Minister's Interpretation of Supreme Court of Canada Decision in AstraZeneca Upheld

On March 20, 2007, Justice Roger Hughes of the Federal Court of Canada released an important decision involving five applications for judicial review (four regarding the medicine ramipril and one regarding the medicine desmopressin). The decision may be the first to apply and elaborate on the reasons for judgment in the Supreme Court of Canada case of AstraZeneca Canada Inc v Canada (Minister of Health), [2006] 2 SCR 560 (noted in a previous issue of E-TIPS®, November 8, 2006, Vol 5 No 10, "Statutory Freeze Period Sought by Innovator Drug Company Under NOC Regulations Denied by Supreme Court of Canada"). In lengthy and detailed reasons, Justice Hughes provides a careful analysis of the process the Minister of Health (Minister) has adopted to determine which patents from the patent register a generic drug manufacturer must address when looking to obtain regulatory approval. In all five situations, the Minister's decisions were upheld. In AstraZeneca the Supreme Court had recognized that multiple patent lists relating to multiple Notices of Compliance could exist for a given product and thus the Minister must identify the precise patents relevant to "early working" by the generic in question. In the applications before Justice Hughes, the Minister led evidence that it had implemented a policy pursuant to which it would use the date on which a generic manufacturer had purchased a comparator drug as the date for determining which patents must be addressed by the generic manufacturer. The applications heard by Justice Hughes involved four patents listed against ramipril on various dates. Novopharm Limited (Novopharm), which purchased the comparator drug on June 22, 2001, was informed by the Minister that it need not address two of the patents that were added to the register in respect of a submission for a Notice of Compliance made by the first person, Sanofi-Aventis Canada Inc (Sanofi-Aventis) after the date of Novopharm's purchase (948 and 089 patents). However, the Minister maintained that Novopharm must still address two other patents that, although they were listed after the date of Novopharm's purchase, were added in respect of submissions made before that date (549 and 387 patents). Novopharm was unsuccessful in its arguments that it could not have "early worked" these patents in any event and that Sanofi-Aventis never received a Notice of Compliance for the uses claimed in the patents; its motion for judicial review of the Minister's decision was dismissed. Apotex Inc (Apotex), which purchased its comparator drug in October 2002, and filed its ANDS on July 22, 2003, was in a similar situation to Novopharm in that it was informed by the Minister that it did not have to address the 549 and 387 patents. However, it had already overcome the 948 and 089 patents in prohibition proceedings concluded in 2006, and thus had already been granted a Notice of Compliance by the Minister. Sanofi-Aventis had sought to have this decision of the Minister set aside because of issues with Apotex's product monograph. Justice Hughes dismissed Sanofi's motion in this respect. The full text of the decision is available at: http://decisions.fct-cf.gc.ca/en/2007/2007fc300/2007fc300.html Summary by: Heather Watts