Recent Cases in the Context of Patent/SPC Infringement Proceedings
Recent judgments of the High Court and Court of Appeal demonstrate the challenges that pharmaceutical companies face when seeking an interlocutory injunction in Ireland to prevent acts in respect of generic medicines that, if unrestrained, would infringe the applicant’s patent or SPC rights. In particular, the judgments demonstrate that it will be difficult to show that damages would not be an adequate remedy for an applicant in those circumstances.
Teva v Mylan  IEHC 324
Teva sought an interlocutory injunction to prevent manufacturing in Ireland by Mylan of a generic version of Teva’s multiple sclerosis medicine Copaxone 40mg, contrary to Teva’s rights under an Irish patent, for export to the US. There was no equivalent US patent in force at the time of the hearing of the application.
The Court, by judgment dated 5 June 2018, agreed with Mylan, who argued that the quantification of such losses should be straightforward as the market for Copaxlone 40mg is stable and well-established and given the extent of available third party prescription and sales data. The Court was not convinced by Teva’s arguments, which included an assertion that Mylan’s activities were likely to result in a significant reduction in Teva’s market share in the US market as well as causing significant permanent and irreversible erosion of the price of the Copaxone 40mg product.
The High Court also held that, if it was wrong about damages being an adequate remedy for Teva, the balance of convenience in any event favoured the refusal of an interlocutory injunction.
Merck v Clonmel  IECA 177
This was an application for an interlocutory injunction seeking to prevent the sale by Clonmel of the generic version of Merck’s cholesterol-reducing medicine Inegy in the context of SPC infringement proceedings. The application was refused by the High Court on 27 April 2018, again on the basis that damages would be an adequate remedy, despite evidence to the effect that Merck would have to reduce its prices by 92% to match Clonmel’s price.
The decision of the High Court was upheld on appeal to the Court of Appeal on 12 June 2018, albeit with a dissenting judgment from one of the three judges. The stability of the market and the fact that Merck’s SPC had only 9 months left to run were significant factors that contributed to the majority’s finding that damages would be an adequate remedy for Merck. The Court also took into account an argument that damages would not be an adequate remedy for Clonmel, if the interlocutory injunction was granted and the SPC later found invalid, due to a loss of “first mover advantage”.
In his dissenting judgment, Hogan J referred to the courts’ constitutional obligation to respect and vindicate the property rights of every citizen; where an established property right – including an intellectual property right – has been infringed, that holder should prima facie be entitled to an injunction to restrain the infringement.
- Prior to these applications, and an application brought by Gilead in 2017 in the context of SPC infringement proceedings which also concerned generic medicinal products, the only reported judgment on an application for an interlocutory injunction in the context of patent or SPC infringement in Ireland was from 2003 (Smithkline Beecham plc. & others v Genthon B.V. and Synthon B.V.  IEHC 623). In that case, the application was also refused on the basis that damages were an adequate remedy for the applicant - a discrete test that the Court held must be satisfied before any other factors that might go towards the balance of convenience can be taken into account.
- The Courts have applied the test set out by the Supreme Court in Curust Financial Services Ltd & Or v. Loewe-Lack-Werk Otto Loewe GmbH & Co & Or  1 IR 450, to the effect that “[d]ifficulty, as distinct from complete impossibility, in the assessment of … damages” is not sufficient to establish that damages would not be an inadequate remedy. That is undoubtedly a high bar and it remains to be seen whether it is one that is capable of being met in the context of alleged patent/SPC infringements in the pharmaceutical field.
- While it must be viewed in light of its particular facts, it is notable that the High Court in Teva v Mylan was prepared to consider evidence on loss that would allegedly be suffered by the applicant (including through related US companies) in the US market, and indeed that the Court held that any such loss could be compensated by an order for damages in the event that Teva was successful at trial.
- The potential relevance to an application for an interlocutory injunction of the relative strength of the parties’ positions on the underlying, substantive issues was addressed in Merck v Clonmel. Two of the judges in the Court of Appeal (including the dissenting judge) took the view that, in light of the fact that the SPC would shortly expire, the judgment on the interlocutory application would be determinative of the dispute between the parties. While it was not explained in the judgment why the parties would not be motivated to seek damages at trial, those judges went on to find that the Court was therefore required to form a view – albeit a tentative and provisional one – on the substantive issues.