Docket: T-1372-10
Citation:
2011 FC 1308
Ottawa, Ontario, November 14, 2011
PRESENT: The Honourable Mr. Justice Barnes
BETWEEN:
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APOTEX INC.
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Applicant
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and
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MINISTER OF HEALTH AND
ATTORNEY GENERAL OF CANADA
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Respondents
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REASONS FOR JUDGMENT AND
JUDGMENT
[1]
This
is an application by Apotex Inc. (Apotex) challenging three decisions made by
the Minister of Health or by the Minister’s delegate (Minister) in connection
with the rejection of its submission for a Notice of Compliance (NOC) for
Omeprazole Magnesium tablets (Apo-Omeprazole).
[2]
For
the reasons that follow, this application must be dismissed as untimely. It
is, accordingly, unnecessary to address the substantive issues raised by Apotex
with one exception – that being its argument that it had vested rights to a NOC
for Apo-Omeprazole tablets or, alternatively, to an external review of the
Minister’s negative decision.
[3]
Apotex
brought a motion returnable at the commencement of this application seeking to
strike out all or portions of the affidavit of Andrew Adams. The grounds for
the motion are that Mr. Adams did not have personal knowledge of the
matters deposed to and that the affidavit contains inadmissible opinions and
hearsay. The Minister answered the motion with the assertion that the
affidavit contains factual evidence based on personal knowledge or,
alternatively, that the evidence is admissible under an exception to the
hearsay rule. When Apotex argued the motion, its objections were limited to
paragraphs 13 to 15, 78 to 80, 27 to 77 (selectively), and 81 to 92. Given
that this evidence refers to substantive issues that I have not needed to
address in these reasons, it is not strictly necessary to deal with Apotex’s
motion. However, because there is some merit to Apotex’s concerns and because
the inappropriate use of affidavits in this Court is a matter of ongoing
concern, I will address the issues raised on the motion.
[4]
Under
Rule 81 of the Federal Courts Rules, SOR/98-106 [Rules], affidavits
relied upon in the context of an application are to be confined to facts within
the deponent’s personal knowledge. This provision has been interpreted to
permit hearsay evidence if it falls within a common-law exception, including
the principled exception, but otherwise, it prohibits the assertion of facts
obtained from others: see Canadian Tire Corp v PS Part Source Inc, 2001
FCA 8 at para 6, 200 FTR 94. Needless to say, affidavits should also be free
of unqualified opinion, argument, conclusions of law or speculation: see Van
Duyvenbode v Canada (AG), 2009 FCA 120 at para 3,
[2009] FCJ no 504 (QL).
[5]
Mr. Adams’
affidavit does not fully conform to these requirements. It is, in some
aspects, argumentative, opinionated, speculative and conclusory. It also
contains some inadmissible hearsay. Substantial portions of the affidavit are
however unobjectionable and it would be possible to sever the offending
material from the rest or to simply ignore it.
[6]
I
am not convinced that paragraphs 13, 14 and 15 contain inadmissible expert
opinion. This is the type of general background evidence, albeit of a
scientific nature, that would be known to Mr. Adams by virtue of his
position and experience within the Ministry. Furthermore, this evidence was
not relevant to a material or controversial issue on the application inasmuch
as Apotex’s legal challenge was based on the fairness of the process and not on
a disagreement about the background science. I would add that Dr. Sherman’s
affidavit, submitted on behalf of Apotex, contains passages bearing on his view
of the background science. These are matters that he too would be able to
speak to based on his experience in running Apotex for many years and are
similarly unobjectionable.
[7]
The
same cannot be said of paragraphs 78 to 80 which do purport to express
Mr. Adams’ opinions, conclusions and arguments on material scientific
issues. There is also no linkage between this evidence and any personal
involvement by Mr. Adams in the decision-making history of this matter.
Whatever Mr. Adams thought the record disclosed is irrelevant.
