Date: 20090304
Dockets: T-876-08
T-886-08
Citation: 2009 FC 226
Ottawa, Ontario, March 4, 2009
PRESENT: The Honourable Mr. Justice
Harrington
BETWEEN:
PFIZER CANADA INC., PFIZER LIMITED,
and
PFIZER IRELAND PHARMACEUTICALS
Applicants
and
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
[1]
In
the course of an application to prohibit the Minister from issuing a Notice of
Compliance with respect to a generic version of a medicine referenced by a
patent listed in the Minister’s Register, the Court may order the generic drug
manufacturer to produce any portion of the submission it filed with the
Minister. Pfizer moved that Apotex produce portions of such submissions.
Prothonotary Aalto dismissed its motion. This is the appeal thereof.
[2]
There
are two passages from Prothonotary Aalto’s order which set out the rationale of
his decision:
On my view of the evidence, Pfizer has
not met, on a balance of probabilities, its burden of demonstrating that
disclosure is required and important, especially in light of the substantial
voluntary disclosure made to date by Apotex.
…
On my view of the evidence of Dr. Klibinov,
Mr. Terrill, their cross-examinations and the evidence of Dr. Byrn, I am not
persuaded that the information sought on this motion is either relevant,
important or required. There is no evidence that Apotex is infringing.
[3]
The
order was discretionary. It is well established that such orders are not to be
disturbed unless they could have been vital to the final issue of the case or,
failing that, unless the order was clearly wrong as based either upon a wrong
principle of law or upon a misapprehension of the facts. In such cases the
judge hearing the appeal is required to exercise his or her discretion de
novo (Merck & Co. v. Apotex Inc., 2003 FCA 488, [2004] 2
F.C.R. 459, 30 C.P.R. (4th) 40 and Fieldturf Inc. v. Winnipeg Enterprises
Corp., 2007 FCA 95, 58 C.P.R. (4th) 15, 360 N.R. 355). Pfizer submits both
that the issue decided was vital to the outcome of the case and that the
Prothonotary was clearly wrong.
BACKGROUND
[4]
Apotex
has served Pfizer with two Notices of Allegation pursuant to the Patented
Medicines (Notice of Compliance) Regulations with respect to its submissions
to the Minister of Health for approval of its tablets comprising amlodipine for
use as an antihypertensive-antianginal.
[5]
Pfizer
has two patents on the Register maintained by the Minister. Apotex alleges with
respect to patent 1,321,393
(‘393)
that no claim for the medicinal ingredient, for the formulation, for the dosage
form, or for the use of the medicinal ingredient would be infringed by its
making, constructing, using or selling its tablets. It alleges that the
relevant claims of the ‘393 patent are limited to the besylate salt of
amlodipine, or a composition or formulation comprising same. Apotex will not
infringe because its tablets will not contain that salt, nor will that salt be
used in any way in the manufacturing process. More particularly, only
amlodipine will be the medicinal ingredient.
[6]
With
respect to the second patent, 2,170,278
(‘278),
similar allegations are made on the basis that the patent is limited to the
R(+) isomer of amlodipine or salt thereof. There will be no infringement
because Apotex’s tablets will use the racemate, not the R(+) isomer. There is
also an undertaking that the Notice of Compliance it seeks will not include an
indication for treatment of conditions requiring inhibition of vascular smooth
muscle cell migration.
[7]
As
Apotex was not content to await the expiry of the two patents before marketing
its product, Pfizer has applied for a prohibition order against the Minister.
Section 6(7)(a) of the PM (NOC) Regulations provides:
|
(7) On the motion of a first person, the court may, at
any time during a proceeding,
(a) order a second
person to produce any portion of the submission or supplement filed by the
second person for a notice of compliance that is relevant to the disposition
of the issues in the proceeding and may order that any change made to the
portion during the proceeding be produced by the second person as it is made;
|
(7) Sur requête de la première personne, le tribunal peut, au cours de
l’instance :
a) ordonner à la seconde personne de produire
les extraits pertinents de la présentation ou du supplément qu’elle a déposé
pour obtenir un avis de conformité et lui enjoindre de produire sans délai
tout changement apporté à ces extraits au cours de l’instance;
|
[8]
During
the course of the proceedings and before the motion was heard, Apotex
voluntarily disclosed to Pfizer a good portion of its New Drug Submissions filed
with the Minister. The Prothonotary ordered that these productions be deemed to
have been made pursuant to s. 6(7), required Apotex to promptly produce any
changes that were made thereto and ordered that the Minister verify that these
productions, and any changes thereto, corresponded fully to the information on
file with him. Those portions of the order are not under appeal.
