Milan - Local Division
UPC_CFI_400/2024
Procedural Order
of the Court of First Instance of the Unified Patent Court
delivered on 04/09/2024
Order no. ORD_45723/2024

APPLICANT
1) A. Menarini Diagnostics s.r.l.
(Applicant) - Via Dei Sette Santi 3 - 50131 - Florence – IT
Represented by
Christopher Maierhöfer

RESPONDENT
1) Insulet Corporation
(Respondent) - 100 Nagog Park - MA 01720 - Acton – US
Represented by Marc
Grunwald

PATENT AT ISSUE
Patent no. Proprietor/s
EP4201327 Insulet Corporation

DECIDING JUDGE
Judge-rapporteur Alima Zana

COMPOSITION OF PANEL – FULL PANEL
Presiding judge Pierluigi Perrotti
Judge-rapporteur Alima Zana
Legally qualified judge Anna-Lena Klein
Technically qualified judge Uwe Schwengelbeck

LANGUAGE OF PROCEEDINGS: English

ORDER
1. SUMMARY OF FACTS AND STATEMENT OF FORMS OF ORDER SOUGHT BY THE
PARTIES
A. Menarini Diagnostics s.r.l. (defendant in the main proceeding) puts forward information in the
Objection to Application for provisional measures dated 6 August 2024, allegedly being of
confidential nature. The respective information is highlighted in grey. With regard to said
information the defendant submitted an application for protection of confidential information under
R. 262A RoP using the dedicated workflow in the CMS (App_45575/2024) and uploaded redacted
versions of their written submissions.
The defendant requests the Court to order the following:
A. the portions of this Objection that are highlighted in gray to be “Confidential Infor
mation”, specifically:
1. the technical descriptions, including drawings, of the Attacked
Embodiment of Defendant of para. 175 and paras. 177 through 183 of this
Objection; and
2. Defendant’s business figures in respect of the Attacked Embodiment,
such as sales numbers, market share, and number of patients as specified in
paras. 195, 205, 213 and 308 of this Objection;
B. access to Confidential Information to be restricted to Defendant, one of Applicant’s employees to be named by Applicant, their UPC representatives, and witnesses and expert witnesses which require access to the Confidential Information for the purposes of these pro-
ceedings;
C. these persons not to disclose any Confidential Information outside of these court proceedings unless the receiving outside party has gained knowledge of the Confidential Information
outside of the proceedings. This obligation shall continue to apply even after the conclusion
of the court proceedings.
D. the public to be excluded from the oral hearing, insofar as any Confidential Information is
to become the subject of the oral hearing;
E. if necessary, the public to be excluded from part of the announcement of the grounds for
the judgment, insofar as any Confidential Information is concerned;
F. the public to be excluded from any access to any filing in the present court proceedings,
insofar they include Confidential Information, or to access only redacted versions thereof;
G. prior to publication of the reasons for the decision or other announcements, any
Confidential Information to be redacted therein.
The Presiding Judge (on behalf of judge-rapporteur) by way of a preliminary order dated 7 August
2024 granted access to the unredacted version of said documents exclusively to the claimant’s
authorised representatives pending a final decision upon the confidentiality request and invited the
claimant to comment.
In response, the claimant submitted that the information allegedly is not secret.
Accordingly, the claimant requests the Court to order the following:

I. Defendant’s motion that certain portions of the Objection highlighted in gray contain confidential
information, which in turn shall trigger certain access restrictions on the part of Applicant, is
rejected.

Auxiliary:
II. The following persons on the part of Applicant shall be granted access to confidential information
in the Objection to the application for provisional measures as well to all information classified as
confidential (in submissions, exhibits etc.) in the future by the Court:
a) Applicant, Applicant’s legal representatives including staff, witnesses, experts, further representatives
of Applicant and all other persons involved in the present proceedings or who have access to
documents of this proceedings, and
b) in particular the following reliable natural persons:
Senior Director, Intellectual Property Counsel at Applicant, Acton, Massachusetts,
USA.

