members of a group
of companies (see: ACT_18551/2024 UCP_CFI_166/2024):
1. Defendant 2 (Meril India)
Meril India is the manufacturer of the attacked embodiments and the parent company of
defendants 1 and 3. As its passive legitimacy is not contested, no further explanation is
necessary.
2. Defendant 1 (Meril Germany)
a. Website
Meril Germany does not have its own website but uses he Meril India`s website to offer
the attacked embodiments. The user is automatically directed to Meril India`s website
when searching for "Meril GmbH". Meril Germany has its own LinkedIn page, which also
refers to the Meril India`s website:
UPC_CFI_501/2023
90
Meril India's website takes visitors directly to "vascular intervention" products, including
"Myval":
UPC_CFI_501/2023
91
The "Myval product section" contains images of the infringing embodiments and an
"Enquire Now" button:
The "Enquire Now" button takes the user to the "Contact Us" page to enable the purchase
of attacked embodiments. The "Contact Us" page lists Meril Germany as the "European
Headquarters" (Appendix K 36):
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92
The user will understand that Meril Germany supplies the infringing embodiments in
Europe. In connection with the disclaimer:
The user will understand from the above that the attacked embodiments are offered for
sale and available in all other Contracting Member States not listed in the disclaimer. Art.
34 UPCA provides that injunctive relief and other corrective measures may be ordered in
respect of all Contracting Member States in which the European patent has effect and for
which a decision of the Court has been requested as long as an act of infringement or the
risk of a first infringement has been proven for at least one Contracting Member State
(UPC_CoA_523/2024 APL_51115/2024 mn. 34).
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93
b. Brochure with order information
The following brochure (Exhibits K21 and K29) is available on the Meril India´s website:
contains information on the attacked embodiments and ordering information
including a reference to Meril GmbH as the only Meril entity in a UPCA Member State:
UPC_CFI_501/2023
94
Again, the disclaimer in the brochure:
does not list all UPCA contracting member states. Furthermore, the territories mentioned
differ from those mentioned on the website. On the other hand, there is information about
a CE classification, which is required for Europe-wide sales. The reader is thus confused
and uses the contact channels to obtain accurate information on the availability of the
advertised products in the relevant territory. A customer contacting the salesperson is
the first step in selling a product. Therefore, these activities fall within the infringing
activity of "offering" in all Contracting Member States. The disclaimer has no effect.
c. Placing on the market
Meril GmbH sold the infringing embodiments in Germany after the grant of the patent (5
May 2021). Meril GmbH sold four Myval kits to Asklepios Klinik Hamburg on 19 May, 28
June and 5 July 2021 (Exhibit K 68) by entering into purchase agreements with Asklepios
Klink Hamburg and instructing Herzzentrum Lahr to transfer the Myval devices previously
delivered to it to Asklepios Klink Hamburg. The following slide illustrates the transactions:
UPC_CFI_501/2023
95
Since Meril did not raise an exhaustion defence, these transactions constitute an act of
putting the attacked embodiments on the market. The detour via the Herzzentrum Lahr
for the physical delivery is of no significance.
This finding is consistent with a finding of the Munich Regional Court I in contempt
proceedings regarding the same transaction. Reference is made to the court order of 14
February 2022 of that court (Exhibit K 66).
d. Conclusion
Infringement can be established as acts of offering and putting on the market by Meril
Germany have been proved.
3. Defendant 3 (Meril Italy)
a. Shipping from India to Italy
Meril India has in the past supplied several products to Meril Italy (Exhibit K-B 2). These
included the Navigator, which is a delivery device included in the assembly of claim 12:
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96
However, there is no allegation that the Navigator was supplied with or for use with the
Myval.
But together with Meril Italy's statement in the revocation actions against EP 825:
this gives rise to a risk of first infringement that the "Myval" and/or the "Navigator" for use
with the "Myval" will be shipped to Italy in the future.
b. Use of Meril.Life.com
A customer searching for "Meril Italy" on Google is directed to Meril.Life.com. Via
Meril.Life.com, the customer is redirected to Meril Germany, the European headquarters,
as explained above. Meril did not contest this at the oral hearing. Therefore, Meril Italy
uses and benefits from the offer activities on that website. The disclaimer on this website
does not mention Italy. Thus, at least in Italy, offering has been established as an act of
infringement.
