UPC_CFI_181/2025_July15 – Qiagen v bioMérieux

Expert Commentary

Confidential Information Facts BioMérieux asked for protection of confidential information. Decision of the JR 1. Prior art is not confidential information, and the JR does not accept the argument that knowledge of the prior art would indirectly disclose the exact lengths of the peptides used by the defendant, as this is too unspecific. 2. A party is free to engage the attorneys it wishes to engage. The representatives are free to choose their team members, for whom they are responsible. 3. A requirement that persons from the claimant who get access to the confidential information should not have been involved in the prosecution of the claimant's patents is not acceptable. 4. External experts who get access to the confidential information should be mentioned by name. Comment 1. In this case, the defendant even wanted the claimant's representatives to name two assistants who would get access and invented “procedural conditions”. That procedural condition, in fact, could have been read as the defendant implicitly threatening to remove all confidential information from the Statement of Defence if the JR did not grant an order precisely as the defendant indicated. Luckily for the defendant, the JR pretended not to understand that “procedural condition,” as I assume a defence without the confidential information would probably have been disadvantageous for the defendant. 2. I think the JR got everything right: Prior art (which is by its nature public) is not confidential information. Representatives choose their own teams, for which they are responsible. Persons from the claimant who get access do not have to be employees but must be named.

Full Decision Text

1 Düsseldorf Local Division UPC_CFI_181/2025 Procedural Order of the Court of First Instance of the Unified Patent Court issued on 15 July 2025 concerning EP 2 726 883 CLAIMANT: QIAGEN Sciences, LLC, represented by its President and Chief Executive Officer Thierry Bernard, its Treasurer and CFO Roland Sackers, its Senior Vice President, Head of Global Operation Antonio Santos, and its Secretary Tim Grabham, 19300 Germantown Rd, Germantown, MD 20874, USA represented by: Attorney-at-law Dr Clemens Plassmann, Attorney-at-law Dr Markus Kuczera, Attorney-at-law Chia C. Chuong and all lawyers of Hogan Lovells International LLP who are authorised to act as representatives before the UPC, Dreischeibenhaus 1, 40211 Düsseldorf, Germany with support by: Patent Attorney Carla Roth, Dipl.-Biologin (graduate biolo- gist), Patent Attorney Dr rer. nat. Lars Hemsath, Dipl.-Biochemiker (graduate biochemist), Hoffmann Eitle Patent- und Rechtsanwälte PartmbB, Mönchenwerther Straße 11, 40545 Düsseldorf, Germany electronic address for service: upc-hub@hoganlovells.com DEFENDANTS: 1. bioMérieux S.A., represented by its Executive Chairman Alexandre Mérieux and Chief Executive Officer Pierre Boulud, 376, chemin de l’orme, F-69280 Marcy-l’Etoile, France 2. bioMérieux Deutschland GmbH, represented by its director Alexandre Schneider, Weber- straße 8, 72622 Nürtingen, Germany represented by: Attorney-at-law Oliver Jan Jüngst, LL.M, Attorney-at-law Dr Annika L. Lückemann, LL.M., Attorney-at-law Selina Schnei- der, Bird & Bird LLP, Carl-Theodor-Straße 6, 40213 Düsseldorf, Germany electronic address for service: oliver.jan.juengst@twobirds.com 2 PATENT AT ISSUE: European patent n° EP 2 726 883 PANEL/DIVISION: Panel of the Local Division in Düsseldorf DECIDING JUDGES: This Order was issued by Judge Dr Schumacher acting as judge-rapporteur. LANGUAGE OF THE PROCEEDINGS: English SUBJECT OF THE PROCEEDINGS: R. 262A RoP – Protection of confidential information SUMMARY OF FACTS: 1. The Claimant filed an infringement action against the Defendants before the Court. 2. The Defendants lodged their Statement of defence on 10 June 2025. On the same date, they filed an application for protection of confidential information under R. 262A RoP with regard to information contained in the Statement of defence and in Exhibits BB 6 to BB 10. 3. On 16 June 2025, the judge-rapporteur issued a preliminary order for the protection of the information referred to in the confidentiality request, providing the Claimant’s representatives with an opportunity to comment. The Claimant’s representatives filed a submission on 26 June 2025. 