2. GROUNDS OF THE ORDER
1. General profiles
1.1. This ruling complies with:
- the principles of flexibility, proportionality and fairness set out in Preamble 2 of
the P.o.R. and the need to protect confidential information;
-the Rule n. 58 UPCA, the Rule N. 262A RoP, the Directive (EU) 2016/943 on
the protection of undisclosed know-how and business information (trade secrets)
against their unlawful acquisition, use and disclosure;
- case law of the UPC on the protection of confidential information.
1.2. This order:
- takes into account that this is an application within an urgent procedure, which requires -
on the one hand- respect for confidential information and -on the other hand- respect for the
principle of a fair trial in view of the urgency of the case, without prejudice to the hearing
already scheduled for 15 October 2024.
-concerns only points A and B of the application. Points C, D, E. F and G will be decided
by the Court at a later date, at the latest at the hearing.
2. Nature of information
2.1.Confidential information declared by the applicant (defendant in the main proceeding)
regards:
a. the technical descriptions, including drawings, of the Attacked Embodiment of Defend-ant
(of para. 175 and paras. 177 through 183 of the Objection);
b. Defendant’s business figures in respect of the Attacked Embodiment, such as sales numbers,
market share, and number of patients (as specified in paras. 195, 205, 213 and 308
of the Objection).
2.2.In support of their argument, the applicant argues that this information:
• contains details about:
▪ defendant’s financial situation and
▪ proprietary technology. which are considered to be trade secrets within the
meaning of Art. 2(1) of Directive (EU) 2016/943.
• has commercial value;
• is not generally known and is not available to third parties;
• is protected by appropriate confidentiality measures.
2.3. The respondent (applicant in the main proceeding) disputes the secret nature of this
information, pointing out that:
- with regard to the information mentioned above under a):
all technical information relating to the infringing embodiment is publicly available. Defendant confirmed that several customers have already obtained the in-fringing embodiment and also the Applicant could obtain a sample as proven by the pictures in the Application for provisional measures in marg. no. 62 – 93;
- with regard to the information mentioned above under b)
- the number of patients using the infringing embodiment is not secret: in the US proceedings the defendant submitted patient data and figures partly in unredacted form;
- as regards the information contained in marg. no. 205, there is no benchmark
whatsoever which would allow third parties to infer absolute figures;
- the R&D costs allegedly incurred by EOFLOW are not a secret, because EO-FLOW is a listed company that is required to prepare a balance sheet, so that cor-responding investments can be viewed by anyone via the balance sheet or the earnings call.
2.4. The Court observes that:
- according to a non strict construction in accordance with the purpose of the law, Article 58 UPCA must be interpreted as meaning that it extends protection not only to trade secrets but also to confidential information;
-although the Court has doubts as to whether the information referred to in point (a) is confidential,
since it concerns technological choices that appear to be incorporated into the products offered to
the public, at this urgent stage- when not all defences have been carried out- it seems prudent to
grant the requested confidentiality, also in order to avoid a possible prolongation of the proceedings
in the event of an appeal by the owner of the information.
- the information referred to point (b) appears to be confidential. Indeed:
a. it concerns commercial sales data (including the number of patients using the in
infringing embodiment) and is therefore relevant to Merarini's business;
b. it is not public. The filing of such information in another legal proceeding, even if
not with the protection of confidentiality, is not likely to make it public;
c. the applicant has an interest in maintaining confidentiality, indicating the sales and
market attractiveness of its products;
Its disclosure to a competitor - such as Insulet - could have a detrimental effect on the applicant that
outweighs the risks of litigation and could unfairly distort competition.
3. Confidentiality club
3.1. Menarini's claim for confidentiality is modulated by a request for limited access to:
- one of Applicant’s employees to be named by Applicant;
- their UPC representatives;
- witnesses and expert witnesses which require access to the Confidential Information for the
purposes of these proceedings.
3.2.The claimant has observed that the confidentiality request is too narrow and disproportionate.
According to R. 262A RoP , the number of persons who have access to confidential information
shall be no greater than necessary to ensure compliance with the right of the parties to the legal
proceedings to an effective remedy and to a fair trial.
3.3.The Court recalls the case law of the UPC on this matter and in particular:
• “When deciding the application of the defendants to grant protection for the allegedly con-
fidential information, the court has to weigh the right of a party to have unlimited access to
the documents contained in the file, which guarantees its fundamental right to be heard,
against the interest of the opposing party to have its confidential information protected.
Both fundamental principles have to be balanced against each other on the instant facts of
the particular case” (Düsseldorf Local Division App_6761/2024 related to the main pro-
ceeding ACT_578607/20239)
• “R. 262A.6 RoP establishes with all desirable clarity as a ground rule of paramount im-
portance that at least one natural person from each party and the respective lawyers or
other representatives are to be granted access in order to ensure a fair trial. The provision
therefore reflects the spirit of the trade secret directive, which also demands for access of
at least :
-one natural person from each of the parties and
-their respective representatives in order
-to guarantee the fundamental right to a fair trial (see recital 25 and Art. 9 (2) of the trade
secrets directive). This has been an express decision by the Member States of the European
Union which is to be respected by the UPC (Art. 20, 24(1)(a) UPCA)” (Düsseldorf Local
Division App_6761/2024 related to the main proceeding ACT_578607/20239);
• “When deciding upon the level of restriction, again the circumstances of the case are to
be taken into consideration (…)
In a dispute revolving around technical aspects it is of fundamental importance that a party
may have resort to technically qualified employees in order to exercise its right to be heard
(Düsseldorf Local Division App App_6761/2024 related to the main proceeding
ACT_578607/20239);
• In case, parallel proceedings abroad are pending, also lawyers representing the party in
parallel proceedings must be part of the confidentiality club in order to align the respective
briefs and arguments as well as to co-ordinate the strategy (cf. LD Paris, order of
19.12.2023, UPC_CFI_230/2023).
3.4. In the light of all foregoing considerations, The Court, balancing opposing interests, considers
to include the club:
a. the claimant’s authorised representatives and their assistants;
b. any private expert upon request , and witnesses which require access to the Confidential
Information for the purposes of these proceedings;
c. the following employees of the claimant

