Bristol-Myers Squibb Holdings Ireland Company v Norton (Waterford) Ltd Trading as TEVA

• Jurisdiction: Ireland
• Court: Court of Appeal (Ireland)
• Judge: Ms. Justice Costello
• Judgment Date: 13 June 2024
• Neutral Citation: [2024] IECA 143
• Docket Number: Court of Appeal Record Number: 2024/31

Between/

Bristol-Myers Squibb Holdings Ireland Unlimited Company

Plaintiff/Appellant

and

Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland

Defendant/Respondent

[2024] IECA 143

Costello J.

Noonan J.

Allen J.

Court of Appeal Record Number: 2024/31

High Court Record Number: 2021/4758P

THE COURT OF APPEAL

CIVIL

Patent – Injunction – Product launch – Appellant seeking an injunction – Whether the balance of justice favoured the granting of an injunction

Facts: The High Court, by a judgment delivered on 8 December 2023 in patent proceedings, held that Irish Patent No. EP (IE) 1 427 415 was invalid; as a consequence, the Supplementary Protection Certificate No. 2011/032 (the SPC) held by the appellant, Bristol-Myers Squibb Holdings Ireland Unlimited Company (BMS), was also invalid. By order dated 2 February 2024, the High Court granted a stay on the revocation of the patent from the register until the first directions hearing of the appeal by BMS in the Court of Appeal. Barrett J refused to renew the pre-trial injunction which he had given in February 2023 restraining the launch by the respondent, Norton (Waterford) Ltd (Teva), of its generic product and he granted a limited injunction up to 4pm on 9 February 2024 restraining Teva whether by itself or its directors, officers, servants or agents from launching, offering or putting on the Irish market a generic version of BMS’s medical product Eliquis (active ingredient apixaban). BMS filed two notices of appeal on 8 February 2024, the first against the judgment revoking the patent and the second against the refusal of an interlocutory injunction restraining the launch of Teva’s generic medicinal product pending the determination of the appeal. The parties agreed to continue the stay on the revocation of the patent until the determination of the appeal; and to continue the injunction pending the appeal by BMS against the refusal of the injunction until the appeal could be heard and determined by the Court of Appeal, on BMS’s undertaking to continue to take steps to seek to ensure no other generic is permitted to launch, or to take preparatory steps to launch, a generic version of apixaban pending the determination of the injunction appeal. The appeal in respect of the refusal of the injunction was heard by the Court of Appeal on 12 and 13 March 2024 and judgment was reserved.

Held by Costello J that the entire balance conducted by the High Court was tainted by the undue weight he placed on the outcome of the trial at first instance. She held that the trial judge failed to approach the question of whether to grant an injunction pending appeal, bearing in mind that the appeal may succeed. She held that the trial judge failed to properly weigh BMS’s right to exclusivity and he dismissed it from his consideration on the grounds that BMS had lost at first instance. She held that the trial judge erred in failing to attribute any weight to the fact that the right at issue was one which, although found to be invalid at first instance, might yet be restored following appeal. She held that there were errors in the assessment of the balance of justice in the application. She held that, in approaching the question of whether damages were an adequate remedy for BMS, the trial judge applied the incorrect test. She held that the trial judge erred in holding that a period of time to plan was an operative factor because that is not what Merck Sharpe & Dohme v Clonmel Healthcare [2020] 2 I.R.1 says and it cannot be correct.

Costello J allowed the appeal and held that the balance of justice favoured the granting of an injunction.

Appeal allowed.

[Approved]

[No redaction needed]

JUDGMENT of Ms. Justice Costello delivered on the 13 ^th day of June, 2024

Introduction

1 . By a judgment delivered on 8 December 2023 in the patent proceedings (2021 No.1 PAP), ( [2023] IEHC 744) the High Court held that Irish Patent No. EP (IE) 1 427 415 (“the patent”) is invalid. As a consequence, the Supplementary Protection Certificate No. 2011/032 (“the SPC”) held by the plaintiff/appellant (“BMS”) is also invalid, as the patent is the basic patent underpinning the SPC. The SPC protects the medicinal product Eliquis ^® (active ingredient apixaban) which is a hugely successful anti-coagulant medicine. If not invalidated, the SPC is due to expire on 19 May 2026.

