UPC CFI 407/2025 & 408/2025 – GENENTECH INC., F. HOFFMANN – LA ROCHE AG v. NV ORGANON, ORGANON HEIST B.V.

Court
Local Division Brussels
Date
Outcome
Partially granted orders to preserve evidence and for inspection against NV ORGANON and ORGANON HEIST B.V.; dismissed against ORGANON & Co. and Shanghai Henlius Biotech Inc.
Sector
Pharma/Bio
Decision Type
Order to Preserve Evidence, Order for Inspection

Expert Commentary

Full Decision Text

Brussels - Local Division ORD 23125/2025 ACT 21478/2025 UPC CFI 407/2025 (Order to Preserve Evidence) ORD 23121/2025 ACT 21486/2025 UPC CFI 408/2025 (Order for Inspection) UPC CFI 407/2025 UPC CFI 408/2025 ORDER of the Court of First Instance of the Unified Patent Court Local Division Brussels Issued on 30 May 2025 Concerning EP 3 401 335 B1 Headnotes: Order to preserve evidence and order to preserve evidence granted. Keywords: Order to preserve evidence – Order for inspection APPELLANTS: GENENTECH INC. F. HOFFMANN – LA ROCHE AG Represented by: Rutger Kleemans and Allard van Duijn, Freshfields LLP, Strawinskylaan 10 – 1077 XZ Amsterdam (The Netherlands), DEFENDANTS (IN THE SENSE OF R. 192 ROP– 198 ROP AND R. 199 ROP): (1) ORGANON & Co. (2) ORGANON HEIST B.V. (3) NV ORGANON (4) SHANGAI HENLIUS BIOTECH INC PATENT AT ISSUE Patent no. Proprietor(s) EP 3 401 335 B1 F. HOFFMANN – LA ROCHE AG UPC CFI 407/2025 & 408/2025 27 May 2025 2 LANGUAGE OF THE PROCEEDINGS: ENGLISH SUBJECT MATTER OF THE PROCEEDINGS 1. ACT 21478/2025 (UPC CFI 407/2025) (Order to preserve evidence R. 192 – R. 198 RoP) 2. ACT 21486/2025 (UPC CFI 408/2025) (Order for inspection R. 199 RoP) PANEL/LOCAL DIVISION The Panel (LD Brussel) consists of the following judges: President – Judge-Rapporteur / Legally Qualified Judge: Samuel Granata Legally Qualified Judge: Petri Rinkinen Legally Qualified Judge: Rute Lopes DECIDING JUDGES: This final order is issued by the panel. ORAL HEARING: An (preliminary) oral hearing was held on 23 May 2025. UPC CFI 407/2025 & 408/2025 27 May 2025 3 ABBREVIATIONS To improve the readability of this order, the following abbreviations and references will be used (in alphabetical order): Applicants Genentech, Inc and ROCHE and F. Hoffmann-La Roche AG Applications The Applications made in workflows ACT 21478/2025 (UPC CFI 407/2025)(order to preserve evidence) and ACT 21486/2025 (UPC CFI 408/2025) (order for inspection). Brussels I Recast Regulation Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (Recast) CE - CDS Capillary electrophoresis sodium dodecyl sulphate CFR Charter of Fundamental Rights of the European Union CN 057 Chinese Patent CN111375057 A filed by Shanghai Henlius Biotech, Inc CMS Court Management System Court Unified Patent Court Defendants Organon & Co, Organon & Co, Organon Heist B.V. and N.V. Organon Defendants II Organon Heist B.V. and N.V. Organon ECHR European Convention on Human Rights EMA European Medicines Agency Enforcement Directive Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights EP 335 (or Patent) EP 3 401 335 B1. EPO European Patent Office GENENTECH Genentech, Inc. HENLIUS Shanghai Henlius Biotech, Inc HLX11 Refers to the bio-similar of Perjeta® that Defendants are about to launch and is the name used presently by the Defendant. LD Local Division of the Unified Patent Court MAA Market authorization application ORGANON BE Organon Heist B.V. ORGANON NL N.V. Organon ORGANON US Organon & Co. (incorporated under the laws of the State of Delaware (US)) Perjeta ® Refers to a cancer medicine for treating adults with “HER2-positive” breast cancer. According to the Applicants claim 1 of EP 3 401 335 B1 covers Perjeta ® Regulation 726/2004 Regulation (EC) No 726/2004 of the European Parliament and the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ROCHE F. Hoffmann-La Roche AG RoP Rules of Procedure of the UPC § (followed by a number) Consideration referred to in this order Trade Secret Directive Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure UPCA Agreement on a Unified Patent Court UPC CFI 407/2025 & 408/2025 27 May 2025 4 I. PROCEDURAL BACKGROUND 1. The Applicants filed an application for an order to preserve evidence (R. 192 RoP) (ACT 21478/2025 (UPC CFI 407/2025) and an order for inspection (R. 199 RoP) (ACT 21486/2025 (UPC CFI 408/2025) on 6 May 2025 in the CMS. 2. With procedural orders dated 15 May 2025, the Judge-Rapporteur summoned the Applicants to an oral hearing to be held by video-conference. In these procedural orders it was stated that the hearing would be organized after having heard the panel and by delegation of the same. The Applicants informed the Sub-Registry that their preferred date would be Friday, 23 May 2025 (3.30 pm). 3. In the mentioned orders the Judge-Rapporteur informed the Applicants that the decision to summon the Applicants was taken after having heard the panel and being delegated by them with regard to the oral hearing. 4. By letter dated 18 May 2025, the Applicants informed the Court of the fact that ORGANON US had initiated invalidity proceedings on 7 May 2025 in the Netherlands (before the District Court in The Hague) against GENENTECH regarding BE 335. Applicants introduced the writ of summons as an additional exhibit (FS28). This Dutch national action was introduced under a so-called “Accelerated Regime in Patent Matters”. The Court was informed that the procedural dates (including a date for the introduction of a Statement of Answer and a Counterclaim for Infringement) were fixed by the District Court in The Hague (The Netherlands). The oral hearing is set at 17 April 2026. 5. By letter dated 22 May 2025, the Applicants introduced an additional request (in view of the above-mentioned national proceedings)(see § 19). 6. At the oral hearing the Judge-Rapporteur discussed some issues (see § 22) and requested an additional exhibit (a copy of CN 057). Applicants uploaded this additional exhibit in workflow App 24778/2025 and App 24779/2025 which are workflows related to the main cases. The oral hearing was recorded and accessible to the panel. II. SUMMARY OF THE FACTS II.A. Parties II.A.1. The Applicants 7. GENENTECH represents itself as “a biotechnology company dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life- UPC CFI 407/2025 & 408/2025 27 May 2025 5 threatening diseases. Genentech’s transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis”. GENENTECH became a member of the Roche Group in March of 2009. 8. ROCHE represents itself as “a large pharmaceutical company located in Basel, Switzerland” and “one of the world’s largest biotech companies, as well as a leading provider of in-vitro diagnostics and a global supplier of transformative innovative solutions across major disease areas”. II.A.2. The Defendants 9. Applicants state in their Application(s) that: • HENLIUS is a Chinese biopharmaceutical company with a focus on manufacturing biosimilars, founded in 2010. • ORGANON US is a US pharmaceutical company. Its main sites are located in Heist-Op-Den- Berg (Belgium) and Oss (the Netherlands). ORGANON became an independent company in 2021 when it was divested from Merck Sharpe & Dohme. • ORGANON BE is a subsidiary of ORGANON US, located in Heist-Op-Den-Berg, Belgium. In Heist-Op-Den-Berg, Belgium, it operates a manufacturing facility where it produces medicines for the Benelux, Europe and the rest of the world. • ORGANON NL is a subsidiary of ORGANON US located in Oss, Netherlands. In Oss, ORGANON NL operates a manufacturing facility where it produces medicines for the Benelux, Europe, and the rest of the world. II.B. The Patent II.B.1. Grant of EP 335 10. EP 335 was filed with the EPO on 28 January 2009 (under number 18157419.5) and expires in January 2029. It was the subject of opposition proceedings in which it was decided that the patent "shall be maintained in amended form" (by decision of 24 March 2025, notified to the patentee (GENENTECH) on 7 April 2025). II.B.2. The (relevant) claims of EP335 11. EP 335 is titled “Composition comprising antibody that binds to domain II of HER2 and acidic variations thereof” and is a divisional application of EP 09709065.8 (EP 2 2238 172). 