4. The Defendants were invited to comment on this submission. They responded with comments and partially amended their requests in a submission dated 9 July 2025. REQUESTS: 5. The Defendants request (whereby the underlined adjustments are taken from the submission dated 9 July 2025 and are requested partially in case that […] is granted access): I. The following information from the Statement of defence dated 10 June 2025 (ACT_9962/2025) as well as the accompanying Exhibits BB 6–10 to the Statement of defence (all filed in CMS on the same date) are classified as confidential within the meaning of Art. 58 UPCA in conjunction with R. 262.2 and R. 262A RoP, namely  information about the peptides used by Defendants, including the sequence, length, and number of peptides as well as information that allow such conclusion to be drawn;  analyses and results; and  supplier documents and technical specifications in particular, the information greyed out in the Statement of defence and shown as follows (whereas “SoD” in the table below stands for Statement of defence of 10 June 2025): 3 II. Access to the unredacted confidential information in the Statement of defence as well as in Exhibits 6–10 is restricted on part of Claimant to the following persons only: 1. Registered UPC representatives of Claimant:  Attorney Dr Clemens Plassmann (Hogan Lovells LLP);  Attorney Dr Markus Kuczera (Hogan Lovells LLP);  Attorney Chia C. Chuong (Hogan Lovells LLP); 4  up to two (2) further representatives from their team who are actively involved in these proceedings, as designated by Dr Clemens Plassmann;  up to two (2) persons from the assistant staff of the law firm Hogan Lovells, who provide organizational support to Claimant’s representatives in the present proceedings, as designated by Dr Clemens Plassmann;  up to two (2) persons from the assistant staff of the law firm Hoffmann Eitle Patent- und Rechtsanwälte PartmbB, who provide organizational support to Claimant’s representatives in the present proceedings, as designated by Claimant’s lead UPC representative Dr Clemens Plassmann. 2. Two (2) natural persons from Claimant, whereas these may not be involved in the prosecution of patents for the Claimant’s group of companies. III. The information classified as confidential in item I. shall be treated as confidential by Claimant as well as Claimant’s representatives (all advisors including party experts) and their teams until further notice. Such information shall not be disclosed to third parties (who are not listed under item II.) or used or disclosed outside of these court proceedings, whereby the information must also be treated as strictly confidential beyond the scope of these proceedings, except to the extent, that it has verifiably come to the knowledge of the receiving party outside of these proceedings in a lawful manner, provided that the receiving party has obtained it on a non-confidential basis from a source other than Defendants or its affiliated, provided that such source is not bound by a confidentiality agreement with or other obligations of secrecy with Defendants or its affiliates. IV. If the Claimant’s representatives (all advisors including party experts) named in item II. 1. above make use of the possibility of giving access to confidential information to other members of their team, it is their responsibility to ensure that their team maintains the confidentiality of the information. In the event of a culpable breach of the confidentiality obligations, Dr Clemens Plassmann, Dr Markus Kuczera, Chia C. Chuong, Dr Michael Plagge, Carla Roth, Dr Lars Hemsath and/or, respectively, […] would therefore be liable. This also applies to any breach of the duty of confidentiality by any member of their team to whom they have granted access. V. In the event of a culpable breach of items II.-IV., the Court may impose a penalty payment for each violation, which will be determined having regard to the circumstances of the individual breach. VI. The information classified as confidential in item I. is excluded from the case files that will be available to third parties also beyond a conclusion of the proceedings before the Court. VII. In the event that confidential information as mentioned in item I. is discussed in any oral hearing relating to these proceedings as well as the pronouncement of the grounds for the judgment, the public shall be excluded from all oral hearings relating to these proceedings as well as the pronouncement of the grounds for the judgment, insofar as the information classified as confidential in accordance with item I. is to be subject of the oral hearing. 5 VIII. Prior to publication of the reasons for a judgment or other announcements, any confidential information as mentioned in item I. be redacted therein. 6. The Claimant requests that the following persons are to be granted access to the confidential (unredacted) version of the Statement of defence: a) Claimant’s Registered Representatives before the UPC – attorneys-at-law  Attorney-at-law Dr Clemens Plassmann,  Attorney-at-law Dr Markus Kuczera,  Attorney-at-law Chia C. Chuong,  Attorney-at-law Dr Michael Plagge,  and team and employees of Hogan Lovells International LLP, as far as they are involved in the present proceedings. b) Claimant’s Registered Representatives before the UPC – patent attorneys  Carla Roth, European Patent Attorney,  Dr Lars Hemsath, European Patent Attorney,  and team and employees of Hoffmann Eitle Patent- und Rechtsanwälte PartmbB as far as they are involved in the present proceedings. c) Natural persons of Claimant  […], VP, Global IP & Licensing, European Patent Attorney, Registered Representative before the UPC, QIAGEN,  […], Director IP & IP Litigation, QIAGEN,  […], VP, Program Head Infectious Disease Portfolio, QIAGEN, and  […], Associate Director QuantiFERON Innovation and Core Technology Assessment, QIAGEN. d) Further required persons  […], CEO of MoleQLar Analytics GmbH,  and team and employees of MoleQLar Analytics GmbH, as far as they are involved in analysing the attacked embodiment (cf. Exhibits HL 27a-27c). 