Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC et al., 2015 FCA 286
| Judge | Dawson, Near and Boivin, JJ.A. |
| Court | Federal Court of Appeal (Canada) |
| Case Date | December 15, 2015 |
| Jurisdiction | Canada (Federal) |
| Citations | 2015 FCA 286;(2015), 480 N.R. 223 (FCA) |
Eli Lilly Can. Inc. v. Mylan Pharmaceuticals (2015), 480 N.R. 223 (FCA)
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Temp. Cite: [2015] N.R. TBEd. DE.022
Eli Lilly Canada Inc. and ICOS Corporation (appellants) v. Mylan Pharmaceuticals ULC and The Minister of Health (respondents)
(A-139-15; 2015 FCA 286)
Indexed As: Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC et al.
Federal Court of Appeal
Dawson, Near and Boivin, JJ.A.
December 15, 2015.
Summary:
Eli Lilly Canada Inc. applied for an order to prohibit the issuance of a Notice of Compliance to Mylan Pharmaceuticals ULC for a generic version of tadalafil, sold by Eli Lilly under the brand name CIALIS, until after the expiration of the Canadian Patent 2,379,948 (the '948 Patent). Mylan alleged that the '948 Patent would not be infringed and that, in any event, the '948 Patent was invalid because it was obvious.
The Federal Court, in a decision reported at (2015), 475 F.T.R. 267, found that Mylan's allegations as to the invalidity of the '948 Patent and as to non-infringement were justified, and dismissed Eli Lilly's application. Eli Lilly appealed.
The Federal Court of Appeal dismissed the appeal.
Food and Drug Control - Topic 1108.2
Drugs - New drugs - Notice of compliance - Prohibition order (incl. compensation by first person) - [See Patents of Invention - Topic 1589 ].
Patents of Invention - Topic 1582
Grounds of invalidity - Lack of inventive ingenuity (obviousness) - Test for obviousness - [See Patents of Invention - Topic 1589 ].
Patents of Invention - Topic 1589
Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - "Eli Lilly" applied for an order to prohibit the issuance of a Notice of Compliance to "Mylan" for a generic version of tadalafil, sold by Eli Lilly under the brand name CIALIS, until after the expiration of the Canadian Patent 2,379,948 (the '948 Patent) - Mylan alleged that the '948 Patent was invalid because it was obvious - The application judge found the allegation was justified - On appeal, Eli Lilly asserted that the judge applied an incorrect test for obviousness, namely, "whether the skilled person had good reason to pursue predictable solutions or solutions that provide a 'fair expectation of success'" - The Federal Court of Appeal dismissed the appeal - The judge went on to note that it was "more or less self-evident" that the invention ought to work, and then concluded "even if the standard is not 'fair expectation of success', I find that the invention was 'obvious to try' according to the test in" Sanofi-Synthelabo (2008) (S.C.C.) - Thus, any error in the initial articulation of the test for assessing obviousness was not material to the judge's decision.
Cases Noticed:
Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, refd to. [para. 4].
Counsel:
Jamie Mills and Beverley Moore, for the appellants;
Tim Gilbert, Sana Halwani and Zarya Cynader, for the respondent, Mylan Pharmaceuticals ULC.
Solicitors of Record:
Borden Ladner Gervais LLP, Ottawa, Ontario, for the appellants;
Gilbert's LLP, Toronto, Ontario, for the respondent, Mylan Pharmaceuticals ULC.
This appeal was heard and decided at Ottawa, Ontario, on December 15, 2015, by Dawson, Near and Boivin, JJ.A., of the Federal Court of Appeal. The following reasons for judgment of the Court were delivered orally from the Bench by Dawson, J.A.
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