As we reported, amendments to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) took effect on September 21, 2017, as part of the broader roll-out of measures implementing the Comprehensive Economic and Trade Agreement (CETA) with the European Union. The amendments introduce significant changes to proceedings under the Regulations, which will now proceed by way of action rather than application.
The Federal Court has now released a Notice to the Parties and the Profession setting out guidelines (the Guidelines) for actions under the amended Regulations. The new Guidelines supersede the court’s earlier Case Management Guidelines for NOC Applications for applications under the new Regulations.
Streamlined process with co-operation expected
The Guidelines confirm that the Federal Court will manage prohibition actions under section 6 of the amended Regulations using a modified version of the rules governing actions.
At the outset of proceedings, parties will be required to make a number of elections. In a letter to be filed with the statement of claim, plaintiffs must indicate whether they renounce the statutory stay. Within 10 days, defendants must serve and file a Notice of Intention to Respond indicating whether they intend to defend by challenging the validity of any of the claims and whether they intend to counterclaim regarding validity. Where invalidity is asserted, defendants must also indicate whether or not they will seek a declaration of invalidity and impeachment.
The Guidelines also make clear that the Federal Court intends these proceedings to move quickly through the court: Trials are to be completed no later than 21 months from the date the action commenced, and are expected to take no more than two weeks. The court also expects parties to “reasonably cooperate and agree on expediting pre-trial procedures.”
Expedited timelines are set out in the Guidelines for case-management and trial-management conferences. In addition, appeals of interlocutory decisions of prothonotaries and judges must now be made directly to the Federal Court of Appeal, and require leave of that court.
Several steps that will streamline the proceeding and limit the evidence required at trial are also set out in the Guidelines, including the exchange of claim charts and discovery plans, pre-trial tutorials for the court, evidence-in-chief to be adduced by way of affidavit, and detailed advance statements for fact witnesses. The court is also encouraging parties to use requests to admit and stipulations to limit the trial time needed for viva voce evidence.
- The Notice to the Parties and the Profession: Guidelines for Actions Under the Amended PMNOC Regulations can be found here.