Docket: T-1572-16
Citation:
2017 FC 1061
Ottawa, Ontario, November 22, 2017
PRESENT: The
Honourable Mr. Justice Lafrenière
|
BETWEEN:
|
|
BRISTOL-MYERS
SQUIBB CANADA AND OTSUKA PHARMACEUTICAL CO., LTD.
|
|
Applicants
|
|
and
|
|
APOTEX INC. AND
THE MINISTER OF HEALTH
|
|
Respondents
|
JUDGMENT AND REASONS
[1]
This is a motion by the Respondent, Apotex Inc.
[Apotex], for an Order dismissing the underlying application in its entirety
pursuant to paragraph 6(5)(b) of the Patented Medicines (Notice of
Compliance) Regulations, SOR/93-133 [the Regulations]. For the reasons that
follow, the motion is granted.
I.
Overview
[2]
The underlying application is one of ten related
prohibition proceedings commenced by the Applicants, Bristol-Myers Squibb
Canada [BMS] and Otsuka Pharmaceutical Co., Ltd. [Otsuka], pursuant to
subsection 6(1) of the Regulations seeking to prohibit the Respondent, the
Minister of Health [the Minister], from issuing a Notice of Compliance [NOC] to
Apotex for multiple dosage strengths of its Apo-Aripiprazole tablets until the
expiry of Canadian Patent No. 2,429,496 [the ’496 Patent] on January 29, 2022.
BMS discontinued the nine other applications in March 2017.
[3]
The ’496 Patent is owned by Otsuka which, as the
patentee, is made a party to the application as required by subsection 6(4) of
the Regulations. The patent is listed on the Patent Register maintained by the
Minister for 2, 5, 10, 15, 20 and 30 mg aripiprazole tablets marketed by BMS
under the brand name ABILIFY.
[4]
The ’496 Patent relates to the use of aripiprazole
for the treatment of people suffering from a number of brain disorders
associated with the serotonin receptor subtype known as 5-HT1A. The only claims
asserted by the Applicants relating to the use of aripiprazole (or a
composition of same) in the treatment of bipolar I disorder are claim 16, which
is dependent on claim 14, which is in turn dependent on claim 11 or 12, and
claim 36, when dependent on claims 34 and 35.
[5]
Claim 16 is for “[t]he
use of aripiprazole in the treatment of, or for the production of a medicament
effective in the treatment of, a disorder of the central nervous system
associated with 5-HT1A subtype, wherein the disorder is bipolar I disorder with
most recent episode of manic or mixed episodes.”
[6]
Claim 36 is for “[a]
pharmaceutical composition comprising aripiprazole, and an acceptable diluent
or excipient, for use in the treatment of a disorder of the central nervous
system associated with 5-HT1A subtype, wherein the disorder is bipolar I
disorder with most recent episode of manic or mixed episodes.”
[7]
On August 8, 2016, Apotex served a Notice of
Allegation [NOA] on the Applicants advising that it was seeking to market 2, 5,
10, 15, 20, and 30mg Apo-Aripiprazole tablets for use as a monotherapy for the
treatment of schizophrenia in adults and adolescents 15 to 17 years of age.
Apotex alleges that no claim for the medicinal ingredient, the formulation, the
dosage form, or the use of the medicinal ingredient in the ’496 Patent would be
infringed by Apotex’s making, constructing, using, or selling of
Apo-Aripiprazole. In particular, Apotex alleges that it would not infringe the
claims of the ’496 Patent because it will not make, use or sell, or induce
others to make, use or sell:
A.
Apo-Aripiprazole for the treatment of the
disorders of the central nervous system claimed in the ’496 Patent, including
bipolar I disorder with most recent episode of manic or mixed episodes; and
B.
Apo-Aripiprazole for the production of a
medicament effective in the treatment of the disorders of the central nervous
system claimed in the ’496 Patent, including bipolar I disorder with most
recent episode of manic or mixed episodes.
[8]
The application was commenced on September 21,
2016, pursuant to subsection 6(1) of the Regulations seeking to prohibit the
Minister from issuing an NOC to Apotex for its Apo-Aripiprazole tablets until
the expiry of the ’496 Patent. BMS disputed the allegation that no claim of the
’496 Patent would be infringed by making, constructing, using, or selling the
Apo-Aripiprazole tablets in Canada without further particularity.
