Federal Court Releases Practice Direction for Patented Medicines (NOC) Proceedings

On December 7, 2007, the Federal Court announced a new Practice Direction for proceedings under the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations). The Practice Direction responds to the increasing challenges to the Court's work load in the intellectual property area, particularly NOC proceedings, and the need for appropriate ways to ensure that the growing numbers of cases are disposed of promptly while ensuring the just, most expeditious and least expensive disposition of the proceeding. Under the Practice Direction (to become effective January 7, 2008), a case management judge or prothonotary will be assigned to each newly commenced NOC proceeding. The judge will convene a conference with counsel shortly after all parties have appeared in the proceeding, or after the time for appearance has expired, in order to address:

1. whether it is appropriate to reverse the order in which evidence is submitted, with the respondent (generic manufacturer) filing evidence first and the applicant(s) (brand manufacturer) filing evidence in response;
2. fixing a schedule for filing evidence, conducting cross-examinations and dealing with other matters, such as motions to strike the NOC proceeding pursuant to section 6(5) of the NOC Regulations;
3. fixing a date for the filing of a requisition for a hearing; and
4. any other matters to ensure the just, most expeditious and least expensive disposition of the proceeding.

The presiding judge may also convene a hearing management conference at least six weeks before the date fixed for the hearing to discuss various matters, including the content of the application record, provision of a compendium of key documents to the hearing judge, provision of materials in electronic form, identification of and settlement of issues, agreements as to any facts and documents, and any other relevant matters. As reported in an earlier issue of E-TIPS® (Vol 6, No 12, December 5, 2007, "Discretion Not Exercised to Reverse Order of Evidence in Patented Medicines (Notice of Compliance) Proceedings"), prior to the release of the Practice Direction the Court considered the reversal of the order of filing evidence in NOC proceedings. While the Court concluded that in general reversing the sequence in which the evidence of the parties is filed would help to narrow the issues in NOC cases, in that particular case it was not appropriate. For a copy of the Practice Direction, visit: http://tinyurl.com/22wbyt Summary by: Nick Wong