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Apotex Inc. v. Eli Lilly Canada Inc., Eli Lilly and Company Limited

April 25, 2014

By Adam Bobker and Amy Dam

On April 24, the Supreme Court of Canada dismissed Apotex’s application for leave to appeal from the Federal Court of Appeal (FCA) in Apotex Inc. v. Eli Lilly Canada Inc., 2013 FCA 282 , which upheld the decision of the Federal Court (Gauthier J.). 

In 2007, the respondent, Eli Lilly Canada Inc. (Lilly), obtained an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex with respect to its olanzaprine products until the expiry of Lilly’s ‘113 patent. Shortly after, a generic manufacturer successfully invalidated the ‘113 patent on the basis that the promised utility was not soundly predicted (the decision was upheld on appeal and the Supreme Court refused to hear the appeal). In October 2009, Apotex received its NOC and then filed a motion to set aside the order of prohibition of 2007 pursuant to Rule 399 of the Federal Court Rules. On September 24, 2010, the Federal Court (FC) dismissed Apotex’s motion, the FCA upheld the FC’s decision on December 4, 2013 and on February 3, 2014 Apotex filed an application for leave to appeal before the Supreme Court.  

The question at issue before the FCA was whether the invalidation of a patent enables the Court to change its earlier order and dismiss an application for prohibition under subsection 6(1) of the Patented Medicines (NOC) Regulations. The FCA referred to two decisions, Syntex1 and Ratiopharm2, and held that a declaration of invalidation of a patent does not enable the Court to retroactively dismiss an application for an order of prohibition granted earlier. 

If such application is withdrawn, discontinued, dismissed, or reversed on appeal, it may permit Apotex to claim damages for loss of profits during the time that the prohibition order kept its products off the market, pursuant to section 8 of the PMNOC Regulations. However, a subsequent declaration of patent invalidation is not an option that can give rise to a claim for damages under section 8.

Apotex further argued that in Syntex and Ratiopharm, the FCA relied on an English Court of Appeal decision, Unilin3, which was overruled in 2013 by the U.K. Supreme Court4. Holding that the cited cases and the case in the present appeal are not based on Unilin to such an extent that they should be reconsidered, the FCA dismissed the appellant’s argument on the basis that “[s]ubsequent decisions of foreign courts that may be somewhat analogous do not normally demonstrate that a contrary decision by a Canadian Court was “manifestly wrong”.”

1 Apotex Inc. v. Syntex Pharmaceuticals International Inc., 2010 FCA 155
2 Pfizer Canada Inc. v. Ratiopharm, 2011 FCA 215
3 Unilin Beheer BV v. Berry Floor N V [2007] EWCA Civ. 354
4 Virgin Airways Limited v. Zodiac Seats UF Limited [2013] UKSC 46

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Adam Bobker Adam Bobker
B.Sc. (Elec. Eng.), LL.B.
416.957.1681  email Adam Bobker
Amy Dam Amy Dam
B.Sc. (Biomed. Sci.), M.Sc. (Pharm.), LL.B.
514.871.2350  email Amy Dam