[9]
BMS also sought a declaration that Apotex’ s NOA
is not a valid NOA as contemplated by the Regulations. However, on October 14,
2016, Apotex disclosed confidential portions of Apotex’s regulatory submission
for Apo-Aripiprazole that had been requested by BMS to allow BMS to assess
Apotex’s allegation of non-infringement, including the proposed draft product
monograph. Updated draft product monographs were provided to the Applicants on
October 26, 2016, and December 13, 2016, respectively. These documents were
verified as accurate by the Minister. BMS made no submissions regarding the
sufficiency of the disclosure at the hearing of this motion and appears to have
abandoned its complaint.
[10]
BMS disputes Apotex’s allegations in respect of
the four claims of the ’496 Patent that relate to the use of compositions of
aripiprazole for the treatment of manic or mixed episodes of bipolar I
disorder.
[11]
On February 17, 2017, BMS served its evidence in
support of the application, which includes:
a) four affidavits from psychiatrists across
Canada that address, in part, Apotex’s allegations of non-infringement:
i.
affidavit of Dr. Vikram Dua, sworn February 17th,
2017 [Dua Affidavit];
ii.
affidavit of Dr. Kevin Dwight Kjemisted, sworn
February 16th, 2017 [Kjemisted Affidavit];
iii.
affidavit of Dr. Ranjith D. Chandrasena, sworn
February 17th, 2017 [Chandrasena Affidavit];
iv.
affidavit of Dr. Atul Khullar, sworn February 17th,
2017 [Khullar Affidavit]; and
b) one affidavit from an expert pharmacologist
that addresses, inter alia, the construction of the ’496 Patent and
Apotex’s numerous allegations of invalidity: the affidavit of Philip Seeman sworn
February 17, 2017 [Seeman Affidavit].
[12]
By the present motion, Apotex seeks an order
dismissing the application on the grounds that it is scandalous, frivolous, or
vexatious or is otherwise an abuse of process. Apotex maintains that BMS’s
evidence cannot support a conclusion of direct or induced infringement of the
’496 Patent by Apotex.
[13]
Apotex has not filed any evidence on this
motion, other than the affidavit of a law clerk attaching the affidavit
evidence served by BMS in the underlying application. The Applicants have not
filed any additional evidence on this motion.
[14]
On May 1, 2017, this Court issued a protective
order to provide for the protection and maintenance of confidentiality of
portions of Apotex’s Abbreviated New Drug Submission [ANDS] for its proposed
Apo-Aripiprazole tablets as well as the affidavits served by the Applicants
that include and/or reference the confidential portions of Apotex’s ANDS.
[15]
The Data Protection Period for ABILIFY ends on
January 9, 2018, which is the earliest date that Apotex may receive a NOC
absent the Regulations, assuming its submission is approvable. Data protection
provisions in section C.08.004.1 of the Food and Drug Regulations, CRC,
c 870, provide an eight-year period of market exclusivity for innovative drugs.
II.
Issues to be Determined
[16]
The issue on this motion is whether this Court
should dismiss the within application on the ground that it is scandalous,
frivolous or vexatious or is otherwise an abuse of process. The parties
disagree about the proper test to be applied on a motion to dismiss pursuant to
subsection 6(5) of the Regulations. They are also at odds over whether BMS has
adduced any evidence to support a finding of infringement by Apotex or to
support a finding that Apotex’s NOC will induce infringement.
III.
Test Applicable on Motions under paragraph
6(5)(b) of the Regulations
[17]
Apotex has brought the present motion for an
order dismissing the application in its entirety pursuant to paragraph 6(5)(b)
of the Regulations, which reads as follows:
|
6 (5) Subject to
subsection (5.1), in a proceeding in respect of an application under
subsection (1), the court may, on the motion of a second person, dismiss the
application in whole or in part
(b) on the ground that it is redundant, scandalous, frivolous or
vexatious or is otherwise an abuse of process in respect of one or more
patents.
|
6 (5) Sous
réserve du paragraphe (5.1), lors de l’instance relative à la demande visée
au paragraphe (1), le tribunal peut, sur requête de la seconde personne,
rejeter tout ou partie de la demande si, selon le cas :
b) il conclut qu’elle est inutile, scandaleuse, frivole ou
vexatoire ou constitue autrement, à l’égard d’un ou plusieurs brevets, un
abus de procédure.
|
[18]
BMS submits that the proper question on this
motion is whether there is any evidence on which the application judge could
possibly base a finding that Apotex’s allegations of non-infringement of claim
16, as it depends on claim 11, is not justified. BMS submits that a motion
judge ought not to substantively consider the sufficiency of its evidence to
determine whether it establishes that the allegations are not justified. It
argues that Apotex must establish that it is “plain and
obvious” that the Applicants cannot make out their case or that the
application is “so clearly futile” that it does
not have the slightest chance of success.