Senior Director and Intellectual Property Counsel at Applicant and co-ordinates
the overall litigation strategy.
He is aware of his obligations under a confidentiality order and is a highly trustworthy
person.
His appointment is in line with Defendant’s request to name one employee of Appli-
cant according to item VIII. of Defendant’s confidentiality request;
d. partner at the US law firm Goodwin Procter LLP.
He is Applicant’s legal representatives in the parallel US proceedings against EOFLOW
before the United States District Court in the District of Massachusetts.
As attorney-at-law, he is bound to strict ethical rules of professional conduct for lawyers in
accordance with the Model Rules of Professional Conduct of the American Bar
Association.
3.5. With regard to the persons mentioned above under a), b) and c):
There is a coincidence between Menarini's application and the applicant's application as
regards the composition of the confidential club.
- Indeed, Their appointment is in line with Defendant’s request.
Therefore, there is no disagreement on the inclusion of these persons in the confidential list.
With regard to the person mentioned above under d):
- there is no coincidence between Menarini's and the applicant's claim Indeed does
not fit into the categories of persons referred by Menarini.
However, in order to respect the adversarial principle and the right of the defence - including
the right to adopt a common defence strategy in different jurisdictions - and in the light of
the earlier decision of the Paris local division of the UPC (19 December 2023, concerning
the defendants of the same party in parallel proceedings), the Court considers that this person
should be included in the club.
This is also in view of the fact that the request for confidential information covers essential
issues (non-infringement and balancing of interests) which, according to Merinarini, would
justify the request to reject the measure.
The right of defence must therefore be fully respected.
These considerations lead to the following assessments as regards the appealability and
suspensive effect of this order.
4.Leave to appeal
Since the questions decided upon in the case at hand are far from being well settled in the newly
established Unified Patent Court, leave to appeal is granted.
5.Suspensive effect
So as not to create a fait accompli, the Court decides not to grant access for the further person named
by the claimant- which is in dispute, before the time period for bringing an appeal and an appropriate
time period to bring an application for suspensive effect before the Court of Appeal before it has
elapsed.
On the contrary it appears to be in the interest to further the proceeding to already grant the persons
named by claimant (and and included in the categories specified by the defendant) immediate access
to the information concerned in order to them being enabled to assist claimant’s representatives in
preparing its defences ( Düsseldorf Local Division UPC_CFI_355/2023)
Indee, pursuant to Section 354 of the RoP, decisions and orders of the Court are directly
enforceable from the date of their notification and an appeal, pursuant to Section 74 of the UPCA,
has no suspensive effect unless the Court of Appeal decides otherwise. However, these provisions
do not prevent the Court of First Instance from deciding that an action should be enforced at a
future date.
If this Order were to take effect immediately, and access was contemporaneous with the
adoption of the Order, Menarini’s possible appeal could not be effective. Therefore, the Court
considers it appropriate to defer the enforceability of this order after the period of 15 days for
bringing an appeal under R. 220.2 RoP and an additional week, after having brought the appeal,
during which an application for suspensive effect may be lodged, has elapsed (Düsseldorf Local
Division UPC_CFI_355/2023).
This gives Merarini sufficient time to appeal and request suspensive effect, pursuant to Article 223
of the RoP.

