PI’s in Pharmaceutical Patent Cases in Ireland

Practitioners often assume that the law in Ireland in patent infringement cases is so similar to English law that the same result in multi-jurisdictional cases is almost a certainty.  However, while the substantive law is indeed very similar, the procedure and the approach of the Irish courts can differ in numerous respects, all of which may have a significant effect on the outcome of the Irish leg of these proceedings.

Since a decision of the Irish High Court in Smithkline Beecham plc v Genthon BV [2003] IEHC 623 in 2003, the difference of approach between the jurisdictions in PI patent proceedings has been marked.  Although the test for interlocutory injunctive relief, namely, (1) whether there is a serious issue to be tried; and (2) if so whether damages would be an adequate remedy and if not then (3) where the balance of convenience lies, looks the same, the manner of answering the second question has tended to be quite different.  The result has been that in considering pharmaceutical patent PI’s Irish courts almost never get as far as considering the balance of convenience, whereas English Courts have worked their way through the whole 3-part test and have not shied away from granting PI’s in this type of case in recent years.

In late 2017, in Gilead Sciences Inc. & anor v Mylan SAS Generics [UK]Limited & anor [2017 No 5984P], and Gilead Sciences Inc & anor v Teva B.V. (Waterford) Limited & anor [ 2017 no 6494P] the High Court followed this approach in finding that in the circumstances damages were an adequate remedy for the plaintiffs and therefore that granting interlocutory injunctive relief would not be appropriate.  This case concerned potential entry to the market of a generic version of Truvada at a stage when the patent had expired but an SPC for Truvada was still current.  Key considerations for the Court in determining that damages would be an adequate remedy were the small and finite nature of the then current market in Ireland for Truvada, the limited distribution channels for the product, the potential for sales to be recorded at various points in the distribution network, the likelihood that the product’s use as a prophylactic would not be reimbursed by the government for several years, the emergence of replacement new generation products and the fact that the SPC was being challenged both in Ireland and elsewhere in Europe.  An environmental factor that is influential in these cases is the possibility that an expedited trial can be scheduled in the Commercial Court so that the delay between hearings will be minimised, which of course limits the downside potential for damages and for price erosion.

The difference in approach between jurisdictions possibly arises at least in part from the different nature of the markets and to some extent because of differences in regulatory practice and court procedural factors.  Each case turns on its specific facts but at least for the time being, potential plaintiffs need to be very aware of the difficulties inherent in obtaining preliminary injunctive relief in pharmaceutical patent cases in Ireland.

Acuatus acted for Mylan in these proceedings

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