[8]
Apotex
concedes that paragraphs 27 to 77 are substantially unobjectionable because
they set out a neutral chronology of events as verified by the record. There
are, however, a few instances where the passages verge into opinion or analysis
or seemingly rely on unspecified hearsay (see paragraphs 33, 53, 57, 63, 65,
68, 70, 71, 73 and 77).
[9]
Paragraphs
81 to 97 of the Adams affidavit deal with a number of departmental
emails that Dr. Sherman has, in his own affidavit, characterized in
unflattering terms. Dr. Sherman deposes in paragraph 134 that the emails
“speak for themselves” but he goes on to describe their content as “the
antithesis of both scientific integrity and respect for the appropriate regulatory
decision making process”. He also speculates about the Ministry’s motives and
advances several arguments about why this evidence discloses a bias. It is
perhaps not surprising that Mr. Adams responded to this material in like
fashion but that does not render the material any less objectionable from an
evidentiary standpoint. The appropriate response to the objectionable material
of this sort is simply to ignore it and to consider the admissible evidence
independently from the views of witnesses who were not privy to its creation.
[10]
In
summary, the affidavit material filed by both parties in this proceeding fell
short of the standards that apply under our Rules. Such lapses are
particularly troublesome because the interlocutory disputes they engender are
wasteful of scarce Court resources. Greater care is to be expected
particularly from litigants who are well versed in the requirements for proper
pleading.
Is This
Application Out of Time?
[11]
The
Minister takes the position that this application is out of time and must be
dismissed for failing to meet the 30-day filing requirement of subsection
18.1(2) of the Federal Courts Act, RSC 1985, c F-7 [Act]. Apotex
argues that it did not file the application out of time because the actions of
which it complains represent a course of ongoing unfair conduct by the Minister
that are open to being judicially reviewed at any time. In the alternative,
Apotex has brought motions to amend its Notice of Application and to extend the
time for bringing this application. The Minister does not oppose the motion to
amend but disagrees that this is an appropriate situation to extend time under
subsection 18.1(2) of the Act.
[12]
Apotex
brought this application on August 26, 2010. In its Notice of Application
Apotex seeks prerogative relief in connection with three ministerial decisions
by which a NOC was refused for its Apo-Omeprazole tablets.
[13]
The
first impugned decision is characterized by Apotex as a revocation by the
Minister on December 5, 2008 of an “approvability status” for its Apo-Omeprazole
tablets. The second impugned decision concerns the Minister’s issuance on
February 9, 2009 of a “Notice of Non-Compliance withdrawal letter” for
Apo-Omeprazole tablets. The third impugned decision concerns the Minister’s
decision on July 27, 2009 to deny Apotex’s request for reconsideration of the
decision to issue a Notice of Non-Compliance withdrawal letter for
Apo-Omeprazole tablets.
[14]
In
its Notice of Application, Apotex characterizes the Minister’s decisions as
unlawful, unreasonable, unfair, discriminatory, illogical, scientifically
untenable and biased. Among other points, it contends that it had a vested
interest in a NOC when the Minister advised it by letter of March 7, 2003 that
the examination of Apo-Omeprazole had been completed but that a NOC would not
issue until the requirements of the Patented Medicines (Notice of Compliance)
Regulations, SOR/93-133 were met – in other words, that Apotex’s
application for a NOC was on patent hold.
[15]
Apotex
also asserts that the Minister’s refusal to approve Apo-Omeprazole continues a
course of unfair conduct dating back to 1988 with respect to many of its
generic pharmaceutical products.
[16]
Dr. Sherman’s
affidavit sworn on September 8, 2010 relates a two decade history of
“apparently systemic” and “unfair and discriminatory treatment” by the Minister
and the Minister’s officials. Much of this history has involved numerous
applications for judicial review by Apotex including a series of applications concerning
Apo-Omeprazole. It is this ongoing history of acrimony and litigation between
Apotex and the Minister that Apotex argues underpins this application and
permits it to avoid the strict 30-day filing requirement for initiating a
judicial review of the three ministerial decisions it challenges. Presumably,
it is this same history that Apotex relies upon to avoid the limitation in Rule
302 that, absent leave of the Court, only one decision at a time can be the
subject of an application for judicial review.
