Preliminary Injunction Granted against Teva Regarding BMS’ Apixaban

The Irish High Court ruled in favour of Bristol-Myers Squibb in its injunction application to restrain Teva from infringing its Supplementary Protection Certificate for a direct oral anticoagulant.

Our Intellectual Property team reviews the courts findings in this case, which marks the third preliminary injunction decision in favour of a patentee delivered in the last few months. This confirms the shift in how these cases are approached by the Irish courts.

The Irish High Court ruled in favour of Bristol-Myers Squibb (BMS) in its injunction application to restrain Teva from infringing its Supplementary Protection Certificate (SPC) for a direct oral anticoagulant (DOAC) called Apixaban. The decision delivered mid-February means that Teva are prevented from launching its version of BMS’ medicinal products Eliquis. We review the courts findings in Bristol-Myers Squibb Holdings Ireland -v- Norton (Waterford) Limited T/A Teva Pharmaceuticals Ireland[1] , which marks the third pro-patentee preliminary injunction decision delivered in Ireland during the last few months.

The SPC in question extends the exclusive rights BMS enjoys under European Patent (IE) 1 427 415 (the Patent). The Patent expired on 17 September 2022 and the SPC is due to expire on 19 May 2026. Apixaban is a DOAC produced by BMS under the brand name Eliquis. Whilst Teva accept that its generic product infringes the Patent and the SPC, it asserts that the Patent owned by BMS and consequently the SPC, is invalid.

Teva with Sandoz[2] were successful in their revocation proceedings in England and Wales regarding the Patent. BMS appealed this decision, but the English Court of Appeal confirmed the High Court’s decision[3].

Background to injunction application

With first mover advantage in its sights, Teva applied for marketing authorisation (MA) for a generic version of Apixaban.

Teva issued a revocation action on 19 March 2021; seeking revocation of the Patent and the SPC, on the grounds of invalidity and lack of priority. The purpose of the revocation action was to clear the path with the intention that Teva would launch its generic Apixaban in 2022. Teva had sought an expeditious hearing on the back of these plans. However, this was with the clear caveat that the proceedings would be prosecuted expeditiously to trial.

On 2 December 2022, BMS sought an interlocutory injunction restraining Teva from infringing its SPC. As set out in BMS’ grounding affidavits, the injunction was sought on a quia timet basis, where Teva had sought an MA and had notified BMS of its intention to launch by mid-2022.

In considering whether the injunction should be granted, Mr Justice Barrett referred to the interlocutory injunction principles considered by the Supreme Court in Merck[4]. These principles are analysed in our article, MSD’s Recent Injunctive Relief – A New Dawn for Patent Litigators in Ireland.

Adequacy of damages

Regarding adequacy of damages, Mr Justice Barrett concluded that the scales of convenience are equally weighed on both sides. Neither party had demonstrated that it would be more or less difficult to compute damages.

On the issue of whether BMS would suffer permanent damage through a collapse in product market share, Mr Justice Barrett noted that he would have found the argument more compelling if one of BMS’ experts had sworn that it would drop its price to match generics. Nonetheless, as observed in Gilead Sciences Inc v. Mylan S.A.S.[5] it would not be difficult to calculate any damages to which the plaintiffs might be entitled in a market that is very mature. The judge accepted that this calculation might become more complex if more generics entered the market but that is not the case here. Mr Justice Barrett noted that it is an undeniable fact that if the injunction is not granted BMS will lose the exclusivity that goes with being an SPC holder, despite the presumptive validity of an SPC. On that basis, he found that BMS would not be adequately compensated if the interlocutory injunction is not now granted, and it wins the revocation action.

On the question of adequacy of damages for Teva, Mr Justice Barrett queried conflicting evidence about whether other generics would follow Teva’s lead. He noted that the parties agree that the perception of risk for other generics will shift dependent on whether an injunction is granted. Any entrance by other generics will make the calculation of damages difficult. As a result, the judge held that Teva would not be adequately compensated by damages if the interlocutory injunction is now granted, and it later succeeds in the revocation proceedings.

Other factors relevant to the balance of convenience/justice

Addressing other relevant factors in the balancing test, Mr Justice Barrett acknowledged:

1) The investment made by BMS to obtain the benefit of the presumption of validity

2) The importance of presumptive validity

3) The important public policy/public interest reasons for having monopoly rights

4) There is a public interest that extant SPC and patents are challenged in an orderly manner, and

5) Teva’s argument that its infringement would result in lower drug prices

Commenting on Teva’s efforts to clear the path, Mr Justice Barrett approved the sentiment in the UK decision in Smithkline Beecham plc v. Generics Ltd.[6]: “If there may be an obstacle in your way clear it out”,

not ‘vault over the obstacle so that you get to your desired end, leaving the path uncleared in your trail’[7]. That said the judge did find fault with some of BMS procedural misdemeanours that led to delays, but he did not consider that these delays were caused by intentional acts by BMS.

Sandoz Ltd v. Bristol-Myers Squibb Holdings Ireland Unlimited Company [2022][8]

Discussing the fact that an equivalent patent has been found to be invalid in England, the judge considered that this is a “far more convincing point”. Mr Justice Barrett noted there were no material differences between the facts in the case in question and the facts in the English case involving Sandoz, Teva and BMS. Ultimately, counter-considerations prevailed when the judge considered whether this case should influence the decision to grant an injunction; such as the fact that the English case was under appeal at the time of the court’s decision, and that the SPC remained presumptively valid in this jurisdiction. The judge also questioned whether the legal principles argued in the revocation action in England regarding plausibility would apply in Ireland.

Clear the way, a commentary

At the outset, Teva confirmed to BMS that it did not seek to or intend to carry out restricted acts while the Patent and /or SPC remained in force in Ireland. Instead, it sought to clear the way by initiating the revocation action.

On the one hand Mr Justice Barrett is critical of BMS noting that efforts to expedite the revocation case were scuppered by BMS due to a discovery default and late introduction of a witness:

“In summary, the defaults, procedural failures and delays of BMS in the Revocation Action are serious and have thwarted Teva’s reasonable attempt to clear the path (and the Court's efforts to accommodate same). The chronologies, transcripts and Orders speak for themselves. In the context of the balance of justice, BMS' attempt to place a retrospective slant on those objective facts, repeating contentions that did not find favour with O’Moore J, and to now blame Teva for those failures is self-serving and untenable.”[9]

On the other hand, as discussed above, Mr Justice Barrett disapproved of Teva’s failure to properly clear the path. He noted that Teva were in control of the date it launched revocation proceedings. He further noted that a litigator with Teva’s experience should have anticipated that the trial date may have been delayed.

As discussed in our last article Biogen wins injunction appeal it seems that the landscape continues to be uncertain for generics looking to launch at risk.

We await the outcome of the Irish revocation trial which is due to take place in July.

For more information on successfully protecting your organisation's intellectual property rights, contact a member of our Intellectual Property team.

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[1] [2023] IEHC 159

[2] Sandoz Ltd v. Bristol-Myers Squibb Holdings Ireland Unlimited Company [2022] EWHC 822

[3] Sandoz and Teva v Bristol-Myers Squibb [2023] EWCA Civ 472

[4] Merck Sharp & Dohme Corporation v. Clonmel Healthcare Ltd [2019] IESC 65, [2020] 2 I.R. 1

[5] [2017] IEHC 666

[6] [2001] EWHC 563 (Pat)

[7] Para 32

[8] EWHC 822

[9] Para 70