Bristol Myers Squibb Holdings Ireland Unlimited v Patents Acts 1992 to 2019; Bristol Myers Squibb Holdings Ireland Unlimited v Norton (Waterford) Ltd T/A Teva Pharmaceuticals Ireland

• Jurisdiction: Ireland
• Court: High Court
• Judge: Mr Justice Max Barrett
• Judgment Date: 02 February 2024
• Neutral Citation: [2024] IEHC 91
• Docket Number: [2021 No. 1 PAP]

In the Matter of Irish Patent Number European Patent (IE) 1 427 415 “Lactamcontaining Compounds and Derivatives Thereof As Factor XA Inhibitors” and Registered in the Name of Bristol-Myers Squibb Holdings Ireland Unlimited Company

and

In the Matter of the Patents Act 1992 to 2019

Bristol Myers Squibb Holdings Ireland Unlimited

Plaintiff

and

Norton (Waterford) Ltd T/A Teva Pharmaceuticals Ireland

Defendant

[2024] IEHC 91

[2021 No. 1 PAP]

[2021 No. 4758 P]

THE HIGH COURT

Summary

In my judgment of 8 ^th December 2023, I held (among other matters) that Irish Patent Number EP (IE) 1 427 415 (the Patent) is invalid. By virtue of Art.15(1)(c) of Regulation (EC) No.469/2009 that invalidity triggers the invalidity of the related SPC. By notice of motion of 15 ^th December, BMS has come seeking (i) a stay pending an appeal to the Court of Appeal from so much of my judgment of 8 ^th December as held the Patent to be invalid, and (ii) (a) a continuation of the interlocutory injunction that I ordered on 23 ^rd March 2023 (following on my judgment of 17 ^th February 2023) pending the outcome of the appeal against my judgment of 8 ^th December, or (b) an interlocutory injunction restraining Teva from infringing the SPC and, in particular, by making, offering, putting on the market and/or using and/or importing or stocking a generic version of Eliquis (active ingredient apixaban) pending the outcome of the appeal. In this judgment I explain why I will grant a stay on the revocation of the Patent and its removal from the register, and why, respectfully, I will not grant the injunctive relief sought.

JUDGMENT of Mr Justice Max Barrett delivered on 2 ^nd February 2024

A. Introduction

1 . The facts underpinning these proceedings have been described in my judgment of 8 ^th December 2023. In that judgment I held, among other matters, that the Patent is invalid. By virtue of Art.15(1)(c) of Regulation (EC) No.469/2009 that invalidity triggers the invalidity of the related SPC. 1

2 . By notice of motion of 15 ^th December, BMS has come seeking (i) a stay pending an appeal to the Court of Appeal from so much of my judgment of 8 ^th December as held the Patent to be invalid, and (ii) (a) a continuation of the interlocutory injunction that I ordered on 23 ^rd March 2023 following on my judgment of 17 ^th February 2023 pending the outcome of the appeal, or (b) an interlocutory injunction restraining Teva from infringing the SPC and, in particular, by making, offering, putting on the market and/or using and/or importing or stocking a generic version of Eliquis (active ingredient apixaban) pending the outcome of the appeal.

3 . I note that:

• (i) what must be sought by BMS at this time is a fresh injunction, not a continuation of the injunction that I granted following on my judgment of 17 ^th February last. That injunction was an injunction “ pending the determination of the proceedings by the High Court”. Those proceedings were determined in Teva's favour (so far as the validity of the Patent is concerned) in my judgment of 8 ^th December last. With that determination, the previous injunction expired. So what is being sought now is a fresh injunction against Teva (and, I note, Teva alone). I am buttressed in my view that the injunction now being sought is a fresh injunction when I have regard to the judgment in MP v. Teaching Council of Ireland [2019] IEHC 148, §24.

• (ii) just because the previous injunction was granted does not of itself entitle BMS to another injunction at this time (per Clarke J., as he then was, in Harding v. Cork County Council [2007] IEHC 31, §3.7).

• (iii) for what it is worth, there appears to be no reported case in this jurisdiction in

  which a generic company succeeded in revocation proceedings but was then injuncted from launching its generic product pending appeal. (I say ‘for what it is worth’ because this may simply indicate that no such injunction was previously sought.)

• (iv) there has been indication at Supreme Court level in the past that the jurisdiction to grant an injunction pending appeal should be exercised sparingly ( Cosma v. MJELR [2006] IESC 44, 3.)

