Apotex Europe Ltd & Ors v Beecham Group Plc & Anor

When exercising the discretion to order the early or conjoined trial of declarations of non-infringement, the court must balance the applicant’s commercial need for clarification against procedural fairness to the opposing party. An application made shortly before trial may be refused where the respondent cannot reasonably prepare, particularly if expert evidence and claim-construction issues remain. The applicant should explain any delay and provide all relevant material supporting the exercise of discretion. Relief may also be refused where the proposed declarations are unnecessary because the existing infringement or validity proceedings will determine the relevant claim boundaries, or where there is no immediate practical urgency.

Apotex sought declarations of non-infringement under section 71 of the Patents Act 1977 concerning three proposed processes for making paroxetine hydrochloride. The application was made shortly before the expedited trial of related patent revocation and infringement proceedings concerning the same patent.

Apotex argued that the declaration issues could be tried with the existing proceedings and would clarify the limits of the patent claims. GSK opposed the application, contending that it could not prepare in time and that the proposed processes had not been operated. The court was also referred to questions concerning hypothetical declarations under section 71.

1. Application refused. The court declined to order that the declarations of non-infringement be tried with the existing proceedings.
2. The application engaged the court’s discretion under section 71 of the Patents Act 1977. It was unnecessary to resolve the wider legal questions concerning hypothetical declarations or the meaning of a person “doing or proposing to do” a process because the application could be decided on procedural fairness.
3. GSK had provided evidence that it could not practicably prepare for trial by the fixed date. Preparation would require inspection of the processes, expert consideration and determination of claim-construction issues, including possible Improver questions. It would be unfair to expose GSK to a determination of non-infringement on a timetable it could not manage, particularly where the declarations might also raise an important validity argument.
4. Apotex had applied only about four weeks before the conjoined trial and had provided no evidence explaining why the application could not have been made earlier, despite having identified the need for clarification approximately two months previously. A party seeking discretionary relief must place all relevant material before the court and explain delay where late relief would impose a substantial burden on the other party.
5. The declarations also appeared unnecessary. The existing trial would require determination of the competing arguments on construction and the relevance of the isopropanol level. There was no proper basis for assuming that the resulting judgment would fail to identify the boundaries of the claims. The absence of immediate urgency was an additional consideration because none of the proposed processes had yet been put into operation.

The application was refused.