12. The (relevant) claim 1, after proceedings before the Opposition Division of the EPO, as formulated in EP 335, is the following: “1. A pharmaceutical formulation comprising a composition comprising a main species HER2 antibody that comprises light chain and heavy chain amino acid sequences in SEQ ID NOs. 15 and 16 respectively and binds to domain II of HER2, and acidic variants UPC CFI 407/2025 & 408/2025 27 May 2025 6 of that main species antibody, in a pharmaceutically acceptable carrier, wherein the main species HER2 antibody is the antibody amino acid sequence structure in the composition which is the quantitatively predominant antibody molecule in the composition, wherein the acidic variants include a disulfide reduced variant.” 13. Mentioned claim 1 of EP 335 is broken down in the following features by the Applicants: (i) a pharmaceutical formulation that comprises (ii) a pharmaceutically acceptable carrier, (iii) a main species HER2 antibody, that binds to domain II of HER2, with light chain and heavy chain amino acid sequences according to SEQ ID NOs 15 and 16, respectively, (iv) which antibody is the quantitatively predominant antibody molecule in the composition, (v) acidic variants of said main species antibody, (vi) wherein the acidic variants include a disulfide reduced variant. 14. Applicants state that the product commercialized by ROCHE in Europe, PERJETA ®, is covered by EP 335. II.C. The alleged imminent infringement of EP 335 15. Applicants refer to the upcoming launch of a “pertuzumab biosimilar” (HLX11, which they hold to be covered by claim 1 of EP 335) by the Defendants. Regarding the alleged infringement, Applicants refer to CN 057 “(showing) that HENLIUS’s HLX11 protein is indeed an HER2 antibody with light chain and heavy chain amino acid sequences according to SEQ ID NOs 15 and 16”. 16. The imminent infringement of EP 335 (on the relevant market) is evidenced by the Applicants referring to the upcoming launch in the territory of the UPC based on the following factual circumstances: • Press Release dated 13 June 2022 in which HENLIUS announces that it entered into a license and supply agreement with ORGANON US for the exclusive commercialization of HENLIUS HLX11. • Earnings call on 31 October 2023 regarding Q3 2024 in which the CEO of ORGANON US stated the following: “(…) The strategy in Biosimilars is to launch a new asset every couple of years. In late 2025 and beyond, additional growth contributors to the Biosimilars franchise will be the denosumab asset then later the pertuzumab asset. Both will be launched in collaboration with Shanghai Henlius, pending FDA review and approval.” • Earnings call on 1 May 2025: in which the CEO of ORGANON US: “And finally, we anticipate launching the portfolio of Henlius products beginning in late 2025 with the denosumab biosimilar in the US, followed by pertuzumab in Europe.” UPC CFI 407/2025 & 408/2025 27 May 2025 7 • Joint Press Release on 28 March 2025 by HENLIUS and ORGANON US confirming that the EMA has validated the MAA for HLX11. • Letter by ORGANON US lawyer dated 28 April 2025 to the Applicants stating that ORGANON US “(…) intends to launch the Organon Product across Europe in due course following approval of the marketing authorization application, and wishes to obtain legal and commercial certainty in respect of certain patent families which are relevant to pertuzumab and are held by the Roche group of entities.” • Additionally, Applicants point out in their letter to the Court dated 18 May 2025 that the introduction of the national proceedings in the Netherlands (see § 4) labelled by ORGANON US as a “preliminary defence against infringement of (EP 335)” indicates the upcoming launch of an alleged imminent infringement. 17. Where Applicants appear to state that they have sufficient evidence of infringement of features (i) to (v) of claim 1 of EP 335, they contend that they lack such evidence regarding the alleged infringement of feature (vi) as there is no public information available regarding this feature. Applicants argue (and substantiate) that it is "highly likely" that the acidic variants contained in HLX11 also include a disulfide-reduced variant, but consider that definitive proof of this can only be obtained by granting the requests set out below. III. THE REQUESTS 18. In its Applications, the Applicants request the following, by immediate enforceable order: As primary requests (i) to authorize the Applicants to proceed through the territorially competent bailiff to make a description of the product manufactured or to be manufactured at any of Organon’s premises in Belgium and the Netherlands, by allowing: (a) taking of photographs and videos (including audio) of the exterior and interior of any appliance and surrounding area that may be used to manufacture the product of claim 1; (b) taking of samples from any compartment inside such appliance under (a); (c) taking of 10 (ten) samples of HLX11 biosimilar formulation; and (d) taking of any other action necessary to describe the manufacturing and composition of the product. (ii) to authorize the Applicants to proceed through the territorially competent bailiff to acquire physical and/or digital copies of: (a) batch records relating to the bio-reactor and/or the product in claim 1 of the Patent, both executed and non-executed form; (b) manuals relating to the bio-reactor and/or the product in claim 1 of the Patent; (c) any and all other documents, in any format, relating to the bio-reactor and/or the product in claim 1 of the Patent; UPC CFI 407/2025 & 408/2025 27 May 2025 8 (d) more specifically and in any event, EMA or FDA regulatory documentation for HLX11, more specifically documentation that relates to the characterization of antibody variants in HLX11, more specifically a completed EMA “COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE QUALITY OVERALL SUMMARY OF MODULE 2 AND MODULE 3:QUALITY” https://www.ema.europa.eu/en/documents/scientific- guideline/ich-m-4-q-common-technical-document-registration- pharmaceuticals-human-use-quality-step-5 en.pdf , more specifically a filled in section 2.3, 3.2.S thereof, even more specifically a filled-in section 3.2.S.3.1 and 3.2.P.5 thereof; (e) internal Organon/Henlius documentation that relates to HLX11 antibody variants; and (f) batch records for the drug substance and/or drug product. (iii) to appoint the following independent technical experts, who may accompany the bailiff during the execution of measures (i) and (ii): • Dr. Frank Hanakam of Granzer Regulatory Consulting & Services GmbH in Munich, Germany; and • Dr. Julia Buschmann of Granzer Regulatory