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Sandoz AG & Ors v Bayer Intellectual Property GMBH [No. 2] (Approved)
Anonymized Summary of High Court Judgment (Commercial — Intellectual Property & Technology)
Factual and Procedural Background
This judgment concerns a challenge by the Plaintiffs to the validity of Irish patent EP (I) 1 845 961 (the "Patent"). The main hearing took place in April and May 2025; judgment was delivered to the parties on 25 June 2025 but was not published generally at that time because of an interim order made at the outset of the hearing preserving the confidentiality of certain disclosed materials.
The dispute before the Court in this judgment arises from an application by the Defendant to make that interim confidentiality protection permanent and to redact parts of the published materials. The Defendant sought three forms of relief: (a) redaction of limited passages of the judgment prior to wider publication; (b) redaction of significant references in the trial transcript; and (c) an order that documents designated as confidential under the parties' confidentiality agreement and which had been "opened" at trial should retain their confidential status.
Background to the disclosure: the Plaintiffs requested voluntary discovery in June 2024 of a body of documents previously produced by the Defendant in related proceedings in another jurisdiction. The parties agreed a consent order for discovery dated 23 September 2024 under a confidentiality agreement pursuant to which the Defendant disclosed 1,012 documents as "Confidential Information." That agreement included procedural provisions governing when confidentiality would cease (for example, if material was read in open court without a protective order) and reserved the Defendant's right to seek protective orders for material used at trial.
Prior to trial the Plaintiffs challenged the confidential status of a number of documents; an independent third party made an interim determination (24 April 2025) that subject to a caveat many of the challenged documents were confidential but that portions disclosed elsewhere, such as in journal articles, were not confidential. At trial a subset of the confidential documents (described in the judgment as the "confidential trial documents") were introduced as attachments to supplemental expert reports and some were expressly referred to in oral evidence. Of the 1,012 documents disclosed, 29 designated confidential were referenced in expert reports; an additional two confidential documents were put to an expert in cross-examination — a total of 31 documents were opened at trial. The Defendant sought permanent protection in respect of 25 of those 31 documents and accepted that six were no longer confidential (and accepted that parts of one remaining document were not confidential).
At the close of the substantive hearing the Court made an interim confidentiality order preserving the confidentiality of the documents pending further order and granted the Defendant liberty to apply to make that order permanent. The Defendant notified the Court it would seek permanent orders (including redaction of portions of the judgment) and the application was set down to be heard. The Plaintiffs opposed the application in its entirety.
Legal Issues Presented
- Whether the interim confidentiality order should be made permanent in respect of some or all of the documents that were designated as confidential and opened at trial.
- Whether portions of the judgment should be redacted prior to publication to protect information asserted to be confidential.
- Whether portions of the trial transcript should be redacted to protect references to confidential documents.
- What legal basis, if any, supports making orders departing from the constitutional principle of public hearings — in particular, whether such orders can be made under the court's inherent jurisdiction (as explained in the leading authority), under section 45(1)(d) of the Court (Supplemental Provisions) Act 1961, under the court rules, or under the EU Trade Secrets regime (and the interaction between those sources).
- Whether the Defendant's evidence established that the information at issue meets the statutory/Directive definition of "trade secret" and/or that disclosure would create a real and pressing risk of harm that justifies a departure from open justice.
Arguments of the Parties
Defendant's Arguments
- The Defendant sought permanent protection for identified confidential trial documents and redactions of limited parts of the judgment and wider trial transcript. It presented the application in three strands: (i) redaction of the judgment (a small number of passages), (ii) redaction of the transcript (substantial references to 19 documents), and (iii) an order preserving confidential status of documents opened at trial (25 documents sought to be protected).
- The Defendant relied on the Confidentiality Agreement between the parties (Clauses 2.1, 2.2, 2.4, 2.5 and Clause 9.1.1(a)), submitting that disclosure had been provided on the basis of strong confidentiality protections and that the agreement acknowledged the Defendant's right to apply for protection in respect of material used at trial.
- Evidence in support included an affidavit from Attorney Haselhorst describing the Defendant's research and development activity in general terms, the identification and clinical development of the drug at issue, the commercial value and sensitivity of development and clinical-trial data, the magnitude of development costs (averred circa €2 billion) and recent worldwide sales (averred as almost €8 billion in 2023–24).
