Interlocutory Issues in NOC Proceedings
by Steven Mason and Tamara Ramsey
Interlocutory Issues in NOC Proceedings
1.
INTRODUCTION/SUMMARY............................................................................................. 1
2.
SUFFICIENCY OF THE NOTICE OF ALLEGATION........................................................ 2
(a)
(b)
3.
MOTIONS FOR DISCLOSURE UNDER 6(7) ..................................................................... 6
(a)
(b)
(c)
4.
Drug Master File ............................................................................................................. 6
Samples ........................................................................................................................... 8
Procedural Issues: Timing and Evidence........................................................................ 9
MOTIONS TO STRIKE UNDER 6(5)................................................................................. 10
(a)
(b)
5.
Requirements of a Notice of Allegation ......................................................................... 2
Pre-Hearing Responses to Insufficient Notices of Allegation ........................................ 5
Redundant, Scandalous, Frivolous or Vexatious: Section 6(5)(b)................................ 11
Patents not Eligible for Inclusion on the Register: Section 6(5)(a) .............................. 12
CONCLUSION..................................................................................................................... 13
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Interlocutory Issues in NOC Proceedings
by Steven Mason and Tamara Ramsey1
1.
Introduction/Summary
This paper will address recent developments in case law with respect to three interlocutory issues
that arise in the course of proceedings for orders of prohibition under the Patented Medicines
(Notice of Compliance) Regulations (the “Regulations”)2: (1) sufficiency of a Notice of
Allegation, (2) motions for disclosure, and (3) motions to strike. Although there have been no
drastic changes to the approach taken by the Courts to these issues, there has been a continued
refinement of the law as the Courts respond to new fact situations.
One issue is the sufficiency of a Notice of Allegation. While the Court continues to hold that an
insufficient Notice of Allegation will result in a prohibition order, the Court continues to defer
this issue to the judge hearing the prohibition application. First persons should respond to an
insufficient Notice of Allegation with a request for disclosure so that it may simultaneously and
properly prepare its case on the merits.
Another interlocutory issue is motions for disclosure under 6(7) of the Regulations. The Federal
Court of Appeal has recently confirmed that disclosure of manufacturing processes contained in
a third party supplier’s Drug Master File is compellable. In other cases, samples of drugs were
ordered to be disclosed if such samples were submitted to the Minister of Health. Motions for
disclosure should be brought without delay and should be supported with expert affidavit
evidence.
A third interlocutory issue is motions to strike an application for prohibition under section 6(5)
of the Regulations. Where an application is alleged to be redundant, scandalous, frivolous or
vexatious under section 6(5)(b), the Court has applied the familiar plain and obvious standard. It
1
Steven Mason is a partner in the litigation department of McCarthy Tétrault LLP and Tamara Ramsey is an
associate in the litigation department of McCarthy Tétrault LLP.
2
Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 as amended by SOR/98-166; SOR/99-379
-2appears that the Court will apply this same standard for motions to strike under 6(5)(a) where an
application relates to a patent that is not eligible for inclusion on the Register.
2.
Sufficiency of the Notice of Allegation
(a)
Requirements of a Notice of Allegation
Pursuant to section 5 of the Regulations, a second person must serve a Notice of Allegation
(“NOA”) on the first person if the second person files or has filed a submission for a Notice of
Compliance (“NOC”) for a drug that compares or makes reference to a drug in respect of which
a patent list has been submitted. On several occasions, the Court has articulated the requirements
for a NOA. While the sufficiency of a NOA will not be finally determined by the Court until the
hearing of the prohibition application, the first person should immediately assess the sufficiency
of the NOA and prepare its case accordingly. Moreover, the Court has held that a deficient NOA
will result in an order that the Minister be prohibited from issuing a Notice of Compliance
(“NOC”) with respect to the purported NOA.3 For example, in AB Hassle v. Apotex Inc., Justice
Kelen stated:
The NOA must provide all of the facts the generic producer
[second person] intends to rely upon in subsequent prohibition
proceedings and it cannot rely on facts that exceed those laid out in
the NOA. The NOA must address all of the patent claims that
describe the basic invention or else the NOA will be defective and
not in compliance with section 5 of the Regulations.4
More recently, in a motion to dismiss pursuant to s. 6(5)(b) of the Regulations, in which the
sufficiency of an NOA was an issue, Justice Layden-Stevenson repeated a similar requirement
that “a second person cannot rely on facts that exceed those laid out in its detailed statement.”5
(i)
Extent to Which Patent Claims Must be Put in Issue
One of the issues to consider in assessing the sufficiency of the NOA is the extent to which the
patent claims must be put in issue. In Genpharm v. Canada, the Federal Court of Appeal held
3
AB Hassle v. Apotex Inc., 2002 FCT 931 at paras. 63 and 67 [Hereinafter AB Hassle v. Apotex] and Genpharm v.
