CaseEli 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 Gileadcase.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 accepted the Federal Court’s construction of the relevant claims as “combinations and formulations of two medicinal ingredients plus a third one of the NNRTI class that could possibly include but is not specifically rilpivirine”. It concluded that these claims were insufficiently product-specific because they did not name the medicinal ingredient, but only the broad class of compounds. Gilead’s patent was denied listing under paragraphs 4(2)(a) and 4(2)(b).

In the Federal Court, Bédard J construed the relevant claims of Lilly’s ’329 Patent to be directed to formulations of spinosad that include other active ingredients such as milbemycin oxime. In her opinion, she was bound by Gilead to find that these claims did not achieve the degree of product specificity required by paragraph 4(2)(b). She reached this conclusion because she interpreted certain statements in Gilead to require that every medicinal ingredient of a combination drug must appear in an eligible claim in order to achieve a “perfect match”.

On appeal, Lilly argued that Bédard J correctly construed the ’329 Patent but misapplied paragraph 4(2)(b). The Minister argued that the ’329 Patent was ineligible for listing because the claims did not include milbemycin oxime.

The Court of Appeal upheld Bédard J’s construction of the relevant claims. The decisive question thus became whether those claims met the threshold of product specificity required by paragraph 4(2)(b).

The majority’s reasons: reading down and distinguishing Gilead

The majority held that in order to satisfy paragraph 4(2)(b), the ’329 Patent was required to contain a claim that included the two medicinal ingredients found in TRIFEXIS® according to the three-part test set out inAbbott.2 The Court found that unlike the patent in Gilead, the ’329 Patent met this threshold for the following reasons:

  1. Gilead is distinguishable. The majority interpreted the Gilead Court’s conclusion to be based upon a construction that did not include rilpivirine (the third medicinal ingredient in COMPLERA®). It emphasised that, by contrast, Bédard J had correctly construed the relevant claims of the ’329 Patent to include the combination of spinosad and milbemycin oxime based upon the definition of “oral formulation” in the description.
  2. Gilead did not require a perfect match. The majority held that “the question at the third step of theAbbott test is not whether the words milbemycin oxime appear in the claims of the ’329 Patent, but whether the claims of the ’329 Patent claim milbemycin oxime in the formulation set out in the patent”. A perfect match is not required.

The majority concluded that as a result of the foregoing, the ’329 Patent was eligible for listing and allowed the appeal.

The concurring reasons: Gilead was wrongly decided

In concurring reasons, Dawson JA agreed with the majority on all but one point: She could not distinguish the claims in Gilead from those of Lilly’s ’329 Patent. In her opinion, Gilead’s patent claimed and would have been infringed by a formulation of the three medicinal ingredients in COMPLERA®. Thus, she regarded the issue inGilead to have been whether the patent could be listed given that did not specifically name rilpivirine as a medicinal ingredient

Madam Justice Dawson stated that “if the patent claims the approved medicinal ingredient there will be a sufficient nexus between the patent and the subject of the notice of compliance to allow the patent to be listed”. She held that this interpretation was consistent with the text of paragraphs 4(2)(a) and 4(2)(b), as well as the purpose of the Regulations: to regulate the early-working exception under the Patent Act.3 She concluded that Gilead was wrongly decided.

Background on recent developments regarding product-listing eligibility

The patent-listing eligibility provisions of the Regulations were amended on June 19, 2015 in order to clarify the application of section 4, particularly as it relates to fixed-dose combination products.4 In the associated Regulatory Impact Analysis Statement, the government explained that aspects of the judgments in Gilead and a more recent case, ViiV, were inconsistent with the policy intent of section 4 because they excluded patents that ought to be eligible for listing.5  The resulting changes are explained in two “Pharma in brief” publications, referenced below. The Lilly case was decided on the law as it stood prior to the June 19 amendments. The Court of Appeal did not refer to either of the amendments or its decision in ViiV.

Link to decisions:

The decisions with respect to the TRIFEXIS® matter can be found by following these links:

Federal Court of Appeal: Eli Lilly Canada Inc v Canada (Attorney General), 2015 FCA 166

Federal Court: Eli Lilly Canada Inc v Canada (Attorney General), 2014 FC 152

In addition, the Pharma in brief publications on recent activity concerning patent-listing eligibility can be found at the following links:

Pharma in brief - Official Publication of Amended PM(NOC) Regulations Now Available — Patents claiming single medicinal ingredients are eligible for listing on the Patent Register for combination drugs

Pharma in brief - Amended PM(NOC) Regulations now in force — Patents claiming single medicinal ingredients are eligible for listing on the Patent Register for combination drugs