Date: 20070329
Docket: T-243-06
Citation: 2007
FC 340
Toronto, Ontario, March 29, 2007
PRESENT: The Honourable Mr. Justice Hughes
BETWEEN:
WYETH
CANADA and WYETH
Applicants
and
RATIOPHARM INC. and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
[1]
This is a
motion brought by the Respondent ratiopharm to dismiss this application for
judicial review brought by the Applicants Wyeth under the Patented Medicines
(Notice of Compliance) Regulations SOR/93-133 (NOC Regulations). The
motion seeks to challenge the listing of a patent in respect of certain Notices
of Compliance (NOC) issued to Wyeth for its drug known as EFFEXOR XR. The
motion was brought under the provisions of both sections 6(5)(a) and (b) of
those Regulations as amended October 5, 2006. Counsel for ratiopharm has
restricted the grounds to those arising only under 6(5)(a). For the reasons
that follow I find that the motion is to be dismissed in respect of certain NOC
listings and not others.
[2]
Section
6(1)(a) of the NOC Regulations as amended October 5, 2006 permits a second person
such as ratiopharm to make a motion to this Court to dismiss the application in
whole or in part in respect of those patents that are not eligible for
inclusion on the register as listed in respect of certain NOCs issued to the
first party Wyeth. This is not a ground which a second party can raise prior
to the institution of Court proceedings in its notice of allegations to a first
party (compare section 5(1)(b) of the NOC Regulations). A
generic drug company that may, at some time, become a second party has no
status to challenge the listing of a patent on the register in the absence of
pending proceedings under the NOC Regulations (Apotex v. Canada (Minister of Health and
Welfare),
(2003), 3 CPR (4th) 1 (FCA)).
[3]
The basis
upon which the Court will proceed under a section 6(1)(a) motion was recently
reviewed in Pfizer Canada Inc. v. Canada (Minister of Health), 2007 FC
187. Where the law can be applied to admissions and relevant evidence that is
reasonably found to be undisputed or plain and obvious, the Court has a duty to
make a determination.
[4]
On this
motion, ratiopharm, has not raised any issue that it is not a “second party”.
It challenges the listing of Canadian Patent number 2,199,778 (the ‘778 patent)
by Wyeth on the Register kept by the Minister of Health under the provisions of
section 3(1) of the NOC Regulations as listed against several NOCs issued to
Wyeth.
[5]
Section
4(2) of the NOC Regulations sets out the criteria to be met for listing a patent
on the Register kept by the Minister. The NOC Regulations were amended
effective October 5, 2006, however, the Transitional Provisions, section 6
provide that patents listed prior to June 17, 2006 (such as the ‘778 patent)
are to be governed by the pre-amendment provisions of section 4 of the NOC
Regulations.
[6]
The ‘778
patent was granted on December 20, 2005 and contains 30 claims many of which
pertain to an extended release formulation of a drug known as venlafaxine
hydrochloride without any restriction as to use. Claim 1, for example, reads
as follows:
An extended release
formulation of venlafaxine hydrochloride comprising a composition containing
spheroids comprised of venlafaxine hydrochloride, microcrystalline cellulose
and hydroxypropylmethylcellulose, the spheroids being coated with a film
coating comprising ethyl cellulose and hydroxypropylmethylcellulose.
[7]
Other
claims such as Claim 29 are directed to the use of the extended release
formulation of venlafaxine in the treatment of depression with diminished
levels of nausea and emesis. Claim 29 reads (as corrected by a certification
of correction):
Use of an extended release
formulation of venlafaxine hydrochloride for the treatment of depression with
diminished levels of nausea and incidences of emesis, wherein, in use, the
formulation provides a therapeutic blood plasma concentration of venlafaxine
over a twenty four hour period and wherein the formulation eliminates the
troughs and peaks of drug concentration in blood plasma and provides a peak
blood plasma concentration of venlafaxine in from about four to about eight
hours, and a peak blood plasma level of no more than about 150 ng/ml.
[8]
Wyeth has
obtained a number of Notices of Compliance (NOC) for its medicine containing venlafaxine
hydrochloride sold under the name EFFEXOR and EFFEXOR XR, the first of which
was issued on July 18, 1994. A number of NOC have subsequently been issued to
Wyeth based on Supplementary New Drug Submissions. There are eight such
further NOCs issued since July 18, 1996 up to September 1, 2005.