7. The Defendants request that the Claimant's requests be rejected insofar as the persons designated for access are not named. They do not oppose the addition of the patent attorneys Carla Roth and Dr Lars Hemsath. GROUNDS FOR THE ORDER: 8. Art. 9 (1) and (2) (a) of Directive (EU) 2016/943 provide that, in judicial proceedings, access to documents submitted by the parties or third parties containing trade secrets or alleged trade secrets may, upon request, be restricted in whole or in part to a limited number of persons. The protection of confidential information is provided for in Art. 58 UPCA and implemented in R. 262A RoP. 9. According to R. 262A.5 RoP, the Court may allow the application for protection of confidential information considering in particular whether the grounds relied upon by the applicant for the order significantly outweigh the interest of the other party to have full 6 access to the information and the evidence in question. 10. That being said, the application is to be granted subject to the following. 1. Classification of information as confidential 11. The information contained in Exhibit 10 does not qualify as confidential information within the meaning of Art. 58 UPCA, R. 262.2 RoP. The Defendants describe the contents of Exhibit 10 as follows: “Prior art documents that contain information that allows conclusion to be drawn about length of peptides used by Defendants”. 12. Prior art documents are neither a trade secret nor other confidential information of a party. The Defendants do not dispute this. 13. Instead, they argue that it is not the prior art itself that is confidential information, but rather that the disclosure of these documents specifically in the context in which they are mentioned in the Statement of defence, allow Claimant (and third parties) to draw a conclusion to sensitive information about the exact length of peptides used by Defendants. However, this does not justify the classification as confidential information. The explanation provided by the Defendants as to why conclusions can be drawn about the exact length of the peptides used by the Defendants is not specific. It is not sufficiently clear why the exact length of the peptides can be inferred from the collection of prior art in Exhibit 10. Furthermore, the information itself must be worthy of protection. Focusing on the context in which the information is presented in the Statement of defence would not enable one to distinguish it from non-protected information. Moreover, it is unclear how the Claimant could effectively protect the information against disclosure. 14. The remaining information qualifies as confidential. Except for Exhibit BB 10, the Claimant has not disputed the confidential nature of the information. Therefore, it must be assumed that the information in question is worthy of protection. 2. Restrictions of access 15. According to R. 262A.6 RoP, the number of persons to whom access is restricted shall be no greater than necessary in order to ensure compliance with the right of the parties to the legal proceedings to an effective remedy and to a fair trial, and shall include, at least, one natural person from each party and the respective lawyers or other representatives of those parties to the legal proceedings. 16. Whether a particular person may be granted full access under R. 262A.6 RoP must be determined on the basis of the relevant circumstances of the case, including the role of that person in the proceedings before the Court, the relevance of the confidential information to the performance of that role and the trustworthiness of the person in keeping the information confidential (UPC_CoA_621/2024, Order of 12 February 2025, par. 12 – Daedalus v. Xiaomi; UPC_CoA_221/2025, Order of 3 July 2025, par. 17 – NST v. Qualcomm). a) Representatives and team 17. As a general principle, a party is free to decide which attorneys it wishes to engage to assist it in the proceedings (UPC_CoA_621/2024, Order of 12 February 2025, par. 16 – Daedalus v. Xiaomi; UPC_CoA_221/2025, Order of 3 July 2025, par. 18 – NST v. Qualcomm). 