[9]
It
is common ground that the active ingredients, as opposed to the ultimate formulation,
are supplied to Apotex by two Indian corporations. They provided what may be
the relevant portions of their Drug Master Files to the Minister on a “closed”
or confidential basis. Apotex does not have these closed portions in its
possession or control. All that Apotex could be ordered to do would be to use
its “best efforts” to encourage its Indian suppliers to provide that
documentation, which documentation would be covered by confidentiality orders already
in place or, if appropriate, by more expansive orders.
[10]
The
other documentation Pfizer seeks is the entire Chemistry and Manufacturing
Section contained in Apotex’s New Drug Submissions. That is information within
Apotex’s possession and control. Certainly parts thereof have already been
voluntarily produced.
[11]
The
evidence before Prothonotary Aalto comprised the affidavit of Dr. Steven Byrn,
a medicinal chemist called by Pfizer, and reply evidence of Dr. Alexander Klibanov,
a professor of chemistry and bioengineering and Dwayne Terrill, Manager of Regulatory
Affairs for Apotex. Dr. Byrn was not cross-examined; the other two affiants
were. Dr. Byrn focused on that portion of Apotex’s submissions to the Minister
which states:
Alternate processes and explanation of
their use:
This information is not provided in the
open part of either of the Drug Master Files. Please refer to the closed portion
of the Drug Master Files.
[12]
Dr.
Byrn speculates that there may be such alternative processes used by the Indian
suppliers and that they might infringe the patents. Dr. Klibanov counters that
such a scenario is highly unlikely and would make no sense.
[13]
More
to the point, however, is that Dr. Klibanov recounts in his affidavit that upon
his review of those portions of Apotex’s New Drug Submissions with which he had
been provided he was of the opinion that: “None of the documents suggests that
Apotex is seeking to market amlodipine besylate or the R(+) enantiomer of
amlodipine.” He went on to explain why, in his opinion, “nothing in the
documents would support [Dr. Byrn’s] speculation.”
[14]
In
my opinion, on the facts before the Prothonotary, there is nothing to indicate
that his decision was vital to the outcome of the case. Apotex has disclosed the
process by which it says it will prepare its tablets. The Applications Judge will
have to decide on the merits whether Apotex’s allegations of non-infringement
are justified. The Applications Judge is not called upon to decide whether some
other process might infringe.
[15]
However,
in support of its submission that the Prothonotary erred in law, Pfizer seizes
upon the following sentence in his order: “There is no evidence that Apotex is
infringing”. It is submitted that that is the very point to be decided by the
Applications Judge. Pfizer is correct.
[16]
However,
Prothonotary Aalto’s words have to be considered in context. He immediately
added:
Indeed, the thrust of the evidence of Dr.
Klibinov, which undermines Dr. Byrn’s theorizing, is that it would be
essentially nonsensical with absolutely no commercial advantage for Apotex to create
amlodipine besylate in its manufacturing process and then destroy it in the
course of producing amlodipine maleate. Similarly, the evidence is that with
respect to the R(+) isomer, it is highly illogical for a manufacturer to create
R(+) amlodipine when such a process would make no chemical sense, would cause
additional regulatory hurdles, would add expense and be contrary to the
manufacturer’s goal of not producing an infringing product.
[17]
In
his affidavit for the purposes of the production motions, Dr. Byrn does not
opine that the material already produced by Apotex evidences an infringement.
Rather, he submits that alternate processes by the Indian suppliers might infringe.
On the other hand Dr. Klibanov, whose evidence Prothonotary Aalto preferred,
clearly is of the view that the material produced so far establishes a
non-infringing process.
[18]
Judicial
prowess aside, I think the following passage from Lord Devlin’s speech in The
Amstelslot, [1963] 2 Lloyd’s Rep. at page 234 drives home the point:
There was a suggestion in the Court of
Appeal that Mr. Justice McNair, who tried the case, got his law wrong on the
elementary point about the burden of proof. The suggestion is based on a
passage in his judgment that has, for the purpose of the argument, to be
isolated from his other statements of the law. For myself, I should want more
than a piece of textual criticism as a bait before I was tempted to swallow the
idea that Mr. Justice McNair, who is the greatest English authority on the
Hague Rules and more experienced than any other Judge in their application,
misunderstood where the burden of proof lay in a “due diligence” case.
[19]
Prothonotary
Aalto’s sentence cannot be taken to mean that he intended to decide the case on
the merits. On the contrary, his was clearly an interlocutory order and it
cannot be suggested that he did not know that he did not have jurisdiction to
issue a prohibition order.