[19]
BMS argues that claim 16 of the ’496 Patent
necessarily involves a claim construction analysis that would be inappropriate
to be heard on a motion to dismiss the application under paragraph 6(5)(b) of
the Regulations. It submits that any doubt as to whether there is an arguable
case on the merits of the application must be left for resolution by the
application judge and any doubt as to whether Apotex has met its burden must be
resolved in favour of the Applicants. Moreover, BMS submits that the Court must
be satisfied that “no judge of the Court would ever not
dismiss the application under paragraph 6(5)(b)”. I disagree.
[20]
BMS is advocating for the application of a
higher standard of proof that is not supported by the wording of paragraph
6(5)(b) or jurisprudence of this Court and the Federal Court of Appeal. The
Court will find the requisite grounds to justify an order to dismiss an
application under paragraph 6(5)(b) of the Regulations when an applicant fails
to lead evidence that the second person’s allegations of non-infringement are
not justified: Sanofi-Aventis Canada Inc v Novopharm Ltd, 2007 FCA 167
(CanLII) at para 13 [Novopharm].
[21]
A party moving for summary dismissal of an
application certainly bears a heavy burden. The dismissal of an application
pursuant to subsection 6(5)(b) is an extraordinary remedy and such relief will
only be granted when the application is “clearly
futile” or it is “plain and obvious” that
the application has no chance of success: Sanofi-Aventis Canada Inc v
Novopharm Ltd, 2007 FCA 163 (CanLII) at paras 28 and 36 [Sanofi-Aventis].
[22]
The moving party bears the entire burden of
proof in a paragraph 6(5)(b) motion: Pfizer Canada Inc v Apotex Inc,
2009 FC 671 (CanLII) at para 33. Further, a motion to dismiss will only be
granted where it is apparent that there is no arguable case on the merits of
the application.
[23]
In order to make such a determination, the
motion judge must be able to make the necessary findings of fact, viewed in the
light most favourable to the first person, and apply the law to the facts. The
Federal Court of Appeal has confirmed that a motion judge is entitled to assess
whether the evidence offered in support of the application is relevant or could
conceivably support the application: Bayer Inc v Fresenius Kabi Canada Ltd,
2016 FCA 13 (CanLII) at para 13. In the present case, I must determine whether
there is any evidence capable of establishing that Apotex will infringe the
’496 Patent, either directly or by inducing infringement by others.
IV.
Analysis
A.
Evidence of direct infringement
[24]
BMS submits that the record is clear that:
a.
Apotex uses, or will use on issuance of the NOC,
aripiprazole to manufacture a drug: Apo-Aripiprazole tablets;
b.
Apo-Aripiprazole tablets are bioequivalent with
ABILIFY and ABILIFY is effective for the treatment of bipolar I disorder;
c.
Apo-Aripiprazole tablets are the same as Apotex’s
US Aripiprazole tablets;
d.
Apotex’s US Aripiprazole tablets were approved
for use in treatment of bipolar I disorder; and
e.
Apo-Aripiprazole tablets are thus effective for
the treatment of bipolar I disorder.
[25]
According to BMS, this evidence establishes that
Apotex will use aripiprazole to manufacture or prepare a drug that is in fact
effective for the treatment of bipolar I disorder as claimed in claim 16 as it
depends on claim 11. This argument is not based any facts.
[26]
When an NOA contains allegations of fact
relating to non-infringement, these allegations are presumed to be true except
to the extent the contrary is shown in the evidence. Apotex clearly states in
its NOA that it is not making or intending to make the drug for the treatment
of bipolar I disorder, but rather for the treatment of schizophrenia in adults
and in adolescents 15 to 17 years of age. Moreover, the draft product monograph
states that Apotex’s Apo-Aripiprazole tablets will be “indicated
as a monotherapy for the treatment of schizophrenia in adults” and “indicated as a monotherapy for the treatment of
schizophrenia in adolescents ages 15 to 17”. No reference is made to the
treatment of bipolar I disorder with most recent episode of manic or mixed
episodes.
