On November 3, 2006, the Supreme Court of Canada issued its decision, Apotex Inc. v. AstraZeneca Canada Inc. et al (2006 SCC 49), allowing Apotex’s appeal of a Federal Court of Appeal decision that had quashed its notice of compliance (NOC) for Apo-Omeprazole (AstraZeneca v. Minister of Health (2005 FCA 189)).
The case turned on the interpretation of the Patented Medicines (Notice of Compliance) Regulations (“Regulations”) and specifically, section 5(1). The issue was whether Apotex was required to address two patents listed on the Patent Register in connection with AstraZeneca’s omeprazole capsules, LOSEC, which had been added to the Register after AstraZeneca had ceased marketing LOSEC in 1996 (while the Court indicated that there is no dispute that LOSEC was not marketed throughout the period from 1996 to the present, that fact was disputed by AstraZeneca). The Minister decided that Apotex need not address the patents and the applications judge agreed (AstraZeneca v. Minister of Health (2004 FC 1277)). While the Court of Appeal reversed and quashed Apotex’s NOC, the Supreme Court agreed with the Minister.
The Court, focussing on the specific LOSEC product that was the subject of Apotex’s bioequivalence studies, stated as follows:
39. …In my view, s. 5(1) of the NOC Regulations requires a patent-specific analysis, i.e. the generic manufacturer is only required to address the cluster of patents listed against submissions relevant to the NOC that gave rise to the comparator drug, in this case the 1989 version of Losec 20.
40. If AstraZeneca had brought to market a Losec 20 product pursuant to the later NOCs and if Apotex had made reference to that modified product for the purpose of demonstrating bioequivalence, Apotex would have been required to file a notice of allegation with respect to the 037 and 470 patents.
41. However, it is clear that AstraZeneca did not market any product pursuant to the subsequent NOCs and that the preconditions to any obligations of Apotex under s. 5(1) were therefore not triggered.
Whether this decision will be interpreted by the Federal Courts as being limited to the unusual facts of this case or as having broader implications remains to be seen.