4. Meril's statements during the oral hearing have not eliminated the risk of repetition.
a. UPC Representative for Meril Italy, Dr. Andras von Falk, said at the oral hearing
[05:49:31.140 --> 05:49:50.790]: “Meril Italy has never and will never offer for sale or
place on the market the [Myval] product. Meril Italy is only concerned with selling or was
concerned with selling the Octacor product and is now engaging in other activities after
the injunction by this panel.” Some time later [06:02:46.380 --> 06:03:02.580] he
explained: “We believe that we're not infringing, we don't want to give an undertaking now
and then have to carry the cost of the proceedings. We believe that this action is mature
for dismissal.” Finally, he declared [: “Yes, I just want to declare on behalf of my clients
Meril Germany sorry Meril GMBH and Meril Italy that neither of these two companies will
engage in any business activities in relation to the Myval THV and in combination with the
navigator product, and have not done so in the past.”
UPC representative for Edwards, Boris Kreye, said in reaction [06:25:11.660 -->
06:25:31.660]: “Even if it was directed to the patent owner we would not accept it without
a penalty clause.”
UPC_CFI_501/2023
97
b. Apart from the fact that this statement was not filed but made at the hearing, it is not
appropriate, in the circumstances of the case, to allow the risk of repetition and/or the
risk of a first infringement to be eliminated without a penalty clause. The three defendants
are all members of the Meril Group. Meril India is the parent company and Meril Germany
is the European headquarters. Meril Italy relies on the website provided by Meril India as
explained above. The website refers customers to Meril Germany as the European
headquarters. The present declaration is not made on behalf of all Meril defendants. In
these circumstances, a declaration to cease and desist without a penalty clause cannot
secure the patentee's interest in defending the exclusive nature of its right in the same
way as a court order. The risk remains that the members of the group will re-organise their
business around such isolated cease-and-desist declarations and thus continue to
infringe the patent in the relevant territories without the risk of having to pay a penalty.
Public Interest defence and proportionality defence
The public interest defence and the proportionality defence are mainly rejected. As both
parties agree that the same facts should be taken into account as in the decision of 15
November 2024 in EP 3 646 825 (ACT_459987/2023 UPC_CFI_15/2023), reference is
made to the reasons given there. The Court found that there was a clear and urgent public
need for Meril's XL prosthetic heart valve. This public need continues to be adequately
met by the existing Medical Request Portal for the Myval valve prosthesis. At the oral
hearing, Edwards conceded and confirmed that the Medical Request Portal for the XL
Myval valve prosthesis will remain operational. The Medical Request Portal allows
physicians to request a single-use licence to treat a specific patient. As the Medical
Request Portal for the Myval valve prosthesis is functioning effectively, it is clear that no
further conditions or restrictions are necessary with regard to the injunction, apart from
the above-mentioned restrictions in the operational part of this decision.
Contrary to the decision of 15 November 2024, it is not necessary to limit/adapt the
orders for recall and destruction. The information regarding the applicability of the
Medical Request Portal to XL-sized Myval devices was already known in the market prior
to the decision of 15 November 2024.
A referral to the Court of Justice of the European Union is therefore not justified.
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98
No grace period
In the circumstances of this case, it is not appropriate to grant a grace period. The
statement of claim was served on the defendants on 5 January 2024 and 7 February 2024.
A primary date for the oral hearing in person was set for 17 December 2024 and an
alternative date for 11 February 2025. UPC's representatives for the defendants argued
that the entire team of defendants would not be available on these two dates for various
reasons. The Judge-Rapporteur asked the defendants to choose between the two dates.
The Defendants chose 11 February 2025 (ORD_598411/2023 of 29 July 2024). The
announcement date is 4 April 2024. Thus, the Defendants have already been granted a
grace period of more than three months compared to a decision following an Oral Hearing
on 17 December 2024. The Defendants have not provided any arguments as to why a
longer period would be necessary.