[9]
The ‘778
patent was submitted by Wyeth to the Minister for listing on the Register the
same day it was granted, December 20, 2005. Listing of the patent was made as
against six different NOCs granted to Wyeth, the earliest of which was
submitted March 14, 2003, with subsequent NOCs granted on dates ranging up to
September 1, 2005.
[10]
The basis
for ratiopharm’s argument that the ‘778 patent was improperly listed rests upon
its argument that the various NOCs against which that patent was listed have
nothing to do with the patented invention.
[11]
Wyeth
argues that it has six NOCs against which the ‘778 patent is listed. One NOC,
it agrees, is administrative only in nature, a manufacturer name change.
Wyeth places no reliance upon it. Some of the others, including one that
relates to nausea reduction and another that relates to maintenance of major
depression, Wyeth argues, are sufficient to sustain the listing of the ‘778
patent.
[12]
The
Federal Court of Appeal in Hoffman-LaRoche Ltd. v. Canada (Minister of
Health), 2006 FCA 335 released October 18, 2006 reviewed the decisions of both
this Court and that Court in which consideration was given as to whether a
particular S/NDS and the resulting NOC could sustain the listing of a
particular patent. This decision was released about two weeks before the
decision of the Supreme Court of Canada in AstraZeneca Canada Inc. v. Canada
(Minister of Health),[2006] 2 S.C.R. 560, 2006 SCC 49.
[13]
In Hoffman-LaRoche,
supra, paragraph 15, the Federal Court of Appeal said that a supplement
to a new drug submission (S/NDS) may or may not be a sufficient foundation for
the filing of a new or amended patent list, depending upon why the supplement
was filed. Thus a change to a brand name for the drug, or change in a
manufacturing site or merger of corporations giving rise to a change of the
manufacturer were held to be incapable of supporting an addition of a patent to
a list. On the other hand a new indication for an existing drug or particular
changes in a product monograph to cross-reference a supplier of a combination
drug were held to be sufficient to sustain the listing of a patent. In Hoffman-LaRoche
the Court held in the circumstances of that case that it would be improper to
list a patent in respect of an S/NDS which reflected the acquisition by the
first party of part of the business relating to drug products of a third party.
[14]
What is
important to learn from Hoffman LaRoche is not any detail as to what could or
could not sustain the listing of a patent. Rather, it is the fact that the
Court held that some S/NDS’s and resultant NOCs would sustain such a listing
and others not. An inquiry must be made in each circumstance.
[15]
The nature
of that inquiry depends on the use of the term “relevance”. Section 4(7)(b) of
the NOC Regulations uses that word in connection with a statement that the
first party has to make that the patent sought to be listed in “relevant to the
dosage form, strength and route of administration of the drug.” That is not
the issue here.
[16]
The issue of
“relevance” was considered by the Federal Court of Appeal in Eli Lilly
Canada Inc. v. Canada (Minister of Health), [2003] 3 FC 140, a decision
subsequently referred to in AstraZeneca by the Supreme Court. In Eli
Lilly the Federal Court of Appeal considered section 4(7)(b) of the NOC
Regulations and the position taken by the Minister that “relevance” required a
relationship between the drug named in the notice of compliance and the patent
sought to be listed, Sharlow, J.A. for the majority (there was a dissent) said
at paragraphs 28 to 30.
28
I need not analyse the requirements of paragraph 4(7)(b) in any detail. I
understand that counsel for the Minister has not taken the position that the
'969 patent is not "relevant to the dosage form, strength and route of
administration" of Tazidime.
29
Based on the foregoing ordinary and grammatical reading of the PM(NOC)
Regulations, the '969 patent should be eligible for inclusion on the patent
lists for Tazidime. That is the interpretation that should be adopted unless
the words of the PM(NOC) Regulations can reasonably bear a different meaning
that would accord better with the purpose of the PM(NOC) Regulations.
30
Counsel for the Minister argued that the PM(NOC) Regulations require a relationship,
which he referred to as "relevance", between the drug named in the
notice of compliance and the patent sought to be included in the patent
register. He submitted that the requisite relationship does not exist if the
invention disclosed in the patent is not somehow included or embodied in the
drug. In this case, for example, it is undisputed that Tazidime makes no use of
the invention disclosed in the '969 patent. It is in this sense that counsel
for the Minister argues that the '969 patent is not "relevant" to the
notice of compliance for Tazidime.
[17]
The
Minister’s argument was rejected by the majority of that Court for two reasons,
first the wording of section 4(7)(b) did not require consideration of any
relationship between the drug named in the notice of compliance and the patent
sought to be listed. Second, they held that the first party should be able to list
a patent that had the potential of preventing infringement. Sharlow, J.A. said
at paragraphs 34 to 36:
34
I am unable to read those words as the Minister argues they should be read.