[17]
Apotex’s
primary Memorandum of Fact and Law also refers to a “pattern of misconduct” and
to a systemic refusal by the Office of Science to “give fair, honest and bona
fide consideration” to its appeal but it is silent on the question of
whether this application was brought out of time. In its motion to extend
time, Apotex merely asserts that at the time of filing it was of the view that
it was not subject to the 30-day filing requirement in subsection 18.1(2) of
the Act. In oral argument, it attempted to justify that view on the
strength of the Federal Court of Appeal decisions in Krause v Canada,
[1999] 2 FC 476 , [1999] FCJ no 179 (QL) [Krause], and Manuge
v Canada, 2008 FC 624 , [2008] FCJ no 787 [Manuge].
[18]
Neither
Krause nor Manuge are applicable to an application like this
which involves a fairness challenge to three discrete administrative
decisions. Both Krause and Manuge were concerned with the
lawfulness of the government’s implementation of policies on an ongoing basis.
This is made clear in the following passage from Krause:
24 I am satisfied that the exercise
of the jurisdiction under section 18 does not depend on the existence of a
"decision or order." In Alberta Wilderness Assn. v. Canada (Minister of Fisheries &
Oceans), Hugessen J. was of the view that a remedy envisaged by that section
"does not require that there be a decision or order actually in existence
as a prerequisite to its exercise." In the present case, the existence of
the general decision to proceed in accordance with the recommendations of the
Canadian Institute of Chartered Accountants does not, in my view, render the
subsection 18.1(2) time limit applicable so as to bar the appellants from
seeking relief by way of [page 493] mandamus, prohibition and declaration.
Otherwise, a person in the position of the appellants would be barred from the
possibility of ever obtaining relief under section 18 solely because the
alleged invalid or unlawful act stemmed from a decision to take the alleged
unlawful step. That decision did not of itself result in a breach of any
statutory duties. If such a breach occurred it is because of the actions taken
by the responsible Minister in contravention of the relevant statutory
provisions.
[Footnote omitted]
[19]
In
Manuge, above, I made a similar point in the following passage:
17 There is no question that much of
what was of concern to the Court in Grenier and in its earlier decisions in Tremblay
v. Canada, 2004 FCA 267, [2004] 4 F.C.R. 165 and in Budisukma Puncak
Sendirian Berhad v. Canada, 2005 FCA 267, 338 N.R. 75, had to do with the
desire for finality around administrative decisions and to ensure that
appropriate deference was accorded to the decision maker (see, for example,
paras. 27 to 30 in Grenier). The Court was also rightfully concerned
about a process which would allow a party to collaterally attack a decision
well beyond the 30-day time limit for bringing an application for judicial
review. All of these are concerns that carry much less significance in a case
where the challenge is limited to the lawfulness of a government policy and
where the application of that policy has on-going implications for the party
affected. It is also perhaps noteworthy that in Grenier, Tremblay
and Berhad, the Court's discussion of these policy considerations
invariably referred to the lawfulness of the underlying decisions and no
explicit reference was made to challenges to government policy, legislation, or
conduct. In Tremblay, the Court also noted "the fine line that
exists between a judicial review and a court action" where extraordinary
remedies are sought.
[20]
Allowing
Apotex to avoid the 30-day filing requirement on this application would open
the door to a multitude of similar belated applications and thereby effectively
extinguish the requirement. It would also sidestep the need for finality for
discrete administrative decisions that are, as here, directly attacked as
unlawful. The Federal Court of Appeal well-expressed the principle of finality
in the following passages from Canada (AG) v Trust Business
Systems,
2007 FCA 89, [2007] FCJ no 379 (QL):
28 In Canada v. Berhad, [2005]
F.C.J. No. 1302, 2005 FCA 267, Létourneau J.A. wrote that the thirty-day limit
for commencing judicial review applications is in the best interest of the
public because it brings finality to administrative decisions and security to
those who comply with the decision or who enforce compliance with it. At
paragraph 60 he stated:
The importance of that public interest is
reflected in the relatively short time limits for the commencement of
challenges to administrative decisions -- within 30 days from the date on which
the decision is communicated, or such further time as the Court may allow on a
motion for an extension of time. That time limit is not whimsical. It
exists in the public interest, in order to bring finality to administrative
decisions so as to ensure their effective implementation without delay and to
provide security to those who comply with the decision or enforce compliance
with it, often at considerable expense. [Emphasis added]
29 Accordingly, when the Tribunal
issued its determination on the motion on April 25, 2005, the applicant was
required under subsection 18.1(2) of the FCA to file its notice of
application for judicial review within thirty days, as Trust's substantive
right to its complaint were finally decided. As the applicant did not do so
within the allotted time frame, it is now time-barred to challenge this issue.
