Docket: T-2072-10
Citation: 2011 FC 919
Ottawa, Ontario, July 25, 2011
PRESENT: The Honourable Madam Justice Mactavish
BETWEEN:
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BRISTOL-MYERS SQUIBB CANADA CO. and
MERCK SHARP & DOHME CORP.
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Applicants
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and
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MYLAN PHARMACEUTICALS ULC and
THE MINISTER OF HEALTH
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Respondents
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PUBLIC REASONS FOR ORDER
AND ORDER
(Confidential Reasons for Order and Order
released July 21, 2011)
[1]
Bristol-Myers
Squibb Canada Co. and Merck Sharp & Dohme Corp. (the applicants) appeal from
an order of Prothonotary Aalto refusing the applicants’ request for the
production of certain documents for use in a proceeding under the Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133. In so doing,
Prothonotary Aalto concluded that the applicants had not established that the
documents in issue were either important or required.
[2]
The
applicants submit that the Prothonotary imposed an unduly high and improper
burden of proof on them to justify compelling the production of information in
the possession of Mylan Pharmaceuticals ULC (Mylan). The Prothonotary further
erred, the applicants say, in misapprehending the expert evidence of Dr. Allan
Myerson. This led the Prothonotary to erroneously conclude that the applicants’
theory that the [*] efavirenz used as a starting material in Mylan’s product
would convert to the Form I crystal form of efavirenz claimed by the patent in
issue during the manufacturing process was speculative.
[3]
The
applicants also submit that the facts of this case are very similar to those in
Glaxosmithkline Inc. v. Pharmascience Inc., 2002 FCT 683, [2002] F.C.J.
No. 925, and that Prothonotary Aalto erred in failing to follow that decision.
[4]
Finally,
the applicants say that the Prothonotary erred in having regard to the fact
that Mylan had already produced a significant amount of documentary material in
this matter, given that none of that material related to the manufacturing
process used by Mylan or to the crystal structure of the efavirenz in Mylan’s
tablets.
[5]
For
the reasons that follow, I am not persuaded that Prothonotary Aalto erred as
alleged. Consequently, the applicants’ appeal will be dismissed.
Standard of Review
[6]
The
first issue for the Court is to identify the standard of review to be applied
to the Prothonotary’s decision. The order made by the Prothonotary in this case
was discretionary in nature. As the Federal Court of Appeal observed in Merck
& Co. v. Apotex Inc., 2003 FCA 488, [2004] 2 F.C.R. 459, at paras.
17-19, discretionary orders of Prothonotaries ought not to be disturbed on
appeal unless the questions raised in the motion are vital to the final issue
of the case, or the orders are clearly wrong in the sense that the exercise of
discretion was based upon a wrong principle or a misapprehension of the facts.
[7]
I
do not agree with the applicants that the questions raised in the motion are
vital to the final issue of the case with the result that the Court should
embark on a de novo hearing of this matter. The issue raised by the
motion before the Prothonotary was simply whether the production of certain
documents should be ordered. That question is not vital to the final issue of
the case: see, for example, Pfizer Canada Inc. v. Apotex Inc., 2009 FC
226, [2009] F.C.J. No. 296 at para. 27.
[8]
Consequently,
the question for the Court is whether the order made by Prothonotary Aalto
dismissing the applicants’ motion for production was based upon a wrong
principle or a misapprehension of the facts. In order to answer this question,
it is necessary to first have regard to the law governing documentary
production under the PMNOC Regulations.
Documentary Production
under the PMNOC Regulations
[9]
Proceedings
under the PMNOC Regulations are intended to be summary in nature, and
the parties do not have the same rights of discovery as they would have in an
infringement or impeachment action: Novartis Pharmaceuticals Canada Inc. v.
Abbott Laboratories, Ltd. (2000), 7 C.P.R. (4th) 264 at 270, [2000]
F.C.J. No. 941 at paras.11 and 12 (F.C.A.).
[10]
Subsection
6(7) of the PMNOC Regulations provides that:
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6. (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; and
(b) order the Minister to verify that any portion
produced corresponds fully to the information in the submission or
supplement.
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6. (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;
b) enjoindre au ministre de vérifier
si les extraits produits correspondent fidèlement aux renseignements figurant
dans la présentation ou le supplément déposé.
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[11]
As
the Federal Court of Appeal observed in Novartis, a condition precedent
to the exercise of discretion pursuant to subsection 6(7) of the Regulations
is that the information sought must be relevant. In exercising the discretion
conferred by subsection 6(7), it must also be determined on a balance of
probabilities that the requested information is “important” or “required”.
Did the Prothonotary Impose an Unduly High
Burden of Proof?
[12]
Prothonotary
Aalto accepted that the information sought by the applicants was relevant to
the issues in the application, but found that it was neither important nor
required. The applicants submit that Prothonotary Aalto erred in finding that
the applicants had not met their evidentiary burden in light of the
uncontradicted evidence of their expert, Dr. Myerson.
[13]
In
support of their contention that Prothonotary Aalto applied a wrong principle
by imposing an unduly high burden of proof, the applicants point to Prothonotary
Aalto’s statement that Dr. Myerson had “not unequivocally stated in the
materials, on this theory of conversion as it applies to [*] efavirenz, that it
does in fact convert” [emphasis added]: see page 3 of the transcript of the
oral reasons of Prothonotary Aalto.
[14]
According
to the applicants, this statement shows that Prothonotary Aalto improperly
required the applicants to provide “unequivocal proof” or “compelling evidence”
that the [*] efavirenz used by Mylan as a starting material will convert to the
Form I crystal form of efavirenz claimed by the patent in issue.