Consulting & Services GmbH in Munich, Germany, which technical experts shall be authorized to engage any necessary auxiliary persons to assist them during and after the execution of the measures (i) and (ii). (iv) to authorize the Applicants to obtain the samples under (i)(b)-(c) from the bailiff; (v) to order the Defendants to fully cooperate with the bailiff and independent experts by providing full and unrestricted access to (a) any building, room, cabinet or safe at the premises of Organon in Belgium and the Netherlands; (b) any device, digital file or document stored at or accessible from the premises of Organon in Belgium and the Netherlands; and in particular, to the extent that any device or digital file may be encrypted, password-protected or otherwise be inaccessible, by providing all cooperation to the bailiff and independent experts to gain entry and to decrypt and/or make any such device or digital file accessible in a format which is sufficient for the purposes of aiming to prove infringement of claim 1. (vi) to determine that the Defendants forfeit an immediately payable penalty of € 200,000.00 for each hour that they fail to cooperate with the order under (v). (vii) to order that the collected information is directly accessible, until further order by the judge, to the lawyers of the Applicants (as defined in the heading of this application) and the technical experts listed above, with the prohibition to disclose the acquired information to third parties. UPC CFI 407/2025 & 408/2025 27 May 2025 9 As a subsidiary request (and this “should the Court consider that the Defendants’ interests in maintaining confidentiality over (parts of) the information seized outweigh immediate disclosure to Applicants”) (i) to appoint an independent expert to inspect and draft a comprehensive expert report detailing the data and information only pertaining to the infringement of EP335. (ii) to order the appointed expert to submit their written report and any collected evidence immediately, and no later than the following day after inspection. (Note by the Court: This subsidiary request is not formulated in the substantive parts of the applications but is argued in the motivational part of the applications.) 19. In their letter to the Court dated 22 May 2025, the Applicants additionally request: “that the Court’s order to preserve evidence expressly provide that the outcome of the measures to preserve evidence may be used not only in the pending proceedings on the merits before the Unified Patent Court, but also in the parallel nullity action commenced against Genentech Inc. on 7 May 2025 before the Dutch district court concerning European patent EP 3 401 335 (EP 335).“ IV. FORMAL REQUIREMENTS AND COURT FEES 20. The formal requirements according to R. 192 (2) RoP have been met, and the court fees (for both applications) have been paid. 21. There is no need to check whether a protective letter has been filed, as it is not listed as a formal requirement to be checked and as it is not listed as a criterium of the examination listed under R. 194 (2) RoP (see § 33-34). V. ORAL HEARING HELD ON 23 MAY 2025 22. During the oral hearing the Judge-Rapporteur requested the following (additional) information and/or clarifications: • Indication of LD The Hague as the LD where an action on the merits would be started on p. 3 of their Applications, and this in view of R. 192 (1) RoP. • The indication of ORGANON US and HENLIUS (as Defendants) for the purpose of the Applications. • Additional information of R. 194 (2) (c) RoP. • Actual plan of execution of the order to preserve evidence / for inspection on two locations. UPC CFI 407/2025 & 408/2025 27 May 2025 10 VI. (INTERNATIONAL) JURISDICTION AND (TERRITORIAL) COMPETENCE VI.A. Jurisdiction UPC 23. EP 335 was opted-out on 20 April 2023 but this opt-out was withdrawn (on 6 May 2025 – 12.17 CET) previous to uploading the respective application(s) in the CMS (on 6 May 2025 – 16.14 CET (regarding ACT 21478/2025 (UPC CFI 408/2025) and 16.35 CET (regarding (ACT 21486/2025) (UPC CFI 408/2025). 24. The Application(s) to preserve evidence / inspection of premises state the execution of the orders at the premises of ORGANON BE and ORGANON NL, and more specifically in Belgium and the Netherlands. 25. Regarding ORGANON US and HENLIUS, the Applicants argued (at the oral hearing dated 23 May 2025) that they are not certain whether property held at the premises of ORGANON NL and/or ORGANON BE is owned by ORGANON US and/or HENLIUS (e.g. servers). Applicants also find that these companies may potentially become (co-)defendants in possible proceedings on the merits before the UPC pursuant to Article 31 UPCA and Articles 4(1), 8(1) and 71(b) Brussels I Recast Regulation in conjunction with Articles 32(1)(a) and 33(1)(a) UPCA. Hence, the Application was lodged against them as well. 26. The fact that ORGANON BE has its registered office in Belgium and the actual and threatened infringement has occurred or may occur in Belgium with respect to EP 335, as argued by the Applicants, and that ORGANON US and HENLIUS have their registered office and premises outside the competent territory of the UPC, does not allow the execution of the order to preserve evidence / for inspection against. Moreover, the order to preserve evidence / for inspection allows the execution at the premises of ORGANON NL and ORGANON BE regardless of whether third parties own any material (including servers) to be found at their premises. As such, the Application(s) for an order to preserve evidence / for inspection are dismissed where they pertain to ORGANON US and HENLIUS as Defendants. V.B. Competence LD Brussels 27. Since no proceedings on the merits have been started, the Applications (R. 192 RoP and R. 199 RoP (juncto R. 192 RoP)) should be filed with the division where the Applicants intend to start proceedings on the merits pursuant to R. 192 (1) (last sentence) RoP. 28. Applicants mention in their Applications (under “Formal Information”, p. 3) regarding the “Main Proceedings on the Merits” that they intend to start proceedings before “the UPC, Local Division The Hague” with a reference to § 13 of their Applications. Under § 13, however, no indication is provided before which LD Applicants intend to start proceedings on the merits. Confronted with the above and having pointed out R. 192 (1) (last sentence) RoP at the oral hearing (dated 23 May 2023), the Applicants informed the Court that this should be UPC CFI 407/2025 & 408/2025 27 May 2025 11 considered a material mistake and that their intend indeed was/is to initiate proceedings on the merits before the LD Brussels. As such the condition as mentioned under R. 191 (1) (last sentence) RoP, is met. 28. Based on the same grounds as mentioned under § 26, specifically its reference to Article 33 (1)(a) UPCA, the LD Brussels could be competent to hear the case on the merits if the outcome of the execution of the orders would indicate Belgium as the place where the actual and threatened infringement has occurred or may occur. VI. GROUNDS FOR DECISION VI.A. Guiding principles in the assessment of the applications 30. As R. 199 (2) RoP (order for inspection) states that R. 192 to 198 RoP (order to preserve evidence) apply mutatis mutandis, the same guiding principles should be considered when examining the Applications, unless a difference between the two orders (of inspection and preservation of evidence) would be articulated in the UPCA (which prevails). 