Eli Lilly Canada Inc v Attorney General of Canada et al, 2014 FC 152

On February 17, 2014, the Federal Court dismissed an application by Eli Lilly for judicial review of the Minister of Health’s refusal to list Lilly’s Canadian Patent No. 2,379,329 in respect of its drug product, TRIFEXIS®. The Federal Court held that it was bound by the decision of the Federal Court of Appeal in Gilead Sciences Canada Inc v Canada (Ministry of Health), 2012 FCA 254, with respect to the product specificity requirements prescribed by paragraph 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations.

The underlying decision indicated that the '329 Patent claimed a formulation comprising only one medicinal ingredient, spinosad, rather than claims for a formulation that contained the two medicinal ingredients present in TRIFEXIS® (spinosad and milbemycin oxime).

The Federal Court held that the Minister erred in construing the claims of the patent, and that, properly construed, the claims of the ‘329 Patent include both spinosad and milbemycin oxime. Yet despite this conclusion, the Court felt bound by Gilead and concluded that the general family of milbemycins in the patent’s definition of oral formulation is not specific enough to conclude that the claims match the formulation contained in TRIFEXIS®.

This decision is significant because it exemplifies the inconsistencies in the law for listing patents and, in particular, the product specificity requirements. The product specificity requirements were initially introduced to restrict listing of patents to those where the subject matter of the patent is linked with the content of the approved drug product. In other words, patents can only be listed where the claimed invention is incorporated into the approved drug product from which generic drug manufacturers can derive a benefit. This decision, by following Gilead, seems to disregard the invention claimed, endorsing a word-search test that requires a perfect match between words found in the patent and words describing the content of the approved drug product.

Click here for the Federal Court decision.