The authorities relied on by the applicant in Ernst Zündel and Canadian
Association for Free Expression Inc., [2000] 4 F.C. 255 and R. v.
Seaboyer; R. v. Gayme, [ 1991] 2 S.C.R. 577 are distinguishable as
they deal with interlocutory issues as opposed to those that have the potential
to bring finality to the proceedings.
[Emphasis in
original]
[21]
I
agree with counsel for the Respondent that Apotex’s position “is no more than a
colourable device intended to permit Apotex to avoid violating both the letter
and the spirit of section 18.1(2) of the Federal Courts Act and Rule
302”. In my view, the 30-day filing requirement does apply to this application
and can only be overcome by a meritorious motion to extend time.
Apotex’s
Motion to Extend Time
[22]
Apotex
acknowledges that its entitlement to relief is dependant upon its demonstration
of all of the following:
a. a continuing
intention to pursue the application;
b. that the
application has some merit;
c. that no
prejudice to the respondent arises from the delay; and
d. that a
reasonable explanation for the delay exists.
[23]
For
the purposes of this motion, it is only necessary to deal with issues (a) and
(d).
[24]
There
is no question that Apotex brought this application well out of time. It was
filed 19 months after the first impugned decision, 17 months after the second
and 12 months after the third. These lengthy delays require a compelling
explanation which is entirely lacking in this case. Indeed, the evidence
adduced by Apotex on this motion is at least as significant for what it fails
to disclose as for what it asserts.
[25]
Dr. Sherman’s
motion affidavit repeatedly claims that “until July 2010” he was unaware of
material evidence that was necessary to make a decision to proceed with
litigation against the Minister. According to paragraph 16 of
Dr. Sherman’s affidavit “[i]t was only upon discovery of these additional
facts that I was able to appreciate the purported bases, or more accurately,
the lack thereof, upon which the decision of the Minister to revoke
approvability and patent hold of Apo-Omeprazole tablets had been founded”.
[26]
The
only significance to Dr. Sherman’s reference to July 2010 is that it was
sometime in that month that he got around to examining the documents disclosed three
months earlier by the Minister in response to Apotex’s Access to Information
request. Despite being quite precise about many other dates,
Dr. Sherman’s affidavit is notably silent about when Apotex received these
documents from the Minister and surprisingly imprecise about when he looked at
them. Under cross-examination, he was asked about the significance of the Access
to Information cover letter
dated April 15, 2010 from Health Canada and he gave the
following evidence:
26 Q. Now the access material itself, you
received in April 2010, correct?
A. Not as far as I know.
I don’t know when it came in.
27 Q. You don’t know when it came in?
A. No. We tried to
find out, actually, because it is a question that actually Mr. Radomski asked me.
What happened was I found, when he asked me about the dating, the requests that
I had sent in, and I found this letter of October 2, 2009. But I did not have
and could not find the covering letter that came with the materials. The
materials, when they came in, had gone to our regulatory department. I went and
got them, and the covering letter wasn’t there.
We tried to figure out when
it might have come in. I know Mr. Radomski made some inquiries of Health Canada, but they never answered.
28 Q. You recall there was a covering letter,
though?
A. I don’t recall;
there would have been. I don’t know if I ever saw it.
