On July 17, 2015, the Federal Court of Appeal set aside a judgment of the Federal Court that upheld Health Canada's refusal to list Canadian Patent 2,379,329 (the '329 patent) owned by Eli Lilly Canada Inc. on the Patent Register maintained under the PM(NOC) Regulations.1
A key victory for innovators, the decision restores the principle (and prior practice) that allows listing of patents claiming ingredients not specifically named in the product, so long as a match exists between the claims as construed and the approved product.
Lilly sought to list its '329 patent on the register in relation to Trifexis®, a chewable tablet containing spinosyns and milbemycin oxime for the treatment of heartworm, and flea infestations in domestic dogs, cats and puppies.2 The '329 patent claimed oral formulations containing spinosad, where oral formulation is defined in the disclosure as potentially including many other known parasitic treatments such as "milbemycins".3
In refusing to list the '329 patent on the Register, Health Canada found the mention of milbemycins in the disclosure was insufficient to meet the requirements for listing under paragraph 4(2)(b) of the Regulations.4
Eli Lilly's application for judicial review of that decision was dismissed by the Federal Court.5 In applying the three step test applicable to listing decisions, the Judge accepted the expert evidence and construed the claims as including milbemycin oxime.6 However, the Judge upheld the Minister's refusal because she interpreted the prior Federal Court of Appeal decision in Gilead7 and the product specificity requirements introduced by the 2006 amendments as requiring a perfect word match between ingredients named in the patent claims and the approved therapeutic product.8
Federal Court of Appeal decision
Before the Federal Court of Appeal, Lilly submitted the judge erred by failing to apply the claims construction from step 1 to step 3. In doing so, Lilly submitted the Judge imposed a perfect word match between the patent claims and approved product that neither the product specificity requirements nor Gilead required. To the extent that Gilead required a word match, Lilly also submitted that Gilead was wrongly decided.9
In thorough reasons, the Federal Court of Appeal accepted Lilly's submissions and allowed the appeal.
The Panel unanimously agreed that by failing to compare the patent claims as construed with the approved product, the Judge erred in applying the third step of the test applicable to reviews of listing decisions.10
For the majority, Justices Nadon and Boivin found the Trifexis matter was distinguishable from Gilead, where listing was refused since the claims as construed in Gilead did not match the approved product.
To arrive at this conclusion, Nadon JA rejected the Minister's submission that the Judge erred in her construction of the patent claims at the first step because no guesswork is allowed in pharmaceutical science.11 Instead, Nadon JA upheld the Judge's construction and approach that a patent is to be read through the eyes of a skilled person willing to understand based on expert evidence12.
Moreover, Nadon JA reiterated that the principles of claims construction have consistently been applied in prior decisions of the Federal Court of Appeal in reviewing listing decisions.13 In this regard, Nadon JA distinguished Trifexis from Gilead.14 Reviewing both the Federal Court and Federal Court of Appeal decisions, Nadon JA noted the evidence accepted on the patent claims construction did not support a match between the patent claims and the approved product.15
Nadon JA also reconsidered the "product specificity" requirement amendments introduced in the 2006 amendments. Nadon JA clarified that the purpose of product specificity was only intended to replace former relevancy requirements as understood before 2006 (Tazidime FCA), and thus does not require a word match as that would ignore claims construction.16
In concurring reasons Justice Dawson concluded that Gilead was wrongly decided.17
Justice Dawson found certain patent claims in the Trifexis appeal were analogous and could not be distinguished from Gilead.18 In agreeing with the majority's result, Dawson JA reiterated that eligibility for listing of the claims does not require each medicinal ingredient be specifically named, but instead requires an inquiry into what the patent claims.19 Dawson JA commented that denying listing of a patent that contains an innovative and useful ingredient is not consistent with the purpose of the PM(NOC) Regulations to regulate the early working exception20, consistent with the majority view.
Eli Lilly Canada Inc. was represented by lawyers Jay Zakaib, Jennifer Wilkie and Kelly A. McClellan.
1 Eli Lilly Canada Inc., v Canada (Minister of Health), 2015 FCA 166 (Reasons)
5 Eli Lilly Canada Inc., v Canada (Minister of Health), 2014 FC 152 (FC Reasons)
6 FC Reasons at para 68-9
7 Gilead v Canada (Minister of Health), 2012 FCA 254
8 FC Reasons at para 83-6
9 Miller v. Canada (Attorney-General), 2002 FCA 370
12 Reasons at para 52-4 and 65
15 Reasons at para 80, 83, 87 and 92