Patent Litigation in Practice Series: Spotlight on Ireland: Preliminary Injunctions in Ireland

Introduction 

Ireland has witnessed a significant increase in patent litigation over the past decade, largely benefitting from the adept case management of the Commercial Court. In response to this surge, a dedicated Intellectual Property and Technology list was established within the Commercial Court in 2021, primarily gaining traction in the patent domain. 

Key developments in Irish patent litigation

The dynamic nature of patent disputes, especially in the pharmaceutical sector has led to several precedents in Irish case law. Notably, the Court of Appeal adopted the principle of comity in the case of Norton (Waterford) Limited t/a Teva Pharmaceuticals Ireland v Boehringer Ingelheim Pharma GmbH & Co KG [2022] IECA 58. 

Landmark case: MSD v Clonmel 

The most significant development in Irish patent litigation was the Supreme Court’s decision in MSD v Clonmel [2019] IESC 65, which redefined the test for injunctive relief. This case reimagined the long-standing Campus Oil (Campus Oil v Minister for Industry and Energy (No. 2) [1983] 1 IR 88 criteria focusing on the adequacy of damages and the balance of convenience, alongside whether there was a fair issue to be tried. 

Prior to this case, the High Court had denied a preliminary injunction sought by the patentee in Gilead v Mylan [2017] IEHC 666, but the revised test from MSD v Clonmel marked a turning point. 

The 8-step process for preliminary injunctions 

In its seminal judgment, the Supreme Court set out an 8-step process for courts to consider when deciding on preliminary injunctions: 

1. Whether a permanent injunction might be granted if the plaintiff succeeds;
2. Whether there is a fair issue to be tried;
3. If there is a fair issue to be tried, how best to manage the matter pending  trial,  considering both the balance of convenience and the balance of justice;
4. Whether damages are an adequate remedy;
5. In commercial cases, the courts should be “robustly sceptical” of claims that damages are inadequate;
6. While difficulty of assessing damages is a factor which can be considered, it is not determinative of the issue; 
7. Although the adequacy of damages is the most important factor in assessing the balance of convenience or the balance of justice, several other factors can be considered and weighed appropriately by a court; and 
8. Recognising the “essential flexibility of the remedy” and the fundamental objective of minimising injustice 

Patent injunctions post-MSD 

The expanded test has reshaped the landscape of patent disputes in Ireland, leading to several preliminary injunctions being granted to patentees since its introduction. 

In Biogen v Laboratorios Lesvi Si the High Court refused the preliminary injunction sought by Biogen to prevent infringement of its patent protecting the drug TECFIDERA ([2022] IEHC 592). However, this decision was later reversed in the Court of Appeal ([2023] IECA 71). 

Subsequently, the High Court proceeded to grant injunctions to MSD against Mylan ([2023] IEHC 24) (in respect of the patent protecting drug JANUMET), and BMS against Teva ([2023] IEHC 159) and McDermott Laboratories (ex tempore) in separate proceedings concerning different patents. 

In BMS v Teva, the generic manufacturer argued that steps taken to ‘clear the path’ (i.e. revoking the patent before launching a generic version on the market) should be taken into consideration by the court when determining whether the balance of convenience leant in favour of granting or rejecting the injunction regarding BMS’ blockbuster anticoagulant drug, ELIQUIS. However, the court ruled that this factor was not dispositive. 

Key takeaways 

While there is a trend towards granting injunctive relief to originators since the Supreme Court’s 2019 decision in MSDv v Clonmel, the BMS v Teva case illustrates the complexity of these cases.

BMS had been granted an interlocutory injunction pending the outcome of the revocation proceedings before the High Court.  Having lost the case in the High Court, BMS applied for a continuation of the injunction pending the exhaustion of the appeals process and it was ultimately successful.    

For further details about preliminary injunctions in Ireland, see our Patent Litigation Country Comparator Q&A.