Canada, infra note 6.
4
AB Hassle v. Apotex, supra note 3.
5
Astrazenaca AB v. Apotex Inc., 2002 FCT 1249 at para. 11 [Hereinafter Astrazenaca AB v. Apotex Inc.].
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-3that a NOA must allege that none of the patent claims will be infringed.6 Mr. Justice Rothstein
elaborated by explaining that it is not necessary for the second person to address each and every
dependant patent claim if the basic claim or claims that describe the invention are addressed in
the NOA, but it is not open to the second person to ignore patent claims that describe the basic
invention.7 What is the basic invention? It is foreseeable that disputes will continue to arise
about what the basic invention is and about whether a particular claim describes the basic
invention.
This issue was considered again a few months later in Pfizer Canada Inc. v. Apotex Inc.8 In this
case Pfizer is the owner of a patent for new uses of sertraline for the treatment of anxiety-related
disorders, in addition to depression. Sertraline is sold and marketed in Canada for the treatment
of depression, panic disorder and obsessive-compulsive disorder. Pfizer’s patent contains claims
for use in the treatment of specific anxiety-related disorders for which no marketing
authorization has been granted. Pfizer argued that for a NOC to issue, an allegation of noninfringement must be justified with respect to all the claims in the patent. Apotex replied that it
should not be kept out of the market for authorized uses on the grounds that it has not adduced
evidence with respect to validity as it relates to non-authorized uses.9 The Court held that Apotex
is not obliged to put in issue the validity of claims contained in a patent for non-authorized uses
of a drug. Relevance is based on the proposed uses by the second person and by the comparison
which triggers application of section 5 of the Regulations.10 More succinctly, “[t]he purpose of
the Regulations does not…require that allegations be made that irrelevant use claims are invalid,
at least where the irrelevant use claims relate solely to non-approved uses of a drug.”11
Pfizer Canada Inc. v. Apotex Inc. seems to provide an exception to the general rule in Genpharm
v. Canada—all claims to the basic invention must be put into issue—by restricting claims to
those that are relevant to the second person’s proposed use. Presumably, Pfizer Canada Inc. v.
6
Genpharm v. Canada (Minister of Health), 2002 FCA 290 at para. 23 (indexed as Proctor & Gamble
Pharmaceuticals Canada, Inc. v. Canada (Minister of Health)) [Hereinafter Genpharm v. Canada].
7
Genpharm v. Canada, supra note 6. See also AB Hassle v. Canada (Minister of National Health and Welfare)
(2000), 7 C.P.R. (4th ) 272 (F.C.A.).
8
Pfizer Canada Inc. v. Apotex Inc., 2002 FCT 1138 at paras. 84-99 [Hereinafter Pfizer Canada Inc. v. Apotex Inc.]
9
Ibid at paras. 84-85.
10
Ibid at paras. 88 and 94.
11
Ibid at para. 96.
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-4Apotex Inc. will be limited to analogous cases in which there is an allegation that the patent is
invalid and the patent contains claims for uses that are not authorized in Canada.