31. As the Applicants did not argue "extreme urgency" (Rule 194(4) RoP), the Court follows the default procedure for such application. 32. In the Court's examination, the Court should consider that the general purpose of an application for an order to preserve evidence/for inspection is to enable the gathering and collection of evidence to prove the infringement and, if granted, to enable the Applicants to commence subsequent infringement proceedings within a specified period of time. 33. As a first step (see § 40 - 47), the Court must consider which of the options set forth in R. 194 (1) (a) to (d) RoP it should, in its discretion (R. 192(2) RoP), apply. The Applicants have informed the Court that, should the Court decide to hear the Defendants before granting the requested relief (i.e. option R. 194 (1) (a) RoP) or to summon the Defendants to an oral hearing (i.e. option R. 194 (1) (b) RoP), they wish to withdraw their Applications (Rule 194 (5) RoP). 34. The Court notes that although the oral hearing held on 23 May 2026 was based on the application of R. 194(1)(c) RoP (being the only possibility to hear the Applicants regarding the issues mentioned under § 22 which could be taken into consideration when assessing the options under R. 194 (1) RoP), the actual examination regarding informing or hearing the Defendants II before issuing a final order in the Applications was not executed and a subsequential application of R. 194(1)(a) to (d) RoP is still possible for the Court. 35. In its substantive assessment of whether or not to grant the requests (see § 48 - 59) (second step), the requirements are not directly articulated in the RoP, but rather in Art. 60 (1) UPCA (which is a transcription of Art. 7 Enforcement Directive) and can be summarized as follows UPC CFI 407/2025 & 408/2025 27 May 2025 12 • The patent underlying the application should be valid; • The patent has been infringed or such infringement is imminent. 36. In relation to the assessment of the alleged infringement or the threat of an infringement and the standard of proof, a balance should be struck between too much (public available) evidence of the alleged infringement (allowing the applicant to immediately initiate proceedings on the merits), which as such does not require an invasive evidence preservation/inspection order, and purely unsubstantiated allegations giving rise to fishing expeditions if the requested orders would be granted. The following fundamental rights should be weighed and balanced when setting the standard of proof regarding measures to preserve evidence / for inspection: • the fundamental rights of an applicant for such orders (right to a fair trial (Art. 6 ECHR)(i.a. right to gather evidence, right of access to the court/judiciary (Art. 47 CFR)) and the right to protection of property (Art. 1 Protocol to the ECHR and Art. 17 CFR) • the fundamental rights of the defendants for such orders (right to a fair trial (Art. 6 ECHR)(right of inter partes and public hearing, right of defence and prohibition of self- incrimination), right to privacy (Art. 8 ECHR), right to freedom of enterprise (Art. 16 ECHR) and right to protection of property (Art. 1 Protocol to ECHR + Art. 17 CFR)). 37. The standard of proof to be considered is "a certain degree of plausibility of the infringement or the threat thereof" (cf. LD Mannheim 3 March 2025, UPC CFI 142/2025). The same certain degree should be considered when assessing the validity of the patent. This “certain degree” is practically translated by the Court as making it “highly likely”. As such, the standard of proof for Applicants is lower compared to infringement actions (on the merits) and preliminary measures actions. Applicants should not already prove infringement, as this would render the order for preservation of evidence/access meaningless. 38. Not only does the burden of presenting and proving the facts rest on the Applicants, but should the Court decide the applications without hearing the Defendants II (as requested by the Applicants), the Applicants are under a strict duty to disclose all material facts known to them which may influence the Court in deciding whether to make an Order without hearing the Defendants II (R. 192(3) RoP). Failure to do so could lead to the inadmissibility of the gathered evidence and report in the proceedings on the merits. 39. In a third step (see § 60 - 71), if an order to preserve evidence/ for inspection is granted, the Court should assess whether the actual requests cover the purpose for which the application to preserve evidence / for inspection was made, again balancing the fundamental rights of the parties. 40. Finally (see § 72 - 78), in a fourth step, additional conditions regarding the execution of the order to preserve evidence / for inspection may be ordered by the Court based on the circumstances of the case. UPC CFI 407/2025 & 408/2025 27 May 2025 13 VI.B. First Step: Assessment R. 194 (1) RoP 41. The Court holds that the conditions are met to decide on the respective applications ex parte i.e. without informing (R. 194 (1)(a) RoP), hearing the Defendants II (R. 194 (1)(d) RoP) or the Applicants (R. 194 (1)(c) RoP) or hearing the parties (R. 194 (1)(b) RoP taking the following into consideration (R.194 (2) RoP): (i) The urgency of the action (R.194 (2)(a) RoP) 42. The Court finds that Applicants have sufficiently demonstrated that they need to obtain evidence of infringement as soon as possible (i.e. as a matter of urgency) in order to enforce their patents as early as January 2026 (the expected launch of HLX11). Applicants substantiate this expected launch in (early 2026) with the evidence listed under § 16. They further substantiate the "urgency" (i.e. market launch in early 2026) from a regulatory perspective, as ORGANON's MAA for HLX11 appears to be already validated, and the Applicants reasonably argue that final approval can be expected in 2025. Reference is made to the list of applications currently under review by the EMA as of 16 April 2025. Considering an alleged timeframe for the actual review of a marketing authorization, this would imply an approval of HLX11 by the end of 2025 and a subsequent launch by the end of 2025 or early 2026. 43. It is indeed common knowledge that once a competitive biosimilar medicine is on the market, it has inevitable effects on the unique position on the market of the reference medicine and frustrates the expectations on return of the high investments made in research and development of new products. 