Bristol Myers Squibb Holdings Ireland Unlimited Company v Norton (Waterford) Ltd

JurisdictionIreland
JudgeMs. Justice Costello
Judgment Date01 March 2024
Neutral Citation[2024] IECA 49
CourtCourt of Appeal (Ireland)
Docket NumberCourt of Appeal Record Number: 2023/279
Between/
Bristol Myers Squibb Holdings Ireland Unlimited Company
Plaintiff/Appellant
and
Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland
Defendant/Respondent

[2024] IECA 49

Costello J.

Noonan J.

Allen J.

Court of Appeal Record Number: 2023/279

High Court Commercial Record Number: 2021/4758P

THE COURT OF APPEAL

CIVIL

[Approved]
[No redaction needed]

JUDGMENT of Ms. Justice Costello delivered on the 1 st day of March 2024

1

. This appeal concerns the scope of an undertaking as to damages offered to the High Court upon an application for an interlocutory injunction pending the trial of the action and, in particular, whether the High Court should have required the appellant to extend the undertaking as to damages to compensate entities who are not parties to the proceedings but who may suffer loss as a result of the injunction sought. The issue arises in the following circumstances.

Background
2

. The appellant (“BMS”) is part of a large international pharmaceutical group. It is the proprietor of an Irish patent (Patent No. EP (IE) 1 427 415) which relates to the compound apixaban. It is also the proprietor of a Supplementary Protection Certificate Number 2011/032 (“the SPC”) in respect of the medicinal product comprising apixaban which is supplied in the State under the brand name Eliquis. The respondent is a biopharmaceutical company incorporated in Ireland (“Teva”). It is part of the international Teva Group of Companies. Teva wished to launch a generic product, Apixaban Teva, and it instituted proceedings seeking to revoke the patent and the SPC. BMS instituted these proceedings seeking to restrain Teva from infringing its presumptively valid SPC 1. In November 2022, Teva gave BMS four weeks' notice of its intention to launch its generic product. On 2 December 2022, BMS issued a motion seeking the following relief:

“An interlocutory injunction restraining the Defendant whether by itself or its directors, officers, servants or agents from infringing Supplemental Protection Certificate No. 2011/032 (the “‘SPC’”) and in particular by making, offering, putting on the market and/or using and/or importing or stocking for the aforesaid purposes, a generic version of [BMS's] medicinal products Eliquis (active ingredient apixaban).”

3

. The application was supported by grounding affidavits including that of Mr. Scott Cooke sworn on 2 December 2022. At para. 93 of his affidavit Mr. Cooke stated:

“I understand that an undertaking to be responsible for any damages sustained by the Defendant between the grant of the pre-trial injunction and the trial of the action or other order is generally required in an application such as this. I confirm that the Plaintiffs [sic] is willing to give such an undertaking in this case.” (emphasis added)

4

. Replying affidavits were filed on behalf of Teva including affidavits of Ms. Laura Reynolds sworn on 20 December 2022 and two affidavits of Mr. William David Potter sworn on 19 December 2022 and 20 January 2023 to which I shall refer later in this judgment. No issue was taken with the undertaking as to damages offered to the court by BMS. The application was heard on 2 and 3 February 2023 and in a reserved judgment delivered on 17 February 2023 ( [2023] IEHC 159) the High Court concluded that it would “grant on the terms sought, the injunction that BMS has come seeking.” (emphasis added)

5

. Teva wished to appeal the decision as soon as possible. Under cover of a letter dated 24 February 2023 Teva's solicitors furnished BMS's solicitors with a draft order. The draft recast the undertaking as to damages offered by Mr. Cooke in his affidavit of 2 December 2022. The draft order read:

“And noting the Plaintiff's undertaking to the Court and to the Defendant to pay compensation for any and all loss suffered as a result of the making of this Order, if and when the Order is subsequently set aside or discharged”. (emphasis added)

6

. The draft order would have extended the undertaking as to damages; it was not confined to loss and damage suffered by the defendant arising from the making of the order.

7

. BMS's solicitors replied on 1 March 2023. They rejected the draft order furnished and attached a version “with some changes which reflect the usual form of such orders”. They formulated the undertaking as follows:

“And noting the Plaintiff's undertaking to abide by any Order which this Court may hereafter make as to damages in the event of this Court being of opinion that the Defendant shall have suffered any damage by reason of this Order which the plaintiff ought to pay.”

