Amgen, Inc. & Ors v Janssen Biotech, Inc.

Although the court generally seeks to try all issues together, it may order separate trials where issues are genuinely severable and case-specific practical considerations justify doing so. Relevant considerations include the commercial consequences of delay, the risk that a combined trial will overrun, whether an issue may become unnecessary, and whether the issues are sufficiently crystallised for trial.

In an unusual multi-party patent dispute, the court retained an earlier trial date for validity and full-label infringement, removed one prior-art citation, and stayed the separately severable skinny-label infringement issues. A claimant’s failure to clarify its proposed launch arrangements may later bear on an application for an interlocutory injunction, although it is not conclusive.

Five related patent actions concerned Janssen’s patent and intended generic launches of Stelara. The claimants challenged validity and alleged full-label infringement issues, while Janssen also pleaded infringement under section 60(2) of the Patents Act 1977 based on possible skinny-label launches.

At a case management conference, the court had to decide whether to retain a five-day trial in June 2024, with two additional days for pre-reading and closings, or defer the whole dispute to September or later. The central issues were whether the non-skinny-label issues had been sufficiently streamlined and whether the skinny-label allegations should be tried with them or separately.

1. Trial date and streamlining. The court held that the issues other than skinny-label infringement could fit within the June 2024 estimate, provided that Amgen removed the Allocca prior-art attack. The remaining collective attacks had been substantially reduced and the parties had agreed to share experts and, generally, counsel.
2. Separate treatment of skinny-label issues. The normal starting point is that all issues should be determined together. That principle must not be applied mechanically. Separate case management may be appropriate where the issues are technically and factually severable, involve different timing considerations and claim-construction questions, or present unusual commercial circumstances.
3. The skinny-label issues were reasonably severable from validity and full-label infringement. They might never require determination if the patent were revoked or the full-label case succeeded on the 44-week issue. Further, the proposed labels, instructions and notifications to prescribers had not been sufficiently specified, making the issues difficult to define for a September trial.
4. The court balanced the real commercial benefit of a June judgment, including the possibility of supply before September and a first-mover advantage, against the risk that a combined September trial would overrun. The June trial was retained and the skinny-label issues were stayed, with liberty to apply to lift the stay. The stay would otherwise continue until the June trial result was known.
5. The claimants were required to give six weeks’ notice of any skinny-label launch. Their failure to clear the way might become an important factor on a later interlocutory-injunction application, but would not be conclusive.

This was a first-instance case management decision. The judgment records that the proceedings had previously been before the court in September 2023, when directions were made by an order dated 12 September 2023.