Dockets: A-452-14
A-453-14
Citation:
2015 FCA 93
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CORAM:
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RYER J.A.
NEAR J.A.
RENNIE J.A.
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Docket:A-452-14
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BETWEEN:
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Viiv HEALTHCARE ULC,
Viiv HEALTHCARE UK LTD
AND GLAXO GROUP LIMITED
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Appellants
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and
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TEVA CANADA LIMITED
AND THE MINISTER OF HEALTH
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Respondent
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Docket:A-453-14
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BETWEEN:
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Viiv HEALTHCARE ULC,
Viiv HEALTHCARE UK LTD
AND GLAXO GROUP LIMITED
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Appellants
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and
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APOTEX INC
AND THE MINISTER OF HEALTH
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Respondents
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REASONS FOR JUDGMENT OF THE COURT
(Delivered from the Bench at Toronto, Ontario, on April 15, 2015)
NEAR J.A.
[1]
Before us are two appeals, A-452-14 and
A-453-14, that were consolidated and heard together in accordance with the
Order of Justice Boivin dated November 21, 2014.
[2]
These appeals concern the eligibility for
listing of Canadian Patent No. 2,289,753 (the ’753 Patent) against KIVEXA, a
drug marketed by ViiV Healthcare ULC, ViiV Healthcare UK Ltd., and Glaxo Group
Limited (collectively, the appellants) under paragraph 4(2)(a) of the Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133 (Regulations).
[3]
For Reasons cited at 2014 FC 328, Prothonotary
Milczynski (the Prothonotary) found that the ’753 Patent was not eligible for
listing against KIVEXA. She issued orders to this effect in separate
proceedings involving the respondent Teva Canada Limited (Teva) and the
respondent Apotex Inc. (Apotex). In a decision made in respect of both Teva and
Apotex, Justice Hughes of the Federal Court (the Federal Court judge) upheld
the decisions of the Prothonotary (2014 FC 893). The appellants have appealed
from that decision.
[4]
The facts underlying these appeals are largely
not in dispute and were set out in some detail by both the Prothonotary and the
Federal Court judge. There is no need to extensively repeat them. KIVEXA is an
anti-retroviral fixed-dose combination (FDC) drug that contains two medicinal
ingredients: abacavir hemisulfate and lamivudine. The Minister of Health
(Minister) issued a Notice of Compliance (NOC) for KIVEXA on July 25, 2005.
[5]
The ’753 Patent was issued on January 23, 2007.
The invention described in the ’753 Patent relates to a novel salt of abacavir.
Claim 2, the claim at issue, expressly claims abacavir hemisulfate. On February
23, 2007, after reviewing the patent list filed by the appellants, the Minister
added the ’753 Patent to the register against KIVEXA.
[6]
Teva and Apotex each served a Notice of
Allegation on the appellants advising that they had filed an Abbreviated New
Drug Submission using KIVEXA as the Canadian reference product. Teva’s proposed
drug is “TEVA-abacavir/lamivudine” and Apotex’s proposed drug is
“APO-Abacavir-Lamivudine”.
[7]
The appellants commenced prohibition
applications against both Teva and Apotex under subsection 6(1) of the
Regulations. In their respective proceedings, both Teva and Apotex brought
motions under paragraph 6(5)(a) of the Regulations arguing that the ’753
Patent was not eligible for listing against KIVEXA.
[8]
The Prothonotary allowed both motions. In her
Reasons, she explained that, under the interpretation of paragraph 4(2)(a)
given in Gilead Sciences Canada Inc. v. Canada (Health), 2012 FCA 254, [2012]
F.C.J. No. 1259 (QL) [Gilead], the ’753 Patent did not have the degree
of product specificity required to be listed against KIVEXA.
[9]
The Federal Court judge heard the appeals from
these motions jointly, and dismissed both. In his Reasons, the Judge provided a
thorough review of the legislative framework and canvassed the relevant
jurisprudence. While his decision (and the decisions of the Prothonotary)
concerned multiple issues, the scope of these appeals is limited to one: the
eligibility for listing of the ’753 Patent against KIVEXA under paragraph 4(2)(a)
of the Regulations based on claim 2. On this issue, the Judge concluded that:
[89] … 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.