- The Defendant submitted that the documents disclosed revealed internal development processes and commercially valuable information which, if revealed, would cause competitive harm and that the Trade Secrets Directive/Regulations and English authorities demonstrate the acceptability of protective measures (including redaction and in camera consideration) in appropriate cases.
- It argued that it had not chosen to initiate the litigation (it was defending the patent) and that it would not have agreed to voluntary discovery if it had understood how the Plaintiffs would deploy the documents; it sought to rely on a possible "chilling effect" argument — that refusing protection could deter voluntary disclosure by patentees in future.
- The Defendant submitted that the proposed redactions to the judgment would not undermine public understanding because they were confined to recitations of document content rather than the Court's reasoning.
Plaintiffs' Arguments
- The Plaintiffs opposed the application in full. They argued that the Defendant's claims of commercial sensitivity were generalised and unsupported by specific, cogent evidence about why disclosure of the particular documents would cause real and pressing harm.
- The Plaintiffs relied on a replying affidavit from Attorney Henry, who explained that in the author's experience many patent cases proceed with confidentiality agreements without being heard in camera and that orders protecting documents had been made only in limited circumstances where clear and immediate commercial sensitivity was demonstrated.
- The Plaintiffs highlighted that much information about the development of the drug at issue was already in the public domain (a "sea of published information") and that expert evidence at trial confirmed that the development process revealed by the documents was consistent with industry expectations. They said the Defendant had not identified anything in the documents that added materially to what was already known.
- The Plaintiffs also pointed out that some documents had been disclosed in other proceedings and that the Plaintiffs had, by the time of the application, launched a generic product — undermining an asserted risk of competitive harm.
- Finally, the Plaintiffs argued that, under the governing constitutional framework, only a current and pressing risk of damage can justify displacing the principle of open justice and that no such risk had been shown in this case.
Table of Precedents Cited
All precedent identifiers below are anonymized; citations and the principles as described in the judgment are recorded as they appear in the provided opinion.
Precedent (anonymized) | Rule or Principle Cited For | Application by the Court in this judgment |
---|---|---|
Precedent A ([2017] IESC 18; [2017] 2 IR 284) | Establishes the governing framework for exceptions to the constitutional rule of open justice (Article 34.1): publicity is fundamental but exceptions exist; any exception must be strictly construed; where no statute applies, the countervailing interests must be very clear and circumstances pressing; consider minimal departures. | The Court treated this authority as the primary framework. It applied the "very clear and pressing" threshold and the requirement of strict construction to assess whether permanent protective measures were justified, concluding the Defendant had not met that high bar. |
Precedent B ([1913] AC 417) | Affirms the central importance of publicity to the administration of justice ("publicity is the very soul of justice"). | The Court cited the principle as part of the background justificatory material that underpins the strict approach to departures from open justice (as rehearsed in Precedent A). |
Precedent C ([1989] IR 126) | Holds that statutory provisions permitting non-public hearings must be applied where administration of justice in public would deny justice or impede it between parties. | The Court noted the case as an earlier authority and recognised it as part of the jurisprudential development considered in Precedent A and Precedent D. |
Precedent D ([1998] 1 IR 359) | Holds that restrictions on public hearings can be authorised under the court's inherent jurisdiction even in the absence of post-1937 statute; refines earlier authorities. | The Court acknowledged this case as qualifying the earlier approach and as support for the proposition that the common-law power can provide for exceptions, but subject to strict tests. |
Precedent E ([2024] IEHC 162) | Applied Precedent A principles to an application to protect an expert's identity; the court there required proof of a real risk of harm and adopted a stance of resolute scepticism. | The Court treated this decision as a close domestic analogue for assessing whether a real risk of harm (here commercial rather than personal) had been established and emphasised the evidential standards applied there. |
Precedent F (no citation provided in opinion) | Cited by affidavit as an instance in which a protection order had been put in place for properly classified confidential documents in prior proceedings; no written judgments referenced in the affidavit. | The Court noted the reference but observed the absence of a written judgment and did not treat it as decisive authority; it was recorded as part of the Plaintiffs' affidavit evidence of professional experience. |
Precedent G (Record No. 1/2014 PAP) | A High Court example in which s.45(1)(d) of the 1961 Act was relied on to permit in camera evidence where a secret manufacturing process would otherwise be disclosed. | The Court referenced this as an example of s.45(1)(d) being applied, while noting the Defendant in the present case did not assert that s.45(1)(d) was engaged because the material did not disclose a secret manufacturing process. |