7 18. Access had to be granted to the representatives (attorneys and patent attorneys) listed in the order. The Defendants did not object to this. 19. Furthermore, the Court has granted these representatives the right to share the relevant information with their team working on the case. Access to confidential information shall not be restricted to the authorised representatives, but extends to other members of their team who are actively involved in the present proceedings, including other UPC representatives, patent attorneys and support staff. As part of their organisational autonomy, the UPC representatives are free to decide whom to involve in handling a case (see UPC_CFI_471/2023 (LD Mannheim), Order of 3 July 2024 – DISH v. AYLO; UPC_CFI_140/2024 (LD Düsseldorf), Order of 8 August 2024 – 10x Genomics v. Curio Bioscience; UPC_CFI_498/2023 (LD Munich), Order of 14 August 2024 – NEC v. TCL; UPC_CFI_145/2024, 146/2024, 147/2024, 148/2024 (LD Munich), Order of 14 January 2025 – Sanofi v. Accord; UPC_CFI_846/2024 (LD Munich), Order of 10 March 2025 – Promosome v. BioNTech). 20. If the Claimant’s representatives who have access to the confidential information make use of the possibility to share this information with other members of their team, it is their responsibility to ensure that their team maintains the confidentiality of the information. In the event of a culpable breach of the confidentiality obligations, the representatives who have been granted access to the information would therefore be liable. This also applies to a breach of confidentiality by their team members to whom they have granted access (see UPC_CFI_140/2024 (LD Düsseldorf), Order of 8 August 2024 – 10x Genomics v. Curio Bioscience; UPC_CFI_402/2023 (LD Munich), Order of 9 August 2024 – Abbott v. Dexcom; UPC_CFI_498/2023 (LD Munich), Order of 14 August 2024 – NEC v. TCL; UPC_CFI_846/2024 (LD Munich), Order of 10 March 2025 – Promosome v. BioNTech). 21. The responsibility of the Claimant’s representatives, as outlined in par. 20, provides the Defendants with sufficient protection. Therefore, the request to name and limit the number of team members was not granted. b) Natural persons 22. As the Defendants have not objected to the four individuals named by the Claimant, the latter are granted access to the confidential information. 23. The Defendants did not follow up on their request that individuals nominated by the Claimant must not be involved in prosecuting patents for the Claimant’s group of companies. In any case, this request could not be approved. The Claimant has clearly and understandably demonstrated that this would unjustifiably restrict its ability to conduct the proceedings. There is also no indication of the information being misused. Therefore, such a restriction would be inappropriate (see UPC_CFI_471/2023 (LD Mannheim), Order of 3 July 2024 – DISH v. AYLO). c) External Experts and team 24. R. 262A RoP does not require that the person to whom access is given be an employee of a party or a representative within the meaning of Art. 48 UPCA (UPC_CoA_621/2024, Order of 12 February 2025, par. 13 – Daedalus v. Xiaomi). In light of this, access can be granted to external experts. 25. Access to the confidential information had to be granted to […], CEO of MoleQLar Analytics 8 GmbH. MoleQLar analysed the attacked embodiment and provided a test report. The Claimant requires […] to analyse the Defendants’ non-infringement arguments, provide relevant technical input on the matters in question and offer a statement on the Defendants’ allegations and studies. The Defendants did not object to this. 26. However, access cannot be granted to the team and employees of MoleQLar as long as the individuals involved are not named. 27. External experts should be named in advance (UPC_CFI_471/2023 (LD Mannheim), Order of 3 July 2024 – DISH v. AYLO; see also UPC_CFI_498/2023 (LD Munich), Order of 14 August 2024 – NEC v. TCL). This follows from the fact that effective protection of confidential information also requires clear accountability (see UPC_CFI_498/2023 (LD Munich), Order of 14 August 2024 – NEC v. TCL). It also applies to MoleQLar. 28. Granting access to an external expert’s team is not comparable to granting access to other members of a UPC representative’s team (see par. 19). Firstly, the involvement of an external expert, MoleQLar in this case, in the proceedings is less comprehensive. As previously explained, the Claimant requires the expert to analyse the Defendants’ non-infringement arguments, provide technical input on the matters in question and offer a statement on the Defendants’ allegations and studies. There is no indication that the individuals required for this purpose could not be identified in advance. Secondly, it should be noted that UPC representatives and their teams are accustomed to handling confidential information. They are bound by the rules of professional conduct for attorneys-at-law or patent attorneys. This does not necessarily apply to external expert employees. 29. The Defendants’ submission does not suggest that access by anyone other than […] is necessary. However, if it is necessary, the Claimant may apply for an extension to this order, specifying the required persons. 3. Procedural condition 30. In their application of 10 June 2025, the Defendants’ representatives included the following “procedural condition”, after requesting a preliminary order: “We declare on behalf of Defendants, that the (unedited) confidential information will only be made available to Claimant under the procedural condition that the Court issues the requested preliminary confidentiality order (for the purpose of commenting, R. 262A.4 RoP) and subsequently issues the final order for the protection of confidential information”. 