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.

Authorization under the Special Access Programme Is Not Previous Approval for the Purpose of the Data Protection Regulations

Teva Canada Limited v. Canada (Health) / ELOXATIN 2012 FCA 106 Stratas JA: Blais, Noël JJA aff’g 2011 FC 507 Campbell J

The main question in this appeal was whether widespread authorization for sale under the Special Access Programme of the Food and Drug Regulations means that a drug is not eligible for listing on the Register of Innovative Drugs. ELOXATIN had been sold by Sanofi from 1999 to 2005 under the Special Access Program, C.08.010(1) (SAP). In 2007 Sanofi received a NOC for ELOXATIN on the basis of an NDS, and ELOXATIN was then listed on the innovative drug register. Consequently, it was eligible for data protection for an eight and a half year term running from the 2007 issuance of the NOC. Teva challenged this listing in 2010 on the basis that authorization under the SAP meant that ELOXATIN was “previously approved” and so did not qualify for listing as an “innovative drug” under the definition in C.08.004.1(1).

Campbell J dismissed Teva’s application for judicial review of the Minister’s decision to list ELOXATIN (blogged here). The FCA has now affirmed, essentially for the same reasons given by Campbell J. First, “sales under the Special Access Programme alone are not evidence of a determination by the Minister of the safety and efficacy of a drug” [28]. Second, a test that looks at whether the Minister in fact had sufficient information to evaluate the safety and effectiveness of Eloxatin “creates lack of clarity and uncertainty” [30]. For this reason, the issuance of a notice of compliance and a drug identification number constitutes “the magic moment” of approval [31]. And third, the data protection regulations are intended to implement TRIPS and NAFTA, and those treaties imply that the approval in question is marketing approval, and in particular issuance of a notice of compliance and a drug information number [37].

While these reasons strike me as persuasive, there is some merit to Teva’s underlying complaint, which was that the authorization of ELOXATIN under the SAP was widespread, and the Minister had received “massive” amounts of information regarding ELOXATIN’s safety and efficacy [29]. In response Campbell J pointed out that “the SAP sales record proves nothing about oxaliplatin’s safety and effectiveness; it proves that many seriously ill people were willing to take the unapproved ELOXATIN in a hope of getting well” [FC 27]; and as the Stratas JA noted, a case by case inquiry looking beyond authorization itself, to the amount of information actually available to the Minister, would undermine the goals of clarity and certainty [32]. While I agree with both these observations, the result is potentially a kind of evergreening, if Sanofi can sell its product under the SAP and then get data protection once the patent has expired. This contrasts with the paradigmatic use of data protection, which is to provide some form of protection to a drug that is not patentable in the first place. If that is the real problem, then it would be better to respond, institutionally at least, by controlling the use of the SAP in the first place. I should emphasize that I am not suggesting that the SAP was in any way misused in this case, as that point was not in issue in this case. It may be that this was simply a case in which the SAP, properly used, nonetheless resulted in widespread authorization. In that case the lesson may be that the complex administrative structure for regulation and protection of drug products cannot deliver ideal results in all cases.

A Purposive Interpretation of “Innovative Drug”

Celgene Inc. v. Canada (Health) / THALOMID 2012 FC 154 de Montigny J

In his decision in THALOMID de Montigny J has held that thalidomide is an “innovative drug” under the Data Protection Regulations, and so Celgene is entitled to have it listed on the Register of Innovative Drugs. While thalidomide has a very unusual history, and de Montigny J himself stated that “the present decision will have a limited impact in the foreseeable future” [47], the reasoning underpinning de Montigny J’s interpretation marks an important and welcome development in the interpretation of the Regulations.

CGPA Lack of Standing Affirmed

Canadian Generic Pharmaceutical Association v. Canada (Health) 2011 FCA 357 Dawson JA: Noël, Trudel JJA aff'g 2011 FC 465 de Montigny J affm'g 2010 FC 1211 Lafrenière Pr

The FCA has affirmed that the Canadian Generic Pharmaceutical Association does not have standing to challenge the listing of a particular drug on the Register of Innovative Drugs, saying, from the Bench, that there was no error in the decisions below. The decision of de Montigny J is blogged here.

Minister has On-Going Duty to Maintain Innovative Drug Register / Participation in SAP Does Not Disqualify from "Innovative Drug" Status

Teva Canada Ltd v Canada (Health) 2011 FC 507 Campbell J

ELOXATIN had been sold by Sanofi from 1999 to 2005 under the “Special Access Program” (SAP) provided for in C.08.010(1) of the Food and Drug Regulations. In 2007 Sanofi received a NOC for ELOXATIN on the basis of an NDS, and ELOXATIN was then listed on the Innovative Drug Register. Consequently, it was eligible for data protection for an eight and a half year term running from the 2007 issuance of the NOC. Teva challenged this listing in 2010. The case raised a procedural point and substantive point.

The procedural point arose because Teva did not challenge the listing in 2007, but in 2010 it requested that ELOXATIN be deleted from the Innovative Drug Register on the basis that it contained a medicinal ingredient that had been “previously approved” and so did not qualify as an “innovative drug” under the definition in C08.004.1(1). The Minister refused to delete it, and notified Teva by letter.

Sanofi argued that Teva could only challenge the listing decision at the time of the original decision, at least in the absence of any new information. The FC agreed with Teva and the Minister, that the Minister has an ongoing duty to maintain the register, and so a decision regarding listing can be made at any time. The Minister accepted that her decision was subject to judicial review, but there was a dispute as to whether Teva had standing. The FC held [18] that Teva did have standing, on the basis that the listing on the Register prevented it from filing an ANDS. The decision in CGPA v Minister of Health and GlaxoSmithKline Inc 2011 FC 465 holding that the Canadian Generic Pharmaceutical Association did not have standing to challenge a listing decision, was distinguished at [34] on the basis that the CGPA is an association which is incapable of filing an ANDS. (While Campbell J referred to this decision as having been released, it is not yet available on the Federal Court website.)

On the substantive point, Teva argued that the Minister’s course of action in allowing extensive use of ELOXATIN under the SAP showed that she must have been satisfied of the safety and efficacy [24]. The FCA rejected this, agreeing with the Minister that approval means market authorization, including safety and efficacy approval, on the basis of an NDS or ANDS under C.08.004. The functional rationale is that an SAP does not require the same data that the normal approval does, and it is the data submitted for the NDS that is the subject of data protection. Teva argued that the data which was the basis for the NDS arose from Sanofi’s participation in the SAP, and so was disclosed prior to the NOC being issued. However, even if this is true on the facts of this case, it is not necessarily true in general. The meaning of “previously approved” in the definition of an innovative drug cannot turn on the extent to which the particular information relied on in the NDS had been previously disclosed.