8

. On 20 March 2023, Teva's solicitors enclosed a further revision of the draft order and stated that:

“The purpose of the amendment to the language of the undertaking is to ensure that all losses sustained by the Defendant ( including losses via and through entities related to the Defendant) as a result of the grant of the injunction are unambiguously covered by the terms of the undertaking. (emphasis added)

We consider that it would be unworkable for the injunction and undertaking to list every individual entity in the Teva Group which may directly or indirectly be restrained in their activities by the injunction and every entity which may suffer a loss arising from the injunction. Nevertheless, it is unequivocally the case that entities other than the Defendant will be subject to the injunction (as envisaged by the reference to ‘servants and agents’ in the draft order) and that the harm caused to the Defendant may in turn cause and/or manifest itself in, damage to other related companies.

Therefore, the enclosed draft Order at Schedule 1 aims to ensure that the benefit of the undertaking as to damages that may ultimately be ordered by a Court extends to the Defendant in the Proceedings and its ‘related companies’ as more particularly defined in section 2(10) and (11) of the Companies Act 2014.” (emphasis added)

9

. BMS would not agree to extend the scope of the undertaking as to damages they had openly offered to the High Court and which had been accepted by the High Court in deciding to grant the injunction sought.

10

. On 23 March 2023 when the matter was before the High Court to finalise the order, counsel for Teva confirmed that the draft order it furnished on 24 February 2023 “would have covered off what we are now dealing with … We proposed from the outset that the undertaking should be broad enough to cover any and all losses suffered as a result of the making of the order.”

11

. Ultimately, the High Court perfected its order while reserving the determination of the scope of the undertaking as to damages for a further hearing and ruling. This enabled Teva to expedite its appeal to this court. The appeal was heard on 24 April 2023 and by a reserved judgment delivered on 29 June 2023 ( [2023] IECA 173) the injunction was upheld. The issue of the undertaking as to damages did not feature in the appeal.

12

. Meanwhile, the High Court directed Teva to file an affidavit setting out why the undertaking as to damages should be extended and to whom. Ms. Reynolds swore a further affidavit on 6 April 2023 which I shall consider later in this judgment. BMS elected not to file a replying affidavit. The application in relation to the scope of the undertaking as to damages was heard by the High Court on 21 June 2023 and on 26 June 2023 ( [2023] IEHC 376) the trial judge delivered his judgment.

13

. Barrett J. held that the form of the undertaking proposed by Teva was the appropriate form of undertaking to be provided in return for the injunction that he had granted. The order was perfected on 28 July 2023 and the operative part provides:

“It is ordered that the undertaking as to damages given by the Plaintiff in connection with the Interlocutory Injunction that is the subject of the Order dated the 23 rd day of March 2023 should not be limited to loss suffered by the Defendant but should also extend to loss suffered by the Defendant's related companies as defined in the Companies Acts, subject to the following propositions on which the undertaking rests:

  • the undertaking (a) does not refer to indirect loss (b) refers to loss simpliciter, and (c) the normal rules of causation will apply to a damages inquiry in the normal way, and (d) the Defendant will still have to prove its loss;

  • the Plaintiff's interests are fully protected insofar as they can argue all of the points they want to make at the damages hearing where the court will have at large jurisdiction to look into causation, quantum, etc;

  • the Order is intended merely to preserve all of the parties' interests in a damages hearing; and

  • the Defendant is not seeking (and will not seek) enhanced damages in any way;”

14

. BMS appealed this order to this court. In the meantime, the invalidity action has been heard and determined by Barrett J. In a reserved judgment delivered on 8 December 2023 ( [2023] IEHC 744) he held that the underlying patent was invalid.

15

. BMS has lodged an appeal against this decision and sought a stay on the order and an injunction further restraining the launch of Teva's generic products. The application for an injunction pending the determination of the appeal will be heard on 12 and 13 March 2024 and the substantive appeal is fixed to be heard over four days commencing on 13 May 2024.

16

. The appeal in respect of the order of 28 July 2023 directing BMS to give an extended undertaking as to damages was heard by this court on 30 January 2023 and judgment was reserved.

The relevant legal principles
17

. At the hearing of the appeal it was common case that the courts have jurisdiction in appropriate cases to require a party who seeks an injunction to give an undertaking as to damages which extends to the losses which may be sustained by a party other than the enjoined party. The jurisdiction is...

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