ACT_48305/2024
UPC_CFI_497/2024
CC_54050/2024
UPC_CFI_571/2024

PROCEDURAL ORDER
of the Court of First Instance of the Unified Patent Court
Central Division Milan
issued on 18 July 2025

CLAIMANT/RESPONDENT
ACT_48305/2024:
bioMérieux UK Limited Represented by Benjamin Husband
Chineham Gate, 1st Floor Crockford Lane,
Chineham - RG24 8NA - Basingstoke – GB
CC_54050/2024:
bioMérieux SA Represented by Benjamin Husband
376 Chemin de l’Orme
69280 Marcy l’Etoile – France
bioMérieux Deutschland GmbH Represented by Benjamin Husband
Weberstraβe 8
72622 Nϋrtingen - Germany
bioMérieux Italia S.p.A. Represented by Benjamin Husband Via di Campigliano 58
Ponte e Ema 50012 Bagno a Ripoli (Fl) - Italy
bioMérieux Austria GmbH Represented by Benjamin Husband
Harry-Glϋck-Platz 2/5
A-1100 Vienna - Austria
bioMérieux Portugal, Lda. Represented by Benjamin Husband
Av 25 de Abril de 1974 N°23-3
2795’197 Linda-a-Velha - Portugal
bioMérieux Benelux BV Represented by Benjamin Husband
Databankweg 26 NL
3821 AL Amersfoort - Netherlands

DEFENDANT/APPLICANT
Labrador Diagnostics LLC Represented by Christof Höhne
701 S. Carson Street, Suite 200 -
89701 - Carson City, Nevada - US

PATENT AT ISSUE
Patent no. Proprietor(s)
EP 3 756 767 B1 Labrador Diagnostics LLC.

DECIDING JUDGE: Panel
Composition of the full panel:
Presiding judge Andrea Postiglione
Legally qualified judge and judge rapporteur Marije Knijff
Technically qualified judge Michel Abello

LANGUAGE OF THE PROCEEDINGS: English

SUBJECT-MATTER OF THE PROCEEDINGS
(Counter)Claim for revocation

GROUNDS FOR THE ORDER
Pursuant to Rule 105.5 of the Rules of Procedure (RoP), following the interim conference (IC), the
JR shall issue an order setting out the decisions taken.
In the present cases, the JR ordered an online IC by preliminary order of 26 May 2025, which IC
was held via Webex at 10 a.m. Milan time on 14 July 2025 and was audio-recorded (Rule 106 RoP).
All parties were duly represented by their representatives. At the IC, next to the full panel, the
following attendees were present:
Claimant: BioMérieux
• James Robertson, Senior Vice President
• Valérie Bitaud, Senior Director
• Elsa Schoen, Patent Attorney
• Agathe Michel-de-Cazotte as UPC representative
• Benjamin Husband as UPC representative
• Hadi Godazgar as UPC representative
• Hiske Roos as UPC representative
• Ben Chapman as UPC representative
• Lawrence Paleschi as UPC representative

Defendant: Labrador
• Christof Höhne, as UPC representative
• Sebastian Fuchs, as UPC representative
• Gyles Darren Smyth, as UPC representative
• Matthew Blaseby, as UPC representative
• Gary Moss, solicitor on behalf of Labrador

