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Glaxosmithkline Biologicals SA v Pfizer Ireland Pharmaceuticals UnLtd Company & Ors (Approved)

High Court of Ireland
Nov 14, 2025
Smart Summary (Beta)

Summarized and Anonymized Ruling

Factual and Procedural Background

This is a ruling of Judge Sanfey delivered on 14 November 2025. Company A brought proceedings alleging infringement of three European patents (referred to in the statement of claim as the "626 patent", the "856 patent" and the "941 patent") by Company B, Company C and Company D. The plaintiff's plenary summons was issued on 07 July 2025. Appearances were entered by Company B and Company C on 15 July 2025, and by Company D on 11 August 2025. A statement of claim was delivered on 21 August 2025 with detailed particulars of infringement attached; the plaintiff seeks damages and an injunction. The defendants have delivered particulars but had not filed a defence at the time of the ruling.

The plaintiff applied for an order directing entry of the proceedings into the Commercial List and assignment to the Intellectual Property and Technology List. The notice of motion was issued on 26 August 2025 and the application was heard on 03 November 2025. The motion relied on Rules O.63A r.1(a)(i), r.1(b) and r.1(d) of the Rules of the Superior Courts.

The dispute forms part of wider multi-jurisdictional litigation between the parties. The plaintiff and a related affiliate initiated proceedings in the US District Court for the District of Delaware on 25 April 2024 (relating to US patents). The plaintiff also initiated proceedings before the Unified Patent Court on 3 and 4 July 2025 (which did not include claims for infringing acts in Ireland). At the European Patent Office there have been opposition proceedings: one (in respect of the 626 patent) was decided in favour of the plaintiff; opposition proceedings in respect of the 856 and 941 patents remained unresolved as at the date of the ruling.

Legal Issues Presented

  1. Whether the proceedings should be entered in the Commercial List and assigned to the Intellectual Property and Technology List under O.63A (in particular r.1(d)).
  2. How O.63A r.4(7) should be interpreted—whether it creates a mandatory obligation ("shall") to enter and assign proceedings falling within r.1(d), or whether the court retains a discretion to refuse entry (for example, for culpable delay or to protect court resources).
  3. If r.4(7) is mandatory in form, what exceptions (if any) allow the court to refuse entry in the interests of the efficient and just conduct of the lists.

Arguments of the Parties

Company A's Arguments (Plaintiff)

  • O.63A r.4(7) uses mandatory language ("shall") and therefore proceedings falling within r.1(d) must be entered in the Commercial List and assigned to the Intellectual Property and Technology List, unless such entry would be contrary to the efficient and just conduct of the lists.
  • There had been no culpable delay in seeking entry; the worldwide Covid-19 pandemic and the plaintiff's resource allocation to pandemic-related matters (with the WHO emergency ending 05 May 2023) explained any delay.
  • Efforts to resolve disputes were ongoing in the context of US proceedings and the plaintiff engaged with Company B and Company C up to July 2025 without resolution.
  • No prejudice to the defendants was asserted; multi-jurisdictional litigation commonly proceeds in some forums before others.

Company B and Company C's Arguments (First and Second Defendants)

  • The court retains a discretion to refuse entry under O.63A r.4(1) and r.4(5) (both use "may") and should exercise that discretion where there has been egregious or culpable delay.
  • The product at issue was given Conditional Marketing Authorisation on 21 December 2020 and began to be administered on 29 December 2020; the plaintiff could have issued proceedings much earlier.
  • Specific measured delays were highlighted: approximately four years and seven months (626 patent), two years and nine months (856 patent) and nine months (941 patent).
  • The plaintiff's litigation strategy was criticised (including exclusion of the UK and Ireland from the UPC proceedings), lack of pre-action correspondence, and the absence of a competing product for the plaintiff such that losses claimed are primarily damages.
  • The defendants emphasised the importance of protecting limited court resources and contended that the plaintiff need not await a showing of prejudice by the defendants to justify refusal of entry.

Company D's Arguments (Third Defendant)

  • Adopted the case made by Company B and Company C.
  • Highlighted the "self-fragmentation" of the plaintiff's litigation campaign, arguing that parties who chose less expeditious routes cannot then seek special expedition in the Commercial Court after delay.

Table of Precedents Cited

No precedents were cited in the provided opinion.

Court's Reasoning and Analysis

Judge Sanfey began by recognising that the Commercial Court has an established discretion to refuse entry to the list, exercised to preserve the court's ethos of expedition and to protect limited judicial resources. The judge noted that Rules O.63A r.4(1) and r.4(5) are cast in permissive terms ("may") and historically have enabled the court to refuse entry where applicants have not acted with appropriate expedition.

The judge then analysed O.63A r.4(7), observing that the latest version (SI 246/2025) narrows r.1(d) to proceedings instituted under the Patents Act 1992 and that r.4(7) is expressed in mandatory terms ("shall"). He concluded that r.4(7) is intended as a "carve-out" from the earlier clauses and that its mandatory language cannot be read down to mean nothing more than a capacity check.

However, the judge emphasised that r.4(7) itself contains an express qualification: entry and assignment are required "save where such entry and assignment of the proceedings would be contrary to the interests of the efficient and just conduct of the Commercial List or the Intellectual Property and Technology List". The judge interpreted that qualification as permitting the court to examine the applicant's conduct and to refuse entry in exceptional circumstances where permitting entry would be inimical to the lists' efficient and just conduct.

Judge Sanfey explained that the standard for refusal in such cases must be higher than ordinary culpable delay. Conduct sufficient to justify refusal where r.4(7) otherwise applies would likely involve "exceptionally excessive delay", particularly if that delay caused significant and particular prejudice to other parties or would otherwise injure the interests and procedures of the list. Any refusal under r.4(7) should be a rare event, reserved for compelling circumstances, because the Intellectual Property and Technology List is the "natural home" for patent matters.

Applying these principles to the facts, the judge accepted that the plaintiff had conducted its multi-jurisdictional litigation in a "somewhat leisurely manner" and that explanations for the delays were not compelling. Nonetheless, there was no evidence of misconduct that would affect the efficient and just conduct of the lists and the defendants did not adduce evidence of prejudice arising from the delay. The judge also noted that, if the application were refused, the proceedings would proceed in the Chancery List where case management can also secure expedition.

Holding and Implications

HOLDING: The court ordered that the proceedings be entered in the Commercial List of the High Court and assigned to the Intellectual Property and Technology List.

Implications:

  • The court construed O.63A r.4(7) as creating a mandatory direction to enter and assign patent proceedings falling within r.1(d), subject to a narrow, exceptional qualification permitting refusal where entry would be contrary to the efficient and just conduct of the lists.
  • Refusal of entry under r.4(7) is permissible but should be rare and reserved for compelling circumstances, such as exceptionally excessive delay causing significant prejudice or otherwise undermining the lists' procedures and resources.
  • Direct effect on the parties: the case will proceed in the Commercial List assigned to the Intellectual Property and Technology List; the judge will hear the parties on any ancillary orders. The ruling did not purport to establish a broad new principle beyond this interpretive application of r.4(7).

Judge Sanfey indicated he would hear the parties in relation to any further ancillary order required to implement the entry and assignment.