Precedent H ([2002] 1 WLR 2253) | Sets out an English approach requiring "very good reasons" to depart from publicity; lists considerations such as the role of the document in the trial, potential chilling effects, need for specific reasons and that confidentiality agreements do not bind the court. | The Court relied on the principles as instructive guidance on the high threshold for redactions and protective orders in patent litigation; it used the decision to identify key considerations to be weighed, and to show the limited weight to be given to general assertions of confidentiality. |
Precedent I ([1999] 4 All ER 498) | Emphasises the public importance of patent litigation and the duty on patentees to make full disclosure; cautions against undue reluctance to hear evidence in camera that would impede disclosure. | The Court cited these policy considerations to underline that patent litigation frequently warrants transparency and that courts should be cautious in restricting public access. |
Precedent J ([1983] 1 AC 280) | Used as an authority stressing the constitutional and public-policy importance of publicity in the administration of justice. | Referred to (via other authorities) to reinforce the starting point that any departure from publicity requires substantial justification. |
Precedent K ([1991] RPC 231) | Describes the duty on a patentee to make full disclosure in patent proceedings and the policy against fettering that duty by exposing material to protective processes which would hinder full disclosure. | Cited in the material relied on by the English courts and invoked by the Court here to reinforce the public interest in full disclosure in patent litigation. |
Precedent L ([2014] EWHC 146 (Pat)) | Examined categories of documents (manufacturing process, regulatory dealings, commercial strategy) and accepted that manufacturing-process documents may require protection where justice could not be done otherwise; more limited protection for other categories. | The Court used the case as a comparative example of a situation where limited permanent orders were made; it treated the careful categorisation and necessity analysis there as instructive in evaluating the present application. |
Precedent M ([2024] Ch. 215) | Emphasises correct characterisation of information; technical trade secrets may justify protection and redaction, but the degree of confidentiality must be established. | The Court relied on this authority to stress that characterisation of the material is crucial and that the degree of confidentiality must be demonstrated before protective relief is granted. |
Precedent N ([2018] RPC 8) | States that redactions require powerful reasons and cogent evidence; identifies factors relevant to redaction applications (nature of information, effect of publication, nature of proceedings, relationship to the judgment and relation of the person seeking restraint to the proceedings). | The Court expressly imported the "powerful reasons supported by cogent evidence" standard into its analysis and applied the enumerated factors to the Defendant's case, finding the required showing absent. |
Court's Reasoning and Analysis
The Court approached the application through the framework established in Precedent A and related authorities. It first considered the correct legal basis for a departure from the constitutional requirement that justice be administered in public (Article 34.1). The Court noted that while there are statutory exceptions such as section 45(1)(d) of the Court (Supplemental Provisions) Act 1961 (which permits in camera hearings for proceedings involving disclosure of a secret manufacturing process), the Defendant did not contend that any confidential trial document disclosed a secret manufacturing process. The Defendant therefore had to rely on the court's inherent jurisdiction (as articulated in Precedent A) and on the broader recognition in the Trade Secrets Regulations implementing the EU Trade Secrets Directive that appropriate protective measures may be available in court proceedings.
The Court emphasised two linked thresholds from Precedent A: (i) any exception to the open-justice principle must be strictly construed; and (ii) where there is no statutory provision, the interest to be protected must be very clear and the circumstances pressing — in practice a demonstration of a current and pressing risk of harm if protection is refused. The Court also accepted that the jurisprudence of England and Wales (including rules such as CPR r 31.22(2) and the line of cases listed in the judgment) is instructive as to how to analyse requests for post-trial redaction or other protective measures, but underlined that there is a different constitutional architecture and that a direct read-across is not possible.
Applying these principles, the Court took a two-stage approach: first, an assessment of jurisdictional and doctrinal issues; second, an evidential assessment of whether the Defendant had shown (a) that the material in question was properly characterised as inherently confidential (for present purposes, whether it met the definition of a "trade secret" under Article 2(1) of the Directive), and (b) that disclosure would give rise to a real and pressing risk of harm to the Defendant's commercial interests sufficient to justify departure from open justice.
On the doctrinal point the Court noted the operation of the Trade Secrets Directive / Regulations (in particular the definition in Article 2(1) and the measures envisaged by Article 9 / Regulation 11) but also observed that reliance on the fact that certain categories of information are recognised in statute as warranting protection does not automatically create a general entitlement to protection in the absence of specific justification.
