On September 21, 2017, the Federal Court released the Guidelines for Actions under the Amended PMNOC Regulations (the “Guidelines”) to coincide with the coming-into-force of the amended PMNOC Regulations (“PMNOC Regulations”). Under the amended PMNOC Regulations, patent disputes relating to the approval of a generic drug product or biosimilar will now proceed as an action with a decision to be rendered within 24 months.

The goal of the Guidelines is to promote efficiency in light of the strict timeline imposed by the amended PMNOC Regulations. The Guidelines are to be applied in conjunction with the Federal Courts Rules and other applicable guidelines or practice notices, including Case Management: Increased Proportionality in Complex Litigation before the Federal Court and the Trial Management Guidelines.

The Guidelines provide an overview of the procedure to be followed for proceedings under the amended PMNOC Regulations. There are several key points of note.

Initial steps in the proceeding

Proceedings under the amended PMNOC Regulations will automatically be case managed. At the outset of the proceeding, the first person must file, at the same time as the statement of claim, a letter to the Court identifying the matter as an NOC proceeding with a request for case management. The letter must also indicate whether the statutory stay has been renounced and identify any other proceeding(s) before the Court involving the same drug.

In addition to a statement of defence to be filed in the normal course, within 10 days of service of the Statement of Claim, the second person must also serve and file a Notice of Intention to Respond. This will need to indicate whether the second person intends to defend the action by challenging the validity of claims and whether this will be sought by counterclaim.

To begin the case management process, the first person will be required to requisition a case management conference within seven days of service of the Notice of Intention to Respond. The requisition letter should set out the following:

  • a joint proposed timetable for the steps leading to trial;
  • the proposed duration, venue, and language for the trial; and
  • dates of mutual availability of counsel for the parties for a trial to be completed no later than 21 months from the date of commencement of the action.

Trials are to be completed in two weeks unless additional time is required.

Case management

The Guidelines highlight the importance of active case management. It is expected that any matter that may affect the orderly and expedited conduct of the proceeding will be brought to the immediate attention of the case management judge. This includes holding a case management conference before any motion is brought.

At the outset of the action, a case management conference is to be held as soon as practicable and no later than 28 days after the issuance of the Statement of Claim. The Guidelines also establish case management as a tool for limiting claim construction issues, for example, by requiring the parties to exchange claim charts and consider early claim construction. Case management will also be used to help streamline discovery. Under the Guidelines the parties are intended to use discovery plans, requests for production of documents, early production of documents, and requests to admit as tools to shorten discovery.

A pre-trial conference is not required in PMNOC proceedings given the active role of case management.

Trial management conferences

Early involvement of the trial judge is also highlighted under the Guidelines, which require the parties to requisition a trial management conference once the trial dates are fixed to discuss the conduct of the trial, the schedule, and the exchange of evidence. For trial, the parties are expected to adduce evidence-in-chief by way of affidavit, unless otherwise directed by the case management judge or trial judge. Where the evidence-in-chief of a fact witness is to be adduced by oral testimony, an outline of the proposed areas of testimony must be submitted in advance of trial. The parties are encouraged to adduce stipulations where factual evidence is uncontested and where there is no need for cross-examination.

A second trial management conference is to be held at least 30 days before trial to discuss matters such as the patents and claims that remain in issue, and any specific claim construction disputes that still exist.

The goal of the Guidelines is to promote efficiency in managing actions brought under the amended PMNOC Regulations. It is expected that there will be procedural issues and further debate during the transition stage of their implementation.