The Court of Appeal (COA) has upheld the order of the High Court of February 2023, granting Bristol-Myers Squibb (BMS) a preliminary injunction restraining Teva from launching a generic version of BMS’ product Eliquis^® (whose active ingredient is Apixaban).

This decision, handed down on 29 June 2023, marks the latest in a series of pro-patent holder decisions in Ireland and highlights the importance of “clearing the path” for generic entrants. One of the interesting aspects of the decision is that it related to an application for a PI not at the commencement of proceedings but some weeks/months before the trial of the main action was due to commence.

Background to Proceedings

BMS maintains a supplementary protection certificate (SPC), which protects Apixaban, the active ingredient in BMS’ anti-coagulant product Eliquis^®. The Irish action forms part of a larger multi-jurisdictional dispute.  Teva, along with several other generic suppliers, obtained marketing authorisation for generic Apixaban products. In early 2021, Teva indicated its intention to launch its generic product, commencing proceedings to revoke the BMS SPC in March of that year. BMS subsequently sought undertakings that Teva would not launch its generic brand of Apixaban while the revocation proceedings were ongoing. Teva did not provide the undertakings and in July 2021 BMS issued infringement proceedings against Teva.

High Court Injunction Application

The trial was scheduled for a hearing in June 2022 but due to several outstanding issues, it was adjourned to July 2023. Teva informed BMS in November 2022 that it would not wait until the determination of the revocation proceedings to launch its generic brand Apixaban. In response, BMS issued a motion in December 2022 for a PI to restrain Teva’s intended launch.

In February 2023, the High Court granted the PI in favour of BMS. In making its order, the High Court relied on the principles set down by the Supreme Court in Merck Sharp & Dohme Corporation v. Clonmel Healthcare Ltd [2019] IESC 65, [2020] 2 I.R. 1. (Our article on that seminal decision can be read here.)

COA Decision

Giving judgment, Costello J stated that the task of the COA was to determine “whether the lesser risk of injustice lies in favour of or against restraining Teva from launching an infringing product pending the trial of the revocation proceedings”. Costello J observed, amongst other considerations, that:

• there was “credible uncontroverted evidence” to support BMS’ claim that an award of damages would not compensate it for the loss it would occur if the PI was refused but BMS ultimately succeeded in defending the revocation action;
• Teva cannot be credited for its attempt to clear the path before launch. That credit can only be afforded to a generic manufacturer where they have, in fact, succeeded in clearing the path, where all arguable objections of the patentee have been disposed of, including the conclusion of any appeal;
• In circumstances where the infringing product is not on the market and where the trial regarding the validity of the patent is due to commence in a few weeks, the preservation of the status quo ante reflects the course of least injustice; and
• the benefit to a generic manufacturer in first mover advantage does not outweigh the right of the IP holder that its patent and/or SPC is presumptively valid.

Key Takeaway

This decision, handed down two months after the COA decision in Biogen (see our commentary here), further cements the importance of both the presumption of validity of a patent and the necessity to clear the path when determining the balance of convenience.  It is another example of a pro-patentee trend that has been applied by the Irish courts in recent years.

For guidance on the impact of this decision, please contact Charleen O’Keeffe or any member of our contentious intellectual property team.

Contributed by Aisling Casey, Louisa Muldowney