The following issues were addressed as per agenda (wherein topics for the IC suggested by the
parties had been taken into account), which agenda has been sent to the parties on Friday 11 July
2025, in the following way:
a. Opposition
The Court has stated to be aware of the fact that bioMérieux France filed an opposition
against the patent on 31 January 2025. BioMérieux has confirmed this and indicated that
Labrador has now replied to the opposition and both parties are awaiting further instruc-
tions in that procedure. The Court expects to be informed about any issue /statement aris-
ing in the opposition procedure which could be relevant to these proceedings.
b. Exhibits allowed
The Court notes that the Affidavit of Dominique Décaux (Exhibit CR-Rev 30 in case
48305/2024 and Exhibit CR-Inf 35 in case 54050/2024) and Cavro/the Tecan brochure (Ex-
hibit CR-Inf 31 in case 54050/2024), which Labrador commented on under paragraph 10 of
her Rejoinder to the Counterclaim for revocation of 26 February 2025, were already al-
lowed by the Court.
c. Further clarification
BioMérieux has agreed to precisely indicate to the Court which sections in her submissions
deal solely with the claims of the patent as granted which she no longer wishes to maintain,
and which sections are thus no longer relevant.
d. Number of attacks and Auxiliary Requests 1, 2 and 3
The panel informed the parties that in its opinion the number of invalidity attacks and the
number of prior art citations is high. The panel has counted about 50 invalidity attacks in
total and 16 prior art citations. There are more than 12 added matter attacks, 3 novelty
attacks, and 30 different combinations of documents to argue against the lack of inventive
step. So many attacks in one case are not efficient for the procedure nor sustainable for
the court. It is impossible to discuss them all during the OH without losing focus. In the end
it is up to the party who believes the patent is invalid to convince the Court of this in a clear
way and in clear terms, outlining a straightforward and consistent strategy.
The Court has therefore asked bioMérieux to narrow down the number of invalidity
attacks.
- When it comes to inventive step: preferable is a number of three attacks;
- When it comes to added matter, the panel has indicated that it is interested in the
added matter arguments which relate to the following features: 1. device, 2. reagent
unit, 3. sample unit, 4. first and second tip, 5. claimed path of the sample (or second
means) and also the 6. (missing) assay unit.
Above this, the Court informed the parties that the panel would be interested in
discussing during the OH the validity of the patent (from that limited number of attacks),
starting from Auxiliary requests 1, 2 and especially 3, which the court considers a
reasonable starting point.
Both parties have taken note of these instructions, without further objections.
In answer to the above, bioMérieux agreed to at least narrow down the number of attacks
to a number as mentioned by the Court, without, however, showing any willingness to
waive in part its legal claims under Rule 263 RoP, even in the view of a future appeal on the
attacks which the Court will not be dealing with during the OH.
BioMérieux will indicate which attacks are the most promising, which attacks (starting from
Auxiliary requests 1, 2 and 3) the discussion during the OH will then focus on and which
attacks (starting from those requests) the Court’s preparation for the OH will also mainly
focus on. The Court hereby requests bioMérieux to make clear to identify which attacks
(added matter, novelty and inventive step, and for the last one in which combination of
prior art documents) against which requests she would like to prioritise. The Court
considers that, when assessing inventive step using the problem-solution approach, the
party challenging the patent's validity must select the most promising starting point.
Clearly, the choice of the most promising documents must be made by the plaintiff, not the
Court. Listing the attacks in order of promise also gives the action greater logical rigour and
consistency.
The Court reserves the right to limit the discussion in the OH only on one or some of the
attacks proposed by BioMérieux.
The Court wishes to point out that its suggestions do not prejudice the possibility that the
parties may, in the time available to them, also address issues that have not been raised by
the Court.
e. Two cases
The OH will be dealing with the Claim for revocation (case 48305/2024) as well as the Coun-
terclaim for revocation (in case 54050/2024).
The Court has asked bioMérieux to indicate whether there are (any material) differences
between the validity attacks in the Claim for revocation case (48305/2024) on the one hand
and the Counterclaim for revocation (in case 54050/2024) on the other hand. If differences
exist, what exactly are those differences? Are there also differences for the attacks she
believes the most promising, which the discussion during the OH and the preparation of
the Court will focus on? And if there are no differences, can the exhibits in the Counterclaim
for revocation (in case 54050/2024), namely Brush (Exhibit CR-Inf 24 in that file) and
Cavro/the Tecan brochure (Exhibit CR-Inf 31 in that file), which deviate from the claim for
revocation case (48305/2024), be ignored? And if not, in what way are those exhibits relevant?
BioMérieux agreed to elaborate on these issues.
BioMérieux has also confirmed that the argument put forward in case 54050/2024, by
which Labrador does not have standing when it comes to the patent, or at least there is a
significant doubt whether the register is correct, is only relevant for the infringement case.
This panel therefore does not need to consider that argument.
f. Course of the OH
BioMérieux has posed the question how the panel intends to open the OH and both parties
have asked for clarity on how the OH will be structured.
To answer that:
The Presiding Judge will open the OH with a short introduction, without expressing a
preliminary opinion of the panel on the case.
Labrador has sent an initial proposal for a time schedule in relation to the issues to be
discussed.
The Court thinks it is indeed wise to agree on forehand on what amount of time the parties
will have during the OH for their respective arguments and rebuttal per topic.
The Court envisions an arrangement of topics, in which the issues of Claim Interpretation,
Clarity and Added Matter will be brought together, because of their areas of overlap (they
are linked to claim construction), and in which the issues of Novelty and Inventive Step will
also be brought together, because probably some same prior art documents will be
reviewed there.
The Court proposes that, after the short opening:
The first 2 hours (roughly from 10.15-12.15h) will be used to talk about: Claim
Interpretation, Clarity and Added Matter,
and after one hour lunchbreak,
the Court will allocate 1,5 hours to discuss: Novelty and Inventive Step.
The Court thinks it would be very helpful and efficient, within those two ‘blocks’ of
combined topics, to dedicate a certain amount of time to one (added matter, novelty or
inventive step) attack, one prior art citation (within which all attacks related to that prior
art citation can be discussed) or one linked issue, and directly reply after that plea, so we
can close the discussion per (sub)topic. For example, one (sub)topic can be – added matter
arguments that the Court is specifically interested in, as indicated during the IC – the
reagent unit and the sample unit, and the dedicated time to that (sub)topic can be 30
minutes (10 minutes plea each and 5 minutes reply each).