[27]
There is no evidence, other than speculation,
that Apotex will use Apo-Aripiprazole to treat bipolar I disorder in Canada.
Simply put, if Apotex does not manufacture Apo-Aripiprazole for the claimed
uses, but rather, manufacturers Apo-Aripiprazole solely for the unclaimed use,
there can be no direct infringement of claim 16.
[28]
I should also add this is not a matter of claim
construction. A patentee’s monopoly cannot be artificially extended to preclude
the manufacture, use, and selling of a generic product simply because there is
a possibility that someone somewhere will use the drug for the prohibited,
patented purpose.
B.
Evidence of induced infringement
[29]
The tripartite test for establishing induced
infringement is articulated in Corlac Inc v Weatherford Canada Ltd, 2011
FCA 228 (CanLII) at para 162 [Weatherford]:
i.
an act of infringement must have been completed
by the direct infringer;
ii.
the completion of the acts of infringement must
be influenced by the acts of the alleged inducer to the point that, without the
influence, direct infringement would not take place; and
iii.
the inducer knows that this influence will
result in the completion of the act of infringement.
[30]
It is important to bear in mind that the test
from Weatherford is conjunctive and if BMS fails to establish all three of the
prongs, their case must necessarily fail.
[31]
BMS submits that its evidence establishes that
Apotex is implicated in infringement of the ’496 Patent by others via
inducement. BMS argues that inducement can be established by inferences reasonably
drawn from a number of factors, alone or in combination, beyond the content of
the product monograph.
[32]
Regarding the first prong of the test from
Weatherford, BMS submits that there is evidence that once Apotex receives an
NOC for Apo-Aripiprazole tablets, its product will be dispensed to patients who
will use it for the treatment of bipolar I disorder, which is treated with
ABILIFY tablets. Once the generic product is available, patients will “likely” receive it because of cost differences and
substitution laws and because physicians will not indicate “No Substitution” on the prescriptions for ABILIFY.
BMS submits that this evidence was accepted in Allergan Inc v Canada
(Health), 2011 FC 1316 (CanLII) at paras 149-150 as sufficient to establish
direct infringement.
[33]
The Federal Court of Appeal has emphasized the
importance of properly applying the test for induced infringement in the
context of proceedings under the Regulations so as not to artificially extend
the monopoly held by the patent holder by effectively transforming all
pharmaceutical patents into compound patents, meaning that the patentee would
monopolize the drug itself even where it is not protected by the patent.
[34]
BMS argues that it is incorrect to suggest that
in law, evidence is required from “a person who states
that he or she will use Apo-Aripiprazole to treat bipolar I disorder” or
that in fact, none of the Applicants’ evidence states that Apo-Aripiprazole
will be used to treat bipolar I disorder. BMS states that the relevant question
is whether Apotex’s tablets will in fact be used by patients for the treatment
of bipolar I disorder. I disagree.
[35]
To successfully prosecute a prohibition
application under the Regulations in relation to a “use”
patent where indirect infringement is alleged, the patentee would have to prove
that third parties would, in fact, use the second person’s product for a
claimed use in the first person’s patent, and that the second person had
actively induced or encouraged such use: AB Hassle Inc v Canada (Minister of
National Health and Welfare), 2002 FCA 421 (CanLII) at paras 47-59 [AB
Hassle].
[36]
In AB Hassle, Mr. Justice Edgar Sexton
stated as follows at paras 57 and 58:
[57] […] 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.
[58] Nor can Apotex be held liable in
patent infringement proceedings under the Patent Act if, contrary to the
evidence presented in the NOC proceeding, third party infringements do occur
after the issue of a NOC, unless Apotex has implicated itself in the
infringements by, for example, inducing or encouraging them […].
[37]
To induce or procure another to infringe a
patent, something active must be done. Mere passivity is not sufficient: Beloit
Canada Ltd v Valmet Oy, (1986) 8 CPR (3d) 289, [1986] FCJ No 87 (QL) at
page 297 at paras 46-47.
