Canadian Federal Court of Appeal Clarifies Listing of Formulation Patent Naming a Single Medicinal Ingredient Against a Combination Product

On July 17, 2015, Canada’s Federal Court of Appeal (FCA) allowed the appeal of Eli Lilly Canada Inc (Lilly) from a finding that the federal Minister of Health (Minister) erred in refusing to list Lilly’s Canadian Patent No 2,379,329 (329 Patent) against Lilly’s fixed-dose combination product TRIFEXIS® (spinosad/milbemycin oxime) (Eli Lilly v Minister of Health, 2015 FCA 166).

The 329 Patent contains formulation claims that expressly refer to spinosad, but not to milbemycin oxime.  The patent disclosure, however, defines the term “oral formulation” as either comprising spinosad alone or in combination with other types of compounds, for example, “milbemycins”. 

The Minister refused to list the 329 Patent against the combination product, finding that the Patent did not contains claims specifying milbemycin oxime as the second medicinal infringement and therefore, it did not meet the product specificity requirement of subsection 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations.

Lilly sought a judicial review of the Minister’s decision.  The Federal Court (FC) determined that the Minister erred in her construction of the claims and held that the claims also included formulations containing spinosad and milbemycin oxime.  Nevertheless, the FC upheld the Minister’s decision, finding that the 329 Patent did not meet the requirement of a “perfect match” between the claimed formulation and those found in the approved drug product, following the FCA’s decision in Gilead Sciences Canada Inc v Canada (Minister of Health), 2012 FCA 254 (Gilead) (Eli Lilly v Canada, 2014 FC 152).

The FCA reversed the FC’s decision, finding that since the FC correctly construed the claims as including a formulation claiming spinosad and milbemycin oxime, the formulation claimed by the Patent was that which was authorized in the NOC.  Nadon JA, writing for the majority, distinguished Gilead on the basis that the patent at issue in Gilead did not claim one of the medicinal ingredients of the approved product, whereas in the present appeal, the formulation claimed was the formulation found in the approved product.  Nadon JA further noted that in assessing relevance, the question is not whether the words “milbemycin oxime” appeared in the claims of the 329 Patent, but whether the claims claim milbemycin oxime as a medicinal ingredient in the formulation set out in the Patent.

In concurring reasons, Dawson JA agreed with the majority on all but one point: she was unable to distinguish Gilead.   She therefore concluded that Gilead was wrongly decided.