4 . I note also that:

• – O'Donnell J., as he then was, in Krikke and ors v. Barranafaddock Sustainability Electricity Ltd [2020] IESC 42, §16, held that a court in considering a stay (but the same surely holds true in the context of an application for injunctive relief) can “ properly have regard” to the first instance decision of a trial court reached “ by a trial judge after a lengthy hearing and…an opportunity to assess the facts and law, and the attitude of the parties, in much greater detail than is inevitably available to a court hearing a preliminary stay application”,

• – “ significant deference” (see Re Boehringer Ingelheim Pharma GmbH & Co KG [2022] IECA 58, §105) will be afforded by any appellate court to my judgment of 8 ^th December, particularly given what I described in §1181 of that judgment as the “ abundant evidence” on which it is based, and

• – in Donegal Investment Group Plc v. Danbywiske, Wilson [2017] IESC 14 Clarke J., as he then was, observed at §5.7, that “[A] n appellate court should show significant deference to the views of a trial judge on the question of findings based on expert evidence”.

5 . The observations quoted in the preceding paragraph are (obviously) observations made by appellate court judges, not by me. Clearly any appellate court called to adjudicate upon any appeal from my judgment of 8 ^th December last will do what it considers to be required by law. However, what the just-quoted references do mean is that some weight can be attached by me in the present application to my judgment of 8 ^th December last, being a considered judgment given by a trial court following a lengthy and complex case and abundant oral evidence.

6 . As mentioned, in the within application BMS seeks both a stay and injunctive relief. The reader might wonder why one would need both a stay and an injunction. I cannot better the explanation that was provided to me in this regard by counsel for BMS (whose submission I respectfully accept as correct):

“ Our submission is that the difference between the stay and the injunction is as follows: If the stay is refused, then the right disappears [from the register of patents] as against all. In respect of the injunction, the parties are at least bound within these proceedings. So, insofar as BMS is suing Teva, if an injunction is granted, Teva is restrained from the market. If an injunction is not granted and we come to the end and the right is reinstated, then obviously BMS would be seeking damages from Teva in relation to that. BMS does not have an existing action with all the world in which it can potentially seek that kind of relief. Now, depending on the circumstances, Judge, obviously people can be written to and so on. But the real danger of a stay is, the right disappears from the register; as a matter of law, there is no obstacle to anybody using the technology, and people who do use the technology can simply say ‘I have accrued rights in the meantime’. In this particular case, there is the extant action which at least binds the parties into some kind of relationship….And I think…[the lead counsel for BMS] also mentioned this morning that there may be issues in relation to reinstating a right that is removed, in circumstances where there's no process for that set out in the Patents Act. So it is a very radical step, and it is a step that we believe is unprecedented, would be unprecedented, the refusal of a stay, in circumstances where it was requested and where there was an appeal pending. [The lead counsel for BMS] reminds me, of course our case is, though, that if the injunction was refused, it would also destroy our exclusivity temporarily. But in that instance, I think the difference between the stay and the injunction is if the right is reinstated on appeal, it would be much more difficult to say we've accrued rights and we can continue to use. The stay is, if I could put it this way, Judge, a sort of turbocharged removal of exclusivity that may never be reclaimed. The injunction threatens the same thing, in fact, but is not quite so devastating in terms of removing a right that, at the moment, is there on the register and that informs people that there is a registered right over this technology.”

B. The Stay

7 . The stay element of this matter can be swiftly dealt with. In Re Lobar Ltd [2018] IECA 129, Irvine J., as she then was, summarised the existing authorities on the principles to be applied by a court on an application for a stay in the following terms:

“ 15. The aforementioned authorities make clear that the court is bound to engage in what is often described as a two-stage test. First, the applicant must demonstrate that they have an arguable ground of appeal and is one which is bona fide rather than tactical.

16. …Assuming…the appellant demonstrates a bona fide and arguable ground of appeal, then the court must consider where the balance of justice is to be found.”

8 . The parties to the within proceedings are agreed that BMS has shown that it has one or more arguable grounds of appeal. (Teva believes that BMS will not succeed in any of its grounds of appeal but is satisfied that they are arguable, which is, in any event, a notably low threshold.) When I read the draft grounds of appeal appended to BMS's written submissions, I respectfully agree with the parties that BMS has shown that it has one or more arguable grounds of appeal. I am not even sure that it is contended by Teva (and, if it is contended, how strenuously it is contended) that BMS's grounds of appeal are tactical rather than bona fide. However, in what have been long and hard-fought proceedings in which BMS clearly and genuinely believes that the Patent (and hence the SPC) are valid and in which BMS has kindly furnished me...