Subsection 4(1) addresses the question of who may submit a patent list, not the
permitted contents of the patent list. Similarly, the emphasized words in
paragraph 4(7)(b) do not describe any relationship between the drug named in
the notice of compliance and the patents that may be included on the patent
list. Rather, "the drug in respect of which the submission for a notice of
compliance has been filed" is, simply, Tazidime.
35
According to Eli Lilly, the Minister's interpretation would tend to defeat the
objectives of the PM(NOC) Regulations. It is theoretically possible that a
generic drug manufacturer could produce a drug consisting of a formulation of
ceftazidime and amorphous lactose that is bioequivalent to Tazidime (even
though it would not be exactly the same as Tazidime because Tazidime does not
contain amorphous lactose). Such a product could infringe the '969 patent. If
the '969 patent is not permitted to stay on the patent lists for Tazidime, Eli
Lilly will be deprived of its right to apply to stop the issuance of a notice
of compliance for the new drug until after the expiry of the '969 patent.
[page159] If that happens, the PM(NOC) Regulations will not have been permitted
to operate as intended. I note that a similar argument was accepted in Apotex
Inc. v. Canada (Minister of Health) (1999), 87
C.P.R. (3d) 271 (F.C.T.D.), but only in obiter dicta, in the context of the
PM(NOC) Regulations before the 1998 amendments.
36 On
balance, it seems to me that the interpretation propounded by Eli Lilly should
be favoured over the interpretation propounded by the Minister, for two
reasons. First, it is more consistent with the words of the PM(NOC)
Regulations. Second, it has at least the potential of preventing infringement
of the '969 patent, while the Minister's interpretation cannot possibly have
that result.
[18]
This
decision was put to the Supreme Court of Canada in AstraZeneca and particularly
commented upon by that Court in paragraph 23 of its unanimous reasons. That
Court emphasized that particular patents are to be linked to particular
submissions. It is clear that the Supreme Court did not approve the listing of
patents simply because the drug was the same and rejected the Federal Court of
Appeal’s analysis in Eli Lilly. They said:
23 AstraZeneca
relies on Eli Lilly Canada Inc. v. Canada (Minister of Health), 2003 FCA 24
(CanLII), [2003] 3 F.C. 140, 2003 FCA 24, for the proposition that a patent
list is submitted in respect of a drug and not in respect of any particular
submission. This is also the view taken by the majority judgment of the
Federal Court of Appeal in this case. On this view a “first person” could
carry on “evergreening” its product indefinitely by the addition of new patents
of marginal significance which would trigger an indefinite series of 24-month
statutory freezes even though such subsequently listed patents are not the
subject of “early working” by the generic manufacturer, and from which (as in
the circumstances here) the generic manufacturer derives no advantage. As this
case further illustrates, AstraZeneca even managed to piggy-back the 037 and
470 patents onto an administrative SNDS. An interpretation that would freeze
the generic product out of the market vacated by AstraZeneca in 1996 for a
further two years or more in these circumstances flies in the face of the limited
purpose authorized by s. 55.2(4) of the Patent Act. It is not to be presumed
that s. 4(5) of the NOC Regulations insisted on linking particular patents to
particular submissions for no purpose.
[19]
Paragraphs
39 and 40 of the AstraZeneca reasons serve to emphasize that the Supreme
Court requires that, in order to list a patent, it had to be relevant to the
NOC against which it is to be listed:
39
... In my view, s. 5(1) of the NOC Regulations requires a patent-specific
analysis, i.e. the generic manufacturer is only required to address the cluster
of patents listed against submissions relevant to the NOC that gave rise to the
comparator drug, in this case the 1989 version of Losec 20.
40 If
AstraZeneca had brought to market a Losec 20 product pursuant to the later NOCs
and if Apotex had made reference to that modified product for the purpose of
demonstrating bioequivalence, Apotex would have been required to file a notice
of allegation with respect to the 037 and 470 patents.
[20]
The use of
the words “comparator drug” and “modified product” by the Supreme Court
indicate that the NOC and the listed patent be related in the manner proposed
by the Minister in Eli Lilly. A relationship is required, that is,
“relevance” between the drug named in the notice of compliance and the patent
sought to be listed.