(ii)
Relationship Between Notice of Allegation and New Drug Submission
Another issue to consider in assessing the sufficiency of a NOA is the relationship between the
NOA and the relevant submissions for a new drug. In Parke-Davis Division v. Canada (Minister
of Health), the Federal Court of Appeal held that a NOA is invalid if no new drug submission
(“NDS” or “ANDS”) is filed by the date of hearing.12 In this case Apotex’s NOA contained
allegations that Parke-Davis is not the exclusive licensee of the patent and that the patent has
been dedicated to public use, so it has either expired or is not valid. Apotex made no allegations
of non-infringement. Based on prior cases, a second person is permitted to engage the
Regulations as early as possible13 and is permitted to serve a NOA before filing a new drug
submission (unless there is an allegation of non-infringement).14 However, a second person is
defined as the person referred to in subsections 5(1) or 5(1.1) and subsections 5(1) or 5(1.1)
apply “where a person files or has filed a submission for a notice of compliance.” The Court
held that it is “incongruous that a person who has not filed a new drug submission by the date of
the hearing should nevertheless be treated as a ‘second person.’”15 The Court further states:
The object of an application for a prohibition order under
subsection 6(1) is, after all, to prohibit the Minister of Health from
issuing a notice of compliance to a second person for a drug that is,
in some relevant respect, comparable to a patented medicine. We
see little point in entertaining a prohibition application if, by the
time of the hearing, the Minister has not even been asked to
consider issuing a notice of compliance because the second person
has filed no new drug submission.16
If there is no proof that a new drug submission is filed by the date of the hearing, the NOA is
invalid. Further, a new drug submission will have to be filed before the deadline for the filing of
affidavit evidence so that a second person may prove that it has been done.
12
Parke-Davis Division v. Canada (Minister of Health), 2002 FCA 454 at para. 60 [Hereinafter Parke-Davis
Division v. Canada].
13
Ibid at para. 44.
14
Ibid at paras. 46, 49 and 50.
15
Ibid at para. 53.
16
Ibid at para. 59
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-5(b)
Pre-Hearing Responses to Insufficient Notices of Allegation
The Regulations do not specifically provide for any interlocutory procedures to challenge the
sufficiency of a NOA. The first person may not have a NOA declared invalid until the Court
hears the application for prohibition. Even then, the court will often hear arguments about and
assess the merits of the case rather than deciding the issue of NOA validity as a preliminary
matter.17 Ultimately, if the Court finds that the NOA is insufficient, prohibition will be ordered,
but there is no equivalent for first persons to motions to dismiss that second persons may bring
under subsection 6(5)(b) of the Regulations to have the issue determined in advance of the
application.
If a first person is of the opinion that the allegations or detailed statement, including voluntary
disclosure, are not sufficient, the first person should bring a motion for disclosure under section
6(7) of the Regulations. Issues concerning the sufficiency of the NOA drive, and are relevant to,
motions for disclosure. In motions for disclosure, the sufficiency of the disclosure in the NOA is
one of the circumstances that may be considered in the Court’s exercise of discretion to order
disclosure of portions of a second persons submissions to the Minister.18 However, it should be
noted that an order for disclosure pursuant to section 6(7) of the Regulations will not cure a
defective NOA and the first person may still raise the argument at the hearing of the application
for prohibition.19
Generally speaking, issues related to the sufficiency of the NOA may not be tested until the
hearing of the prohibition proceeding. As a consequence the first person must simultaneously
prepare a case on the merits and a case about the sufficiency or validity of the NOA. There is
also an obligation on a first person to bring motions to get disclosure of portions of a second
person’s submissions for a notice of compliance to supplement the NOA and allow it to prepare a
case on the merits. At the same time, the first person should provide notice of its intent to raise
issues about the NOA and to raise objections about the admissibility of evidence at the
prohibition proceeding while applying for and responding to other motions.
17
See e.g. Parke-Davis Division v. Canada, supra note 12 at para. 66.
See e.g. Novartis Pharmaceuticals Canada Inc. v. Abbot Laboratories Ltd. (2000), 7 C.P.R. (4th) 264 at para. 18
(FCA).
19
Genpharm v. Canada, supra note 6 at para. 10.
18
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-6-
3.
Motions for Disclosure under 6(7)
A first person may bring a motion pursuant to subsection 6(7)(a) for production of relevant
portions of a second person’s submission for a NOC. In June 2000 the Federal Court of Appeal,
in Novartis Pharmaceuticals Canada Inc. v. Abbot Laboratories Ltd., provided judicial authority
for the exercise of discretion pursuant to subsection 6(7). Writing for the Court, Justice
Rothstein held that production is discretionary and a condition for the exercise of the court’s
discretion is that the information sought is relevant to the issues in the proceeding. Criteria that
the Court may consider in the exercise of its discretion include whether disclosure is required or
important. Other criteria is the adequacy of the disclosure in the notice of allegation. The court
will also consider the evidence in respect of disclosure on a balance of probabilities standard.20
In Novartis Pharmaceuticals Canada Inc. v. Abbot Laboratories Ltd., Justice Rothstein
cautioned that the exercise of discretion under subsection 6(7) should not be formulated as a test:
No criteria are specified to limit or guide the Court in the exercise
of its discretion under subsection 6(7). It is open to the Court to
assess which criteria are appropriate in the circumstances.