44. Waiting for the HLX11 to reach the market (and to obtain a sample through public access) could cause irreparable harm to the Applicants. Considering the time frame for the execution of the requested order, the results of the execution of the requested orders and a subsequent infringement proceeding will minimize the harm to the Applicants. (ii) Reasons of not hearing the Defendant are well-founded (R.194 (2)(b) RoP) 45. The Court finds that the reasons for not hearing the Defendants II are well-founded in the sense that the delay could indeed cause irreparable harm to the Applicants, as the information deemed necessary to initiate infringement proceedings could only be obtained after the launch of HLX11, which would lead to potential irreparable harm to the Applicants, as they would not be able to obtain an infringement decision before the expected launch. (iii) Evidence may be destroyed or otherwise cease to be available (R.194 (2)(c) RoP) UPC CFI 407/2025 & 408/2025 27 May 2025 14 46. Part of the requested information appears to be part of the documentation of the MAA held by the EMA and could be considered, as such, held by a third party. On the other hand the Applicants convinced the Court that in respect of this information held by the EMA it is (at least) not common to seize evidence at this European regulatory administrative office. As such the Court holds that Applicants sufficiently argue that it would be highly likely that the evidence may indeed cease to be held available at the premises of ORGANON NL and ORGANON BE after starting proceedings on the merits. (iv) Conclusion 47. Concluding and weighing the above considerations, the Court finds, in the exercise of its discretion, that the grounds put forward by the Applicants do not require the Defendants II to be notified, the Defendant II to be heard or the parties to be summoned to a hearing in order for the Court to decide on the application(s) for an order to preserve evidence / for inspection. VI.C. Second Step: Granting or dismissing the application(s) for an order to preserve evidence / for inspection VI.C.1. Validity of EP 335 48. The Court holds that the Applicants sufficiently prove, taking into consideration the required standard of prove at this stage (“highly likely”), that EP 335 is valid. The court motivates as follows: • Generally, EP 335, as a granted patent, should be presumed to be valid and enforceable. • EP 335 has been maintained in first instance opposition proceedings before the EPO, strengthening the presumption of validity and enforceability. • On the date of introduction of the Applications EP 335 was not the subject of any pending validity challenges. It was only one day later (7 May 2025) that ORGANON US introduced national proceedings in the Netherlands regarding the validity of EP 335 (limited to the Dutch national part). Applicants point out in their letter dated 18 May 2025 that no additional prior art was introduced compared to the opposition proceedings at the EPO (which maintained EP 335). Therefore, there is no reason for the Court, at this stage of the proceedings, to examine the validity of the patent. • The reference in ORGANON US' counsel's letter of 28 April 2025 that his client "has thoroughly analysed the Patents, their respective prosecution histories, and the prior art, and has concluded that the validity of the Patents is, at a minimum, not obvious" does not in any way substantiate why validity is not highly likely. Again, in the absence of any argument by ORGANON US to support its statement, it is not for the Court at this stage of the proceedings to review the validity of the patent. UPC CFI 407/2025 & 408/2025 27 May 2025 15 VI.C.2. Alleged Infringement of EP 335 49. The Applicants sufficiently prove that, considering the required standard of proof at this stage (“highly likely”), EP 335 is infringed because claim 1 of EP 335 seems to cover HLX11. 50. At the outset, it should be noted that in its letter of 28 April 2025, ORGANON US, in addition to informing the Applicants of its launch plans, stated that after having "(...) thoroughly analysed [EP 335], the respective prosecution histories and the prior art", it had "come to the conclusion that the validity of EP 335 is at least not obvious". Although ORGANON US's use of the term "at least" might suggest to the Applicants that there is also a problem with an infringement argument, it does not explicitly raise the issue of non-infringement. A presumption of infringement, be it modest, could be inferred from this failure to raise the issue of non-infringement. 51. The (modest) presumption is strengthened by the Applicants by sufficiently demonstrating, considering the required standard of proof at this stage (“highly likely”), that the features of claim 1 cover HLX11. 52. In arguing the presence of the features of Claim 1 in HLX11, Applicants will refer mainly to CN 057 filed by HENLIUS (together with the Chinese patent itself (in original and translation) reference is made to the “sequence alignment of HLX11 with EP 335” (exhibit FS13), the machine translated Table 15 of CN 057 (exhibit FS14), machine translated Figures 5E-5F of CN 057 (exhibit FS15)) and the research paper Zhang et al. 2020 (Exhibit FS16). (i) Features (i) and (ii) 53 The Applicants sufficiently prove, taking into consideration the required standard of proof at this stage (“highly likely”), that HLX11 is a pharmaceutical formulation and comprises a pharmaceutically acceptable carrier. (ii) Features (iii) and (iv) 54. The Applicants sufficiently prove, taking into consideration the required standard of proof at this stage (“highly likely”), that HLX11 contains the active substance pertuzumab (see FS12) which seems to be an HER2 antibody with light chain and heavy chain amino acid sequence according to SEQ ID NOs 15 and 16, respectively that binds to domain II of HER2. 55. Further, Applicants refer to CN 057 which shows that the HLX11 protein is an HER2 antibody with light chain and heavy chain amino acid sequence according to SEQ ID NOs 15 and 16. More explicitly Applicants refer to Example 1 of CN 057 with the title “Preparation of HLX11 protein” and where it is explained that “It was determined that the obtained protein product was an anti-Her2 monoclonal antibody, and its light chain amino acid sequence was as shown UPC CFI 407/2025 & 408/2025 27 May 2025 16 in SEQ ID NO: 1 in the sequence listing, and its heavy chain amino acid sequence was as shown in SEQ ID NO: 2 in the sequence listing. The obtained protein product was named HLX11 monoclonal antibody or HLX11 protein.” Referring to the sequence alignment of HLX11 in CN 057 (exhibit FS13), Applicants convincingly prove, taking into consideration the required standard of proof at this stage, that the “light chain and heavy chain animo acid sequence according to SEQ ID NOs 15 and 16, respectively”, as disclosed in CN 057 are identical to the light chain and heavy chain amino acid sequence according to SEQ ID NOs 15 and 16, respectively” as recited in EP 335. 