Pharma In Brief - Federal Court Of Appeal Relaxes The 'Perfect Match' Requirement For Patent Listing Under The Patented Medicines (Notice Of Compliance) Regulations

Case: Eli Lilly Canada Inc v Canada (Attorney General), 2015 FCA 166 (Court File No. A-146-14) [Lilly]

Drug: TRIFEXIS® (spinosad/milbemycin oxime)

Nature of case: Judicial review of refusal by the Minister of Health (Minister) to list CA 2,379,329 (the '329 Patent) against TRIFEXIS® pursuant paragraph 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations)

Successful party: Eli Lilly Canada Inc. (Lilly) (on appeal)

Date of decision: July 17, 2015

Summary

The Minister of Health refused to list a patent on the Patent Register in respect of a fixed-dose combination product because it did not contain a claim for each medicinal ingredient in the approved product. The patentee sought judicial review. A Federal Court judge dismissed the application for judicial review because the claims of the patent did not refer specifically to both medicinal ingredients in the fixed-dose combination product. The Court of Appeal reversed the Minister's decision and held that the patent was eligible for listing on the Patent Register. A majority held that the Court's previous decisions did not require every medicinal ingredient to be recited in the claims — only that they all be claimed. In concurring reasons, a minority held that this case was not distinguishable from an earlier one with a contrary result and declared that the earlier case was wrongly decided.

Analysis

The issue: TRIFEXIS® and the '329 Patent

TRIFEXIS® is a fixed-dose combination of two veterinary antiparasitic medicinal ingredients, spinosad and milbemycin oxime. The manner in which this combination was claimed in the '329 Patent is the pivotal issue in the case. The '329 Patent claims an oral formulation of spinosad. The term "oral formulation", is defined in the description to comprise spinosad alone or in combination with certain classes of other medicinal ingredients. Several suitable classes are given as examples, including "milbemycins". The second medicinal ingredient of TRIFEXIS®, milbemycin oxime, is a member of that class but is not mentioned by name. Lilly sought listing of the '329 Patent under paragraph 4(2)(b) of the Regulations.

At first instance and in the Court of Appeal, this matter turned largely on interpretations of the Gilead case.1 Gilead concerned claims to the medicinal ingredients and formulation of COMPLERA® (tenofovir disoproxil fumarate/emtricitabine/rilpivirine), a triple-combination drug. In that case, the Court of Appeal...