Accordingly, it is not entirely accurate to describe such criteria as
“tests”, as some of the cases have done, because that implies a rule
applicable to all applications for disclosure and thus a limitation on
discretion rather than the exercise of discretion.21
This approach implies that the criteria that guide the exercise of discretion under subsection 6(7)
will adapt to accommodate new fact scenarios. Some of the new fact scenarios with which the
Court has been challenged include requests for disclosure of Drug Master Files, requests for
samples as well procedural issues of timing for disclosure motions and evidence required for
disclosure motion.
(a)
Drug Master File
In the very recent decision of Abbott Laboratories v. Canada, the Federal Court of Appeal
addressed the issue of whether the Court could order production of portions of the Drug Master
20
Novartis Pharmaceuticals Canada Inc. v. Abbot Laboratories Ltd. (2000), 7 C.P.R. (4th) 264 at paras. 12 and 1719 (F.C.A.) [Hereinafter Novartis Pharmaceuticals Canada Inc. v. Abbot Laboratories Ltd.].
21
Novartis Pharmaceuticals Canada Inc. v. Abbot Laboratories Ltd., supra note 20 at para. 13.
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-7File (“DMF”) belonging to the second person’s third party supplier.22 Although Justice Sherlow
held that the appeal by Pharmascience was both out of time and moot she finds that it is
appropriate to comment on the merits.23 This is so, particularly because “the debate as to the
scope of Regulation 6(7) that arose in this case has arisen in numerous other prohibition
proceedings cases in the Federal Court, and interlocutory appeals in such proceedings are often
impracticable because of time constraints.”24
As in many cases, the details of the manufacturing process to be used in the making of the drug
in issue were contained in the third party supplier’s DMF filed with the Minister. The ANDS
filed in this case by Pharamscience incorporates that information by cross-reference, a practice
permitted by the Minister of Health. Justice Sherlow held that this administrative practice does
not shield the DMF from production:
Details about the manufacturing process are an essential part of an
abbreviated new drug submission. But for the administrative
practice referred to above, Pharmascience would have been
compelled to physically include the Teva information in its
abbreviated new drug submission. The fact that the Minister
permits suppliers like Teva to submit material separately and
confidentially, and then permits generic manufacturers like
Pharmascience to cross-reference the confidential material without
necessarily having read it, has no legal significance under the Food
and Drug Regulations. Information that is cross-referenced in that
fashion is an integral part of the abbreviated new drug submission,
whether or not the generic manufacturer has actual knowledge of
the information.25
However, the Court went on to note that disclosure of the DMF ought not to be ordered if it is
established by credible evidence that a generic manufacturer cannot obtain or has no legal right
to obtain a copy of the DMF for the purpose of disclosing it in the Prohibition Proceeding. A
party cannot be ordered to do something that it cannot do. According to Justice Sherlow, it
would be open to a judge to order the second person to use its best efforts to obtain the
information, and to insist on a credible explanation if those best efforts fail. In this case there
22
Abbott Laboratories v. Canada (Minister of Health), 2003 FCA 666.
Ibid at paras 21 and 29.
24
Ibid at para 29. See e.g. Smithkline Beecham Pharma Inc. v. Apotex Inc. (1999), 3 C.P.R. (4th) 22 at para. 8 ,
Pfizer Canada Inc. v. Apotex Inc. (2002), 18 C.P.R. (4th) 323 and Glaxosmithkline Inc. v. Pharmascience Inc., 2002
FCT 683 at para 33-36.
25
Ibid at para 31.
23
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-8was no evidence that Pharmascience did not or could not obtain the DMF so it was correct to
order production of the DMF.
(b)
Samples
One of the issues to emerge under subsection 6(7) is the compellability of samples of the drug
manufactured by the second person. Thus far, the courts have held that if certain prerequisites
are met, samples are compellable.
