Date: 20070615
Docket: T-1232-05
Citation: 2007 FC 642
Ottawa, Ontario, June 15,
2007
PRESENT: The Honourable Mr. Justice Phelan
BETWEEN:
PFIZER
CANADA INC.
Applicant
and
THE
MINISTER OF HEALTH and APOTEX INC.
Respondents
and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Respondent/Patentee
REASONS FOR JUDGMENT AND JUDGMENT
I. INTRODUCTION
[1]
This
is an application by Pfizer Canada Inc. (Pfizer) for an order declaring that
(a) a letter of undertaking not to use the product for a particular purpose is
not part of a Notice of Allegation as contemplated by the Patented Medicines
(Notice of Compliance) Regulations and therefore the Notice of Allegation
is insufficient for purposes of granting a Notice of Compliance, and (b) in the
alternative, an order prohibiting the Minister of Health from issuing a Notice
of Compliance to Apotex Inc. (Apotex) for quinapril until the expiry of
Canadian Patent No. 2,023,089 (089 Patent).
[2]
At
the centre of Pfizer’s contention is (a) that Apotex’s Notice of Allegation
(NOA) is insufficient in that it contains evidence as to intended use
infringing the 089 Patent which cannot be rectified by an undertaking not to
engage in infringing use and (b) that Apotex’s quinapril will be used by
physicians and patients in ways which will infringe Pfizer’s 089 Patent.
II. FACTUAL
BACKGROUND
[3]
Accupril
is the brand name of a drug product marketed by Pfizer containing quinapril as
the active ingredient. Quinapril belongs to a class of drugs called ACE
inhibitors. Accupril is approved in Canada for the treatment of
hypertension and congestive heart failure.
[4]
Apo-Quinapril
is the name of a drug product which Apotex intends to make, use and sell in 5,
10, 20 and 40 mg. doses. The Apo-Quinapril draft product monograph and draft
labels stated that Apo-Quinapril is intended to be used for both hypertension
and congestive heart failure. Whether this is an accurate statement of intended
use and the consequences of its accuracy or otherwise is a central issue in
this proceeding.
[5]
Pfizer’s
089 Patent limits the claims to the treatment of cardiac and vascular
hypertrophy and hyperplasia by administration of angiotensin converting enzyme
(ACE) inhibitors (“Patented Use”).
[6]
Apotex’s
NOA alleges that it would not infringe the 089 Patent because it would not
make, use or sell Apo-Quinapril for the Patented Use – the treatment of cardiac
or vascular hypertrophy and hyperplasia - and it undertakes that it will only
make, use or sell the Apo-Quinapril for the treatment of hypertension. The NOA
also alleged invalidity but that allegation has not been pressed and is treated
as abandoned.
[7]
Congestive
heart failure is a common ailment whereas cardiac hypertrophy is quite rare.
Cardiac hypertrophy may be, but is not necessarily, “co-morbid” (exist
together) with congestive heart failure. There are many instances where the
congestive heart failure exists without hypertrophy.
[8]
In
the arguments before this Court, the conditions of vascular hypertrophy and vascular
and cardiac hyperplasia played no significant role.
[9]
The
Patented Use for cardiac and vascular hypertrophy and hyperplasia has not been
approved by the Minister of Health under the Food and Drug Regulations.
Therefore, even Pfizer cannot sell Accupril for use in the treatment of these
conditions.
[10]
The
root of the problem in this case is that the NOA stated that Apo-Quinapril
would only be used for hypertension whereas the draft product monograph and
draft labels as well as the Abbreviated New Drug Submission (ANDS) all referred
to the intended use for hypertension and congestive heart failure.
[11]
The
NOA of June 3, 2005 is quite specific as to its non-use for the Patented Use:
There will be no infringement because our
tablets will be made, used and sold only as an ACE inhibitor for treatment of
hypertension. More particularly, we will not make, use, or sell for treatment
of cardiac and/or vascular hypertrophy and/or hyperplasia.
More particularly, we undertake that we
will ensure that, in our Product Monograph issued with our Notice of
Compliance, we will ensure that the only indication is for treatment of
hypertension and that any use for treatment of cardiac and/or vascular
hypertrophy, and/or hyperplasia is excluded.
This NOA was signed by the Chairman and
CEO of Apotex.
[12]
It
has been Pfizer’s contention that the allegations in Apotex’s NOA are
insufficient because of the inconsistency between the NOA letter of June 3,
2005 and the draft product monograph, and draft labels filed with the Minister
of Health. Pfizer further contends that the allegation of non-infringement is
unjustified because Apotex will be marketing Apo-Quinapril to treat congestive
heart failure which will treat cardiac hypertrophy in some cases because of the
close relationship between the two conditions.
