High Court grants patent infringement case entry to Commercial List and Intellectual Property List.

THE HIGH COURT

COMMERCIAL

[2025] IEHC 660

[Record No. 2025/3802P]

BETWEEN

GLAXOSMITHKLINE BIOLOGICALS SA

PLAINTIFF

AND

PFIZER IRELAND PHARMACEUTICALS UNLIMITED COMPANY

PFIZER HEALTHCARE IRELAND UNLIMITED COMPANY

BIONTECH MANUFACTURING GMBH

DEFENDANTS

JUDGMENT ruling of Mr Justice Mark Sanfey delivered on the 14th day of November ,2025.

Introduction.

1. This is my ruling on the application of the plaintiff for a direction that the proceedings be entered into the Commercial List of the High Court and assigned to the Intellectual Property and Technology List. The defendants oppose the application, which raises a particular issue as to the interpretation of the Commercial court rules.

2. The proceedings involve a claim that the plaintiff’s patents have been infringed by the defendants. The plenary summons was issued on 07 July 2025. Appearances were entered by the first and second named defendants on 15 July 2025, and by the third named defendant on 11 August 2025.

3. The notice of motion for entry to the Commercial List was issued on 26 August 2025, and was returnable for the vacation sitting on 03 September 2025. It was clear that the application would be contested, and a timetable for exchange of affidavits was agreed between the parties. The application was heard by this Court on

03 November 2025.

4. The motion sought entry into the Commercial List and assignment to the Intellectual Property and Technology List pursuant to O.63A r.1(a)(i), r.1(b) or r. 1(d) of the Rules of the Superior Courts.

5. A statement of claim was delivered on 21 August 2025. It alleges that three European patents – the “626 patent”, the “856 patent”, and the “941 patent” – of which patents the plaintiff is the registered proprietor, have been infringed by the defendants, as a result of which the plaintiff has suffered loss and damage. Detailed particulars of infringement are annexed to the statement of claim. The plaintiff seeks damages, and an injunction to restrain further infringement. The defendants have raised particulars but have not yet delivered a defence.

6. The proceedings are part of an ongoing dispute between the plaintiff and the defendants in respect of the defendants’ “SARS-Cov2” Covid 19 vaccine, called “Comirnaty”. Essentially, the plaintiff’s case is that Comirnaty applies the technologies of the patents and thus infringes a number of the claims of each of the patents.

7. These proceedings are part of a general dispute between the parties. The plaintiff is pursuing patent infringement proceedings against a number of Pfizer and Biontech entities in other jurisdictions.

8. On 25 April 2024, the plaintiff and Glaxosmithkline LLC initiated proceedings against inter alia Pfizer Inc and the third named defendant in the US District Court for the district of Delaware. Those proceedings relate to US patents and do not include a claim for infringement in Ireland of the patents in the present proceedings.

9. On 3rd and 4th July 2025, the plaintiff instituted two separate patent infringement proceedings before the Unified Patent Court (“UPC”) against a number of Pfizer and Biontech entities. These UPC proceedings do not make any claims for any infringing acts undertaken in Ireland.

10. In addition, there have been opposition proceedings at the European Patent Office. While opposition proceedings in respect of the 626 patent have been determined in the plaintiff’s favour, there remain opposition proceedings in being in respect of the 856 and 941 patents which are as of yet unresolved.

11. In their grounding affidavit for entry, the plaintiff asserts that there has been “no culpable delay” in seeking to enter the proceedings in the Commercial List. The defendants take fundamental issue with this assertion. They point out that their product was granted Conditional Marketing Authorisation on 21 December 2020, and that Comirnaty began to be administered to patients on 29 December 2020. They say that the plaintiff could have issued the present proceedings at any time from that date. Likewise, proceedings could have been issued alleging infringement of the 856 patent at any time since the date of its grant on 07 October 2022, and in respect of the 941 patent at any time since the date of its grant on 23 October 2024.

12. The defendants say therefore that there have been delays until the initiation of the present proceedings of

• four years and seven months in respect of the 626 patent;

• two years and nine months in respect of the 856 patent; and

• nine months in respect of the 941 patent.

13. The defendants are critical of the litigation strategy of the plaintiff in respect of the general dispute, and point to the exclusion of the UK and Ireland from the UPC proceedings, which were in any event only initiated on 3rd and 4th July 2025. They point to a lack of pre-action correspondence. They also say that the plaintiff does not currently have any competing product in the market, so that the plaintiff is not suffering lost sales or market share. They contend that the plaintiff’s claim is essentially one for damages.

14. The plaintiff points to the existence in 2020 of a worldwide pandemic, and the fact that the plaintiff was finding solutions to the problems presented by Covid-19. They say that it was not until 05 May 2023 that “the head of the United Nations World Health Organisation declared an end to Covid-19 as a public health emergency”. While it is not specifically stated, the implication by the plaintiff is that it would have been unreasonable to expect the plaintiff to divert its resources or concentration from combatting the Covid-19 virus until May 2023 at the earliest.