No compensation payment in lieu of an injunction
As regards compensation in lieu of an injunction, the Court finds that this is not justified
by the circumstances of the case. Reference is made to the parallel decision in EP 3 646
825 of 15 November 2024 (ACT_459987/2023 UPC_CFI_15/2023).
The relief sought is widely justified
In the light of the foregoing, it can be concluded that Edwards is entitled to the following
relief:
1. Injunctive relief
Pursuant to Art. 63(1) UPCA, Meril shall be obliged to cease and desist from further
infringements. The auxiliary request can be granted with regard to the independent and
dependent claims. The wording of the order is taken from UPC_CoA_382/2024
APL_39664/2024. As the act of "making" is not included in the requests it must not be
included in the grated relief (Art. 76(1) UPCA).
As mentioned above, this order does not apply to XL devices where a physician has
successfully applied for an individual exemption on behalf of a patient. It is agreed that
Edwards will respond promptly to such requests, provided that the practitioner provides
all necessary information.
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2. Declaration of infringement
According to Art. 64(2)(a) UPCA, the court may declare that the attacked embodiments
infringe the asserted patent claims.
3. Information
Edwards also has a claim against Meril for information pursuant to Art. 67(1) UPCA in
conjunction with R. 191 RoP. This request is mostly justified and proportionate. Among
other things, the request for information is intended to obtain information on the
distribution channels of the infringing embodiment and the quantities and prices of the
products supplied. In addition, the identity of third parties involved in the distribution of
the infringing embodiment is of particular importance to Edwards to effectively enforce
its exclusive rights. The information shall be provided at least in electronic form. This is
required by considerations of good faith. To illustrate these considerations, reference can
be made, for example, to German law (§ 242 BGB), under which the debtor is obliged to
perform the obligation owed in a manner consistent with the requirements of good faith
and customary practice, which the court also considers applying to orders of the UPC. It
goes without saying that it is now common practice to collect and provide information in
electronic form. However, it has not been established that it is customary to provide the
information in both paper and electronic form. The remainder of the request must
therefore be rejected.
Further the information is only due from the date after the grant of the patent (5 May
2021). Edwards requested information from 24 June 2020, the date of the application's
publication. This is possible per se, as Rule 118.1 RoP and Art. 32(1) UPCA provide for
compensation derived from the provisional protection of a European patent application.
However, Edwards failed to provide any pleading that and why Meril also used the subject
matter of the claims of the application. Therefore, the remaining request must be
rejected.
4. Recall
Edwards is entitled to recall the infringing goods and their final removal from the
distribution channels pursuant to Art. 64 II (b) UPCA. Again, this order does not apply to
XL devices if a physician has successfully applied for an individual exemption on behalf
of the patient.
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5. Destruction
Edwards may also require Meril to destroy the infringing goods in its possession in
countries where the UPCA applies pursuant to Art. 64 (2) (e) UPCA. Again, this order does
not apply to XL devices if a doctor has successfully applied for an individual exemption
on behalf of the patient.
6. Publication by Edwards
Edwards has a legitimate interest in the publication of the decision in five public media,
including trade journals of its choice, pursuant to Art. 80 UPCA. In the event of full
publication, the judgment delivered today shall be published in its entirety. In the event
of partial publication, the full text of the rubric and the full operative part of the judgment
shall be made available.
7. No publication by Meril
The request that Meril be ordered to publish the operative part of the Court's decision on
its website is rejected as disproportionate. Although such an order would essentially fall
under Art. 80 UPCA, the Court finds that no further publication order is necessary at this
stage other than granting Edwards the right to publish the decision. Edwards has not
provided any justification as to why this additional and humiliating method of publication
is necessary.
8. Damages
Edwards is entitled to damages under Art. 68 UPCA in conjunction with R. 118.1 RoP
because Meril acted culpably. Since Edwards is not yet able to quantify the damages it
has suffered, it has a legitimate interest in having Meril's liability for damages determined.
9.Provisional damages
In addition, Edwards is entitled to payment of provisional damages pursuant to Art. 68
UPCA in conjunction with R. 119 RoP. The final determination of the amount of damages
can be the subject of separate proceedings. The proposed amount of €663,000 has not
been contested by Meril and shall therefore be awarded.