31. The judge-rapporteur does not understand the “procedural condition” as meaning that any deviation from the requests will result in the Statement of defence, including the Exhibits, should be treated as though it had not been submitted to the file. This interpretation does not follow from the wording of the condition. Furthermore, the Defendants placed both the condition itself and the justification for it solely in the context of a Preliminary Order (see application of 10 June 2025, pages 5 and 13). Consistently, the Defendants did not return to this point after a preliminary order had been issued. 32. However, access to the unredacted version of Exhibit 10 will only be granted one week after the order has been served. 4. Further requests 33. Decisions on motions VI to VIII will be made in due course. 9 ORDER: I. The following information is classified as confidential within the meaning of Art. 58 UPCA, R. 262.2 RoP: The information set out in detail below and greyed out in the Statement of de- fence dated 10 June 2025 and blackened in Exhibits BB 6, BB 7, BB 8 and BB 9 to the Statement of defence relating to information about the peptides used by De- fendants, including the sequence, length, and number of peptides, analyses and results, supplier documents and technical specifications: 10 II. Access to the unredacted version of the Statement of defence and to the unredacted versions of Exhibits BB 6, BB 7, BB 8 and BB 9 to the Statement of defence shall be restricted, on the part of the Claimant, to the following persons only: 1. Representatives of the Claimant (attorneys-at-law): o Attorney-at-law Dr Clemens Plassmann, o Attorney-at-law Dr Markus Kuczera, o Attorney-at-law Chia C. Chuong, o Attorney-at-law D. Michael Plagge, o and team and employees of Hogan Lovells LLP, as far as they are involved in the present proceedings. 2. Representatives of the Claimant (patent attorneys): o Carla Roth, European Patent Attorney, o Dr Lars Hemsath, European Patent Attorney, o and team and employees of Hoffmann Eitle Patent- und Rechtsanwälte PartmbH, as far as they are involved in the present proceedings. 3. Natural persons of Claimant: o […], VP, Global IP & Licensing, European Patent Attorney, Registered Representative before the UPC, QIAGEN, o […], Director IP & IP Litigation, QIAGEN, o […], VP, Program Head Infectious Disease Portfolio, QIAGEN, and o […], Associate Director QuantiFERON Innovation and Core Technology Assessment, QIAGEN. 4. Further required person: o […], CEO of MoleQLar Analytics GmbH. III. The information classified as confidential in paragraph I. shall be treated as such by the persons referred to in paragraph II. and shall not be used or disclosed outside of these court proceedings, except to the extent that it has verifiably 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 Defendants or their affiliates, provided that such source is not bound by a confidentiality agreement or other obligation of secrecy with the Defendants or their affiliates. IV. In the event of a culpable breach of this Order, the Court may impose a penalty pay- ment for each breach, to be determined having regard to the circumstances of each case. V. If the Claimant’s representatives named in paragraph II. 1. and 2. (attorneys-at-law and patent attorneys) make use of the possibility of giving access to confidential infor- mation to other members of their team, it is their responsibility to ensure that their team maintains the confidentiality of the information. In the event of a culpable 11 breach, Dr Clemens Plassmann, Dr Markus Kuczera, Chia C. Chuong, Dr Michael Plagge, Carla Roth and/or, respectively, Dr Lars Hemsath, would therefore be liable. This also applies to any breach of the duty of confidentiality by any member of their team to whom they have granted access. VI. The Defendants’ request for protection of confidential information concerning Exhibit 10 is rejected. Access to the unredacted version of Exhibit 10 shall only be granted one week after service of the order. DETAILS OF THE ORDER: App_27426/2025 related to the main proceedings ACT_9962/2025, CC_26510/2025 and CC_27456/2025 UPC-Number: UPC_CFI_181/2024, UPC_CFI_497/2025 and UPC_CFI_ 516/2025 Subject of the Proceedings: Patent infringement action and Counterclaim for revocation Issued in Düsseldorf on 15 July 2025 NAMES AND SIGNATURES Judge Dr Schumacher

Key Holdings

• Prior art cannot be confidential information.
• Representatives select their own team; specific assistants need not be named.
• No restriction on prosecution attorneys accessing confidential info.
• External experts must be named for access.

Tags

• Access to Documents
• Confidentiality
• Legal Representation

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