15. The plaintiff also asserts that efforts have been made in the context of the US proceedings to resolve matters world-wide in relation to all disputes, and it is alleged on affidavit that Glaxosmithkline “continued to engage with Biontech and Pfizer up to July 2025 without resolution”. The defendants in turn do not accept that there was substantive engagement in this regard, stating that “the level of any prior [i.e. to June 2024] or subsequent discussions was very limited”.

16. The plaintiff denies that there has been any culpable delay. However, it submits that, pursuant to O.63A, r.4(7), the court must enter proceedings which fall under r.1(d) of O.63A into the Commercial List and assign them to the Intellectual Property and Technology List, “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”.

17. The current version of O.63A, r.1(d), included in the Rules of the Superior Courts (Planning and Environment) 2025 (SI 246/2025), which came into force on 18 June 2025, is as follows: “(d) any proceedings instituted, or any application or reference made, or appeal lodged, under the provisions of the Patents Act 1992, not including an application under section 108(4) of that Act”.

18. This category is far less expansive than the category included in the immediately previous version of O.63A, SI 530/21, in which r.1(d) simply referred to “intellectual property proceedings”, which term as defined in O.63A included an array of enactments dealing with trademarks, copyright, patents etc and other intellectual property matters, proceedings in connection with which were suitable for entry into the Commercial List. It should be pointed out that O.63A, r.4(7) in SI 530/21 remains unaltered in SI 246/2025.

19. Counsel for the plaintiff accepted that, in the normal case, the court has always had a discretion to refuse entry to the list, particularly where an applicant has delayed in applying for entry to such an extent that the court would be of the view that the application should be refused. The rationale for this – which was accepted by the parties in the present case – is that, while the court has significant powers to expedite and case-manage matters before it, the court also has limited resources, and that the benefit of expedition or efficiency should not be bestowed on litigants who have not for their own part shown urgency and efficiency in their own conduct of the proceedings. To do so would work an injustice on other users of the list who have taken care to act promptly and with appropriate expedition.

20. Counsel for the plaintiff however argued that r.4(7) of O.63A was an exception to this principle: “Where the proceedings which are the subject of an application pursuant to sub-rule (2) are proceedings falling within sub-paragraph (d) of the definition of ‘commercial proceedings’ in rule 1, the proceedings shall be entered in the Commercial List and assigned to the Intellectual Property and Technology List, 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”.

21. It was submitted that the use of the word “shall” in the rule meant that a case which fell within O.63A, r.1(d) – such as the present proceedings – must be entered in the list unless to do so “would be contrary to the interests of the efficient and just conduct of the Commercial List or the Intellectual Property and Technology List”.

22. Counsel referred to the rationale for setting up a dedicated list to hear intellectual property and technology disputes, as set out at para. 10.4.9 of the “Review of the Administration of Civil Justice” (2020): “Further, the review group recommends the establishment of a dedicated list, by way of adjunct to the Commercial Court, to hear and determine intellectual property disputes and disputes concerning technology. The review group recognises the benefits which are likely to result from the introduction of a specialised intellectual property list and recommends that the appropriate resources be made available so as to ensure that the courts of Ireland remain an attractive forum for parties seeking to resolve such disputes in as timely and cost-effective manner as possible”.

23. Essentially, it was argued that the usual discretion does not apply, and that it is mandatory for proceedings which come within r.1(d) to be entered in the list if the list has capacity to include the matter, so that it would not be contrary to the interests of the efficient and just conduct of the list to do so.

24. Counsel was emphatic that there was in fact no undue delay. It was suggested that there had been no litigation prior to May 2023 in relation to Covid vaccines. Counsel contended that there was no prejudice claimed by the defendants. It was submitted that it was “absolutely routine” in multi-jurisdictional patent litigation for proceedings to be issued in one jurisdiction and proceedings not to be issued in another jurisdiction until months or perhaps years had elapsed.

25. The defendants did not accept that the normal discretion of the court to refuse entry into the list was somehow disapplied in the case of r.4(7). Counsel for the first and second named defendants referred to rules 4(1) and 4(5), which are as follows: “4.(1) Upon application made in accordance with sub-rule (2), commercial proceedings may be entered in the Commercial List by order of the Judge of the Commercial List and, in an appropriate case, may be assigned to the Intellectual Property and Technology List.

…

(5) Upon the hearing of the motion referred to in sub-rule (2), the Judge of the Commercial List may direct that the proceedings be entered in the Commercial List, or may direct that the proceedings be entered in the Commercial List and assigned to the Intellectual Property and Technology List.”

26. Considerable emphasis was laid by counsel upon the use of the word “may” in these sub-rules. It was submitted that there was egregious and culpable delay in the present case, and that the court could not be deprived of its usual discretion to exclude a case in which expedition had not been shown by the applicant. It was contended that the court must be able to protect its own resources in this regard.

