In Apotex Inc. v Eli Lilly Canada Inc., the Federal Court of Appeal dismissed Apotex’s appeal of the Federal Court decision that prohibited Apotex from receiving a Notice of Compliance for tadalafil until the expiry of Canadian Patent No. 2,226,784.
The 784 Patent covers the new use of tadalafil for the treatment of erectile dysfunction. In the prohibition application below, Apotex alleged that the 784 Patent was invalid for double patenting in light of Canadian Patent No. 2,181,377. Without determining the relevant date for the double patenting analysis, the Federal Court held that Apotex’s allegations were not justified and issued a prohibition order (see our previous post, here).
Apotex then appealed, arguing that the relevant dates for assessing double patenting set out below and in Mylan FCA (see our previous post, here) were wrongly decided in light of the Supreme Court of Canada’s decision in Whirlpool. According to Apotex, Whirlpool established that the relevant date for the analysis is the publication date of the later patent.
The Federal Court of Appeal disagreed, holding that Whirlpool did not determine which date was relevant for the double patenting analysis and that the relevant date “remains an open question”. Justice Pelletier further held that while the parties in the previous litigation involving the 784 Patent had framed the double patenting issue in terms of competing assessment dates, the framework used in Mylan FCA may not necessarily be the correct one:
 I might add that the analysis in the Earlier Cases, in Mylan FCA, and in this case was driven by the fact that the parties chose to frame the issue in terms of the date for comparison of the claims of the patents in issue. Having conducted the analysis on the basis chosen by the parties, we should not be taken as having decided that this framework for analysis is the correct one. The fact that this issue has not arisen in this form in the past may be an indication that there may be other ways to approach it. Perhaps, the Court, having construed the claims of each of the patents with the assistance of the persons skilled in the art, simply compares the claims and decides whether the later claims are patentably distinct from the earlier claims on the basis of the insights which it has gained in the course of the construction of the patents. This appears to be what was done in Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, and more recently in Apotex Inc. v. Sanofi-Synthelabo Canada Inc. This is not to argue that this approach is any more correct than the comparison date approach but rather that, going forward, parties should not feel that they are locked into the framework chosen by the parties in these cases. [citations omitted]
A copy of the decision may be found here.