[21]
The
question then arises as to how that relationship is established. The Supreme
Court of Canada in Bristol-Myers Squibb
Co. v. Canada (Attorney General), [2005] 1 S.C.R. 533 (Biolyse)
discussed this issue. Binnie, J. for the majority of paragraph 53 cautions
that it is not every use of a patented invention that will trigger the NOC
Regulations:
53
Secondly, it is not every use of the patented invention that will trigger the
NOC Regulations. Section 55.2(4) is specifically directed to preventing
infringement by persons who use “the patented invention” for the “early
working” exception and the “stockpiling” exception set out earlier in ss.
55.2(1) and 55.2(2). That is all the Governor in Council is authorized to
regulate. (The stockpiling exception was repealed by S.C. 2001, c. 10, s.
2(1); assented to June 14, 2001.)
Binnie J. pointed out in paragraph 52 of Biolyse that
regard is to be given to the patented invention which is not necessarily
co-extensive with the patent claims. The Regulations are directed to
the “patented invention”:
Firstly,
the regulations are to be directed to persons who are making use of the
“patented invention”. As pointed out by this 52 Court in Monsanto Canada Inc.
v. Schmeiser, 2004 SCC 34 (CanLII), [2004] 1 S.C.R. 902, 2004 SCC 34, the
patented invention is not necessarily co-extensive with the patent claims. The
distinction was critical in that case to the issue of remedy. While farmer
Schmeiser had used the patented product (Roundup Ready Canola seed), he had not
taken advantage of the patented invention (its herbicide resistant property)
because he had not sprayed his crop with Roundup. The Court thus rejected
Monsanto’s claim to Schmeiser’s profits from his canola crop.
The
difficulty with the trial judge’s award is that it does not identify any causal
connection between the profits the appellants were found to have earned through
growing Roundup Ready Canola and the invention. On the facts found, the
appellants made no profits as a result of the invention. [Emphasis in
original; para. 103.]
The
use of the expression “patented invention” in s. 55.2 is therefore an important
clue to the scope of the regulations it authorizes to be made. BMS did not
invent or discover paclitaxel.
[22]
Given AstraZeneca
and Biolyse it can be seen that what the Minister must do under section
3(1) of the pre-October 5, 2006 NOC Regulations for purposes of determining
whether a patent is to be listed as against a particular NOC is to look at the
“patented invention” and determine if there is a “relationship” between that
“patented invention” so as to make it “relevant” to the particular NOC against
which it is sought to be listed or, if listed, to be de-listed.
[23]
Taking
this approach, the ‘778 patent will be examined to determine what the “patented
invention” (not necessarily the claim) is. Turning to the specification at
page 1, line 32 to page 2, line 7, the previously known drug form (prior art),
is described as a tablet which, because it releases the medicine quickly, is
known to cause nausea and vomiting:
Venlafaxine, 1-[2-dimethylamino)-1-(4-methoxphenyl)ethyl]cyclohexanol,
is an important drug in the neuropharmacological arsenal used for treatment of
depression. Venlafaxine and the acid addition salts thereof are disclosed in US patent 4,535,186.
Venlafaxine hydrochloride is presently administered to adults in compressed
tablet form in doses ranging from 75 to 350 mg/day, in divided doses two or
three times a day. In therapeutic dosing with venlafaxine hydrochloride
tablets, rapid dissolution results in a rapid increase in blood plasma levels
of the active compound shortly after administration followed by a decrease in
blood plasma levels over several hours as the active compound is eliminated or
metabolized, until sub-therapeutic plasma levels are approached after about 12
hours following administration, thus requiring additional dosing with the
drug. With the plural daily dosing regimen, the most common side effect is
nausea, experienced by about 45 percent of patients under treatment with
venlafaxine hydrochloride. Vomiting also occurs in about 17 percent of the
patients.
[24]
There
follows, at page 2, a brief description of the invention, it is an
encapsulated formulation that provides release of the medicine over a twenty-four
hour period. At lines 12 to 15:
In accordance with this
invention, there is provided an extended release (ER), encapsulated formulation
containing venlafaxine hydrochloride as the active drug component, which
provides in a single dose, a therapeutic blood serum level over a twenty-four
hour period.
[25]
The use of
this formulation as described at page 2, lines 28 to page 3, line 2, provides a
moderation of blood plasma peaks and valleys and reduction of nausea and emesis:
Hence, in accordance with the
use aspect of this invention, there is provided a method for moderating the
plural blood plasma peaks and valleys attending the pharmacokinetic utilization
of multiple daily tablet dosing with venlafaxine hydrochloride which comprises
administering to a patient in need of treatment with venlafaxine hydrochloride,
a one-a-day, extended release formulation of venlafaxine hydrochloride.