[15]
I do
not agree that the Prothonotary erred in relation to the burden of proof. The
comment relied upon by the applicants must be read in the context of the
Prothonotary’s reasons as a whole. At pages 5 and 6 of the transcript of his
oral reasons, the Prothonotary refers to the Novartis decision cited
above, and correctly identifies the burden of proof as being that of the
balance of probabilities. Moreover, it is clear from a review of the reasons as
a whole that Prothonotary Aalto’s examination of Dr. Myerson’s evidence was
conducted with this standard in mind.
Did the Prothonotary Misapprehend the Evidence
of Dr. Myerson?
[16]
The
applicants submit that in concluding that Dr. Myerson’s evidence was
speculative, Prothonotary Aalto erred in misapprehending the uncontradicted
expert evidence before him. The applicants say that the Prothonotary ignored
several of Dr. Myerson’s statements in which he clearly articulated his expert
opinion that the [*] efavirenz used as a starting material in the manufacture
of Mylan’s product would convert to the Form I crystal form of efavirenz
claimed by the patent in issue.
[17]
Dr.
Myerson stated in both his affidavit and on cross-examination that [*] efavirenz
“may” convert to crystalline Form I efavirenz under certain conditions. He
hypothesized that this would occur in the case of [*] because other crystalline
forms of efavirenz convert to the more stable Form I when energy is applied.
[18]
I am
not persuaded that Prothonotary Aalto misapprehended Dr. Myerson’s evidence or
that he erred in characterizing Dr. Myerson’s conversion theory as
“speculative”. Dr. Myerson was “certain” that “some efavirenz form” would
convert to Form I if energy was applied through grinding the material with a
mortar and pestle. However, as Prothonotary Aalto observed, Dr. Myerson also
acknowledged in cross-examination that he really had no information about [*]
efavirenz.
[19]
Dr.
Myerson also did not conduct any studies of [*] efavirenz. He says that there
were references in the literature to the behavior of forms of efavirenz other
than Form I when energy was applied. However, Dr. Myerson did not know whether
this literature specifically considered the behavior of [*] efavirenz: see questions
153-155 of the cross-examination of Dr. Myerson.
[20]
In
these circumstances, it was open to Prothonotary Aalto to weigh Dr. Myerson’s
evidence as it related to his conversion theory, and to conclude that the
applicants had failed to demonstrate on a balance of probabilities that the
evidence sought was important or required.
Did the Prothonotary err in Failing to Follow
the Glaxosmithkline Decision?
[21]
The
applicants contend that Prothonotary Aalto further erred in failing to follow
the decision of Justice Blanchard in the Glaxosmithkline case cited
above.
[22]
Glaxosmithkline also involved a motion
for production under subsection 6(7) of the PMNOC Regulations.
Pharmascience alleged in its Notice of Allegation that the patent in question
would not be infringed because its tablets were made using paroxetine
hydrochloride anhydrate, and not the paroxetine hydrochloride hemihydrate
claimed in the patent. The applicants contended that the Pharmascience tablets
could contain the patented drug. The applicants adduced expert evidence
indicating that the conversion of Pharmascience's anhydrate material to
crystalline paroxetine hydrochloride hemihydrate may occur during processing.
[23]
On
the basis of the expert evidence before him, Justice Blanchard was satisfied
that the information and samples sought from Pharmascience were relevant to the
question of non-infringement in that case, and that paroxetine hydrochloride
anhydrate is known to and may convert to paroxetine hydrochloride hemihydrate
under certain conditions. This was a factual determination, based upon Justice
Blanchard’s assessment of the expert evidence adduced in that case.
[24]
I
agree with Mylan that Prothonotary Aalto properly distinguished the present
case from Glaxosmithkline on the basis that the expert evidence
regarding the issue of conversion in this case was more equivocal and
speculative in nature. Consequently, I am not persuaded that the Prothonotary
erred in failing to follow the result in Glaxosmithkline.
The Significance of Mylan’s Other Productions
[25]
Finally,
the applicants say that Prothonotary Aalto erred in having regard to the fact
that Mylan had already produced a significant amount of documentary material in
relation to this matter and had agreed to produce additional information. This
was an error, the applicants say, as none of the documentary evidence produced
by Mylan related to Mylan’s manufacturing process or the crystal structure of
the efavirenz in Mylan’s tablets.
[26]
I do
not understand Prothonotary Aalto’s reasons to say that he was dismissing the
applicants’ motion because the applicants had already, or were going to receive
documentary disclosure with respect to Mylan’s manufacturing process or the
crystal structure of the efavirenz in Mylan’s finished product. Rather, he was simply
observing that Mylan had already provided extensive disclosure in the course of
this proceeding.
[27]
Even
where it is established that the information sought is relevant, a production
order will not automatically follow. As was noted earlier, proceedings under
the PMNOC Regulations are intended to be dealt with in a summary manner.
In exercising his discretion in determining whether a production order should
be made in this case, it was open to Prothonotary Aalto to have regard to the
extent of the productions already made, or which Mylan had undertaken to
provide: see Pfizer Canada Inc., above, at para. 23.
Conclusion
[28]
For
these reasons, the appeal is dismissed. The parties have agreed that the
winning parties should be entitled to their costs in the amount of $2,500 in
any event of the cause.
ORDER
THIS COURT ORDERS that the
appeal is dismissed, with costs to the defendants fixed in the amount of $2,500,
payable in any event of the cause.
“Anne
Mactavish”
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