On November 4 2016 the Federal Court of Appeal dismissed Apotex's appeal in Apotex Inc v Eli Lilly Canada Inc (2016 FCA 267) and upheld the Federal Court's order of prohibition for tadalafil (Eli Lilly's Cialis) regarding Patent 2,226,784 (the '784 patent')(1). In doing so, the Federal Court of Appeal chose not to depart from its recent decision in Mylan Pharmaceuticals ULC v Eli Lilly Canada Inc (2016 FCA 119) (for further details see "Canadian Federal Court of Appeal clarifies test for double patenting"), holding that Whirlpool Corp v Camco Inc (2000 SCC 67) did not settle the question of the relevant date for obviousness-type double patenting. The court also found that Apotex's argument with respect to insufficiency was without merit.
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 2,181,377, which claims the use of a number of compounds ‒ including tadalafil ‒ as a medicine in humans. Eli Lilly commenced separate applications for orders of prohibition to prevent the minister from issuing a notice of compliance to Apotex and Mylan.
In January 2015 the Federal Court granted Eli Lilly's application against Mylan (2015 FC 17), 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 inapplicable 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 had 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 was the publication date of the second patent. If Apotex were correct, the Federal Court of Appeal could depart from Mylan FC as being wrongly decided.
On April 20 2016 the Federal Court of Appeal dismissed Mylan's appeal and declined to definitively decide the issue of the relevant date for obviousness-type double patenting.
Writing for the Federal Court of Appeal, Justice Pelletier 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 Justice Binnie'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 also stated that the framework for analysis presented by the parties was not necessarily the correct one:
"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 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."
The Federal 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 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 appeal this decision only if leave is sought and granted by the Supreme Court of Canada.
For further information on this topic please contact Shirley Liang Komosa at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
(1) For further details see here.