Pharma In Brief - Federal Court Of Appeal Raises New Questions About The Test For Obviousness-Type Double-Patenting In Tadalafil Case

Case: Apotex Inc. v Eli Lilly Canada Inc, 2016 FCA 267 (A-330-15), aff'g 2015 FC 875 (T-1598-13)

Drug: CIALIS® (tadalafil)

Nature of case: Appeal from application for prohibition order granted pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations)

Successful party: Eli Lilly Canada Inc. and ICOS Corporation (collectively Lilly)

Date of decision: November 4, 2016

Summary

Lilly markets CIALIS® (tadalafil) in Canada for the treatment of erectile dysfunction (ED). Both Mylan Pharmaceuticals ULC and Apotex Inc. sought approval for generic versions of tadalafil and were opposed by Lilly. In each case, the Federal Court allowed Lilly's application and granted prohibition orders. As we reported, earlier this year, the Court of Appeal dismissed an appeal from the decision in the Mylan case (the Mylan Appeal).

In this case, Apotex asked the Court of Appeal (FCA) to overturn the lower court's findings on obviousness-type double-patenting, overruling its own decision in the Mylan Appeal, as well as insufficiency. The FCA dismissed Apotex's appeal on both counts.

Background

The double-patenting issue in the tadalafil cases concerns two of Lilly's patents. The earlier patent, Canadian Patent No. 2,181,377 (377 Patent), claims tadalafil and the use of tadalafil in the treatment of various disorders, but not treatment of ED specifically. The later patent, Canadian Patent No. 2,226,784 (784 Patent), claims the use of tadalafil for the treatment of ED. Mylan and Apotex both alleged that the later patent was invalid for obviousness-type double-patenting over the earlier one.

The parties in each case framed the double-patenting issue as turning on the relevant date for comparing the two patents. The issue was significant because it determined whether the court was permitted to consider art published after the priority date of Lilly's first patent, which Mylan and Apotex said substantiated their allegations.

The Mylan case. In the Mylan case, Justice de Montigny decided that the relevant date was one of the two priority dates and based his analysis upon the earlier 377 Patent priority date. The FCA found no reviewable error with this approach and declined to definitely choose between the two priority dates. The FCA did, however, reject Mylan's assertion of a later date: the publication date of the second 784 Patent. The Apotex case. Apotex argued that the relevant date was the publication date of the...

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