The use of the one-a-day
venlafaxine hydrochloride formulations of this invention reduces by adaptation,
the level of nausea and incidence of emesis that attend the administration of
multiple daily dosing. In clinical trials of venlafaxine hydrochloride ET, the
probability of developing nausea in the course of the trials was greatly
reduced after the first week.
[26]
Claim 1, previously
set out, is a broad claim directed to a formulation of the medicine in coated
spheroid form. Claims 16 and 17 are directed to encapsulation of those
spheroids. None of claims 1 to 21 claim any particular use or benefit. Claim
22 however claims that the formulation “provides diminished levels of nausea
and incidence of emesis.” Claims 23 to 25 and 29 and 30 are directed to
the use of the formulation “for treating depression providing diminished
levels of nausea and incidence of emesis” and contains certain blood plasma
level profites.
[27]
Thus, the
“patented invention” for purposes of the NOC Regulations can be seen to be a
formulation of a known medicine in spheroids suitable for encapsulation such as
to enable relatively uniform release of the medicine into the body over a
twenty-four hour period so as to reduce nausea and emesis.
[28]
The next
step is to review the NOCs issued for the drug. They are indicated in the Table
below with an asterisk beside the NOCs against which the ‘778 patent is
presently listed.
|
Submission No.
|
Submission Date
|
NOC Date
|
Description
|
|
|
October
21, 1991
|
July
18, 1994
|
New
Drug: EFFEXOR Tablets
|
|
|
December
23, 1996
|
February
16, 1998
|
New
Dosage Form: EFFEXOR XR Capsules
|
|
|
|
September
28, 1999
|
New
indication: symptomatic relief of anxiety in patients with generalized
anxiety disorder
|
|
082937
|
February
21, 2003
|
March
14, 2003
|
Manufacturer
name change *
|
|
070529
|
August
9, 2000
(or
March 1, 2001)
|
April
25, 2003
|
New
indication: Maintenance Treatment of Major Depressive Disorder *
|
|
074443
|
October
10, 2001
|
June
13, 2003
|
New
Indication: Social Anxiety Disorder *
|
|
083387
|
February
25, 2003
|
September
13, 2004
|
Revisions
to the product monograph regarding nausea
reduction *
|
|
088901
|
November
14, 2003
|
December
10, 2004
|
“description
of clinical trial in treatment of SAD”: submission of additional long and
short term safety and efficacy data for cleared indication *
|
|
094252
|
Sep
22, 2004
|
Sep
1, 2005
|
New
indication: symptomatic relief of panic disorder *
|
[29]
The first
of these, that issued July 18, 1994 relates to the “prior art”, the old tablet
form.
[30]
The second
of these, issued February 16, 1998, relates to the new encapsulated form. The
‘778 patent is not listed against that form. At the time of submission,
December 23, 1996, the application for the ‘778 patent had not been filed in Canada. A priority application had
been filed in the United States Patent Office on March 29, 1996 but the
Canadian application had not been filed until March 12, 1997. It is only the
Canadian filing date that will trigger the right to list a patent under the NOC
Regulations, (Pfizer Canada Inc. v. Canada (Attorney General) 2003 FCA
138 at paragraph 13). I pause here to comment on my Reasons in Ferring Inc.
v. Canada (Minister of Health) 2007 FC 300 at paragraph 43 where I spoke,
in the last sentence of the deemed filing date according to PCT obligations.
Counsel argued in the present motion that since the PCT date could also refer
to the priority date in some circumstances, I must have been speaking of the
priority date. Definitely not so, I was speaking of the deemed Canadian filing
date.
[31]
Thus the most
logical NOC against which to list the ‘778 patent was unavailable because the
Canadian patent application had not been filed before the application for the
NOC, thus section 4(4) of the NOC Regulations precluded filing.
[32]
The ‘778
patent was listed as against the remaining six NOCs. Wyeth’s counsel concedes
that the NOC issued March 14, 2003 directed to a manufacturer’s name change
does not, as the jurisprudence reviewed in Hoffman-LaRoche bears,
support a valid listing. Of the remaining five, Wyeth’s counsel raised issues
only as to two, that of April 25, 2003 directed to a new indication,
“Maintenance Treatment of Major Depressive Disorder” and September 13, 2004,
“Revisions to the product monograph regarding nausea reduction.” The remaining
three, on the uncontradicted evidence of ratiopharm’s expert witness, Dr.
