Approved Prescription Services Ltd v Merck & Co Inc

Where a commercially important patent-construction issue is self-contained and can be decided quickly, the court may list it for early determination even though related proceedings involving other parties are pending. Avoiding inconsistent decisions and duplicated judicial effort is an important consideration, but it is not decisive. The court must balance that concern against a party’s legitimate need for an early determination.

The court’s case-management powers include limiting disclosure, evidence, cross-examination and the duration of a hearing. A simplified or otherwise tightly controlled trial may be ordered where the issues justify it.

Approved Prescription Services Ltd sought directions in an action for a declaration of non-infringement of Merck’s European Patent (UK) No. 0 352 918. The dispute concerned the construction of product claims for simvastatin, particularly the limitation to products containing less than 0.2% dimeric impurity.

APS wished to market a generic product after the expiry of a supplementary protection certificate. Related validity and infringement proceedings involving other generic manufacturers were listed for a later hearing. The central issues were whether APS’s construction issue should be expedited and how the proceedings should be managed.

1. Expedited listing. The application for directions was allowed. The construction issue was to be heard at the end of March or the beginning of April, notwithstanding the related proceedings listed for June.
2. Balancing competing considerations. It was undesirable for two judges to determine substantially the same patent-construction issue, since that could waste court time and produce inconsistent judgments. That risk was materially reduced because the issue was one of construction rather than the assessment of complex disputed facts. It did not outweigh APS’s legitimate commercial interest in obtaining an early determination.
3. Case management. The court could limit disclosure, restrict or exclude evidence and cross-examination, and impose a time limit on the hearing. The court’s powers to control its own process extended to fixing an advance limit on the duration of a hearing. The proceedings were therefore to proceed on the basis that the hearing would last no more than one day.
4. The court noted that a simplified trial could be imposed if justified by the circumstances. Any application by other manufacturers to intervene or to have their construction issues determined with APS’s action would be considered on its merits, but would not ordinarily be allowed to enlarge the short hearing window.

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