Eli Lilly Canada Inc. v. Canada (Attorney General). 2015 FCA 166 (Nadon J.A., Dawson J.A., Boivin J.A.)
July 17, 2015
Jay Zakaib, Jennifer Wilkie, and Kelly McClellan of Gowling Lafleur Henderson LLP for the Appellant Eli Lilly Canada Inc.
Eric Peterson of William F. Pentney for the Respondents Attorney General of Canada and Minister of Health
This is an appeal from a decision of the Federal Court dismissing an application for judicial review of a refusal by the Minister of Health (the “Minister”) to list Canadian Patent No. 2,379,329 (the “Patent”) on the patent register. The appeal was allowed and the matter returned to the Minister of Health for reconsideration.
The relevant Notice of Compliance (“NOC”) was for a formulation including spinosad and milbemycin oxime for parasite control in animals. Claims 1 and 5 of the patent claimed formulations comprising spinosad. The Patent also disclosed that milbemycins generally could be included in combination with spinosad.
The Minister refused to list the Patent, interpreting subsection 4(2) of the Patented Medicines (Notice of Compliance) Regulations (the “Regulations”) as requiring that the Patent include a claim expressly reciting both spinosad and milbemycin oxime, and pointing out that milbemycin oxime specifically was not disclosed. The Federal Court found that the claims, while not expressly reciting milbemycin oxime, would include within their scope formulations including milbemycin oxime as in the NOC. However, the Federal Court then found that reference to milbemycins generally in the disclosure did not meet the specificity requirement of subsection 4(2).
The Federal Court’s construction of the claims as including within their scope formulations having milbemycin oxime was found to be reasonable. However, the Federal Court’s interpretation of subsection 4(2) as requiring the words “milbemycin oxime” to be present in a claim was incorrect and resulted in the unreasonable finding that the Patent could not be listed in respect of the NOC. The matter was remitted to the Minister of Health for reconsideration.
The Court of Appeal clarified that the specificity requirement of subsection 4(2) was to be interpreted in the context of the “relevance” test which the specificity requirement was introduced to replace by amendments to the Regulations in 2006. Subsection 4(2) requires that a claim include within its scope the specific product in the NOC. Subsection 4(2) does not require express reference in a claim to each feature of the product.
In a concurring judgment, Dawson J.A. interpreted Gilead Sciences Canada Inc. v. Canada (Minister of Health), 2012 FCA 254 as requiring express reference in a claim to each feature of a product covered by a notice of compliance. Dawson J.A. found that this requirement was inconsistent with the purpose of the Regulations and that Gilead was wrongly decided.
By: David Wood, Borden Ladner Gervais LLP