[10]
The issue in these appeals is whether Justice
Hughes erred in holding that the ’753 Patent is not eligible for listing
against KIVEXA under paragraph 4(2)(a) of the Regulations. Crucial to
this determination is whether Gilead is distinguishable, and, if not,
whether Gilead was correctly decided.
[11]
The parties agree that the question at issue –
the eligibility for listing on the register of a claim to a single medicinal
ingredient against an FDC drug containing more than one medicinal ingredient – is
a question of law. Thus, it is reviewable on the standard of correctness (Housen
v. Nikolaisen, 2002 SCC 33 at para. 8, [2002] 2 S.C.R. 235).
[12]
The appellants submit that the Federal Court
judge erred in three respects: he failed to appreciate the distinctions between
the case at bar and Gilead; he misinterpreted Bayer Inc. v. Canada
(Health), 2009 FC 1171, [2009] F.C.J. No. 1471 (QL); and he failed to apply
the principles of interpretation set out in Bristol-Myers Squibb Co. v.
Canada (Attorney General), 2005 SCC 26, [2005] 1 S.C.R. 533.
[13]
The respondents Teva and Apotex ask this Court
to dismiss the appeals. They submit that the Federal Court judge properly held
that Gilead is applicable to the case at bar, and that, as a result, the
’753 Patent is not listable against KIVEXA under paragraph 4(2)(a).
[14]
The Minister is also a party to these appeals.
The Minister’s position is that the ’753 Patent may be listed. The Minister
submits that Gilead is distinguishable, or alternatively, wrongly
decided.
[15]
In our view, both the Prothonotary and the
Federal Court judge correctly concluded that Gilead applies to the facts
of this case. In Gilead, this Court found that paragraph 4(2)(a)
of the Regulations sets an exacting threshold of specificity between what is
claimed in the patent and what has been approved in the NOC—a patent that does
not explicitly claim all of the medicinal ingredients contained in the drug for
which the NOC was issued cannot be listed against that drug.
[16]
In Gilead, the Court considered
the policy arguments put forward by the appellants and the Minister in this
matter with respect to the interpretation of paragraph 4(2)(a) and did
not accept them. Despite counsel’s submissions that the Court in Gilead
was dealing with a different, more complex situation, and not a simple compound
claim, we do not see how this alters the pivotal holding in Gilead with
respect to paragraph 4(2)(a). Further, the Federal Court judge, starting
at paragraph 50 of his Reasons, dealt extensively with the policy arguments
advanced by the appellants and the Minister and rejected the submission that
they in any way affect the applicability of the conclusion reached in Gilead to this case. We agree with his analysis.
[17]
The Court in Gilead comprehensively
addressed subsection 4(2) as a whole, and came to a conclusion inconsistent
with the position of the appellants in this case and inconsistent with the
policy of the Minister. Both the appellants and the Minister note in their
materials that the Minister has indicated for several years that she may amend
the Regulations to address the Gilead decision. The possibility of
amendment does not serve as a basis upon which to find that the interpretation
given to paragraph 4(2) as a whole, and to 4(2)(a) specifically, by the
Court in Gilead can be distinguished on the facts, as urged on us
by the appellants.
[18]
The Minister submitted an alternative argument
that Gilead was wrongly decided, but did not specifically argue that Gilead
was manifestly wrong in the way contemplated by Miller v. Canada
(Attorney General), 2002 FCA 370, 293 N.R. 391 [Miller]. In Miller,
the Court found that to overrule a decision of another panel of this Court, the
previous decision must be “manifestly wrong, in the sense that the Court
overlooked a relevant statutory provision, or a case that ought to have been
followed” (at para. 10). Accordingly, the question of whether Gilead is
manifestly wrong was not before us.
[19]
The appeals will therefore be dismissed, with
costs fixed in the amount of $5,000 in each appeal to be awarded to Teva Canada
Limited and $2,500 in each appeal to be awarded to Apotex Inc.
[20]
A copy of these reasons shall be placed on each
file.
"D.G.Near"
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