An application for a preliminary injunction (PI) can be brought if a patent holder has reasonable grounds to apprehend that a launch or other infringing act is imminent. An application should be made without delay, as any delay may be taken into account by the court in refusing an application for a PI, particularly if the delay has resulted in a change in the present circumstances.
A PI would generally be sought inter partes. If there was an immediate urgency, the applicant could apply for an interim ex parte injunction, which would generally be heard and an order (with short-term effect) made on the same day.
A party seeking a PI is required to give an undertaking to the court to compensate the defendant in damages if a PI is ordered, but ultimately the defendant succeeds at trial. The court will have to be satisfied as to the plaintiff’s ability to honour such an undertaking. A defendant can, in certain limited circumstances, bring an application for security for costs, which could require a plaintiff to make a lodgement into court or provide a bond to provide security for the defendant’s costs.
While not a formal requirement, a warning letter or pre-action correspondence would normally be sent asserting the patent holder’s rights and seeking confirmations or undertakings as regards steps taken and/or intentions for any launch or other infringing actions in Ireland. Such correspondence, and the failure to provide adequate undertakings or commitments, would assist in forming the basis for the application for the PI.
Evidence required
For a preliminary injunction, the patent holder would need to show inter alia that there is a genuine or fair or serious question to be tried. This is a relatively low threshold. The patentee would need to show some evidence or information for asserting that there was or was likely to be infringement. Failure to respond to a warning letter or to provide undertakings not to infringe would also raise an inference that infringing acts would take place.
The court will then assess whether the balance of convenience/balance of justice favours it exercising its discretion to grant the PI. Important considerations here will involve the likely impact of the anticipated infringement on the patent holder. This could involve evidence about commercial factors such as the relevant product market and the competitive landscape.
Factors that the courts take into consideration
While the court would not, at the stage of hearing a PI application, engage with the substantive issues of invalidity, it would consider, at a high level, whether there are any challenges to the validity of a patent. In finely balanced cases, the court could have regard to the substantive question of validity if it was apparent that either side’s arguments in relation to that were strong and/or if there had been successive determinations in favour of a similar challenge in other jurisdictions.
The question of whether damages are an adequate remedy is the most important element in assessing the balance of convenience. Following the Irish Supreme Court decision in Merck Sharp & Dohme Corporation v Clonmel Healthcare Ltd [2019] IESC 65, adequacy of damages is not considered a separate and antecedent requirement that must first be satisfied before moving on to assess the balance of convenience. However, it remains the most important part of any assessment.
The Irish courts traditionally applied a high bar when considering the adequacy of damages and refused to grant PIs in patent infringement cases on the basis that damages were an adequate remedy; however, Merck v Clonmel lowered that threshold.
The Supreme Court held that: “…difficulty in assessing damages may be a factor which can be taken account of and lead to the grant of an interlocutory injunction, particularly where the difficulty in calculation and assessment makes it more likely that any damages awarded will not be a precise and perfect remedy. In such cases, it may be just and convenient to grant an interlocutory injunction, even though damages are an available remedy at trial.”
Detailed commercial evidence, including evidence of revenue streams in Ireland, market shares and, possibly, projections, would likely form part of the evidence required to demonstrate that the patentee would suffer irreparable harm in the event that a PI is not awarded. However, demonstrating that the patentee would merely suffer financial loss is insufficient unless it could also be demonstrated that the loss could not be compensated by damages (or at least that it would be very difficult to calculate those losses). Non-pecuniary loss could well be helpful to bolster an argument that irreparable harm would be suffered in the event that a PI is incorrectly refused.
Obtaining a PI
In Ireland, PIs can be obtained very quickly, within days or even hours in exceptional circumstances. They can be granted across not only the pharmaceutical sector but more generally across patent subject matters.
The more flexible approach adopted by the Courts can be seen in the 2024 decision of Bristol-Myers Squibb v Teva [2024] IEHC 91 where the Court of Appeal granted an injunction restraining Teva from introducing its rival generic product whilst the outcome of the Bristol Myers Squibb invalidity appeal was pending. This was a decision in which an injunction was granted pending an appeal where the patent had been deemed invalid at first instance. The court found the damage to the patent holder was "both more certain to occur and greater in magnitude than the damage to the defendant".
Enforcement
A PI typically becomes effective upon formal issuance by the court, either through a court order granted after a hearing on notice, or an ex parte interim order. The PI is binding on any person who is on notice of the order being made. It is a contempt of court to act contrary to an injunction once the individual is aware of its existence.
Appeal
In the context of patent litigation, every decision of the High Court, including decisions in respect of preliminary injunctions, can be appealed to the Court of Appeal. An application can also be brought to discharge or vary the injunction. It should be noted that filing an appeal does not suspend the PI, and as with the granting of a PI in a short time frame, the urgent nature of PI appeals means they will receive priority listing.