On the evidential assessment the Court considered the evidence relied on by the Defendant. The principal factual material was the affidavit of Attorney Haselhorst. The affidavit described, in general terms, the nature of research and development activity, asserted the commercial value of development and clinical-trial data, and provided figures for development cost and sales. The Court found, however, that much of that evidence was generic and failed to identify with particularity the features of the documents over which protection was sought. Crucially:
- The Defendant did not identify in the affidavit or in subsequent submissions specific passages or features of the documents which, if published, would create a real and pressing risk of commercial harm.
- Some of the very information the Defendant sought to protect had been disclosed in journal articles and other public sources; the independent third party tasked with resolving a pre-trial confidentiality dispute had expressly indicated that where material was in substance published in journal articles the relevant portions were not confidential.
- Expert testimony at trial confirmed that the development process revealed by the documents was consistent with industry expectations for the development of a new anticoagulant at the priority date; that evidence indicated the contents were not novel in the circles which normally deal with such information.
- Many of the documents over which protection was now sought were put into evidence by the Defendant itself during the trial.
- The Plaintiffs had by the time of the application launched a generic product, which undermined the Defendant's contention that publication would cause a pressing competitive risk.
On the particular question of redaction of the judgment, the Court observed that the Defendant proposed redactions where the judgment recited the content of confidential trial documents. The Court found no coherent distinction between the passages the Defendant sought to redact and material appearing elsewhere in the judgment which the Defendant accepted could be published: if the remainder of the judgment did not contain valuable confidential information, it was impossible to understand how the limited passages proposed for redaction would disclose confidential information not otherwise disclosed. More generally, the Court applied the "powerful reasons supported by cogent evidence" standard (as articulated in Precedent N) and concluded that such reasons were absent.
The Court concluded that the Defendant had not established either that the relevant material met the definition of "trade secret" for present purposes (Article 2(1) of the Directive) or that there was a real and pressing risk of harm from publication sufficient to justify a departure from the normal rule of open justice. The Defendant's evidence consisted largely of broad assertions of commercial sensitivity; there was an absence of specific evidence explaining why disclosure of the identified materials would cause harm, and much of the assertedly confidential information was already known or consistent with industry expectations. For those reasons, and having applied the strict tests required by Precedent A and the comparative authorities considered, the Court refused each facet of the Defendant's application.
Procedural disposition and ancillary matters: the Court indicated that the judgment would be published electronically and that, in the event of an appeal, the judgment could be published with the Defendant's proposed redactions pending determination of any appeal while a stay would be placed on discharge of the interim order in respect of the transcript and other documents pending the appeal. On costs the Court provisionally indicated that the Plaintiffs were entitled to the costs reasonably incurred in opposing the application and granted the parties liberty to address the Court or apply for a different costs order at a mutually convenient time.
Holding and Implications
Core ruling: The Defendant's application for permanent protective measures and for redactions of the judgment and trial transcript was refused in its entirety.
Direct consequences and implications (as indicated in the judgment):
- The interim confidentiality order made earlier in the proceedings remains in place pending any appeal concerning the protective measures; the Court indicated it would publish the judgment but was prepared to permit a temporary publication with the proposed redactions pending appeal and to stay discharge of the interim order in respect of transcripts and documents pending appeal.
- The Defendant failed to satisfy the high evidential threshold required to justify a departure from the constitutional principle of open justice under the governing jurisprudential framework; the Court concluded the Defendant had not shown that the materials in issue met the statutory definition of trade secret or that disclosure would present a pressing risk of harm.
- The Plaintiffs were, on a provisional basis, awarded the costs reasonably incurred in opposing the application; the parties have liberty to apply for a different costs order or to address the Court on the terms of any final order.
- The judgment applied existing authorities (domestic Supreme Court authorities and relevant English jurisprudence as instructive) and confined its analysis to those established principles rather than purporting to create a novel rule permitting broader departures from open justice in other contexts.
If the parties seek adjustments (for example, by making a further application about costs or by seeking post-judgment orders as to publication pending appeal), they have liberty to apply to the Court at a mutually convenient time.
Note on anonymization: all party names and identifiable individuals referenced in the source opinion have been replaced with standardized role or professional placeholders (e.g., "Plaintiffs", "Defendant", "Judge Mulcahy", "Attorney Haselhorst", "Attorney Henry", "Attorney Crowther") to preserve confidentiality and to comply with the instruction to anonymize PII. The summary otherwise follows only the information contained in the provided opinion and does not add factual or legal material beyond that text.
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