29 Q. I have a copy of a letter here that
says:
“Dear Dr. Sherman: This is in response to your request
under the Access to Information Act ...”
…and then the request is quoted. And it
says:
“Enclosed are copies of records which
respond to your request ...”
…and so on. It appears to be a covering
letter for the materials, transmitting to you the materials. It is dated April
15, 2010.
A. I don’t have that. What
of it? I don’t have it.
30 Q. But you have no reason to believe that
this material was sent later than that, do you?
A. I don’t know. I
don’t have any information. All I can tell you is that when it came in it would
have gone to the regulatory department. It was in July that I turned my mind to
figuring out what we were going to do, in fact, what we could do, about this
file, because Health Canada wasn’t cooperating, and…
31 Q. If we can go off the record for a
second?
A. Yes.
MR. RADOMSKI: Okay.
--- Discussion off the Record
THE WITNESS: As I was
saying, I don’t know when it came in. It may well have been in May or, you say
there was a letter the end of April. What date did you say?
MR. WOYIWADA: April
15.
THE WITNESS: It may
well have come in in late April, but it would have gone to the regulatory
department and no one would have had any reason to review it. I turned my mind
to what to do, if anything, in July, and went and got what was available; I got
the file to review it, and that was sitting in the file.
When I went through it, I
found these surprising ... things that seemed very surprising to me, and sent
them to Mr. Radomski, as I have explained.
In my view this evidence is unsatisfactory
because it fails to provide a reasonable justification for the delay in filing
this application between April 2010 and late August 2010. The inference I draw
from the evidence is that this four month delay was the result of either a lack
of diligence or a lack of interest but neither meets the test to establish a
continuing intention to proceed or explain the failure to do so.
[27]
While
there was undoubtedly some information in the Access to Information
records provided to Apotex in April 2010 that could help to inform a decision
to bring this application, this will almost always be the case with respect to administrative
decisions of this type. Affected parties will rarely have access to all of the
information in the decision record. More often than not, parties like Apotex
make critical litigation decisions on the basis of incomplete disclosure.
[28]
Apotex
is a sophisticated litigant with a long history of highly adversarial
litigation with the Minister. According to Dr. Sherman’s motion affidavit,
Apotex is the victim of more than 20 years of unfair and unprincipled decision-making
at the hands of the Minister and the Minister’s officials. Against this
background, it is disingenuous for Dr. Sherman to assert in his motion
affidavit that he was “astounded” by what the Access to Information documents
revealed to him. It is simply not open to a well-informed and well-represented
litigant like Apotex to claim the luxury of at least a year and then to bring
an application for judicial review. Cases that are arguably far more
meritorious and significant to the parties than this one are dismissed by this
Court for delays much shorter than those arising here.
[29]
Even
if there was merit to Apotex’s argument that it had no evidentiary basis to
proceed with this application until it had reviewed the Access to
Information records, there is nothing to explain why it failed to make that
request until September 30, 2009 – some two months after the last of the
Minister’s impugned decisions.
[30]
There
is no merit to Apotex’s motion to extend time to bring this application and the
motion is accordingly dismissed.
Did Apotex
Have a Vested Right to a NOC?
[31]
There
is only one substantive issue raised by Apotex that I must resolve because it
is arguably not disposed of by the failure to bring this application on a
timely basis.
[32]
Apotex
argues that it had a vested right to a NOC for its Apo-Omeprazole tablets when
the Minister advised it on March 7, 2003 that the examination of Apo-Omeprazole
had been completed subject to the application being placed on patent hold. If
Apotex had such a vested right it may well have a corresponding entitlement to
bring an application for prerogative relief to enforce the right at any time.
Because I do not agree that Apotex has such a vested right, I need not decide
whether the temporal requirement of subsection 18.1(2) of the Act applies
to the determination of this issue.
