NAPP Pharmaceutical Holdings Ltd v Dr Reddy's Laboratories (UK) Ltd & Anor

When deciding whether to order a preliminary issue, the court must consider both the appropriateness of doing so in principle and the directions, timing and consequences of the proposed trial. Those questions cannot properly be separated where an early determination is intended to affect preparation for an interim injunction. The court should also consider the relationship between the proposed preliminary issue, any interim injunction, expert evidence, validity issues, undertakings and the overall risk of injustice. A party should not ordinarily be compelled to argue the principle of a preliminary issue at short notice when the relevant evidence and proposals have only recently been served.

Napp brought patent infringement proceedings concerning proposed seven-day buprenorphine transdermal patches against Sandoz and Dr Reddy's. Both defendants sought retrospective permission to make applications on short notice under Civil Procedure Rules 1998, rule 23.7(4). They sought preliminary issues concerning infringement or the construction of the patent claims, with hearings proposed for April or June 2016, while interim injunction applications were listed for the following week.

The central issue was whether the court should decide immediately, and separately from directions, whether a preliminary issue should be ordered.

1. Short notice. The defendants had failed to give the ordinary three days' notice required by Civil Procedure Rules 1998, rule 23.7(1)(b). The court declined to require Napp to address the substance of the applications immediately. Napp was entitled to time to consider the applications in light of the evidence, including Sandoz's product and process description, and the different positions taken by the defendants.
2. Preliminary issue and directions. The question whether a preliminary issue was appropriate could not be divorced from the directions and timing required for its determination. The purpose of the applications was a rapid decision on infringement and claim construction. Accordingly, the court had to consider whether the proposed timetable was fair and practical, and what alternative timetable might be required.
3. Interconnected case-management issues. Relevant matters included the parties' expert evidence, the availability of Napp's proposed expert, the parties' positions on validity, the effect of any preliminary determination on the interim injunction applications, and the undertakings offered by the defendants. These matters were interconnected because the timing of a preliminary issue could alter the balance of the risk of injustice.
4. Disposition. The applications were not determined substantively at that hearing. The fairer course was to consider together the applications for preliminary issues and the interim injunction applications, when the court would be fully seized of all relevant aspects and better placed to select the course involving the least ultimate risk of injustice.

First-instance decision. No appellate history is stated in the judgment.