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
The Hearing: Compendiums, Outlines for Argument and
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
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