[33]
It
seems quite obvious to me that until a NOC is issued, a proponent enjoys no
vested interest in a favourable outcome at least with respect to issues that
properly fall within the Minister’s lawful discretion (ie. pertaining to public
safety and efficacy). There is no legal significance attaching to an
application for a NOC that has been placed on patent hold. The Minister is
fully entitled to revisit scientific issues at any point in the process up to
the actual issuance of a NOC. It is only at that point that the Minister’s
examination is completed in accordance with C.08.004 of the Food and Drug
Regulations, RSC 1985, c F-27. Indeed, given the lengthy delays that can
arise, the Minister would be remiss if such applications were approved at the
expiry of the patent hold period without further scrutiny: see Apotex Inc v
Canada (MOH), 2011 FCA 86 at paras 6-8, [2011] FCJ no 334 (QL). In this
view, I am supported by the decision of Justice Roger Hughes in Ferring Inc
v Canada, 2007 FC 300, [2007] FCJ no 420 (QL) where he held:
78 In the present case, the Minister
is acting in a purely administrative capacity, he is processing an ANDS from
its submission to the issuance of an NOC. From time to time, information is
provided or sought and obtained and steps are taken by the Minister. The
Minister is not acting as a tribunal at all (Novopharm Ltd. v. Canada
(Minister of National Health and Welfare) (1998), 78 C.P.R. (3rd) 54 at
paragraph 16 (F.C.) and Saskatchewan Wheat Pool v. Canada (Canadian Grain
Commissioner) (2004), 260 F.T.R. 310 at para. 24). This role is a
continuing one of the type considered by the Supreme Court of Canada in Comeau's
Sea Foods Ltd. v. Canada (Minister of Fisheries and Oceans) (1997), 142
D.L.R. (4th) 193. The Minister, as explained by the Supreme Court in Comeau's
Sea Foods at paragraphs 39 to 51 of its Reasons, is entitled to visit and
revisit circumstances from time to time as conditions change and new issues
arise. It is only when the final step is taken, in that case, the issuing of a
fishing licence, can the issue of functus arise. Here that final step is
the issuance of an NOC.
79 The process here is analogous to
considerations given by the Commissioner of Patents under the Patent Act,
supra, as to whether he will entertain an application for a compulsory
licence (Merck and Co. v. Brantford Chemicals Inc. (2005), 37 C.P.R.
(4th) 481 (F.C.A.)), or as to whether he will involve a person who is not the
person applying for a patent at the point when the patent is allowed (Monsanto
& Co. v. Canada (Commissioner of Patents) (2000), 1 C.P.R. (4th) 500
(F.C.)). In such situations, the actions of the Commissioner, or here the
Minister, cannot be and to be of such finality that they cannot be revisited
where appropriate.
80 Even in circumstances where the
final step has been taken such as a prohibition against the Minister from
issuing an NOC by a Court order, the matter has been revisited where the
underlying patent has been held, in other proceedings, to be invalid (Hoffmann-La
Roche Ltd. v. Canada (Minister of Health and Welfare), [1999] F.C.J. No.
662 at para. 14).
81 I find, therefore, that the Minister
cannot be said to have been functus at any point in the process. The
Minister is entitled, at a point where appropriate, to consider whether a
generic is, in the circumstances of the case, a "second person"
within the meaning of section 5(1) of the NOC Regulations.
[34]
It
follows, as well, from this that Apotex enjoyed no vested interest in the
earlier stipulated process of external review. By the time the Minister got
around to making the decision to refuse a NOC to Apotex, that process had
changed and all that was required was an internal reconsideration. Apotex had
the benefit of that review. It was well aware of the issue that concerned the
Minister and it had a meaningful opportunity to make its case for
reconsideration. That was all that was required in the circumstances.
[35]
For
the reasons given above, I reject Apotex’s claim that it enjoyed a vested
interest in a NOC for its Apo-Omeprazole tablets or, alternatively, to an
external review of the Minister’s decision. In the result, this application for
judicial review is dismissed with costs in the agreed amount of $10,000.00
payable by Apotex to the Minister.
JUDGMENT
THIS COURT’S JUDGMENT
is that
this application for judicial review is dismissed
with costs in the agreed amount of $10,000.00 payable by Apotex to the
Minister.
"R.L.
Barnes"
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