ORDER
I. access to the unredacted version of the Menarini’s Objection to Application for provi-sional
measures dated 6 August 2024, containing confidentional information as high-lighted
in grey therein, which is hereby classified as confidential, shall be restricted from
the Insulet Corporation side exclusively to the persons as follows:
-with immediate effect
a. the claimant’s authorised representatives and their assistants
b. any private expert upon request , and witnesses which require access to the Confi-dential
Information for the purposes of these proceedings;
c. the following employees of the claimant
Senior Director, Intellectual Property Counsel at Applicant, Acton,
Massachusetts, USA,
- After the period of 15 days for bringing an appeal under R. 220.2 RoP and an additional
week, after having brought the appeal, during which an application for suspensive effect
may be lodged, has elapsed:
d. Partner at Goodwin Procter LLP, Boston, Massachusetts, USA.
II. The information referred to in paragraph 1 shall be treated as confidential by the per-sons
referred will be treated confidentially in that paragraph;
III. Such information shall not be used or disclosed outside of these court proceedings, ex-
cept to the extent that it has come to the knowledge of the receiving party outside of
these proceedings, provided that the receiving party has obtained it on a non-confidential
basis from a source other than the defendant or its affiliates, provided that such source is
not bound by a confidentiality agreement with or other obligation of secrecy with the
defendant or its affiliates.
IV. The foregoing persons shall also be under an obligation to the claimant to maintain the
confidentiality of the information contained in the unredacted versions of the foregoing
documents.
This obligation of confidentiality shall continue to apply after the termination
of these proceeding;
V. in the event of a breach of this order the Court may impose a penalty pursuant to Rule
No. 354(3) R.o.P.;
VI. leave to appeal is hereby granted;
VII. the costs relating this proceeding will be settled together with the costs of the main pro-
ceedings.

Issued in Milan on 4 September 2024

ORDER DETAILS
Order no. ORD_45723/2024
UPC number: UPC_CFI_400/2024
Related proceeding no. Application No.: 40442/2024
Application Type: Application for provisional measures (RoP206)