Tuesday, October 14, 2014

More on the Perfect Match Requirement of Listing on the Patent Register

ViiV Healthcare ULC v Teva Canada Ltd 2014 FC 893 Hughes J aff’g 2014 FC 328
Milczynski J (here)
            abacavir & lamivudine. / KIVEXA & TRIZIVIR / 2,289,753

Hughes J applied the “perfect match” requirement for listing of a patent on the Patent Register, as set out by the FCA in the leading case of Gilead / COMPLERA 2012 FCA 254 (blogged here), to uphold Milczynski J decision (blogged here) that the ‘753 patent cannot be listed on the Patent Register against KIVEXA or TRIZIVIR. There is not really any new law in this decision, though Hughes J does provide a thorough review of the case law at [47], and a list of principles emerging from those cases at [48]. The main point of interest is that in this litigation, the Minister of Health had argued that while a perfect match is required to list a patent claiming a formulation under 4(2)(b) of the NOC Regulation, a perfect match is not required to list of a patent claiming a medicinal ingredient, which is governed by 4(2)(a). However, as Milczynski J held, in Gilead the FCA clearly held that the perfect match is required under 4(2)(a), and Hughes J has now affirmed. In other posts on the listing requirement I have argued that the perfect match requirement is rigid formalism, because eligibility for listing turns on how the claims are drafted rather than on the substantive scope of the claims. I can understand how the “relevant” standard developed by the courts under the old Regulations was too liberal, but requiring a perfect literal match strikes me as too strict; it seems to me that a “would necessarily infringe” standard would strike a better balance. But the point is settled law now.

Here is the summary of the law provided by Hughes J:

[48] I draw the following principles respecting the interpretation of the various subsections of 4(2) of the NOC Regulations having regard particularly to the Federal Court of Appeal decisions and the Reasons of Justice Russell in Bayer, as affirmed by the Federal Court of Appeal:
• There is no sound reason to adopt different legislative requirements of product specificity for the various subparagraphs of subsection 4(2) of the NOC Regulations (Gilead, paragraph 39);
• absent precise and specific matching between what the patent claims and the product/use/dosage forms for which the NOC has been granted to the first person, the Minister cannot properly list the patent (Purdue, paragraphs 43; Abbott, paragraph 49; Gilead, paragraphs 37-38);
• a claim for a formulation means a claim that includes both medicinal and non-medicinal ingredients. A claim directed to medicinal ingredients, without claiming also non-medicinal ingredients, does not qualify for listing as a formulation under subsection 4(2)(b) of the NOC Regulations (Gilead, paragraphs 27 to 32, 49; Bayer, paragraphs 67 to 69).
• where a patent claims only one medicinal ingredient, it cannot be listed as against an NOC obtained for two (or more) medicinal ingredients; at least where, to use the words of Russell J, at paragraph 69 of Bayer, where “…a drug with one medicinal ingredient will have a different effect from a drug where two medicinal ingredients are combined “to achieve the desired effect [emphasis added].” This same distinction appears in Gilead, where Trudel JA wrote at paragraphs 31 and 32:
31 Finally, the overall inventive step of the '475 Patent, as found by the Judge, is the combination of chemically stable medicinal ingredients. The '475 Patent emphasizes the beneficial effects of combining chemically stable combinations of medicinal ingredients.
32 Thus, I conclude that the '475 Patent falls under paragraph 4(2)(a), as the relevant claims consist of chemically stable combinations of medicinal ingredients.

As the last bullet point indicates, Hughes J considered whether the prior case law left open the possibility that a patent claiming one medicinal ingredient might be listable against a drug with two medicinal ingredients if there was no synergy between drugs. However, he ultimately held that

[89] In my view, it is not productive when considering the listing requirements of subsection 4(2) of the NOC Regulations to consider synergy or not. The decision of the Federal Court of Appeal in Gilead is sufficiently clear. 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.

For a discussion of the facts related to KIVEXA, see my post on Milczynski J’s decision, here. This appeal also consolidated a closely related proceeding in which Apoex also challenged the listing of the ‘753 patent against KIVEXA [9], as well as a third proceeding in which Apotex challenged the listing of the ‘753 patent against TRIZIVIR. The legal issues were substantially the same in all the proceedings.

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