56. Regarding the “predominance” (feature (iv) “the quantitatively predominant antibody molecule in the composition”), Applicants convincingly, taking into consideration the required standard of proof at this stage (“highly likely”), refer to Example 4 of CN 057. Example 4 is titled “Preliminary stability control study of HLX11 formulation and Perjeta” where “the stability of the HLX11 Perjeta ® biosimilar formulation is compared with Perjeta ® which was purchased from Roche”. The results are displayed in Table 15 (exhibit FS14) and the Figures 5E-5F (exhibit FS15). Based on these results Applicants sufficiently prove, taking into consideration the required standard of proof at this stage, that feature (iv) of claim 1 of EP 335 is present in HLX11 where the Court refers to the following analysis which convinces the Court, taking into consideration the required standard of proof at this stage: “The stability measurements in Example 4 are performed by cation exchange chromatography (CEX) as well as other tests. CEX separates proteins according to charge, whereby acidic variants elute earlier than the mean peak antibody and basic variants elute later than the main peak antibody (see also [0026] of EP335). Table 15 of CN111375057 A evidences that, at week 0, HLX11 contains an acidic fraction totalling 21,1% as measured by CEX. Table 15 shows that, at week 0, the main peak percentage for HLX11 is 74,8%. These results are in line with Figures 5E-5F of CN111375057 A. It is evident that the CEX main peak for HLX11 is the main species antibody as recited in claim 1, i.e. the HER2 antibody with light chain and heavy chain amino acid sequences according to SEQ ID NOs 15 and 16, respectively. The reason is that, in Example 1 of CN111375057 A, it is precisely this antibody structure that is identified as the HLX11 protein (see above). Furthermore, since we know that in Perjeta® the main species HER2 antibody is the one that is recited in claim 1 of EP335, it is clear that this must also be the case for the HLX11 Perjeta® biosimilar.” (iii) Feature (v) 57. Applicants sufficiently prove, taking into consideration the required standard of proof at this stage (“highly likely”), that Table 15 and Figure 5F of CN 057 presents the results of CEX- measurements that identifies the presence of an acidic fraction. (iv) Feature (vi) UPC CFI 407/2025 & 408/2025 27 May 2025 17 58. It is regarded the presence of this feature (i.e. “wherein the acidic variants include a disulfide reduced variant”) that Applicants indeed effectively indicate that no public information is available. The Applications are mainly filed in order to gain information of this feature 59. The provided information makes it likely enough for the Court for the purpose of an order to preserve evidence / for inspection that the there is reason to accept the Applications as it is sufficiently demonstrated that the acidic variants contained in HLX11 also include a disulfide- reduced variant. This is convincingly demonstrated by the following elements: • As HLX11 is presented as a Perjeta® biosimilar it is likely that HLX11 includes a disulfide- reduced variant. • Applicants refer to Figure 1B of Zhang et al 2020 (exhibit FS16) (showing a chromatogram of non-reduced (nr) CE-SDS experimentation). Based on this Figure 1B Applicants sufficiently indicate that, when HENLIUS performs nrCE-SDS experimentation on HLX11 and then concludes that HLX11 has a similar profile as Perjeta®, HLX11 will highly likely also contain a disulfide reduced variant. • The highly likelihood that HLX11 contains a disulfide reduced variant, Applicants convincingly refer to the paper Xu et al. 2019 (exhibit FS17) and specifically Figure 5 B. In this Figure 5B it seems that “the same non-reduced CE-SDS chromatogram of HLX01 (being a rituximab biosimilar and is known to contain a disulfide-reduced variant) is displayed, and it is explicitly indicated in said Figure 5B that the minor peak represents “2H1L”” which seems to be a well- known abbreviation for a “two heavy chains, one light chain” variant. VI.D. Third Step: Assessment of the actual requests 60. As mentioned in § 37, in a final assessment, the actual requests should be weighed against the general aim of the order to preserve evidence / for inspection and the fundamental rights of the parties, taking into consideration the circumstances of the case. The Court limits and/or denies and/or makes the execution subject to the following conditions as hereafter mentioned: (i) As primary requests under (i)(see § 18) 61. The request under (i) is limited to the premises of ORGANON BE and ORGANON NL in Belgium and the Netherlands. 62. The authorization under (a), where it refers to “surrounding area”, is denied as this holds no direct link to the alleged infringement and the proof that the Applicants wish to obtain. The reference to “surrounding area” is held to be unbalanced in view of the fundamental rights of the Defendants II, more specifically their right of privacy. 63. The authorization under (d) is denied because the Applicant do not substantiate what could be understood as "any other action necessary". Such an authorization renders the order UPC CFI 407/2025 & 408/2025 27 May 2025 18 unenforceable and/or at least creates uncertainty for the Defendants II (especially if restraints are requested and granted). (ii) As primary requests under (ii) (see § 18) 64. The authorization under (d) to obtain FDA regulatory documentation is denied because such authorization and the subsequent launch of a product are not related to any alleged infringement in the territory of the UPC. (iii) As primary requests under (iii) (see § 18) 65. The Court refers to the limited task of the experts as articulated under § 77. (iv) As primary requests under (iv) (see § 18) 66. The Court refers to the confidentiality measures imposed under § 73. (v) As primary requests under (v) (see § 18) 67. The Court refers to the confidentiality measures imposed under § 73 and further limits the unrestricted access to those physical places and digital documents which relate to the object of the Applications (i.e. to prove infringement of claim 1). (vi) As primary requests under (vi) (see § 18) 68. The Court sets a maximum of € 5.000.000 and states that the start of an hour will be considered as an hour for the purpose of calculating the penalties. (vii) As primary requests under (vii) (see § 18) 69. This request is denied whereby the Court refers to the confidentiality measures imposed under § 73. (viii) Subsidiary requests under (i) and (ii) (see § 18) 70. This request is denied whereby the Court refers to the confidentiality measures imposed under § 73. (ix) (Additional) request as mentioned in the letter dated 22 May 2023 related to the use of the outcome of the execution of the orders to preserve evidence/for inspection in light of the national proceedings initiated on 7 May 2025 before the District Court of The Hague (see § 19) UPC CFI 407/2025 & 408/2025 27 May 2025 19 71. Based on R. 196(2) RoP, the court may order, in an order to preserve evidence / for inspection, that the outcome of the measures may be used in other proceedings than those on the merits of the case. Given that the Dutch national proceedings and (eventual) UPC proceedings have the same subject matter—the alleged invalidity and alleged infringement of EP 335—the Court deems it procedurally efficient to allow the outcome of the measures to be used in other proceedings, limited to the Dutch proceedings initiated before the District Court of The Hague on 7 May 2025 (and an appeal following the decision). Please note that acceptance of this outcome as evidence in the aforementioned Dutch proceedings is subject to Dutch procedural law and the Dutch courts. VI.E. Fourth Step: Additional conditions regarding the execution of the order to preserve evidence / for inspection VI.E.1. Notice 72. Pursuant to R. 197 (2) RoP, this order, together with a copy of the Applications and its annexes (including the exhibits introduced after the date of the Applications) shall be served by the Bailiff(s) on the Defendants II at the Defendants II's premises together with the execution of this order, in accordance with the applicable national law on the service of judicial documents. VI.E.2. Confidentiality 73. In application of Art. 58 UPCA and R. 196 (1) RoP, the court orders that access to all information gathered by the appointed experts during