Canadian Federal Court of Appeal Considers Key Patent Law Issues

On April 20, 2016, Canada’s Federal Court of Appeal (FCA) released its judgment in Mylan Pharmaceuticals ULC v Eli Lilly Canada Inc, 2016 FCA 119, dismissing an appeal by Mylan Pharmaceuticals ULC (Mylan) from an order prohibiting regulatory approval of Mylan’s generic version of the Eli Lilly Canada Inc (Lilly) drug CIALIS® (tadalafil) until the expiry of Canadian Patent No. 2,226,784 (the 784 Patent).

In the decision below (2015 FC 17; previously reported in E-TIPS® newsletter here), de Montigny J of the Federal Court allowed Lilly’s application holding that Mylan’s allegations of lack of utility and obviousness-type double patenting were not justified.

The following aspects of the FCA’s decision are noteworthy:

1. Prior art: while not explicitly addressing the “reasonably diligent search” test for citability for anticipation and obviousness, the FCA defined prior art as comprising “any publically available teaching, however obscure or not generally accepted”;
2. Obviousness vs. obviousness-type double patenting: the FCA held that these are different grounds of invalidity.  The former addresses whether there is indeed an invention, whereas the latter is directed to the prevention of evergreening through a later patent (in effect, an extension of an earlier patent without offering a new invention to the public);
3. Relevant date for assessing obviousness-type double patenting: the FCA stated that the publication date of the later patent is not an appropriate “relevant date” for this assessment.  However, the FCA declined to make further findings on this issue, since Mylan could not succeed on this ground of appeal by relying on either of the remaining possible dates - the priority date of the earlier patent or the priority date of the later patent;
4. Utility for Markush claim: the FCA confirmed that a Markush claim requires that each compound in the claimed class have utility.