Chief Justice Crampton of the Federal Court has released a notice to parties and the profession (the “Notice”)1 that sets out the standard procedure governing proceedings under the Patented Medicines (Notice of Compliance) Regulations (“NOC Proceedings”). The Notice provides a useful guide to the uninitiated regarding the procedure generally followed in such proceedings. The Notice also sets out various new steps to be followed in NOC Proceedings, and thus is a must-read for parties and lawyers actively practicing in this area. Notable aspects of the Notice are discussed below.
Timing of Hearings
The Notice provides that the hearings of NOC Proceedings will typically be conducted in 2 or 3 days, and will not extend beyond 5 days absent extraordinary circumstances. This is in keeping with the Court’s traditional practice, although some proceedings have extended beyond 5 days in the past.2
Case Management Conferences
Three new case management conferences (CMCs) are contemplated by the Notice. The first CMC is to be presided over by both the hearing judge and the case management judge, and is to take place within 30 days of the filing of the requisition for hearing. This CMC will cover the general timing of events (such as the filing of evidence, cross-examinations, the production of documents, interlocutory motions and the filing of application records) and other procedural matters. The Notice also suggests that the case management judge will encourage the requisition of hearing as early as possible during the proceeding.
The second CMC, termed a “Hearing Management Conference”, will take place after both parties have filed their application records, about two months before the hearing date. The hearing judge and the case management judge will both preside. Topics will include the identity of the counsel who will attend, any remaining motions, and the identification of the evidence to be relied on at the hearing. Another interesting discussion point is whether any “tutorial session” would benefit the Court. The form, content and timing of such sessions are not elaborated upon, and thus questions such as whether they would adopt a general form (written or oral? presented by counsel or independent experts?) remain unanswered.
The final CMC is contemplated at least 30 days before the hearing. Discussion points include the identification of those patents and claims remaining at issue and a statement of agreed facts and/or documents. Statements of agreed facts and/or documents have been sparingly used in NOC Proceedings in the past.
The Notice also provides for the filing of claims charts by each party at least 90 days prior to the hearing date. The form of such charts is not discussed, other than to say that they must be “in a format that has been previously approved by the case management judge at a case conference.” The 90 day deadline for these claim charts may force parties to formally narrow the claims in focus at an earlier point than sometimes occurs in NOC Proceedings currently, which do not require the filing of claims charts.
The Hearing: Compendiums, Outlines for Argument and Demonstratives
The Notice requires that parties submit compendiums containing only the relevant portions from the evidence and jurisprudence cited in their respective Memorandums of Fact and Law at least 15 days prior to hearing. The Notice also places a 30 page cap on any Outline of Argument that is submitted at the hearing, and requires that any demonstrative evidence sought to be used be exchanged by the parties at least 30 days before the hearing.
The Notice clearly aims to involve the hearing judge at an earlier date. This will be achieved through earlier requisitions for hearing and by involving the hearing judge in case management conferences with the parties. The Notice will also arm the hearing judge with a greater amount of information that is more focused at an earlier stage in the proceeding. This is achieved, for example, by requiring claim charts and the early filing of the compendia, and possibly through “tutorial sessions” for the Court.