[38]
With respect to the second prong of the
Weatherford test, according to BMS Apotex has taken actions that an application
judge could ultimately consider to be the requisite influence leading to direct
infringement by physicians and patients.
[39]
BMS refers to paragraph 18 of the Kjernisted
Affidavit and argues that the prescribing decisions (the act of infringement)
of physicians would be influenced by Apotex’s product information contained in
the monograph, of which Apotex obviously has knowledge. BMS also references
paragraphs 20-23 of the Kjernisted Affidavit to argue that information
contained in the Canadian draft product monograph and the US prescribing
information would influence Dr. Kjernisted to allow for substitution with the
generic product. BMS maintains that this would represent an act of infringement
with the knowledge of Apotex.
[40]
BMS also relies on paragraph 21 of the
Chandrasena Affidavit to show the influence of Apotex’s US drug approvals for
the bipolar I indication “informing” his
teaching, practice, and prescribing of drug products in Canada.
[41]
Referring to paragraphs 24-28 of Dr.
Kjernisted’s affidavit, BMS argues that the Apo-Aripiprazole draft product
monograph presents information concerning comparative bioavailability, which “certainly emanates” from Apotex, would influence a
doctor’s decision to allow patients to receive Apo-Aripiprazole.
[42]
Regarding Apotex’s US promotional materials, BMS
submits that Dr. Khullar attests to his and other physicians’ understanding
that Apotex is representing that its generic aripiprazole product may be
substituted for ABILIFY with the same indications. Further, there is evidence
that the approved indication as found in the US “would
influence” such use and “would convince”
physicians to approve and direct the use of Apo-Aripiprazole tablets by
prescribing it for the treatment of bipolar I disorder.
[43]
Dr. Kjernisted states at paragraph 28 of his
affidavit that if the same Apotex aripiprazole tablet was specifically approved
for bipolar I disorder in the US, which he was asked to assume, and was
available in Canada, then it “would convince [him] and
other physicians to approve and direct its use in Canada by prescribing it for
the treatment of bipolar I disorder”.
[44]
BMS submits that the specific comparative
bioavailability generated by Apotex and presented in its draft product monograph
would influence physicians’ decisions to prescribe Apo-Aripiprazole Tablets and
not only ABILIFY with a “no substitution”
warning. BMS argues that because the draft product monograph for
Apo-Aripiprazole indicates that it has a formulation that does not present
concerns about bioavailability, this information would influence physicians to
allow substitution of ABILIFY with Apo-Aripiprazole.
[45]
BMS submits that it is a logical and reasonable
inference to assume the US and Canadian Apotex tablets are the same. BMS
submits that physicians would naturally identify the name “Apotex” as the same generic company and would know
that Apotex’s US product and Canadian products are manufactured in Canada by
Apotex at the same location.
[46]
The Applicant’s evidence falls well short of
establishing any influence by Apotex in inducing infringement. In proceedings
under the Regulations, an allegation of non-infringement of a claim for the use
of a medicine is justified if the generic drug manufacturer is seeking an NOC
only for a use that is not within the new use claim and the evidence fails to
establish that the generic drug producer will infringe the new use claim by
inducing others to prescribe or use the generic product for that new use. Such
a proceeding is focused on the actions of the “second
person”, in this case Apotex. Absent evidence of inducement by Apotex,
any potential infringement by patients, physicians or pharmacists cannot
support the granting of a prohibition order.
[47]
Even knowledge that one’s product will likely be
used “off label” by another party in direct
infringement of a patent is not sufficient to meet the second prong of the
test, as held in Aventis Pharma Inc v Apotex Inc, 2005 FC 1461 (CanLII)
at para 32; aff’d 2006 FCA 357:
[32] It strikes me as clear that
Apotex's recognition that "off label" prescription by doctors,
dispensation by pharmacists, and subsequent consumption by patients does not
meet the "something more" requirement established by Sexton J.A. in AB
Hassle, supra. Whether the "something more" consists of
inducement, procurement, marketing or some other nexus will depend upon the
facts of each particular case. However, there must be a nexus. Mere passive
recognition that "off-label" prescription and/or consumption will
occur does not amount to "something more". (See also Pfizer Canada
Inc. v. Apotex Inc., 2005 FC 1421 (F.C.) at paragraph 167.)
