Eli Lilly Canada Inc v Canada (Attorney General), 2015 FCA 166
The Federal Court of Appeal (“FCA”) again revisited the product specificity requirement in paragraph 4(2)(b) of the PM(NOC) Regulations (“Regulations”) when it overturned the Federal Court’s decision in Eli Lilly Canada v Canada, 2014 FC 152 a previously summarized decision. The FCA rejected the notion adopted by the Federal Court that a higher level of specificity is required to adhere to the Regulations than is required for an element to be claimed as a matter of claim construction.
Background
The patent at issue is Eli Lilly’s Canadian Patent No. 2,379,329 (“the ‘329 patent”). The Minister of Health refused to list the ‘329 patent against its new drug, Trifexis, on the patent register, because she thought the patent did not claim the product’s two medicinal ingredients: spinosad and milbemycin oxime.
The Federal Court reviewed the decision and observed that although the ‘329 patent explicitly claimed a formulation with spinosad, the only reference in the claims made no direct reference to milbemycin oxime. The only reference to milbemycin oxime was in the specification’s definition of “formulation”, which listed the family of milbemycin molecules as a possible component. [7-9, FC]
The Federal Court determined that this reference was sufficient to extend the patent’s claims to include a formulation with both medicinal ingredients as a matter of claim construction, [80, FC] but that the patent nevertheless did not satisfy the “perfect matching” requirement in paragraph 4(2)(b) of the Regulations. The Federal Court thought it was following the FCA’s decision in Gilead by requiring that the patent explicitly name each medicinal ingredient in the Trifexis’ Notice of Compliance in its claims in order to be eligible for listing. [40]
The relevant rule in paragraph 4(2)(b) is provided:
4(2) A patent on a patent list in relation to a new drug submission is eligible to be added to the register if the patent contains
(b) a claim for the formulation that contains the medicinal ingredient and the formulation has been approved through the issuance of a notice of compliance in respect of the submission; [19, emphasis added]
The relevant claims in the ‘329 patent are provided:
- A single-dose oral formulation for controlling an ectoparasite infestation on a dog or cat comprising an ectoparasiticidal amount of spinosad, or a physiologically acceptable N-demethyl derivative or salt thereof, and a physiologically acceptable carrier in a dosage form selected from tablet, capsule or liquid suitable for administration once every at least 7 days at a dose of 10 to 100 mg of spinosad per kg of body weight. [9, emphasis added]
Claim 5, which is also at issue, claims the same formulation in a chewable treat. [9]
The relevant section of the disclosure that was said to extend claims 1 and 5 to include milemycin oxime by reference to the word “formulation” is as follows:
“The formulations of this invention may further include, in combination with the spinosyn component, one or more other compounds that have activity against the specific ectoparasite or endoparasite to be controlled, such as, for example, synthetic pyrethroids, natural pyrethins, organophosphates, organochlorines, carbamates, foramidines, avermectins, milbemycins, … [8, emphasis added]
And the specification’s definition of “formulation”:
“claim for the formulation” means a claim for a substance that is a mixture of medicinal and non-medicinal ingredients in a drug and that is administered to a patient in a particular dosage form; [20]
The FCA Insists that PM(NOC) Regulations Requires a Patent to Claim each Medicinal Ingredient, but Need Not Explicitly Name each Medicinal Ingredient
The FCA determined that the Federal Court did not err when it construed the claims of the ‘329 patent to claim a formulation with both spinosad and milbemycin oxime, [67] but it erred when it determined that the patent needed to explicitly list these medical ingredients in order to comply with paragraph 4(2)(b). [90]
The majority thought that the Federal Court must have misread Gilead. [76] According to the majority, the patent at issue in Gilead did not claim each of the medicinal ingredients set out in the NOC, and therefore was not compliant with paragraph 4(2)(b). [81, 92] As such, Gilead was mistaken to require that each medicinal ingredient be spelled out in the claims of the listed patent. [90]
The majority thought that this misreading was understandable given that Court’s comments that “a patent could not meet the product specificity requirement if it referred to a class of compounds rather than to a specific medicinal ingredient” [91, 93] as the ‘329 patent did. However, the majority stressed that the reason that the Court in Gilead found that paragraph 4(2)(b) was not satisfied was because not all of the medicinal ingredients were claimed by the patent. [92]
Dawson Concurrence Finds Gilead Wrongly Decided
Dawson J.A. agreed with the majority on the law, but took a different view on how Gilead should be read. Dawson read Gilead as concluding that the patent at issue could not be listed because although it claimed each of the medicinal ingredients, it did not explicitly name one of them. [102] As such, Gilead must have been wrongly decided in light of this case. [100]
Commentary
This case may be the tail end of a series of cases debating the product specificity requirement in paragraphs 4(2)(a) and 4(2)(b) of the Regulations (See 2012 FC 2 (Gilead FC), 2012 FCA 254 (Gilead FCA), 2014 FC 152 (Eli Lilly FC), 2014 FC 893 (ViiV FC), 2015 FCA 93 (ViiV FCA)). Each of these cases seek to answer what the matching requirement in paragraphs 4(2)(a) and 4(2)(b) is in comparison with claim construction. This latest case clearly states that there is no difference: if a patent claims the medicinal ingredients specified in the NOC, then the product specificity requirement is met.
Interestingly enough, a different panel of judges on the FCA earlier this year endorsed the opposite view that the Regulations require an “exact matching” between medicinal ingredients in an NOC and medicinal ingredients named in a claim. Read that summary here.
All of this judicial decision-making is being done in the shadow of proposed amendments made by Industry Canada to the PM(NOC) Regulations that would eliminate this “exact matching” requirement. A summary of the proposed amendments can be read here.
This most recent decision from the FCA on the product specificity requirement seems to be in line with the proposed amendments.