Federal Court of Appeal reinterprets product specificity requirements

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 Patented Medicines (Notice of Compliance) Regulations (Eli Lilly Canada Inc v Canada (Minister of Health) 2015 FCA 166). 

A key victory for innovators, the decision restores the principle (and prior practice) that allows the listing of patents claiming ingredients not specifically named in the patent, provided that a match exists between the claims as construed and the approved product.

Facts
Lilly sought to list the ‘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 and cats. The ‘329 patent claimed oral formulations containing spinosad, where oral formulation was defined in the disclosure as potentially including many other known parasitic treatments such as milbemycins.

In refusing to list the ‘329 patent on the register, Health Canada found that the mention of milbemycins in the disclosure was insufficient to meet the requirements for listing under Paragraph 4(2)(b) of the regulations.

Eli Lilly’s application for judicial review of that decision was dismissed by the Federal Court (Eli Lilly Canada Inc v Canada (Minister of Health), 2014 FC 152). In applying the three-step test applicable to listing decisions, the judge accepted the expert evidence and construed the claims as including milbemycin oxime. However, the judge upheld the minister’s refusal because she interpreted the prior Federal Court of Appeal decision in Gilead v Canada (Minister of Health) (2012 FCA 254) 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.

Federal Court of Appeal decision
Before the Federal Court of Appeal, Lilly submitted that the judge erred by failing to apply the claims construction from step one to step three. In doing so, Lilly submitted that 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 (Miller v Canada (Attorney-General) 2002 FCA 370).

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.

Majority reasons
For the majority, Justices Nadon and Boivin found that 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 rejected the minister’s submission that the judge had erred in her construction of the patent claims at the first step because no guesswork is allowed in pharmaceutical science. Instead, Nadon 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 evidence. 

Moreover, Nadon reiterated that the principles of claims construction have consistently been applied in prior decisions of the Federal Court of Appeal in reviewing listing decisions. In this regard, Nadon distinguished Trifexis from Gilead.  Reviewing both the Federal Court and Federal Court of Appeal decisions, Nadon noted that the evidence accepted on the patent claims construction did not support a match between the patent claims and the approved product.

Nadon also reconsidered the product specificity requirement amendments introduced in the 2006 amendments. Nadon clarified that the purpose of product specificity was intended only to replace former relevancy requirements as understood before 2006 (Tazidime, Federal Court of Appeal) and thus did not require a word match as that would ignore claims construction. 

Concurring reasons
In concurring reasons Justice Dawson concluded that Gilead was wrongly decided.

Dawson found that certain patent claims in the Trifexis appeal were analogous and could not be distinguished from Gilead. In agreeing with the majority’s result, Dawson 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. Dawson commented that denying listing of a patent that contains an innovative and useful ingredient is not consistent with the purpose of the Patented Medicines (Notice of Compliance) Regulations to regulate the early working exception, consistent with the majority view.