Patent power play: the growing importance in Ireland of ‘clearing the path’

Rising trend for Irish injunctions

In a series of recent decisions, a clear trend has emerged in the Irish courts that preliminary injunction (PI) applications now strongly favour patentees, and generic entrants have many hurdles to overcome to resist a PI. This is in stark contrast to the situation that existed in Ireland less than five years ago, when the case law favoured generic entrants.
The injunction test in Ireland comprises a number of elements to be weighed up. However, this article reviews the development of the principle of ‘clearing the path’ and what this means for PI applications.

The leading Irish authority on preliminary injunctions

In 2019, the Irish Supreme Court clarified the injunction test in Ireland, following on from a series of decisions in which PIs had been refused on the basis that damages would be an adequate remedy for the patentee. The leading Irish authority on PIs is now the Supreme Court decision in Merck Sharp & Dohme v Clonmel Healthcare (the MSD Decision). In deciding that case, the Supreme Court set out eight steps that a court should follow in determining whether to grant an injunction. Distilled down, the key questions a court will consider are:

• Is there a fair/serious issue to be tried?
• What does the balance of convenience favour?

In its judgment, the Supreme Court highlighted that the most important element in the balance of convenience assessment is, in most cases, the question of adequacy of damages. However, the Supreme Court also commented that weight should be given to the clearing the path argument but warned that it could not be accepted without qualification as dispositive of the issue. It was part of the balance of convenience limb of the injunction test, with the Supreme Court remarking that the fact that the supplementary protection certificate in question “is valid until otherwise declared invalid by a court […] is also relevant to the balance of convenience”.

Interestingly, in relation to the argument that a generic challenger should always clear the path, the Supreme Court observed that clearing the path poses problems for generics, since any such invalidity proceedings would clear the path not just for the applicant, but for any other generic, which would essentially be given a free ride on the application.

Recent Irish case law following the MSD Decision

More recent cases of the Irish courts applying the principles set out in the MSD case shed light on what expectations the courts now have as to the lengths that a generic entrant must go to in order to sufficiently clear the path to resist a PI. In March 2023, the Court of Appeal ruled in Biogen MA Inc. & Biogen International GMBH v Laboratorios…