2 . By order dated 2 February 2024 (perfected 7 February 2024) the High Court granted a stay on the revocation of the patent from the register until the first directions hearing of the appeal by BMS in the Court of Appeal. Barrett J. ( [2024] IEHC 91) refused to renew the pre-trial injunction which he had given in February 2023 restraining the launch by the defendant (“Teva”) of its generic product and he granted a limited injunction up to 4pm on 9 February 2024 restraining Teva whether by itself or its directors, officers, servants or agents from launching, offering or putting on the Irish market a generic version of BMS's medical product Eliquis. He did not restrain Teva from importing or stocking such products or taking other steps preparatory to the launch of its product.

3 . The order of 2 February 2024 was perfected on 7 February 2024. BMS filed two notices of appeal on 8 February 2024, the first against the judgment revoking the patent and the second against the refusal of an interlocutory injunction restraining the launch of Teva's generic medicinal product pending the determination of the appeal. The parties agreed to continue the stay on the revocation of the patent until the determination of the appeal; and to continue the injunction pending the appeal by BMS against the refusal of the injunction until the appeal could be heard and determined by the Court of Appeal, on BMS's undertaking to continue to take steps to seek to ensure no other generic is permitted to launch, or to take preparatory steps to launch, a generic version of apixaban pending the determination of the injunction appeal.

4 . The appeal in respect of the refusal of the injunction was heard by this Court on 12 and 13 March 2024 and judgment was reserved.

Jurisdiction of an appellate court in relation to discretionary orders of the High Court

5 . The approach which this Court is required to take when considering an appeal from a decision of the High Court to grant or refuse an interlocutory injunction is well settled (see Betty Martin Financial Services Ltd. v. EBS DAC [2019] IECA 327; Lawless v. Aer Lingus [2016] IECA 235; Collins v. Minister for Justice, Equality and Law Reform [2015] IECA 27; Clare County Council v. McDonagh [2020] IECA 307 and Word Perfect Translation Services Ltd. v. Minister for Public Expenditure and Reform [2021] IECA 305). To quote Whelan J. from Clare County Council (at para. 32):

“In summary therefore, a party seeking to set aside an interlocutory order of the High Court made in the exercise of its discretion must establish that an injustice will be done unless the order is set aside. In making its assessment, this court will place great weight on the views of the trial judge but is untrammelled by any a priori rule restricting the scope of that appeal….”

If an appellant establishes that an injustice will be done if the decision of the High Court remains in effect, then this Court ought to intervene.

Principles to be applied in an application for an injunction pending appeal

6 . In Harding v. Cork County Council [2008] 4 I.R. 318 Clarke J. (as he then was) in the High Court confirmed that the High Court in an appropriate case has jurisdiction to continue an injunction or to grant new or different injunctions so as to preserve the position pending an appeal. It is not disputed that it was open to both the High Court and this Court pending the hearing of the appeal to this Court to grant the injunction sought by BMS notwithstanding the decision of the High Court that the patent in suit is invalid.

7 . The principles to be applied in considering whether or not to grant such relief have been set out by Clarke J. in C.C. v. The Minister for Justice and Equality [2016] 2 I.R. 680. Speaking for the Supreme Court, Clarke J. referred to the statements of McCarthy J. in Redmond v. Ireland [1992] 2 I.R. 362, and Emerald Meats Ltd. v. Minister for Agriculture [1993] 2 I.R. 443 that the fundamental consideration is that the court maintains a balance with a view to ensuring that justice is not denied to either party. Clarke J. continued at para. 36 of the report:

“As in all cases, the first question is as to whether there is any stateable or arguable basis for the appeal itself. If there is, then the Court has to assess the potential injustice which may result from, on the one hand, intervening in favour of the appellant only to find that the appellant loses, as opposed to not intervening in favour of the appellant only to find that the appeal is successful.”

8 . I should observe that there is no suggestion in C.C. that this is a jurisdiction which should be exercised sparingly: insofar as Cosma v. Minister for Justice, Equality and Law Reform [2007] 2 I.R. 133, which was relied upon by the High Court, says to the contrary, it must be regarded as no longer good law and having been overtaken by C.C.

9 . It is not disputed that BMS has arguable grounds of appeal. This was accepted by the trial judge, though he remarked that this was a low threshold. While this may be so, it is the threshold mandated by the Supreme Court and is therefore the only threshold which any appellant must satisfy.

10 . In C.C. Clarke J. continued that the test whether there should be a stay or another intervention (an injunction) pending an appeal is the same as that identified in Okunade v. Minister for Justice [2012] 3 I.R. 152. He observed however that the precise way in which the overall approach may apply may differ depending on the context. He observed that the...