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 Weberstraβe 8 72622 N ϋ rtingen - Germany

Represented by Benjamin Husband

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 Harry- Glϋck -Platz 2/5 A-1100 Vienna - Austria

Represented by Benjamin Husband

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 Databankweg 26 NL 3821 AL Amersfoort - Netherlands

Represented by Benjamin Husband

DEFENDANT/APPLICANT

Labrador Diagnostics LLC

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 Legally qualified judge and judge rapporteur Technically qualified judge

Andrea Postiglione

Marije Knijff 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

Represented by Christof Höhne

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 instructions in that procedure. The Court expects to be informed about any issue /statement arising 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 (Exhibit 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 allowed 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 Counterclaim 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 b efore 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 bioMérieux 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/videos 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 special 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 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).

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

Presiding judge

Marije Knijff

Legally qualified judge and judge rapporteur

Michel Abello

Technically qualified judge

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

Not provided Not provided