Considering that no more than a couple of pages of the statements are dedicated to the
issue of Sufficiency, the Court doesn’t think this topic needs to be discussed further during
the OH.
Parties agreed with the suggestion of the Court that bioMérieux, as she will inform the
Court after this IC on which invalidity attacks she will focus, at that same time bioMérieux
will also inform the Court into which (sub)topics she wishes to divide those attacks and
which amount of time she would like to plea on which (sub)topic, the starting point being
that Labrador should be given the same amount of time to respond to this topic.
Considering that a time management per (sub)topic is more demanding than a plea divided
into separate parts, and of course the Court will also be able to ask questions and useful
discussions may arise. There will be room for this on the day of the OH if necessary.
g. VIDAS Manual
According to Labrador bioMérieux has not met the burden of proof that the VIDAS manual
was publicly available before the relevant date. That’s why before the IC Labrador
requested the Court for a procedural ruling that the manual will not be admitted as prior
art.
BioMérieux on the other hand, has indicated that she wants to know whether the Court
would require more evidence on this topic.
According to the preliminary opinion of the panel, the VIDAS Manual will not be of decisive
importance for the discussion in the OH. So, the Court sees no reason to reject the manual
as prior art and will rely on the documents which have already been filed in the procedure.
Both parties took note of this opinion.
The Court also asked bioMérieux the question whether the VIDAS Manual is still relevant
in the light of Rogers (Exhibit CR-Rev 9 in case 48305/2024 and Exhibit EIP-16 in case
54050/2024). BioMérieux then indicated that she could imagine that one of the inventive
step attacks to be chosen would be one starting from the VIDAS Manual/Rogers, but she
has to think about that.
Labrador stated that if bioMérieux still wishes to present the VIDAS Manual as a basis for
an invalidity attack, then she maintains her objections to that document, pointing out that
she may have to get into detail about whether the VIDAS manual was publicly available
before the relevant date, which will take time of the OH.
The Court notes that also in a later stage of the procedure, for example at the end of August
or the beginning of September, when it is clear which attacks have been chosen by
bioMérieux and the parties can specify what and why time should be set aside during the
OH for this topic, there is the possibility to issue a further procedural order with further
specification about the course of the OH.