[20]
A
good deal of the argument before me attempted to identify the test to be
applied by the Court in determining whether a second person within the meaning
of the Regulations, i.e. Apotex, should be ordered to produce portions of its New
Drug Submissions to the Minister as part of the approval process for its
generic version of a drug. In Biovail Corp. v. Canada (Minister of
National Health and Welfare), 2002 FCT 1143, 22 C.P.R. (4th) 503, Mr.
Justice Simon Noël stated at paragraph 40:
In order to be able to justify the application
of subsection 6(7) of the Regulations, a party must convince the Court on three
matters:
a)
That the request for disclosure is done in a timely manner;
and
b)
That the information already provided is not sufficient to
deal with the issues at stake; and
c)
That the disclosure of the required information is
necessary because it is relevant to the disposition of the issues in the
proceeding.
[21]
However,
in appeal, 2003 FCA 406, 29 C.P.R. (4th) 129 at para. 33, and basing himself on
the earlier decision of the Court of Appeal in Novartis Pharmaceuticals
Canada Inc. v. Abbott Laboratories, Ltd. (2000), 7 C.P.R. (4th) 264, Mr.
Justice Nadon held that the first and foremost consideration is whether the
documents sought to be produced are relevant:
…Once
satisfied that the documents sought are relevant, a judge may consider a number
of factors in deciding whether he or she ought to order production, one of
these factors being, in my view, whether the application was brought in a
timely manner. To hold otherwise would, in my respectful view, make no sense.
[22]
Prothonotary
Aalto did not rule against Pfizer on the timeliness point. Rather, he was not
persuaded that the information sought was relevant, important or required. In
so doing he preferred the evidence of Dr. Klibanov over that of Dr. Byrn.
Pfizer submits that he “erred in law in usurping the function of the
applications judge by resolving conflicting expert evidence.” I fail to
appreciate this submission. Although interlocutory motions in applications are
often left to be decided by the Applications Judge, that is not the case here.
Pfizer could, and did, bring on its application which the Regulations say could
be brought on “at any time” or at least in a timely manner. In considering
whether the documentation might be relevant, the Prothonotary had to take into
account the opinions of the experts. This was a pre-requisite to exercising his
discretion, which discretion ought to have been exercised before the hearing on
the merits. His preference is not to be disturbed because he did not make a
palpable or overriding error (Housen v. Nikolaisen, 2002 SCC 33, [2002]
2 S.C.R. 235, applied to interlocutory decisions of Prothonotaries in Hershkovitz
v. Tyco Safety Products, 2006 FC 1228, 56 C.P.R. (4th) 47 and Tazco
Holdings Inc. v. Advantage Products, 2008 FC 464, 65 C.P.R. (4th) 390).
[23]
Indeed,
like him, I cannot see how the information is relevant. The issue to be
determined by the Applications Judge is whether the process Apotex states it
will use would infringe, not whether some other process might infringe. Even if
it could be said that the information might be relevant, a production order
does not automatically follow. This is an application which is intended to be
heard in a summary manner, not an action in which a party in its affidavit of
documents must reveal all (Rules 222 and 223 of the Federal Courts Rules).
In exercising his discretion, Prothonotary Aalto properly took into account
Apotex’s productions to date, and was not clearly wrong in deciding that the
information was not relevant, was not important or was not required.
[24]
Even
if Prothonotary Aalto could be taken to task, which he should not, for
accepting the hearsay evidence from Apotex’s Mr. Terrill that the Indian
suppliers did not have an alternate process, he acted within his discretion,
particularly considering the wealth of material Apotex has already provided.
[25]
In
the circumstances, it is not necessary in this case to consider what “best
efforts” would have to be undertaken by Apotex to endeavour to persuade its
suppliers to disclose the closed portion of their Drug Master Files (PharmaScience
Inc. v. Canada (Minister of Health) 2003 FCA 333, 28 C.P.R. (4th) 27).
[26]
As
to production of the entire Chemistry and Manufacturing Section of Apotex’s New
Drug Submissions, again given Apotex’s extensive productions to date, the
Prothonotary’s refusal was not based on an error of fact or law.
[27]
In
conclusion, the Prothonotary’s decision was not, and could not have been, vital
to the outcome of the case. Furthermore, the exercise of his discretion was not
clearly wrong. However, should I have misapplied the test stated by the Court
of Appeal in such cases as Merck v. Apotex, above, so that I am required
to exercise my discretion de novo, for the reasons set out herein I
would also dismiss the motions.
ORDER
THIS COURT
ORDERS that:
1. The appeal
from the order of Prothonotary Aalto in Court file T-876-08 dated 19 January 2009 is
dismissed.
2. The appeal
from the order of Prothonotary Aalto in Court file T-886-08 dated 19 January
2009 is dismissed.
3. Apotex shall have its costs,
calculated on a single motion in appeal.
“Sean Harrington”
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