Schneider, do not bear any relationship to the ‘778 patent.
[33]
As to
“Maintenance Treatment of Major Depressive Disorder” Dr. Schneider
distinguished between “maintenance” and “single episode” or “recurrent”
disorders. He referred to examples in the ‘778 patent and opined at paragraphs
33 to 35 of his affidavit that those examples would not lead a psychiatrist or
physician to conclude that “maintenance” was under consideration.
[34]
Wyeth’s
counsel argues that Wyeth’s product monograph in the section entitled “Indications
and Clinical Use” expressly states that the drug is to be used for “symptomatic
relief of major depressive disorder” and “maintaining an anti-depressive
response”. Wyeth further argues that claims 23 to 30 of the ‘778 patent
include a direct reference to the treatment of depression.
[35]
As to the
NOC respecting “Revisions to the Product Monograph regarding nausea reduction”,
those revisions are additions at pages 6 and 11 to the revision dated December
7, 2004. They are:
At page 6:
Results of testing in healthy
volunteers demonstrated differences in the gastrointestinal tolerability of
different formulations of venlafaxine. Data from healthy volunteers showed
reduced incidence and severity of nausea with EFFEXOR XR capsules, compared
with immediate release tablets.
At page 11:
Analysis of safety data from
this trial showed that the incidence of treatment-emergency nausea and nausea
severity over time were lower with EFFEXOR XR than with immediate release
tablets. Additionally, the incidence of vomiting was lower with EFFEXOR XR
than with immediate release tablets.
[36]
Counsel
for ratiopharm argues that these changes to the product monograph were insubstantial
and did not serve the support a “relationship” between the “778 patent and that
particular NOC. Wyeth’s counsel argued that the changes were specific to
nausea and emesis and were clearly related to the patented invention.
[37]
The
jurisprudence as reviewed by the Federal Court of Appeal in Hoffman-LaRoche,
supra, particularly at paragraphs 19 and 20 in dealing with a product
monograph indicates that bona fide substantive changes to a product
monograph can sustain a patent listing against the related NOC. Further,
consideration must be given to the expertise of the Minister as stated by the
Federal Court of Appeal in Abbott Laboratories v. Canada (Minister of
Health) (2004), 31 C.P.R. (4th) 321 at paragraph 21, questions
of law are reviewable on a correctness standard while questions of fact and
factual inferences are reviewed on the palpable and overriding standard.
[38]
While it
can reasonably be said that the law is in a state of flux in this area, the law
as it now stands directs the Minister to determine if there is a “relationship”
or “relevance” between the “patented invention” of the ‘778 patent and the
subject matter of the two NOCs in question namely “maintenance treatment of
major depressive disorder” and “revisions to product monograph regarding nausea
reduction”. The Minister has, in law, created such relationship by listing the
‘778 patents against those NOCs. While there is no record as to what factual
deliberations, if any, the Minister undertook in establishing such
relationship, one must presume that he did so deliberate and determined,
factually, that such relationship existed. This presumption would not arise in
all cases where for instance, it was clear no such relationship existed.
However, where there is a reasonable dispute as to the facts and opinions
necessary to establish such relationship, deference must be given to the
Minister.
[39]
Therefore,
the Court must conclude that there exists a sufficient relationship between the
“patented invention” of the ‘778 patent and the NOCs of April 25, 2003 “maintenance
treatment of major depressive disorder” and September 13, 2004, “revisions to
product monograph regarding nausea reduction” such that, on this motion,
listing of that patents against those NOCs should not be set aside. As to the
balance of the NOCs against which the ‘778 patent was listed, on the evidence
and concessions of Wyeth’s counsel, those listings should be removed.
[40]
The motion
is therefore dismissed in respect of the April 25, 2003 and September 13, 2004 NOCs
and allowed in respect of those of March 14, 2003, June 13, 2003, December 10,
2004 and September 1, 2005. Given the newness of the law in this area, and
divided success there shall be no order as to costs.
ORDER
For the Reasons given, THIS COURT
ORDERS that:
1.
The motion
is dismissed in respect of EFFEXOR XR capsule NOCs issued April 25, 2003 and
September 13, 2004;
2.
The motion
is granted in respect of such NOCs dated March 14, 2003; June 13, 2003;
December 10, 2004 and September 1, 2005 and the Minister is directed to de-list
Canadian Patent No. 2,199,778 in respect of those NOCs.
3.
No order
as to costs.
“Roger
T. Hughes”
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