Nordic-Baltic - regional division
UPC_CFI_8/2023
Procedural Order
of the Court of First Instance of the Unified Patent Court
delivered on 18/09/2024

HEADNOTES:
Article 45 UPCA means that also the written procedure of the Court shall, in principle, be open to
the public unless the Court decides to make it confidential, to the extent necessary, in the interest
of one of the parties or other affected persons, or in the general interest of justice or public order.
If a person has made an application under Rule 262.1(b) for access to pleadings or evidence and
provided a credible explanation for why he/she wants access, the application shall be approved
unless it is necessary to keep the information confidential.

KEYWORDS:
RoP 262.1 (b)

APPLICANT/S
1)
(Applicant) - - -
-
Represented by

RELEVANT PROCEEDING PARTIES
Claimant Edwards Lifesciences Corporation
One Edwards Way - 92614 - Irvine, California – US
Represented by Magnus Dahlman Siddharth
Kusumakar, Tessa Waldron and Bryce Matthewson

Defendent I Meril Lifesciences PVT Limited - Bilakhia House, Survey No. 135/139,
Muktanand Marg, Chala, - 396191 - Vapi, Gujarat - IN
Defendent II Meril GmbH- Bornheimer Strasse 135 – 137 - 53119 - Bonn - DE
Defendent III Smis International OÜ Harju maakond, Kesklinna linnaosa, Kaarli pst 9-1a -
10119 - Tallinn - EE
Defendent IV Sormedica UAB - V. Kuzmos str. 28 - 08431 - Vilnius - LT
Represented by Dr Andreas von Falck , , Alexander Klicznik, Kerstin Jonen, Felipe Zilly
Claude, Lukas Wollenschlaeger, Beatrice Wilden (Hogan Lovells International LLP) Assisted
by: Dr. Kyra Lueg-Althoff

PATENT AT ISSUE
Patent no. Proprietor/s
EP2628464 Edwards Lifesciences Corporation

DECIDING JUDGE Kai Härmand

COMPOSITION OF PANEL – FULL PANEL
Presiding judge Stefan Johansson
Judge-rapporteur Kai Härmand
Legally qualified judge Rute Lopes
[Technically qualified judge Elisabetta Papa]

LANGUAGE OF PROCEEDINGS: English

SUBJECT-MATTER OF THE PROCEEDINGS
Request for access to the written pleadings and evidence

SUMMARY OF FACTS
1. On 5 June 2024 filed a request to access pleadings and evidence in several cases
(counterclaims App. Nos.: 33491/2024; 33492/2024; 33493/2024; 33494/2024 and infringement
claim App. No.: 33316/2024). On 19 June 2024, the Judge Rapporteur issued an order requiring
to identify the identity of the applicant and specify the nature of its interest in the
proceedings. On 2 June 2024, filed a further submission. The parties have been
invited to submit their comments and they submitted their written comments on 16 July 2024.
2. The Applicant requested access to all pleadings and evidence as a member of the public, in
particular being a board member and investor in a medical device company within the field of
cardiac implant technology. The purpose of this request is therefore based on a direct interest
and concern as a competitor regarding the validity of the patent of the proceedings with regard to
a third-party product under development potentially similar to the allegedly infringing products of
the defendants and covered upon market entry by the granted claims of the present patent of the
proceedings.
3. Claimant requests the request to be dismissed. Claimant argues that request must include a
concrete, verifiable and legitimate reason for making written pleadings and evidence available to
a member of the public. Claimant refers to the Munich CD order of 20 September 2023 in Amgen
v. Sanofi-Aventis, UPC_CFI_1/2023 and Court of Appeal decision in Ocado v AutoStore dated 10
April 2024 (ORD_19369/2024, UPC_CoA_404/2023. In the request no mention was made of the
Applicant involvement in any medical company (let alone SWAT Medical), and the request was
explicitly said to be filed as a member of the public or investor in medical device technology. The
Applicants have not specified the nature of the pleadings and evidence which are being sought,
but simply cast the net as widely as possible, seeking “all pleadings and evidence”.
4. Defendants request the request to be dismissed and access to all written pleadings and
evidence in the present proceedings is to be denied already because the R.262-Request does not
comply with the requirements set out in Rule 262.1(b) RoP in the strict alternative, that the R.262-
Request be dismissed to the extent that any written pleadings, evidence or other submissions as
further specified below in Section B.2. be excluded from access; III. in case the R.262-Request is
granted in part or in full, that it be ordered that the applicants are required to keep the written
pleadings and evidence the applicants were given access to confidential and not to use the
information obtained against Counterclaimants, be it in court proceedings or out of court (see
Section C.); IV. the applicants of the R.262-Request are ordered to bear the costs (see Section D.).
Defendants argue that the Court has to must weigh the interests of a member of the public in
getting access to the written pleadings and evidence against the interests mentioned in Art. 45
UPCA. In Ocado Innovation Limited v Autostore AS the Court of Appeal has clarified the balance
and how the meaning of reasoned request has to be interpreted. Defendants also refer to the
Munich CD order of 2 0.10.2023 in Sanofi-Aventis Deutschland GmbH et al. v Amgen Inc.
The purpose is not clear and plausible as the applicant and co-applicant SWAT Medical AB operates
in the field of embolic protection devices. Embolic protection devices are neither prosthetic heart
valves as herein concerned nor delivery catheters nor a system comprising a prosthetic heart valve
and a delivery catheter. Rather, embolic protection devices are used to protect against cardiac
embolism during TAVI and thus, in particular, strokes, by filtering or diverting cardiac emboli during
TAVI to reduce cardiac embolic events. Given the different intended use and configuration of such
devices, there can obviously be neither a concern "regarding the validity of the patent of the
proceedings with regard to a third-party product under development potentially similar to the
allegedly infringing products of the defendants and covered upon market entry by the granted
claims of the present patent of the proceedings" nor an interest precisely related to the subject-
matter of the proceedings at hand.
Identical request was filed in the counterclaim proceedings concerning EP 3 646 825 B1
(App_33487/2024, App_33489/2024), EP 3 669 828 B1 (App_33485/2024), EP 3 769 722 B1
(App_33473/2024, App_33475/2024, App_33476/2024, App_33478/2024, App_33480/2024,
App_33481/2024) and that a largely identical request was filed in the infringement proceedings
concerning EP 3 646 825 B1 (App_33373/2024), EP 2 628 464 B1 (App_33316/2024), EP 3
669 828 B1 (App_33377/2024), and EP 3 769 722 B1 (App_33375/2024).
Counterclaimants and the public's interest in the integrity of the pending proceedings prevails any
interest in getting access to written pleadings and evidence submitted in the counterclaim
proceedings as herein concerned.