h. Declarants
The Court has stated that it’s not going to summon any declarant, but if one of the parties
would like a declarant (in this case only bioMérieux has submitted statements, namely of
Bruno Prevost and of Dominique Décaux) to provide further clarification on a matter to be
discussed during the OH, that party can bring that declarant(s). To bring the declarant(s) in
person to the OH is preferred, but online presence can also be organised.
The Court takes note that Dominique Décaux might have some comprehension issues in a
proceedings in English and is ready to find specific solutions. The Court requests bioMé-
rieux to indicate before the OH if (one of) the declarants will be present, and if so, how. If
bioMérieux wants a declarant to provide further explanation on a specific (sub)topic, this
can be done within the given plea time allowed for that (sub)topic.
i. Demonstratives
The Court also requested the parties to let the Court know in advance of the OH if they
want to bring/show demonstratives to/during the OH. If a party wishes to show photos/vid-
eos to support her arguments, then the necessary preparations can be made. Other
demonstratives can simply be taken to the OH and shown. In case of demonstratives spe-
cial arrangements between the parties about time management will be required.
j. Value of the actions
Up until now, both parties agree that the value of the action in accordance with Rule 370.6
should be set at € 5 million, but they disagree on how that value should be applied to the
Claim for revocation action (case 48304/2024) and the Counterclaim for revocation action
(in case 54050/2024).
The Court has given consideration to the parties to find a reasonable solution for this
matter among themselves, so that the Court can concentrate on the important material
issues of the case and does not have to spend precious time on consideration of this
(normally resolved by the parties themselves) matter.
Both parties took note of this advice and indicated that they will look for a solution.
k. Further submissions
The Court considers the case does not require further evidence.
However, the Court considers it sensible for Labrador to file the main request and the Aux-
iliary Requests renumbered in both cases, in such a way that the amended claim 9 becomes
claim 1 and the amended claim 14 becomes claim 2 (so that the numbering per request
matches the numbering as the patent should ultimately remain valid according to Labra-
dor).
l. Preliminary estimate of legal costs
The Court orders the parties to submit, in advance of the OH, a preliminary estimate of
the legal costs that they will seek to recover, under Rule 118.5 RoP, so that this can be
discussed during the OH if necessary.

In summary and with the agreed deadlines:
- BioMérieux will inform the Court in a week after the IC, so at the latest on 21 July
2025:
o which sections in her submissions deal solely with the claims of the patent as
granted which she no longer wishes to maintain, and which sections are thus no
longer relevant,
o which invalidity attacks she believes are the most promising, which attacks
(starting from Auxiliary requests 1, 2 and especially 3) the discussion during the
OH will then focus on and which attacks (starting from those attacks) the Court’s
preparation for the OH will also mainly focus on, and thereby identifies which
invalidity attacks (added matter, novelty and inventive step, and for the last one
in which combination of prior art documents) against which requests she would
like to prioritise,
o whether there are (any material) differences between the validity attacks in the
Claim for revocation case (48305/2024) on the one hand and the Counterclaim
for revocation (in case 54050/2024) on the other hand. If differences exist, what
exactly are those differences? Are there also differences for the attacks she
believes the most promising, which the discussion during the OH and the
preparation of the Court will solely focus on? And if there are no differences,
can the exhibits in the Counterclaim for revocation (in case 54050/2024),
namely Brush (Exhibit CR-Inf 24 in that file) and Cavro/the Tecan brochure
(Exhibit CR-Inf 31 in that file), which deviate from the claim for revocation case
(48305/2024), be ignored? And if not, in what way are those exhibits relevant?
o into which (sub)topics she wishes to divide the chosen attacks and which
amount of time she would like to dedicate to which (sub)topic,
- Labrador will file in a week after the IC, so at the latest on 21 July 2025:
o the main request and the Auxiliary Requests renumbered in both cases, in such
a way that the amended claim 9 becomes claim 1 and the amended claim 14
becomes claim 2 (so that the numbering per request matches the numbering as
the patent should ultimately remain valid according to Labrador).
- Both parties will submit, at the latest on 10 September 2025:
o a preliminary estimate of the legal costs that they will seek to recover, so that
this can be discussed during the OH if necessary.

ORDER
- Parties will provide the Court the information according to the above.

Issued on 18 July 2025

Andrea Postiglione

ORDER DETAILS
Order no. ORD_69409/2024 in ACTION NUMBER: ACT_35332/2024, CC_54050/2024
UPC number: UPC_CFI_571/2024
Action type: Counterclaim for Revocation in infringement action
Related proceeding no. Not provided Not provided