In Apotex Inc. v. Pfizer Canada Inc. (2009 FC 631), the Federal Court (FC) dismissed Pfizer Canada Inc.’s (Pfizer) motion for summary judgment. Due to the complicated statutory interpretations of s.8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOCR), summary judgment had never been granted in the past. The issue was whether Apotex’s Statement of Claim failed to disclose a genuine issue for trial so that summary judgment should be granted. In particular, whether Pfizer’s application for an order of prohibition caused any damages allegedly suffered by Apotex, such that Pfizer is liable under s.8 of the PMNOCR. The question of whether the outcome of any proceeding could be considered when determining whether Pfizer’s had wrongly delayed Apotex’s generic drug approval weighed against summary judgment. (more…)
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FCA Upholds Validity of Generics’ Remedy Against Innovators’ Failed Prohibition Applications, Rejects Disgorgement and Future Losses
In Merck Frost Canada v. Apotex (2009 FCA 187), the Federal Court of Appeal (FCA) upheld the Federal Court’s (FC) decision (2008 FC 1185) holding s. 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOCR) was intra vires s. 55.2(4) of the Patent Act and within the authority of Parliament under s. 91(22) of the Constitution Act, 1867, and that the FC had jurisdiction to hear the s. 8 action. The FCA also upheld the FC’s ruling that s. 8 of the PMNOCR does not contemplate disgorgement of an innovator’s profit. However the FCA found the remedy does not allow compensation for losses suffered outside the period the Minister of Health is prevented from issuing a Notice of Compliance (NOC) to the generic. (more…)
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