The application by the patentee (BMS) was the first of its kind in Ireland where an interlocutory injunction was sought restraining patent infringement pending appeal despite the patent being found invalid in the High Court (Barrett J).
Background
By order dated 2 February 2024, Barrett J refused the application by BMS to continue the pre-trial injunction granted in February 2023 restraining Teva from launching its generic apixaban product. Barrett J's main ground for refusing the injunction was the fact that in the pre-trial application for an injunction, Barrett J accepted that BMS had a interest in the presumptively valid SPC but that following on from his invalidity judgment there was “now a ‘firm assumption’ that the patent is invalid” and that this “cannot be ignored”.
BMS appealed the February 2024 order and the parties agreed to continue the injunction pending the determination of the injunction appeal.
Appeal judgment
Due to the absence of any Irish authority on this novel issue, BMS placed significant weight on the decision of the Court of Appeal in England and Wales in Novartis AG v. Hospira UK Limited [2014] 1 W.L.R. 1264. As acknowledged by Ms Justice Costello in the CoA judgment, the Novartis authority is not binding in Ireland, but "it is persuasive, and...is of relevance to this Court’s consideration of the principles" ([20]).
Ms Justice Costello went on to state that "in emphasising the importance of the outcome of the trial at first instance, the High Court did not even address, never mind follow or distinguish, the decision of the Court of Appeal of England and Wales in Novartis, where Floyd L.J. expressly condemned the decision of the High Court in that case because the trial judge had weighed in the balance of justice the outcome of the trial at first instance. In this case, the trial judge does not appear to have afforded this persuasive authority any consideration, if only to explain why he disagrees with it. In my opinion the entire balance conducted by the High Court is tainted by the undue weight he placed on the outcome of the trial at first instance." ([29-30]).
Citing the Irish Supreme Court decision in Merck v. Clonmel, Ms Justice Costello held that clearing the path in Ireland does not entail anything less than it entailed in England and Wales where it is abundantly clear that clearing the path means clearing it until all appeals have been exhausted. Ms Justice Costello held that the High Court fell into error "affording Teva’s partial clearing of the path significant weight." ([93])
Contrary to the High Court judgment, Ms Justice Costello found there was irreparable damage and that it clearly favours BMS finding that "the interchangeable decision of the HPRA and the readiness of Mylan and Rowex (and possibly more generics) to launch generic products, an immediate and sharp downward price spiral in the interval between now and the decision on appeal is highly likely. If BMS prevails, it would therefore be confronted with a market which would have become accustomed to lower prices and as was observed by Floyd L.J. in Novartis where restoring its monopoly position “will, if possible at all, be accompanied by harm of other kinds.” ([104])
A way ahead?
Ms. Justice Costello acknowledges that the CoA judgment may be read as suggesting that no generic can ever get on the market until it successfully exhausts the appeal process but provides some hope by requoting O'Donnell J in Merck by saying “different facts may alter the equation and therefore the outcome” and suggests the best way to minimise the risk of injustice to such a generic is for the Courts to "seek to expedite the procedures and to list the trials and appeals for as early a date as is possible and for judgments to be delivered as soon as possible thereafter". ([107])
In my opinion the entire balance conducted by the High Court is tainted by the undue weight he placed on the outcome of the trial at first instance”
