The Irish Court of Appeal ruled in favour of Bristol-Myers Squibb (BMS). It granted an injunction restraining Teva from infringing its Supplementary Protection Certificate (SPC) by launching a generic Apixaban product called ‘Eliquis’. This injunction will remain in place pending the outcome of its substantive invalidity appeal. The decision means that Teva are prevented from launching its version of BMS’ medicinal product, Eliquis. The case is interesting as it is the first to determine granting an injunction pending an appeal where a patent has been held invalid at first instance. We review the court’s findings.
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. The SPC is due to expire on 19 May 2026. Apixaban is a DOAC produced by BMS under the brand name Eliquis.
High Court decision
The High Court found the SPC to be invalid at first instance in December 2023. This decision was appealed to the Court of Appeal and a hearing took place in May 2024. A decision is awaited.
In an effort to prevent Teva from launching its competing product while the appeal decision was outstanding, BMS applied to the High Court [1]for an injunction restraining Teva from launching during this time. Mr Justice Barrett refused to renew the pre-trial injunction. This decision was made as he held the patent to invalid. The initial injunction, granted in February 2023, had restrained Teva from launching, pending the determination of the appeal.
BMS appealed this decision. The parties then agreed to continue the stay on the revocation of the patent until the determination of the appeal. They also agreed to continue the injunction pending the appeal by BMS against the refusal of the injunction . This arrangement was to remain in place until the appeal could be heard and determined by the Court of Appeal. This was based on BMS’s commitment to continue to take steps to seek to ensure no other generic is permitted to launch. BMS also agreed not to allow any preparatory steps for launching a generic version of apixaban until the determination of the injunction appeal.
Court of Appeal decision
The appeal of the refusal of the injunction was heard in March 2024. It is that appeal to which this decision relates. The substantive appeal on the merits has also been heard but not yet determined.
This was the first example of an application for an injunction restraining infringement of a patent pending appeal where the patent has been found to be invalid in this jurisdiction. Instead, BMS relied on the English decision of Novartis AG v. Hospira UK Limited[2] which is of persuasive authority in this jurisdiction. In Novartis, an injunction was granted on the basis that the damage to the patent holder was “both more certain to occur and greater in magnitude than the damage to the defendant”. Further, due to the probable entry of two other generic companies to the market, the possibility of the defendant enjoying the benefits of first mover advantage were considered remote. The fact that the market will have become accustomed to lower prices was a significant factor in the court findings that restoring any monopoly would be, if possible at all, accompanied by harm of other kinds.
The Court of Appeal noted that in England the threshold question is whether the appeal has a real prospect of success. Whereas in Ireland, the question is whether the appellant has an arguable or stateable appeal. However, the Court was satisfied that the fact that the thresholds are different does not alter the principles to be applied to an application of this nature once the relevant threshold is met.
The Court of Appeal ultimate found that it was not possible to protect both BMS and Teva from the risk of injustice but that the balance clearly favoured BMS. It considered the damage to BMS to be more certain to occur and greater in magnitude than the damage to Teva. This was particularly due to the readiness of other generics to launch and the resulting immediate and sharp downward price spiral.
The following points are of particular note for patent owners:
- The Court of Appeal found that the High Court placed “undue weight” on the outcome of the first instance invalidity decision in refusing the injunction.
- The Court of Appeal considered it incorrect to find that the presumption of validity was gone following the first instance decision.
- The Court of Appeal found that the High Court did not have proper regard to BMS’s right to exclusivity. It also noted that this right may not be capable of being sufficiently restored should the invalidity appeal succeed.
- The Court of Appeal found that the High Court had failed to recognise the risk of uncompensable damage to BMS in the event of further generic entry and a resulting price spiral.
The Court of Appeal emphasised that the test for adequacy of damages is not simply whether there exists a method to calculate damages. It confirmed that the test is whether the remedy in damages can be said to be “necessarily commensurate with any possible injury”. Further, where a court concludes that damages would not be or would be an adequate remedy for a party, this is not decisive. Instead, it is only a factor to be considered in determining where the balance of justice lies.
Conclusion
This decision will come as a disappointment to generics. It could be read as suggesting that no generic can ever launch onto the market until it successfully exhausts the appeal process. This is both an expensive and time-consuming process. The Court of Appeal acknowledges this and says that different facts may alter the equation. It suggests that the best way for the court to minimise the risk of injustice to generics is to seek to expedite the procedures. The court should aim to list the trials and appeals for as early as possible and to deliver judgments shortly thereafter. However, this is possibly little comfort to generics given that the courts are restricted by their workload.
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[1] [2024] IEHC 91
[2] 2014] 1 W.L.R. 1264,