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10. Costs of the proceedings
As the losing party, Meril must pay the costs and other expenses incurred by Edwards
pursuant to Art. 69 (1) UPCA. The partial dismissals to the detriment of Edwards have no
weight.
11. Penalty payment and costs of compliance with above orders
Pursuant to R 354.3 RoP, the decisions and orders of the Court may provide for periodic
penalty payments to be made to the Court in the event that a party fails to comply with
the terms of the order or any previous order. The amount of such payments shall be fixed
by the Court having regard to the importance of the order in question. In the present case,
a penalty payment of EUR 1,000 per day of delay seems appropriate.
Pursuant to Art. 63 (2) UPCA and R 354.3 RoP, non-compliance with the injunction is
subject to a recurring penalty payment payable to the court. In view of the five-figure
market price of the product in question, it seems appropriate to impose a penalty of
€20,000 per case of non-compliance with the injunction and per infringing product.
According to Art. 64(3) UPCA, the Court is to order that those measures be carried out at
the expense of the infringer, in this case Meril, unless there are special reasons for not
doing so. No particular reasons for not doing so have been invoked here.
No condition pursuant to Art. 56 (1) UPCA, R 118.2 (a) RoP.
No condition under Art. 56 (1) UPCA, R 118.2 (a) RoP is justified under the facts of this
case.
1. Under R 118.2 (a) RoP the court may give its decision on the merits of the infringement
action, including its orders, subject to the condition under Article 56(1) UPCA that the
final decision in the revocation proceedings does not invalidate the patent in whole or in
part, if an infringement action is pending before a local or regional division while a
revocation action between the same parties is pending before the central division.
2. The sub-conditions of this provision are not met because the court has ruled on the
counterclaim for revocation and decided to dismiss it.
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Security for enforcement
As no request is made, it is not required to pay a deposit. The court also sees no reason
to do so ex officio.
Immediately enforceable v. R 118.8, 352, 354 RoP
This decision is immediately and directly enforceable from the date of service in each of
the Contracting Member States (R 354.1 RoP). This means that no security must be
lodged beforehand and there is no condition under Rule 118.2.a RoP. However, Rule
118.8 RoP must be complied with.
DECISION
For all these reasons and after having heard the parties Panel 1 of the Local Division
Munich
I. dismisses the preliminary objections and the counterclaim for revocation and
II. orders the three Meril defendants individually and jointly to refrain from
offering, placing on the market, using, or importing or storing for the said
purposes any product according to claims 1 to 13 of the patent at issue (EP 3
669 828 B2), in particular with the transcatheter prosthetic heart valve called
"Myval" as shown below, or an assembly that comprises the "Myval" and a
delivery apparatus called "Navigator" (together: the Infringing Products") as
shown below:
UPC_CFI_501/2023
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within the territory of the Agreement on a Unified Patent Court where the
patent has effect (except in Malta), (jointly: the Territory);