27. Counsel was scornful of the excuses put forward by the plaintiff to justify the delay since December 2020 at the earliest for not bringing forward proceedings. In relation to the point made by the plaintiff that the defendants did not suffer prejudice by any delay, it was submitted that the defendants do not have to show prejudice; that the court’s power to refuse entry was essentially for the protection of the court’s resources.

28. The third named defendant adopted the evidence and the submissions of the first and second named defendants in opposing the application. Counsel for the third named defendant made particular reference to the “self-fragmentation” of the plaintiff’s litigation campaign, and in particular the carving-out of the UK and Ireland from the UPC proceedings, contending that parties who could have chosen a more expeditious route but did not do so could not come looking for expedition in the commercial court in circumstances where they had clearly delayed.

Conclusions

29. At the outset, it is important to say that I am not asked to dismiss or strike out the proceedings. If I refuse the plaintiff’s application, the matter will simply proceed in the Chancery List rather than in the Commercial List. It should be said that the Chancery court not only welcomes applications for case-management, but frequently initiates case management of its own motion. Cases get on for trial without undue delay. With a basic level of cooperation between each other, litigants can move cases along expeditiously in the Chancery List, just as in the Commercial List. Should a case require a level of experience or expertise which a particular judge in the Commercial List has by reason of familiarity with such cases, arrangements can be made for that judge to preside in the Chancery List if need be.

30. There is no doubt that, while not explicitly stated in O.63A, the Commercial court has a general discretion to refuse entry to the list in circumstances where it considers it necessary. In practice, the court has exercised this discretion in order to enforce compliance with its ethos of ensuring expeditious disposal of matters through the close supervision of case-management. This involves close attention being paid by the court to the detail and progress of cases, with papers being read by the court in advance of hearings.

31. The success of this system has always depended on the compliance by the parties with the directions of the court, and requires a high level of cooperation between litigants. Given the necessarily limited court resources, only litigants who themselves demonstrate expedition by their actions are entitled to be accommodated by the system.

32. Having said that, it is clear in my view that r.4(7) is intended as a “carve-out” from the preceding clauses of r.4, and particularly r.4(1) and r.4(5). While the latter rules are cast in general terms, r.4(7) is quite specific and is cast in mandatory terms. Whether or not it is an error that the latest version includes only proceedings under the Patents Act, rather than, as previously, the full panoply of intellectual property causes of action, is not a matter on which I wish to speculate.

33. However, the sub-rule is subject to the entry in the list and assignment to the Intellectual Property and Technology List being “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”. I do not accept the submission of counsel for the plaintiff that this merely involves the court being satisfied that it has the capacity to deal with the matter.

34. In my view, “the interests of the efficient and just conduct” of the list entitles a court to examine, in a given case, whether an applicant has conducted itself in such a way that it would be inimical to “the interests of the efficient and just conduct” of the list to permit that applicant entry of the proceedings to the list. It seems to me that, where an applicant for entry to the list has conducted itself in a manner which conflicts to a significant degree with the spirit and intendment of the Commercial court’s procedures, such a situation is potentially injurious to the interests of the court and other litigants who rely on its resources.

35. I accept that the conduct of such an applicant would have to extend beyond the usual criteria applied by the court in refusing an application on the grounds of “culpable delay”. Without intending to be prescriptive, conduct justifying a refusal to an applicant otherwise entitled to entry under r.4(7) might include exceptionally excessive delay, particularly that which caused particular and significant prejudice to the other parties in the case.

36. However, I accept that any such refusal of entry in respect of a case which otherwise comes within r.4(7) should be a rare event, which would occur only in compelling circumstances. The Intellectual Property and Technology List is clearly a “natural home” for intellectual property matters, and entry should only be refused in unusual circumstances where inclusion of a matter in the list cannot be justified in the interests of the integrity and procedures of the list itself.

37. In the circumstances I do not consider that the applicant in the present case should be refused entry to the list. The explanations for the undoubtedly significant delays in the present case have not been compelling; the plaintiff has conducted its multi-jurisdictional campaign of litigation in a somewhat leisurely manner. However, there is no evidence of misconduct on its part which affects the efficient and just conduct of the list. The case must be dealt with somewhere, and I accept that the Intellectual Property and Technology List is the most appropriate “home” for such a case. The defendants do not adduce any evidence of prejudice; if they consider that the delay of the plaintiff gives rise to the need to bring an application of some sort, they can do so in the Intellectual Property and Technology List.

38. In the circumstances, I will make an order directing that the proceedings be entered in the Commercial List of the High Court and assigned to the Intellectual Property and Technology List on the grounds that the proceedings constitute “commercial proceedings” within the meaning of r.1(d) of the Rules of the Superior Courts. I will hear the parties in relation to any further ancillary order.