[13]
Therefore,
the two issues to be addressed are:
(a) the
sufficiency of the NOA; and
(b) the
allegation of non-infringement of the 089 Patent.
III. ANALYSIS
A. Sufficiency
of NOA
[14]
The
purpose of the NOA is to frame the factual and legal issues with sufficient
particularity that a potential applicant in this Court can know whether and how
to rebut the allegations of non-infringement (or other grounds as the case may
be).
[15]
As
confirmed in Pharmascience Inc. v. Sanofi-Aventis Canada Inc., 2006 FCA
229, “insufficiency” is used in two senses:
·
primary – whether
there is sufficient information in the NOA to know whether to seek a
prohibition order; and
·
secondary – whether a
non-infringement allegation is not justified because it fails to address a
relevant patent claim or because it is not capable of establishing non-infringement.
[16]
Pfizer
does not allege primary insufficiency. It knew enough from the NOA to know
whether to seek a prohibition order. Pfizer’s actions in vigorously opposing
Apotex, as it is entitled to do, establishes that it knew what it had to do.
[17]
The
Applicant’s complaint of insufficiency is of the secondary type. It says that
the Respondent’s NOA is deficient and inaccurate because its undertaking to use
Apo-Quinapril for hypertension ignores the fact that it intends to use it for
congestive heart failure (which arguably includes hypertrophy) as evidenced by
the drafts of the product monograph and labels.
[18]
The
Applicant relies extensively on AB Hassle v. Canada (Minister of
National Health and Welfare) (2000) 7 C.P.R. (4th) 272 (F.C.A.)
to argue that a “second person” – Apotex – cannot add facts to those contained
in the detailed statement. The Applicant takes the position that the
“Undertaking” contained in the NOA restricting the use of Apo-Quinapril to
hypertension is an addition to the detailed statement and is not permitted.
[19]
However,
this AB Hassle decision was based on the principle that the detailed
statement had to be sufficiently clear that it would allow a first person to
decide whether to contest the Notice of Compliance. The Court of Appeal discussed
the problem of adding new facts and evidence to the NOA which are different
from those contained in the detailed statement. In that case, the second person
was adding new prior art in the Notice of Compliance proceeding.
[20]
The
Court of Appeal was concerned about the prejudice caused to the first person by
having to deal with a Notice of Compliance on a piecemeal basis, the potential
for delay in proceedings that have a 24-month time frame and the need for
expeditious dealing with the matter.
[21]
None
of those factors exist in this instance. There is no question that the
Applicant had sufficient information to decide whether to contest the Notice of
Compliance. There has been no evidence of prejudice. The Undertaking given in
the NOA and confirmed at the Court hearing withdraws a potential area of
dispute, and does not add to the issues in dispute. The Undertaking should have
had the effect of shortening the Notice of Compliance proceeding by withdrawing
an area of contention.
[22]
Taken
to its logical conclusion, the Applicant’s position is that any variance
between the detailed statement and other parts of the NOA constitutes
insufficiency and therefore results in the granting of a prohibition order. The
position ignores the type of variance and the purposes underlying the
principles of sufficiency. There is no reason in this case, applying the
principles of sufficiency, to find against the Respondent.
[23]
Pfizer
also attacks the Undertaking as being inaccurate in that Apotex will infringe
the 089 Patent. It says so because Apo-Quinapril will be used to treat
hypertrophy and hypertrophy is co‑morbid with congestive heart failure –
in this case, the treatment of one is the treatment of the other.
[24]
The
Applicant’s position in this regard is more related to the issue of
infringement than to the issue of sufficiency. The challenge to the Undertaking
and its force and effect is answered in two ways – (a) it is an undertaking
signed by Apotex’s CEO and binding on the company, and (b) the undertaking can
be incorporated in any Notice of Compliance issued by the Minister.
[25]
Pfizer
has also complained that Apotex has added to the NOA in terms of factual and
legal proposition. (However, these facts and legal proposition arose in
response to Pfizer’s contentions.) As held in AstraZeneca AB v. Apotex
Inc.
(2005), 335 N.R. 1 by Evans J.A.:
11. …
A second person should not be required to anticipate every theory of possible
infringement, however speculative, in the detailed statement supporting its
allegations.
[26]
Therefore,
Apotex’s NOA is not “insufficient” or otherwise inadequate. The Court must then
turn to the issue of non-infringement of the 089 Patent.
B. Non-Infringement
[27]
There
is no issue that if Apotex’s sale of Apo-Quinapril was for hypertension only,
there is no basis of infringement. The contentious area is in respect of the
treatment of congestive heart failure and the derivative use that may be made
of Apo-Quinapril.
