Wednesday, May 28, 2014

Perfect Match Required for Listing on Patent Register for Medicine as Well as Formulation

ViiV Healthcare Ulc v Teva Canada Ltd 2014 FC 328 Milczynski J
            abacavir & lamivudine. / KIVEXA / 2,289,753

In Purdue / TARGIN 2011 FCA 132 (blogged here) and Gilead / COMPLERA 2012 FCA 254 (blogged here), the FCA established what has been aptly called a “perfect match” requirement for listing a patent against a drug on the Patent Register, so as to require a generic to address the patent before obtaining an NOC. This decision reaffirms that the perfect match requirement applies under all branches of s 4(2)(a) of the NOC Regulations.

A perfect match requires that each medicinal ingredient be explicitly named in a claim; it is not enough that the generic product would necessarily infringe the claim, and it is not enough that all the ingredients are explicitly listed in the description. So, in this case, the 753 patent claims abacavir (Claim 1) [4], as well as abacavir in combination with any nucleoside reverse transcriptase inhibitor (NRTI) (Claim 32). The 753 patent also disclosed that abacavir can be used in combination with other therapeutic agents, specifically naming lamivudine, which is an NRTI [16]. KIVEXA is a fixed dose dual combination drug containing abacavir and lamivudine. Consequently, it is clear that a combination drug containing abacavir and lamivudine would infringe both Claim 1 and Claim 32. The 753 patent was listed on the Patent Register against KIVEXA

Teva argued successfully that the listing was improper, notwithstanding that a generic version of KIVEXA would necessarily infringe the 753 patent, because there was no claim that specifically named abacavir and lamivudine in the claim itself. It does not matter that Claim 32 specifies a class that uncontroversially includes lamivudine, and it does not matter that lamivudine was specifically named in the description.

In Teva / KIVEXA both the patentee and the Minister argued that a perfect match is not required for listing under s 4(2)(a) of the NOC Regulations. Ths Minister’s position in noteworthy because both of the FCA cases establishing the perfect match requirement arose from the Minister’s refusal to list a patent; in this case, in contrast, the Minister is of the view that the patent is eligible.

The Minister’s position was that a perfect match is required under para 4(2)(b), which applies to “a claim for the formulation that contains the medicinal ingredient,” but not under para 4(2)(a), which applies to “a claim for the medicinal ingredient” [22]. The Minister’s view is that a perfect match should not be required under 4(2)(a) because when the basic breakthrough is the identification of a new drug, it is normal that the treatment is subsequently refined by combining that drug with other ingredients, and the innovator should be able to list that basic breakthrough invention against the subsequent improvements [23]. In contrast, if the technical contribution is the particular combination, then there a perfect match should be required under 4(2)(b) [22]. This explains why the Minister refused listing in Gilead under 4(2)(b), but supports it now under 4(2)(a). 

There is considerable logic to the Minister’s policy position, though I can’t agree with it entirely. If the technical contribution is the recognition that a particular known drug interacts advantageously with an entire class of other compounds, the innovation is a formulation, so it falls under 4(2)(b), and yet a perfect match requirement strikes me as too stringent; the effect is to require the patentee to list each complementary drug by name in the claim, rather than referring to the class as a whole, which strikes me as pointless formalism

In any event, while we can quibble about policy and logic, as a matter of law the Minister’s position runs squarely up against Gilead / COMPLERA. While the Minister in Gilead opposed registration under 4(2)(b), the FCA refused registration under 4(2)(a). Thus Gilead is not distinguishable from this case, and Milczynski J was right to hold that “The requisite degree of product specificity is the same for section 4(2)(a) of the PMNOC Regulations as it is for each of sections 4(2)(b), (c) and (d)” [29].

This decision makes no new law, but it does illustrate once again the absurd nature of the perfect match requirement.

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