Federal Court of Appeal Affirms Dismissal of Prohibition Application for Mylan’s Tadalafil

In February 2015, the Federal Court dismissed Eli Lilly’s application for an order prohibiting Mylan Pharmaceuticals from receiving a Notice of Compliance for its generic version of the drug tadalafil.  Justice de Montigny held that each of Mylan’s allegations were justified and thus dismissed Eli Lilly’s application for prohibition (see our previous post here).

The main issue on appeal was Eli Lilly’s assertion that Applications Judge applied the wrong test for obviousness when he wrote that the test was “whether the skilled person had good reason to pursue predictable solutions or solutions that provide a ‘fair expectation of success’”.

The Court of Appeal agreed that this was not the correct test. The Applications Judge should have applied the test set out by the Supreme Court in Apotex clopidogrel:

“For a finding that an invention was ‘obvious to try’, there must be evidence to convince a judge on a balance of probabilities that it was more or less self-evident to try to obtain the invention. Mere possibility that something might turn up is not enough.”

Nonetheless, the Court of Appeal upheld the Applications Judge’s decision. Although the decision set out the wrong test, it went on to note that it was “more or less self-evident” that the invention ought to work and “even if the standard is not ‘fair expectation of success’, I find that the invention was ‘obvious to try’ according to the test in Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61”.

Since the Applications Judge also addressed the correct obviousness test, his articulation of the incorrect test was not material to the decision and thus not a basis to overturn the decision.

A copy of the Federal Court of Appeal’s judgment can be found here.