[28]
Pfizer
contends that because Apotex’s draft product monograph included an indication
for “congestive heart failure” and those with congestive heart failure may (but
not necessarily do) suffer from hypertrophy, use for congestive heart failure
will infringe the 089 Patent.
[29]
It
is well established that incidental treatment of a patented use through the
administration of medicine to treat a non-patented use is not grounds, on its
own, to grant prohibition (see H. Lundbeck A/S v. Canada (Minister of
Health)
(2004), 30 C.P.R. (4th) 97). Pfizer accepts that in order to
succeed, it must show “something more” than non-patented use. In this case, that
“something more” is the product labels and draft product monograph which
include treatment for congestive heart failure which will induce use for which
there is patent protection.
[30]
Firstly,
it is my view that the Undertaking in the NOA is a complete answer to that
allegation. The completeness of that answer is reinforced by the incorporation of
the Undertaking in any Notice of Compliance issued. Apotex would be limited to
selling Apo-Quinapril for use in the treatment of hypertension only, and will
have to modify the draft product monograph and draft labels so that the only
indication for Apo-Quinapril is hypertension.
[31]
Secondly,
if physicians engage in “off label” use by prescribing Apo-Quinapril for
something other than the approved use, Apotex can only be said to infringe the
089 Patent if it is implicated in inducing the infringing use by a physician or
pharmacist. This liability has been made clear in the Federal Court of Appeal’s
recent decision of Sanofi-Aventis Canada Inc. v. Novopharm Ltd., 2007
FCA 167:
10. … Unless Novopharm
is so implicated, the infringement by the physician or pharmacist would not be
the kind of infringement that can support the granting of a prohibition order
under the NOC Regulations.
11. A generic
drug manufacturer may be implicated in the infringement by others of a claim
for a new use of a medicine if the generic drug manufacturer induces that
infringement. Infringement by inducement may be established, for example, by
inferences reasonably drawn from the contents of the product monograph for the
generic drug product, or evidence relating to the dosage form of the generic
product, or its labelling or marketing. However, an inducement to infringe
generally cannot be inferred from a mere reference to the new use in the
product monograph, for example, in the course of explaining contraindications
or drug interactions, or as part of a list of scientific references.
[32]
There
is no evidence that Apotex will actively induce physicians to prescribe quinapril
pills to treat hypertrophy. Quite apart from any limitations imposed on the Notice
of Compliance by virtue of the undertaking, if the 089 Patent covered a valid
use of the drug, one would have thought Pfizer would have used its patent
rights to do so. However, that specific use has not been approved by Health Canada.
IV. CONCLUSION
[33]
Pfizer
has attempted to use the 089 Patent, restricted to hypertrophy and hyperplasia,
to prevent Apotex’s drug from coming to market despite the failure of Pfizer to
obtain authority to sell its own drug for the Patented Use. Such a result would
allow a non-using monopoly holder to prevent a lower cost drug from coming to
market.
[34]
This
was never the intention of the legislation. Justice Sexton in AB Hassle Inc.
v. Canada (Minister of
National Health and Welfare) (2002), 22 C.P.R. (4th) 1
(F.C.A.) commented on this policy issue and the potential for societal harm as
follows:
57. Thus Apotex
cannot be prevented from obtaining a NOC solely on the basis that it will sell
omeprazole. If it were otherwise, then serious policy issues would arise. If
there was any likelihood that a patient would consume a generic product for a
patented use, then the generic product would not be approved. This would
prevent new uses from being approved for existing drugs because there is always
the possibility that someone somewhere will use the drug for the prohibited,
patented purpose. This would result in a real injustice: since a generic
company cannot possibly control how everyone in the world uses its product, the
prevention of the generic from marketing the product would further fortify and
artificially extend the monopoly held by the patent holders. The patent holder
would, therefore, effectively control not just the new uses for the old compound,
but the compound itself, even though the compound itself is not protected by
the patent in the first place. The patent holders, as a result, would obtain a
benefit they were not meant to have. In the end, society would be deprived of
the benefit of new methods of using existing pharmaceutical medicines at a
lower cost.
[35]
For
these reasons, this application will be dismissed with costs. Any Notice of
Compliance to be issued shall contain a condition consistent with the
Undertaking contained in the NOA letter of June 3, 2005.
JUDGMENT
THIS COURT
ORDERS AND ADJUDGES that this
application will be dismissed with costs. Any Notice of Compliance to be issued
shall contain a condition consistent with the Undertaking contained in the NOA
letter of June 3, 2005.
“Michael
L. Phelan”
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