III. orders the three Meril defendants to comply with the order under item II.
above, subject to a recurring penalty payment of up to EUR 20,000.00 for each
violation of, or non-compliance with, the order. The placing on the market of
each individual Infringing Product will be considered as a separate violation;
IV. declares that the three Meril-defendants have infringed the Patent-in-suit with
respect to the products identified in item II. above in the Territory;
V. orders the three Meril defendants individually and jointly, under threat of a
recurring penalty payment of up to EUR 1,000 for each day of delay, within a
period of three weeks from the date of service of the decision, to provide
Edwards with information on the extent to which the three Meril-defendants
have committed the acts referred to in item II. since 5 May 2021 in the Territory,
specifying:
1) the origin and distribution channels of the infringing products,
2) the quantities produced, manufactured, delivered, received or ordered, as
well as the prices paid for the infringing products, and
3) the identity of any third person involved in the manufacture or distribution of
infringing products;
whereby the list with the data has to be at least transmitted electronically in a
form that can be evaluated by means of EDP (e.g. Excel table), and copies of
the relevant purchase documents (namely invoices, alternatively delivery bills)
are to be submitted by Defendants as proof of the information, whereby
confidential details outside the subject of the information to be disclosed may
be redacted;
VI. orders the three Meril defendants individually and jointly, under threat of a
recurring penalty payment of up to EUR 1,000 for each day of delay, to take the
following actions within one week of service of the Decision with regard to the
Infringing Products placed on the market in the Territory since 5 May 2021:
a. to recall the Infringing Products not yet implanted with reference to the
legally established patent-infringing nature of the products, and with the
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104
binding commitment to take back the products and to bear any fees as well
as necessary packaging and transport costs and customs and storage
costs associated with the return, and
b. to take back the Infringing Products, with the proviso that these are then
permanently removed from the distribution channels;
VII. orders the three Meril defendants individually and jointly, under threat of a
recurring penalty payment of up to EUR 1,000 for each day of delay, within a
period of one week after service of the Decision, to immediately disclose and
hand over the Infringing Products described in item II. above and/or the
relevant materials (including any products and/or materials that come into its
direct and/or indirect possession and/or ownership pursuant to item VI. or
otherwise) or, at its option, to surrender them to a bailiff to be named or
appointed by Edwards for the purpose of destruction;
VIII. orders the three Meril defendants to allow Edwards to publish the Court's
decision in whole or in part, including the publication of the decision in five
public media and trade journals of its choice;
IX. declares that the three Meril defendants are jointly and severally obliged to
compensate Edwards for the damage (including interest) that Edwards has
suffered and will suffer as a result of the acts described in item II. above,
committed since 5 May 2021;
X. orders the three Meril defendants to jointly and severally pay EUR 663,000 as
provisional damages to Edwards within two weeks after service of the
Decision;
XI. orders the three Meril defendants to jointly and severally bear the reasonable
and proportionate legal costs and other expenses incurred by Edwards in the
proceedings;
XII. orders that the measures mentioned above are to be carried out at the joint
expense of the three Meril defendants;
XIII. declares that the above orders do not apply to XL devices where a physician
has successfully applied for an individual exemption on behalf of a patient;
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105
XIV. declares that this decision is immediately and directly enforceable from the
date of service in each Contracting Member State;
XV. dismisses all other requests.
INFORMATION ABOUT APPEAL
An appeal against the present Decision may be lodged at the Court of Appeal, by any
party which has been unsuccessful, in whole or in part, in its submissions, within two
months of the date of its notification (Art. 73(1) UPCA, R. 220.1(a), 224.1(a) RoP).
INFORMATION ABOUT ENFORCEMENT
Art. 82 UPCA, Art. Art. 37(2) UPCS, R. 118.8, 158.2, 354, 355.4 RoP. An authentic copy of
the enforceable decision will be issued by the Deputy-Registrar upon request of the
enforcing party, R. 69 RegR.
DETAILS OF THE DECISION
Order no. ORD_598588/2023 in ACTION NUMBER: ACT_597277/2023
UPC number: UPC_CFI_501/2023
Action type: Infringement Action
Order no. ORD_69128/2024 in ACTION NUMBER: CC_23112/2024
C number: UPC_CFI_501/2023
Action type: Counterclaim for revocation
UPC_CFI_501/2023
106
Read in open court in Munich on 4 April 2025
Zigann
Presiding Judge and Judge-rapporteur
Kokke
Legally Qualified Judge
Pichlmaier
Legally Qualified Judge
Wilhelm
Technically Qualified Judge
For the Deputy-Registrar
Matthias
ZIGANN
Digital unterschrieben
von Matthias ZIGANN
Datum: 2025.04.01
16:17:59 +02'00'
Tobias Günther
Pichlmaier
Digital unterschrieben von
Tobias Günther Pichlmaier
Datum: 2025.04.01
16:23:04 +02'00'
Stefan
Maria
Wilhelm
Digitally signed by
Stefan Maria
Wilhelm
Date: 2025.04.01
16:32:53 +02'00'
Margot
Elsa KOKKE
Digitally signed by
Margot Elsa KOKKE
Date: 2025.04.01
16:50:04 +02'00'
Anja
Mittermeier
Digital unterschrieben
von Anja Mittermeier
Datum: 2025.04.02
09:56:09 +02'00'