Eli Lilly Canada Inc. v. Canada (Attorney General), 2014 FC 152

Lilly sought to list Canadian Patent No. 2,379,329 on the patent register for their product TRIFEXIS®. The Minister refused, stating that the patent did not contain claims for the formulation combining both medicinal ingredients (spinosad and milbemycin oxime). Rather, the Minister was of the view that the patent claimed a formulation comprising only one of the two medicinal ingredients present in Trifexis, namely spinosad, and that, referencing the general family of milbemycins in the definition of oral formulation provided in the disclosure of the patent was insufficient to meet the product specificity requirement.

The Court agreed with Lilly’s construction of the patent, finding that the claims are not directed  only to a formulation including spinosad as the  only active ingredient, but also to formulations that include other active ingredients such as, but not restricted to, milbemycin oxime.

However, Lilly was not successful in the result once the Court applied the product specificity jurisprudence to this case. The Court stated that for a formulation claim, all of the medicinal ingredients included in the drug product as authorized must  be included in the patent claims. Finding that there was no perfect match between what is claimed  and what is authorized, the patent did not meet the product specificity requirements and thus was not eligible for listing.