Eli Lilly Canada v Canada (Attorney General), 2014 FC 152

The Federal Court upheld the decision of the Minister of Health to exclude Eli Lilly’s Canadian Patent No. 2,379,329 (the “’329 Patent”) on the combination drug Trifexis from the register of patents for failing to claim a formulation of each of the medicinal ingredients as required by paragraph 4(2)(b) of the PM(NOC) Regulations. [86] The ‘329 Patent explicitly claimed a formulation with one of the medicinal ingredients, spinosad, but the only reference in the claims made to the second medicinal ingredient, milbemycin oxime, was in the specification’s definition of “formulation”, which listed the family of milbemycin molecules as a possible component. [7-9] The Court determined that as a matter of claim construction the ‘329 Patent could extend to a formulation of both medicinal ingredients, [80] but nevertheless did not satisfy the “perfect matching” requirement in paragraph 4(2)(b) of the Regulations between what is claimed and what is authorized.

Background

The Minister of Health denied the listing of the ‘329 Patent on the patent register because of her holding that the patent did not contain claims for a formulation combining both of the medicinal ingredients in Trifexis, namely spinosad and milbemycin oxime, contrary to the product specificity requirement in paragraph 4(2)(b) of the Regulations. [2] There was no reference to milbemycin oxime in any of the claims or in the description, except indirectly through more general reference to the family of milbemycin molecules in the definition of “formulation” in the specification. [12] Eli Lilly argued that the Minister conflated claim construction with its interpretation of paragraph 4(2)(b), [22] and that a formulation containing spinosad and milbemycin oxime was claimed by representative claims 1 and 5, which include the defined term “formulation”, which the specification defines as possibly containing milbemycins. [25]

Representative claims 1, 5, and the definition of “formulation” are provided:

1. 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 100mg of spinosad per kg of body weight. [emphasis added] [8]

5. 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 chewable treat oral dosage form suitable for administration once every at least 7 days at a dose of 10 to 100mg of spinosad per kg of body weight. [emphasis added] [8]

And,

“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, […].milbemycins, […]” [emphasis added] [9]

The Minister concluded that this reference did not amount to claiming a formulation containing spinosad with milbemycin oxime as a matter of claim construction. [70] Subsequently, the product specificity requirement in paragraph 4(2)(b) of the Regulations, which requires that the claimed formulation must include both medicinal ingredients, [72] was not met. [2]

Paragraph 4(2)(b) of the Regulations reads as follows:

(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.

Issues

The issues before the Federal Court were:

(1)  Did the Minister correctly construe the ‘329 Patent?

(2)  Did the Minister correctly interpret the requirements set out in paragraph 4(2)(b) of the Regulations?

(3)   Was the Minister’s decision to exclude the ‘329 Patent from the patent register reasonable? [20]

The Minister Erred in Construing the ‘329 Patent

The Federal Court reversed the Health Minister’s claim construction to find that the ‘329 Patent could extend to a formulation containing both spinosad and milbemycin oxime. [69, 80]

The Court relied on the principle in Purdue Pharma v Canada (Attorney General), 2011 FCA 132, that in the context of an eligibility assessment under the Regulations, a patent must be construed with the principles articulated in Whirlpool Corp v Camco Inc, 2000 SCC 67. [61] The person skilled in the art would have understood that milbemycin oxime is a compound that is included in the class of compounds described as milbemycins. [68]

The Minister Correctly Interpreted Paragraph 4(2)(b) of the Regulations

Despite her error in claim construction, the Court determined that the Minister interpreted paragraph 4(2)(b) of the Regulations correctly in holding that the product specificity requirement requires a perfect match between what has been claimed and what has been authorized. [73, 78]

To contrast the “perfect matching” requirement in the Regulations to the kind of “matching” that would occur in a patent infringement analysis, the court cited G.D. Searle & Co v Canada (Minister of Health), 2009 FCA 35 for the principle that determining whether the patent to be listed on the register could be infringed is not the same analysis that occurs when interpreting the Regulations. [76] The Court further cites Purdue as applying this principle to paragraph 4(2)(c) of theRegulations to bring out the matching requirement: “Absent precise and specific matching, the patent is not eligible for listing on the patent register under the Regulations.” [77]

The Minister Reasonably Excluded the ‘329 Patent from the Register

Despite her error in construing the claims to not extend to a formulation of spinosad and milbemycin oxime, and despite the fact that her decision to exclude the ‘329 Patent from the register was based directly on this construction, [79] the Court still found her decision to exclude the ‘329 Patent from the register to be reasonable. [86]

The Court was of the view that referring to the general family of milbemycins in the definition of oral formulation was not specific enough to conclude that the claims match the formulation contained in Trifexis. [85] The Court framed the issue to be, more specifically, whether “the fact that the claims can be read as covering a formulation that could, but that does not necessarily, comprise the specific ingredient, milbemycin oxime, is sufficient to meet the strict matching requirement with Trifexis’ NOC which clearly comprise this specific ingredient”. [81] The Court felt bound by Gilead Sciences Canada Inc v Canada (Ministry of Health), 2012 FCA 254, where the FCA endorsed FC’s exclusion a patent from the register in a similar situation [82] based on the principle that “it was insufficient for a patent to meet the product specificity requirement by referring to a class of compound rather than to a specific medicinal ingredient.” [84]

Commentary

It seems the Minister’s decision on claim construction was in error for taking a results-based approach by considering how claim construction would impact the paragraph 4(2)(b) analysis when it was in fact unnecessary for it do so. The Senior Patent Officer at the Office of the Patented Medicines and Liaison, a witness, even acknowledged that the patent, when read by itself, without applying the requirements of subsection 4(2) of the Regulations, could extend to a combination of spinosad and milbemycin oxime. [36] This case makes it clear that such a consideration is misguided, since a patent may be found to claim certain medicinal ingredients as a matter of claim construction without meeting the product specificity requirement. This decision clearly states 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.

This case comes three months after an announcement from Industry Canada of its intention to change PM(NOC) Regulations regarding combination drugs such as Trifexis. Industry Canada intends to confirm Health Canada’s established practices with respect to listing patents on the register that claim only one medicinal ingredient even though the medicinal ingredient in the Notice of Compliance is the combination of medicinal ingredients. This case, however, sidesteps the concern raised in the announcement, since the ‘329 Patent was found to claim both of the medical ingredients in Trifexis’s Notice of Compliance.

The Industry Canada announcement is said to address what might have been an adverse trend in the case law after Gilead and other cases. The Federal Court in ViiV Healthcare ULC v Teva Canada Limited, 2014 FC 893 relied on Gilead for the proposition that “[a] patent claim for only one medicinal ingredient cannot support a listing under the NOC Regulations where the underlying NOC is for a combination (synergistic or otherwise) of two or more medicinal ingredients,” [89, ViiV] which would seem to run contrary to Health Canada’s established practice by enhancing the product specificity requirement. Notably, the Court in this case felt bound by Gilead, but did not read Gilead as having enhanced the product specificity requirement. [73]