One of the first cases to address this issue was Pfizer Canada Inc. v. Apotex Inc. in which Pfizer
sought production of samples of bulk azithromycin together with production of azithromycin
tablets. 26 In the NOA, Apotex alleges that its tablets will contain azithromycin but will contain a
monohydrate instead of a dihydrate.27 Pfizer filed evidence that production of the samples were
relevant, necessary and important because Pfizer’s experts needed to determine whether there is
any dihydrate present in the samples. Pfizer’s experts found that dihydrate was present when
they followed the method previously disclosed by Apotex.28 The Court held that production of
samples are required to enable the applicants to analyze the tablets so that the Court will have
access to relevant information in determining whether the NOA is justified.29 The first
prerequisite for obtaining an order for production of samples is persuading the court that the
criteria for exercising its discretion under 6(7) has been proven on a balance of probabilities.
With respect to the issue of the compellability of samples, the Court held that whether samples
are compellable depends upon whether samples were provided to the Minister as part of the
submission for a NOC. The applicant is not expected to show that samples were provided to the
Minister.30 Rather, the Court addressed this issue by requiring the generic to advise whether or
not samples were submitted and by requiring the Minister of Health to verify, pursuant to an
order under 6(7)(b), that they were not provided.31 Thus, the second prerequisite for obtaining an
order for production of samples is that samples were submitted to the Minister as part of the
submission for a notice of compliance.
26
Pfizer Canada Inc. v. Apotex Inc. (2002), 18 C.P.R. (4th) 323 (F.C.T.D.) [Hereinafter Pfizer Canada Inc. v. Apotex
Inc.]
27
Ibid at para. 4.
28
Ibid at paras. 7 and 8.
29
Ibid at para. 32.
30
Ibid at para. 28.
31
Ibid at para 29.
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-9In a motion decided a few months later, in Glaxosmithkline Inc. v. Pharmascience Inc., the Court
examined the same two prerequisites: (1) whether criteria for exercise of discretion had been
met, and (2) whether samples were submitted to the Minister.32 The Court again held that if
samples were submitted to the Minister, they must be produced under 6(7) and if samples were
not submitted, the Court required the Minister to verify that fact.
(c)
Procedural Issues: Timing and Evidence
With respect to the issue of timing for a motion for disclosure, in Biovail Corp. v. Canada the
Court held that the words “at any time” in subsection 6(7) should not be interpreted literally.
The first person must satisfy the court that the motion is presented without delay particularly in
light of the 24 month period in which the Minister is prohibited from issuing notice of
compliance.33 If there is a delay, affidavit evidence should be filed to explain it.34 However,
there is no absolute requirement about the timing of a motion for disclosure:
Normally, motion[s] for disclosure are presented before the filing
of the evidence of the party requesting the production.
Exceptionally, such motion[s] can be made after the filing of the
evidence when new matters are brought up in the other party’s
evidence which was not foreseen and that some explanation is
given for the delay.35
It is, therefore, important that motions for disclosure include affidavit evidence about the timing
of the motion particularly if they are not brought shortly after issuing the Application for
Prohibition.
To succeed on a motion for disclosure, first persons should file affidavit evidence to prove the
relevance, necessity or importance of the information sought, or the insufficiency of previous
disclosure. The affidavits should be evidence from experts. In Biovail Corp. v. Canada, Justice
Noël comments that it is by assessing the affidavit evidence from experts to support a 6(7)
motion that the Court, in an analogous case, was able to grant the request for disclosure.36 In
Merck Frosst Canada & Co. v. Canada, the Court makes it clear that an expert’s evidence
32
Glaxosmithkline Inc. v. Pharmascience Inc., 2002 FCT 683.
Biovail Corp. v. Canada (Minister of National Health & Welfare), 2002 FCT 1143 at para 41.
34
Ibid at para 45.
35
Ibid at para 53.
36
Ibid at para 53.
33
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-10should specifically state that the disclosure of the requested portions are required or important to
the issues.37
The cases demonstrate that motions for disclosure are complex motions that require a significant
degree of preparation and resources. They should be brought without delay and first persons
should have experts assess the NOA, detailed statement and any voluntary disclosure and
provide affidavit evidence to support the request for disclosure. Although it seems obvious that
detailed information about manufacturing processes and composition are relevant, important and
necessary to answer an allegation of non-infringement, expert evidence will be required to satisfy
the criteria for an order pursuant to 6(7).
