Federal Court Prefers Blinded Expert Witness’s Testimony in Allergan v Apotex Inc

On April 1, 2014, in Allergan Inc v Apotex Inc, 2016 FC 344, the Federal Court dismissed Allergan’s application for a prohibition order brought under the Patented Medicines (Notice of Compliance) Regulations, on the basis that Allergan failed to demonstrate utility of its Canadian Patent Number 2,307,632 (the ‘632 Patent). Allergan had sought an order prohibiting the Minister from issuing a Notice of Compliance to Apotex for its ophthalmic product Gatifloxacin until after the expiry of the ‘632 Patent.

The Court found that the ‘632 Patent’s promised utility encompassed three advantages which were not soundly predicted. The Court rejected Rennie J’s approach in AstraZeneca Canada Inc v Apotex Inc 2014 FC 638, and followed the Federal Court of Appeal (Eli Lilly Canada v Apotex Inc, 2009 FCA 97) and Supreme Court of Canada’s (Apotex Inc v Wellcome Foundation Ltd, 2002 SCC 77) decisions to include the factual basis and the line of reasoning for the sound prediction assessment of the ‘632 Patent’s utility.  The Court held that not all of the three promises of the ‘632 Patent had been met and therefore dismissed Allergan’s application.