[48]
The Chandrasena Affidavit is entirely irrelevant
to a consideration of inducement of infringement of the ’496 Patent for the
following reasons:
i. Dr. Chandrasena does not comment on Apotex’s draft product monograph
for Apo-Aripiprazole.
ii. He does not refer to Apotex at all in providing his brief opinion.
iii. He does not suggest that Apo-Aripiprazole tablets would be
prescribed in the treatment of bipolar I disorder with a most recent episode of
manic or mixed episodes in such a manner as to infringe the ’496 Patent, let
alone that such infringement would be directly influenced by Apotex’s actions.
[49]
The Dua Affidavit is similarly irrelevant to the
consideration of inducement of infringement as Dr. Dua does not comment on
Apotex’s draft product monograph and only considered a US product monograph for
aripiprazole tablets that were indicated to have been manufactured by Apotex.
Dr. Dua was not informed or asked about how Apotex would market its
Apo-Aripiprazole tablets in Canada. Further, he does not opine that he or any
other psychiatrist would prescribe Apo-Aripiprazole tablets in the Canada for
the treatment of bipolar I disorder because of Apotex’s influence.
[50]
The Khullar Affidavit is also insufficient to
establish inducement by Apotex as Dr. Khullar does not comment on the draft
Canadian product monograph and only looks to promotional material for US
aripiprazole tablets. Dr. Khullar does not express any opinion about how Apotex
would market its tablets in Canada. Nor does he opine on how he or any other
psychiatrist would prescribe Apo-Aripiprazole in Canada for the treatment of
bipolar I disorder.
[51]
Finally, Dr. Kjernisted is only prepared to
state at paragraph 25 that “[i]n most cases, I would be
open to considering allowing substitution based on this specific bioavailability
information, though there may be rare exceptions related to any patient
specific consideration.” None of the affiants were willing to assert
that they would actually prescribe Apo-Aripiprazole based on bioavailability
data.
[52]
At paragraph 28 of his affidavit, Dr. Kjernisted
opines that “[t]he same Apotex aripiprazole tablet
having been specifically approved for bipolar I in the US would convince me and
other physicians to approve and direct its use in Canada by prescribing it for
the treatment of bipolar I”. However, Dr. Kjernisted does not indicate
how a physician would be made aware that the tablet to be sold in Canada is the
“same tablet” that is approved in the US.
Indeed, Dr. Kjernisted states in the last sentence of paragraph 27 of his affidavit
that “[t]his only assumes, as I have been asked to
assume, that the Apotex tablet information is the same for the US and Canada.”
[53]
Dr. Kjernisted’s evidence is that clinicians
make prescribe ng decisions not on the “approved”
indications of a generic drug, but on other bases, namely by scientific data
that supports the use of the active ingredient (aripiprazole) for a particular
disorder, and comparative bioavailability. Dr. Kjernisted does not suggest that
the “scientific data that support the use of the active
ingredient” emanates from Apotex.
[54]
BMS’s reliance on the marketing of aripiprazole
tablets in the US by Apotex in Canada is unfounded as the lawful promotion of a
drug in another country, for an indication approved in that jurisdiction,
cannot serve as the basis for inducement of infringement of a patent in another
jurisdiction.
[55]
In light of the above, it is plain and obvious
that there is no evidence capable of meeting the second prong of the
Weatherford test.
[56]
As for the third prong of the test, none of the
affiants were asked to opine on the question of whether the alleged inducer,
Apotex, knows that its influence will result in the completion of the act of
infringement. There is nothing in the record that shows that Apotex would be
permitted to assert lawfully that Apo-Aripiprazole, approved in Canada, can be
used to treat bipolar I disorder. In particular, there is no evidence that
Apotex would violate, knowingly or otherwise, Canadian food and drug
regulations by actively promoting the US product monograph or promoting
information beyond that set out in the Canadian monograph to Canadians in or
outside of Canada.
V.
Conclusion
[57]
For the above reasons and for the reasons set
out in Apotex’s submissions, which I adopt and make mine, I conclude that the
motion pursuant to paragraph 6(5)(b) of the Regulations dismissing the
application related to the ’496 Patent should be granted.
[58]
At the end of the hearing, it was agreed by the
parties that costs of $10,000.00, inclusive of disbursements and taxes, should
be awarded in favour of the successful party.
Email this Content