4.
Motions to Strike under 6(5)
The genesis of subsection 6(5) generally has been elaborated by Noël J.A. in Apotex Inc. v.
Merck Frosst Canada Inc:
The promulgation of subsection 6(5) follows in time the decision
of this Court in David Bull Laboratories (Canada) Inc. v.
Pharmacia Inc., which held that the proper way to demonstrate
that an application for a prohibition is wholly without merit is to
appear and argue the matter on the main application. On that
occasion the Court stated:
This [motion to strike] well illustrates the waste of
resources and time in adding on to what is supposed to be a
summary judicial review proceeding the process of an
interlocutory motion to strike. This motion to strike has
involved a hearing before a trial judge and over one-half
day before the Court of Appeal, the latter involving the
filing of several hundred pages of material, all to no avail.38
Subsection 6(5) provides a means by which an application under subsection 6(1) may be
dismissed at an early stage. However, decisions of the Federal Court suggest that the moving
party will have to meet an onerous burden seemingly so as to avert the risk that motions under
subsection 6(5) will become the norm.
37
38
Merck Frosst Canada & Co. v. Canada (Minister of Health), 2003 FCT 287 at para 28.
Apotex Inc. v. Merck Frosst Canada Inc. 87 C.P.R. (3d) 30.
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-11(a)
Redundant, Scandalous, Frivolous or Vexatious: Section 6(5)(b)
In one of the first cases to consider the issues involved in dismissing an application as redundant,
scandalous, frivolous or vexatious, Justice Lemieux, in Pfizer Canada Inc. v. Apotex Inc. noted
that:
Paragraph 6(5)(b) of the Regulations has its source in paragraph
(b), (c) and (f) of Rule 221 of the Federal Court Rules, 1998 which
themselves were based on similar paragraphs of Rule 419 of the
old Federal Court Rules which concerned actions rather than
applications… The test Apotex had to meet has been set out in a
consistent line of cases interpreting from Rule 419(1)(c).39
After surveying the law with respect to case law under the Fedral Court Rules for dismissing
actions (Rules 221(1)(a) and 221(1)(c)), Justice Lemieux dismissed the appeal on the basis that
“counsel for Pfizer having raised a number of issues which cannot be said to be so futile, so
devoid of merit that the application deserves to be struck.”40
More recently, Madam Justice Layden-Stevenson applied the “very exceptional circumstances”
standard in the context of a 6(5) motion, citing David Bull Laboratories v. Pharmacia: “Apotex
must therefore demonstrate that each of the grounds advanced by AstraZeneca is futile”.41
Justice Layden-Stevenson dismissed the motion on the following basis:
A motion to dismiss pursuant to paragraph 6(5)(b) of the
Regulations is not a forum for a determination of the merits of an
application. The task of the motions judge is to determine whether
the application is so clearly improper as to be bereft of any
possibility of success. Here, with respect to the ground of whether
the NOA is an abuse of process, much will turn on the evidence of
Dr. Sherman. His credibility is important because it is directly
relevant to several issues, not the least of which is whether the
previous NOAs were withdrawn due to regulatory difficulties.
AstraZeneca has enumerated a number of differences that exist
between the previous proceedings and this one, the crossexamination of Dr. Sherman and the resulting concern with
credibility being, in my view, the most significant. I cannot
conclude, on a summary application, notwithstanding that the
argument was in excess of four hours on a general sittings day, that
39
Pfizer Canada Inc. v. Apotex Inc., [1999] 1 C.P.R. (4th) 358 at paras 28-29.
Ibid at para. 37.
41
AstraZeneca Canada Inc. v. Apotex Inc., [2002] F.C.J. No. 1707 (T-660-02) at para 8
40
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-12this ground is so clearly improper as to be bereft of any possibility
of success. Apotex has failed to persuade me that this is the case.
Having so concluded, I need not address the other grounds
argued.42
Consistent with previous jurisprudence of the Federal Court, a very high threshold must be met
before an application for prohibition will be dismissed at the interlocutory stage.