GROUNDS FOR THE ORDER
Public scrutiny of the court procedures and access to public information are both valuable
principles of the democracy and the rule of law. According to the Art 47 of the Charter of
Fundamental Rights of the European Union, the principle of fair trial includes the possibility of a
public trial.
Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001
regarding public access to European Parliament, Council and Commission documents stipulates in
its recital 2, that openness contributes to strengthening the principles of democracy and respect
for fundamental rights. Pursuant to the Art 1 (a), the public shall have the widest possible access
to the institutions' documents. However, the right of access is subject to limits for reasons of public
or private interest. According to Art. 4 (2) access to a document may be refused in order to protect
court proceedings and legal advice, which ensures the protection of the integrity of the
proceedings.
The UPCA have to be interpreted in the light and in line of the general principles of the EU law.
Therefore, the transparency and public access of the proceedings have to be widely interpreted.
Article 45 UPCA stipulates that the proceedings of the Court shall be open to the public unless the
Court decides to make them confidential, to the extent necessary, in the interest of one of the
parties or other affected persons, or in the general interest of justice or public order. This general
provision is not limited to decisions, orders or oral hearings, but refer to the proceedings as such.
According to Article 52 UPCA, the proceedings before the Court consist of a written, an interim and
an oral procedure. In this Courts view, this means that also the written procedure shall, in principle,
be open to the public, unless the Court decides to make it confidential, to the extent necessary, in
the interest of one of the parties or other affected persons, or in the general interest of justice or
public order.
Rule 262 RoP contain provisions on the publics access to decisions and orders made by the Court,
and to written pleadings and evidence. It specifies that decisions and orders made by the Court
shall be published, while written pleadings and evidence, lodged at the Court and recorded by the
Registry shall be available to the public upon reasoned request to the Registry. The decision is
taken by the judge-rapporteur after consulting the parties.
The Court acknowledges that public generally has an interest in written submissions and evidence
being made available. This allows for a better understanding of the decisions of the court and it
also allows for the court's scrutiny, which is important for public confidence in the court.
However, the Court has to weight the interests of the parties against the purpose of the request.
The applicant sets out a very general request to obtain written pleadings and evidence because of
a direct interest and concern as a competitor regarding the validity of the patent of the proceedings
with regard to a third-party product under development potentially similar to the allegedly
infringing products of the defendants and covered upon market entry by the granted claims of the
present patent of the proceedings.
The core essence of the patent system is to give monopoly over information that may be
considered trade secret in nature in return for a detailed disclosure of the invention. The
description of the invention and the wording of the claim should be sufficiently precise to enable
potential competitors to understand whether the invention they are developing or proposing to
develop, infringes or may infringe an already existing patent. The description of the allegedly
infringing patent and the allegedly infringed patent are already in the public domain as both of
them are granted patents. Therefore, the pleadings and the evidence of the case would not be able
to add such information that does not already exist in public domain.
A civil litigation is in its essence a private dispute and the protection of the integrity of the
proceedings ensures that the parties can present their arguments and evidence independently and
without influence and the court, as intermediary, is able impartially and independently, without
unnecessary interference from third parties, solve the conflict. The interest in the integrity of the
proceedings usually lasts until the end of the proceedings, meaning that the general interest
mentioned above and the protection of the integrity of the proceedings – are usually properly
balanced when a member of the public is granted access to pleadings and evidence after the
proceedings have been terminated by a decision of the court.
The specific medical field where applicant or co-applicant operate is not very much relevant in the
eyes of this Court as a company may change its line of activity any time. The legitimate interest
may also be that a legal entity, planning to change its activities, is making preparations to do so.
The protection of the integrity of the ongoing proceedings hereby outweighs the interest in
information asserted by the applicant, so that the parties can present their arguments and
evidence and so that the court can conduct the proceedings impartially and independently,
without influence or interference from external parties in the public sphere. Therefore, the access
to the pleadings and a evidence is denied at this point in time.
As the request is rejected there is no need for the Court to formulate a position in the
confidentiality issue raised by the parties.

ORDER
1. The request for access to pleadings and evidence is rejected.
2. Leave for appeal is granted.

INFORMATION ABOUT APPEAL
Leave to appeal of the order shall be granted as it is of the general interest to clarify the
interpretation of the law.

INFORMATION ABOUT COSTS AND DAMAGES
The costs can be decided in separate proceedings at the request of the party. The Applicant is
ordered to bear the costs of the proceedings.

ORDER DETAILS
Order no. ORD_36465/2024 in ACTION NUMBER: ACT_459769/2023
UPC number: UPC_CFI_8/2023
Action type: Infringement Action
Related proceeding no. Application No.: 33493/2024; 33492/2024; 33491/2024; 33316/2024
Application Type: APPLICATION_ROP262_1_b