On November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc  v Eli Lilly Canada Inc2016 FCA 267 and upheld the Federal Court’s Order of prohibition for tadalafil (Eli Lilly’s CIALIS) regarding Patent No. 2,226,784 (“784 patent”) (previously reported). In doing so, the Federal Court of Appeal chose not to depart from its recent decision in Mylan Pharmaceuticals ULC v Eli Lilly Canada Inc2016 FCA 119(reported here), holding that Whirlpool Corp v Camco Inc2000 SCC 67 (“Whirlpool”) did not settle the question of the relevant date for obviousness-type double-patenting.  The Court also found Apotex’s argument with respect to insufficiency to be without merit.

Obviousness-Type Double-Patenting

Background

The 784 patent claims the use of tadalafil to treat erectile dysfunction. Apotex and Mylan alleged separately that the relevant claims of the 784 patent were invalid, including for double-patenting relative to Patent No. 2,181,377, which claims the use of a number of compounds, including tadalafil, as a medicine in humans. In response, Eli Lilly commenced separate applications for Orders of prohibition to prevent the Minister from issuing an NOC to Apotex and Mylan.

In January 2015, the Federal Court granted Eli Lilly’s application against Mylan (2015 FC 17) (“Mylan FC”), holding that, regardless of whether the relevant date for obviousness-type double-patenting was the priority date of the first patent or the priority date of the second patent, the 784 patent was patentably distinct. The Court found that Whirlpool was of no assistance because it did not consider the issue of the relevant date. Mylan appealed.

On July 20, 2015, the Federal Court followed its decision in Mylan FC and granted Eli Lilly’s application against Apotex (2015 FC 875). The Court found that, although the Supreme Court in Whirlpool established that the date for claims construction is the publication date of the patent, it did not decide the relevant date for obviousness-type double-patenting. As in Mylan FC, the Court declined to make a determination on the relevant date as it would not have changed the result. Apotex commenced the present appeal. The narrow issue was whether Whirlpool had decided that the relevant date for obviousness-type double-patenting is the publication date of the second patent. If Apotex were correct, the Federal Court of Appeal could depart from Mylan FCA (see below) as being wrongly decided.

On April 20, 2016, the Federal Court of Appeal dismissed Mylan’s appeal (2016 FCA 119) (“Mylan FCA”), declining to definitively decide the issue of the relevant date for obviousness-type double-patenting.

Federal Court of Appeal decision in Apotex’s appeal

Justice Pelletier J.A., writing for the Federal Court of Appeal, dismissed Apotex’s appeal finding that the relevant date for obviousness-type double-patenting remains an open question.

Apotex argued that it was clear from Binnie J.’s reasons in Whirlpool that he would have assessed double patenting as of the second patent’s date of publication. The Federal Court of Appeal disagreed, finding that Whirlpool did not decide the relevant date. The Court went on to state that the framework for analysis presented by the parties is not necessarily the correct one. Rather, “[p]erhaps, 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 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”.

Sufficiency

The Court of Appeal found that applying the legal test for sufficiency of disclosure to the facts of this case was a question of mixed law and fact reviewable on a palpable and overriding error standard. The Court of Appeal held that it was not in a position to second-guess the Federal Court’s decision as it turned on an assessment of the expert evidence.

Apotex can only appeal this decision if leave is sought and granted by the Supreme Court of Canada.