(b)
Patents not Eligible for Inclusion on the Register: Section 6(5)(a)
Subsection 6(5)(a) of the Regulations provides a procedure for a second person to have an
application under 6(1) dismissed at an interlocutory stage if:
[T]he court is satisfied that the patents at issue are not eligible for
inclusion on the register or are irrelevant to the dosage form,
strength and route of administration of the drug for which the
second person has filed a submission for a notice of compliance.43
Prior to the 1998 Amendments, the conventional means of challenging the eligibility of a patent
to be on the Patent Register was to bring a judicial review proceeding challenging the Minister’s
decision or, in the case of a challenge to the merits of a Prohibition Case, to raise the argument at
the hearing of the main application.44
The first case to consider section 6(5)(a), Merck Frosst Canada Inc. v. Apotex Inc., remains
unreported. Justice Pinard, upon considering a motion to dismiss an application on the basis that
one of the patents at issue was ineligible for listing on the Register pursuant to s.6(5)(a) and (b),
ruled that the Court could not dismiss only part of an application.45 Nevertheless, Justice Pinard
provided these comments on the burden which the moving party must overcome to succeed on a
motion under section 6(5)(a):
Furthermore, even if the Court could dismiss only part of an
application under subsection 6(5) of the Regulations, I am of the
view that Apotex has failed to establish beyond doubt that this is a
plain and obvious case justifying such a draconian result. In light
of the Eli Lilly case [cite omitted], the applicants’ (collectively
“Merck”) contention that lovastatin, the subject of the ‘380 patent,
42
Ibid at para. 15.
Regulations, 6(5)(a)
44
E.g., Novopharm Limited v. Minister of National Health and Welfare et al (1998), 78 C.P.R. (3d) 54 (F.C.T.D.).
45
Merck Frosst Canada Inc. v. Apotex Inc., unreported, T-418-98, 27 March, 1998, per Pinard J.
43
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-13although used as an intermediate in the manufacture of simvastatin,
nevertheless has a very clear therapeutic value and is a medicine
within the definition of that term in section 2 of the Regulations
cannot be characterized as so clearly futile as to not have the
slightest chance of succeeding.46
The Court of Appeal affirmed the Order of Pinard J. dismissing the motion on the basis that
subsection 6(5) does not permit a court to dismiss only part of an application for prohibition
without commenting on the burden.47
In May of this year the first reported decision to address subsection 6(5)(a) was issued in Procter
& Gamble Pharmaceuticals Canada, Inc. v. Canada.48 With respect to the standard or test that
should be applied in assessing the merits of a motion under subsection 6(5)(a), Madame Justice
Gauthier found that “a motion to strike a notice of application filed under subsection 6(1) based
on the fact that the only patent on the Register should not be there, is or is akin to a motion to
strike out the proceeding on the basis that there is no reasonable cause of action.”49 Based on this
interpretation, the second person must prove that it is plain and obvious that a patent is not
eligible for inclusion in the Register, a much higher standard than would be applied in a judicial
review of the Minister’s decision to include a patent on the Register.
5.
Conclusion
Each stage in an application for prohibition, from the second person’s drafting of the NOA
through to an assessment of the merits, requires a great deal of analysis and preparation. Each of
the issues discussed in this paper—sufficiency of the NOA, motions for disclosure and motions
to strike—adds both complexity and context to applications for prohibition. From the
perspective of the first person, an application requires assessment of the NOA and preparation of
a case on the merits despite deficiencies in the NOA. First persons should consider the necessity
of a motion for disclosure of manufacturing processes including the DMF or samples of the drug.
Second persons should consider the advisability of bringing a motion to dismiss the application
46
Ibid.
Apotex Inc. v. Merck Frosst Canada Inc. et al (1999), 87 C.P.R. (3d) 30 per Noel, J.A. (Desjardins, Décary JJ.A.).
The Court of Appeal rejected Apotex’s argument that separate from the Regulations, the Court could strike the
application by invoking its implied jurisdiction to control its process (para. 34). The Court of Appeal said: “Having
regard to the conclusion we have reached on the first ground, it is not necessary to express an opinion on the motion
Judge’s alternative ground for dismissing the motion to strike”. (para. 34)
48
Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health and Welfare), 2003 FCT 583.
49
Ibid at para 14.
47
McCarthy Tétrault LLP TDO-MCTET1 #3839725 v. 4
-14under section 6(5) given the court’s imposition of a very high burden and its reluctance to
dismiss applications in advance of a hearing on the merits.
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