the execution of the order(s), as well as to the expert report itself, shall be limited to the representatives of the parties. Subsequently, a "confidentiality circle" will/could be established in order to identify the relevant information for the purposes of this order, as well as the information that should be considered "confidential" (in accordance with UPCA, RoP and Trade Secret Directive) and should be kept confidential in the sense that access is limited to identified persons. VI.E.3. Time-Limits procedure on the merits 74. Proceedings on the merits should be initiated taking into the consideration the term stipulated under R. 198 (1) RoP and this from the date of execution of the order to preserve evidence (ACT 21478/2025) (UPC CFI 407/2025) and the order for inspection (ACT 21486/2025) (UPC CFI 408/2025) at one or both of the Defendants II. VI.E.4. Security 75. Although Art. 60 (7) UPCA does not seem to allow the court to make the execution of an order for inspection conditional on a security (see § 30), the Applicants' requests are of such a nature that they combine an order to preserve evidence and an order for inspection. UPC CFI 407/2025 & 408/2025 27 May 2025 20 76. Therefore, in application of R. 196 (3) RoP and R. 196 (6) RoP, the Court holds that the order(s) is (are) enforceable on condition that the Applicants make a recorded payment of security by depositing € 25.000,00 on the dedicated UPC account. The Applicants are requested to provide proof to the UPC to the LD Brussels of such deposit prior to enforcement of the Order(s). VI.E.5. Other Conditions 77. Where the order should be executed based on national law (in this case the laws of Belgium and The Netherlands), the Court, in its discretion and in order to balance the rights of the parties, orders the following additional conditions (which should be disregarded if they do not comply with national law): • The Applicants should execute the order(s) within one month of their issuance, which is consistent with its own urgency arguments. • The independent technical experts should not be considered as experts of the Court and they should limit their contact with the Applicants to the extent necessary to carry out their task. These experts should receive the same information submitted to the Court (i.e., the application(s) and its exhibits) along with this Order and this to ensure their independence. • The task of these experts is to "preserve evidence" and "inspect premises" and they perform their task without any contact with the parties, except to the extent necessary to perform their duties in accordance with the execution of this Order. The experts, due to the ex parte nature of these proceedings, have only received one-sided information. Therefore, no report in the sense of advising the Court on the alleged infringement is permitted, except to the extent necessary to perform their duties in accordance with the execution of this Order. • Although not expressly requested but as clarified at the oral hearing dated 23 May 2025, Applicant will organize the execution of the respective orders simultaneously at the premised of ORGANON BE and ORGANON NL. Therefore, ORGANON BE and ORGANON NL are not permitted to contact directly or indirectly each other during the execution of the order(s) for the purpose of preserving evidence / for inspection if execution is scheduled simultaneously. This prohibition is made subject to a recurring the penalty of € 250.000 for every contact made (by any means) during the execution of these orders by respectively ORGANON BE and ORGANON NL to respectively ORGANON NL and ORGANON BE. • The granted order(s) to preserve evidence / for inspection should be executed during normal business hours, taking into account national holidays in Belgium and The Netherlands. • The Defendants II are permitted to contact their legal representative and/or technical representative who may participate in the actual execution of the order to preserve evidence / for inspection, but the actual execution of these orders may not be delayed in any way. • Should any problems/issues arise during the execution of the order(s), the said experts are invited to contact the LD Brussels by e-mail, whereupon a R. 9 RoP may be issued, if necessary. Any such communication should be sent by the expert(s) to the parties. UPC CFI 407/2025 & 408/2025 27 May 2025 21 VII. ORDER The Court 1. Dismisses the Applications where they pertain to ORGANON & Co. and Shanghai Henlius Biotech Inc. 2. Grant of requests Grants the following requests: (i) authorizes the Applicants to proceed through the territorially competent bailiff to make a description of the product manufactured or to be manufactured at the NV ORGANON (with registered offices at Kloosterstraat 6, 5349 AB Oss (The Netherlands)) and the BV ORGANON HEIST (with registered offices at Industriepark 30, Heist-Op-Den-Berg, 2220 (Belgium)), by allowing: (a) taking of photographs and videos (including audio) of the exterior and interior of any appliance that may be used to manufacture the product of claim 1; (b) taking of samples from any compartment inside such appliance under (a); (c) taking of 10 (ten) samples of HLX11 biosimilar formulation; and (ii) authorizes the Applicants to proceed through the territorially competent bailiff to acquire physical and/or digital copies of: (a) batch records relating to the bio-reactor and/or the product in claim 1 of the Patent, both executed and non-executed form; (b) manuals which relating to the bio-reactor and/or the product in claim 1 of the Patent; (c) any and all other documents, in any format, relating to the bio-reactor and/or the product in claim 1 of the Patent; (d) more specifically and in any event, EMA regulatory documentation for HLX11, more specifically documentation that relates to the characterization of antibody variants in HLX11, more specifically a completed EMA “COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE QUALITY OVERALL SUMMARY OF MODULE 2 AND MODULE 3:QUALITY” https://www.ema.europa.eu/en/documents/scientific-guideline/ich- m-4-q-common-technical-document-registration-pharmaceuticals- UPC CFI 407/2025 & 408/2025 27 May 2025 22 human-use-quality-step-5 en.pdf , more specifically a filled in section 2.3, 3.2.S thereof, even more specifically a filled-in section 3.2.S.3.1 and 3.2.P.5 thereof; (e) internal Organon/Henlius documentation that relates to HLX11 antibody variants; and (f) batch records for the drug substance and/or drug product. (iii) appoints the following independent technical experts, who may accompany the bailiff(s) during the execution of measures (i) and (ii): • Dr. Frank Hanakam of Granzer Regulatory Consulting & Services GmbH in Munich, Germany; and • Dr. Julia Buschmann of Granzer Regulatory Consulting & Services GmbH in Munich, Germany, which technical experts shall be authorized to engage any necessary auxiliary persons to assist them during and after the execution of the measures (i) and (ii). The experts should send their written report together with its annexes to the Sub- Registry of the LD Brussels within 14 days upon the execution of this order. On the same day the experts should send a copy of this report and its annexes to the representatives of the parties (if known regarding NV ORGANON and BV ORGANON HEIST) and this taking into consideration the confidentiality measures