and
Beverley Moore
NOC PROCEEDINGS
Court of Appeal finds that Proceeding should be
Dismissed instead of Terminated
Apotex v. Janssen-Ortho
This proceeding has a complex history, summarized in our July 19, 2010 Bulletin. Apotex appealed the decision of the Trial Division, which terminated its proceeding against Janssen. The Court of Appeal allowed the appeal.
The Court of Appeal considered the language of the Order "terminating" instead of "dismissing" the proceeding, holding that the Trial Judge seems to have intended to prevent Apotex from bringing an action under s. 8 of the NOC Regulations.
The Court of Appeal held that it was an error for the Judge to investigate whether Apotex could bring an action under s. 8, as it was beyond the scope of the motion before the Court. Furthermore it was unfair. The Court of Appeal held that Apotex could not have reasonably expected that its motion for dismissal of the prohibition application for mootness would extend to the issue of whether a subsequent s. 8 proceeding was available.
Thus, the Court of Appeal set aside the Federal Court's order and dismissed the application.
Court of Appeal Accepts Judge's Recusal
Janssen-Ortho v. Apotex
In the same proceeding discussed above, the original Hearing Judge had recused himself from sitting on the matter of redetermination (this case is summarized in our June 28, 2010 Bulletin). Janssen appealed that decision. The Court of Appeal upheld the recusal.
The Court of Appeal held that the decision was remitted to the Judge with the implicit expectation that his judicial function would be performed impartially. "A judge cannot be faulted for recusing himself when he lacks the fundamental qualification at the heart of impartiality". The Court of Appeal thus accepted the Judge's determination and had no basis upon which to doubt it.
OTHER CASES OF INTEREST
Court of Appeal Refuses to Reinstate Patent when Fees
Paid by Someone other than the Authorized Agent
Unicrop Ltd. v. Canada (Attorney
General)
This is an appeal of a judgment dismissing an application for a judicial review of a decision of the Commissioner of Patents. The appellant appointed a law firm as its patent agent. The law firm paid maintenance fees for the first two years but did not pay the third anniversary payment in time. The application was deemed abandoned. However, before a year was up, a new law firm sent two letters to the Commissioner of Patents. The first letter requested reinstatement pursuant to Section 73(3) and included the reinstatement fee and the third maintenance fee. The second letter submitted the fourth maintenance fee. The Commissioner acknowledged receipt of the fees, however, advised that the fee to maintain an application can only be paid by the authorized correspondent for a particular application. An executed Appointment of Agent was submitted, but after the period for reinstatement had passed. The Commissioner advised the new law firm that the application had been abandoned and could not be reinstated. Judicial review was sought of this decision.
The Federal Court dismissed the application for judicial review. The Court of Appeal upheld that ruling. The Court of Appeal held that the Patent Rules effectively prohibit the Commissioner from dealing with anyone other than the authorized correspondent for the application. The Court held that to accept the appellants submission that it intended to appoint the new agents, requires that the definition of an "authorized agent" be read out of the rules. This would create the very uncertainty which the definition seeks to eliminate. The Court of Appeal dismissed the appellant's arguments based on equity, holding that equitable relief cannot be invoked to counter the application of a clear statutory rule.
Minister's Decision to Reject NDS at Screening Stage
Quashed
Hospira Healthcare Corporation v. Attorney General
of Canada
In this case, the Hearings Judge dismissed Hospira's application for judicial review of the Minister of Health's decision to reject a New Drug Submission (NDS) without prejudice to the ability to refile. Hospira appealed, and the Court of Appeal allowed the appeal.
The Minister's decision to reject the NDS was based on the fact that it did not contain pre-clinical and clinical data. The record before the Court contains uncontradicted evidence that no such clinical trials could be done ethically. The Court of Appeal held that the Minister has discretion as to the nature and form of the information that will be accepted as meeting the requirements of the Food and Drug Regulations for determining safety and efficacy. Thus, the Food and Drug Regulations did not require the Minister to reject the NDS at the screening stage. The Minister's decision was quashed and the NDS was referred back to the Minister for reconsideration in light of these reasons.
OTHER INDUSTRY NEWS OF NOTE
Health Canada has posted information on How to Pay Fees and a Submission Fee Application Form.
Health Canada has posted the Draft Guidance Document Hepatotoxicity of Health Products. Comments are requested by May 17, 2011.
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Motion - Discussing What Matters Superclusters – Episode 2, Part 2 of 2 (Video)