ordered under 4 of this order. (iv) authorizes the Applicants to obtain the samples under (i)(b)-(c) from the bailiff; (v) orders ORGANON NV and ORGANON HEIST BV to fully cooperate with the bailiff and independent experts by providing full and unrestricted access to (a) any building, room, cabinet or safe at their premises in Belgium and the Netherlands which relate to the object of the Applications (i.e. to prove infringement of claim 1); (b) any device, digital file or document stored at or accessible from their premises in Belgium and the Netherlands which relate to the object of the Applications (i.e. to prove infringement of claim 1); and in particular, to the extent that any device or digital file may be encrypted, password-protected or otherwise be inaccessible, by providing all cooperation to the bailiff and independent experts to gain entry and to decrypt and/or make any such device or digital file UPC CFI 407/2025 & 408/2025 27 May 2025 23 accessible in a format which is sufficient for the purposes of aiming to prove infringement of claim 1. (vi) Determines that ORGANON NV and ORGANON HEIST BV forfeit an immediately payable penalty of € 200.000,00 for each hour that they fail to cooperate with the order under (v) and this to a cumulative maximum of € 5.000.000 whereby the start of any hour will be considered as an hour for the calculation of the penalties. 3. Notice • Orders that this order, together with a copy of the application(s) and its annexes, shall be served by the Bailiff(s) on ORGANON NV and ORGANON HEIST BV at their premises together with the execution of this order, in accordance with the applicable national law on the service of judicial documents. 4. Confidentiality • Orders that access to all information gathered by the appointed experts during the execution of the order(s), as well as to the expert report itself, shall be limited to the representatives of the parties. Subsequently, a "confidentiality circle" will/could be established in order to identify the relevant information for the purposes of this order, as well as the information that should be considered "confidential" (in accordance with UPCA, RoP and Trade Secret Directive) and should be kept confidential in the sense that access is limited to identified persons. 5. Time-Limits procedure on the merits • Orders proceedings on the merits to be initiated taking into the consideration the term stipulated under R. 198 (1) RoP and this from the date of execution of the order to preserve evidence (ACT 21478/2025) (UPC CFI 407/2025) and/or the order for inspection (ACT 21486/2025) (UPC CFI 408/2025). 6. Security • Orders the Applicants, before the execution of this order, to make a make a recorded payment of security by depositing € 25.000,00 on the dedicated UPC account. • Requests the Applicants to provide proof to the UPC LD Brussels of such deposit prior to enforcement of the Order(s). UPC CFI 407/2025 & 408/2025 27 May 2025 24 7. Use of the outcome of the executed orders Allows the use of the outcome of the measures in other proceedings than the proceedings on the merits of the case (limited to the Dutch proceedings initiated before the District Court The Hague on 7 May 2025). 8. Additional Conditions • Orders the Applicants to execute the order(s) within one month of its issuance. • States that the independent technical experts are not considered as experts of the Court and they should limit their contact with the Applicants to the extent necessary to carry out their task. These experts should receive the same information submitted to the Court (i.e., the application(s) and its exhibits) along with this Order and this to ensure their independence. • Limits the tasks of the appointed experts to "preserve evidence" and "inspect premises". • Orders the appointed experts to perform their tasks without any contact with the parties (except to the extent necessary to perform their duties in accordance with the execution of this Order). • Prohibits ORGANON NV and ORGANON HEIST BV, should Applicants organize the execution of the respective orders at the premises of ORGANON NV and ORGANON HEIST BV simultaneously, to directly or indirectly contact each other during the execution of the order(s) and this under a pecuniary restraint of € 250.000 for every contact made (by any means). • Orders the execution of the granted order during normal business hours, taking into account national holidays in Belgium and the Netherlands. • Permits ORGANON NV and ORGANON HEIST BV to contact their legal representative and/or technical representative who may participate in the actual execution of the order, but the actual execution of these orders may not be delayed in any way. • Invites the appointed experts, should any problems/issues arise during the execution of the order(s), to contact the LD Brussels by e-mail, whereupon a R. 9 RoP may be issued, if necessary. Any such communication should be sent by the expert(s) also to the parties. Order issued on 30 May 2025 by the following panel of the LD Brussels: Samuel GRANATA President LD Brussels UPC CFI 407/2025 & 408/2025 27 May 2025 25 Legally Qualified Judge Petri RINKINEN Legally Qualified Judge Rute LOPES Legally Qualified Judge Clerk COSTS Any costs decisions will be stayed until decision on the main proceedings. INSTRUCTIONS TO THE REGISTRY An access code must be generated for both the experts and the Defendants II upon the execution of the order. Applicants are ordered to inform the Registry of the date of the execution of the orders. REVIEW As the order to preserve evidence / for inspection have been issued without hearing the Defendants II, a review may be lodged by the Defendants II within 30 days after the execution of the measures (R. 197 (3) RoP). INFORMATION ABOUT APPEAL An appeal may be lodged by the parties within fifteen days upon the issuance of this order for the Applicants and upon the execution of this order for the Defendants II (R. 73 (2) UPCA, R. 220.1.(c) RoP and R. 224 (1) RoP). ORDER DETAILS ORDER Number: ORD 23125/2025 Action Number: ACT 21478/2025 UPC Number: UPC CFI 407/2025 Action type: Order to preserve Evidence (R. 192 RoP) ORDER Number: ORD 23121/2025 Action Number: ACT 21486/2025 UPC Number: UPC CFI 408/2025 Action type: Order for inspection (R. 199 RoP)

Key Holdings

  • The standard of proof for granting an order to preserve evidence/for inspection is 'a certain degree of plausibility of the infringement or the threat thereof,' practically translated as 'highly likely.'
  • An ex parte decision (without hearing defendants) is justified by urgency and the risk of evidence destruction, especially when a biosimilar launch is imminent.
  • The outcome of evidence preservation measures may be used in related national proceedings (e.g., Dutch invalidity actions) if the subject matter is the same.
  • Orders for evidence preservation and inspection must be balanced against fundamental rights, leading to specific limitations on the scope of access and information disclosure.
  • A security payment is required for the enforceability of combined orders to preserve evidence and for inspection.

Tags

  • Biosimilar
  • Confidentiality
  • Ex Parte Order
  • Infringement
  • Inspection
  • Interim Measures
  • Pharmaceuticals
  • Preservation of Evidence
  • Unified Patent Court

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