Date: 20090331
Dockets : T-371-08
T-372-08
Citation: 2009 FC
269
Ottawa, Ontario, March 31, 2009
PRESENT: The Honourable Mr. Justice Harrington
Docket: T-371-08
BETWEEN:
ASTRAZENECA CANADA INC. AND
ASTRAZENECA AKTIEBOLAG
Applicants
and
APOTEX INC. AND
THE MINISTER OF HEALTH
Respondents
Docket: T-372-08
AND BETWEEN:
ASTRAZENECA CANADA INC. AND
ASTRAZENECA AB
Applicants
and
APOTEX INC. AND
THE MINISTER OF HEALTH
Respondents
PUBLIC VERSION OF THE CONFIDENTIAL
REASONS FOR ORDER AND ORDER
ISSUED 17 MARCH 2009
[1]
March 7,
2010. Prothonotary Aalto surely had that date in mind when he dismissed
AstraZeneca’s motion for an order requiring Apotex to provide certain portions
of the Abbreviated New Drug Submission it filed with Health Canada. This is an appeal of that
decision. On March 7, 2008 AstraZeneca filed applications under these two
docket numbers, as well as five others, for orders prohibiting the Minister
from issuing Apotex a Notice of Compliance with respect to its generic esomeprazole
magnesium tablets for the treatment of gastric ulcers, and other conditions
requiring a reduction in gastric acid secretion, until patents on file with the
Minister expired. Under the Patented Medicines (Notice of Compliance)
Regulations, those applications have the effect of preventing the Minister
from issuing Notices of Compliance until March 7, 2010, the date by which, in
the normal course, the Court is expected to have rendered its decision as to
whether the various allegations in Apotex’s Notices of Allegations are
justified.
[2]
The PM
(NOC) Regulations provide at s. 6(7) that a party such as AstraZeneca may seek
an order from a party such as Apotex for the production in whole or in part of
the documentation it filed with Health Canada in support of its application for
approval of its generic version of a drug, which approval takes the form of a
Notice of Compliance.
[3]
It is well
known that these applications are complex and time consuming, with the clock
always running. In December 2007, the Chief Justice issued a Notice to the
Parties and the Profession directing that all such proceedings forthwith
continue as specially managed proceedings. These two applications are specially
managed. Prothonotary Aalto is the case manager. As case manager he convened a
conference at an early date which dealt with a number of issues, such as fixing
schedules and “other matters useful to ensure the just, most expeditious and
least expensive disposition of the proceeding.” Indeed it is a general
principle, as enunciated in Rule 3 of the Federal Courts Rules, that the
rules “…shall be interpreted and applied so as to secure the just, most
expeditious and least expensive determination of every proceeding on its
merits.”
[4]
Although in
taking stock of all the applications, matters of both patent invalidity and
non-infringement are in issue, the motions before Prothonotary Aalto only dealt
with Apotex’s allegations that it would not infringe Canadian patents 2,290,963
(‘963) and 2,139,653 (‘653). The title of patent ‘963 is S- Omeprazole Magnesium
Trihydrate. Its very title indicates a water content. The title of patent ‘653
is “Optically Pure Salts of Pyridinylemethyhl sulfinyl-1H-Benzimidazole Compounds.”
The words “optically pure” suggest enantiomers as indeed disclosed in the
background portion of the patent.
[5]
In its
Notices of Allegation, Apotex states that it will not infringe patent ‘963
because its product is not a trihydrate. However, if it is, it suggests a
purposeful, and perhaps limiting, meaning to be given to the claims of the
invention, particularly as regards crystalline forms. As regards patent ‘653,
the basic allegation is that the patent will not be infringed as its product
will be the Mg2+ salt of esomeprazole.
[6]
As
ultimately argued before Prothonotary Aalto, AstraZeneca’s motions were
primarily limited to: 1) the water content of certain material manufactured by
a supplier to Apotex, and 2) the infrared (IR) spectroscopy analysis referred
to in the Abbreviated New Drug Submission and details pertaining thereto.
[7]
AstraZeneca
relied upon an affidavit from Dr. Stephen Byrn, an expert chemist, while Apotex
relied upon the affidavit of Dr. Michael Cima, another expert chemist. Neither
was cross-examined. Dr. Byrn’s point was that without the requested information
he could not assess whether or not Apotex’s allegations of non-infringement
were justified. Dr. Cima, on the other hand, was of the view that the
documentation voluntarily provided by Apotex permitted such an assessment to be
made, and that it was unnecessary to obtain further production. Prothonotary
Aalto preferred the evidence of Dr. Cima.
[8]
Basing
himself upon Biovail Corp. v. Canada (Minister of National Health and
Welfare), 2002
FCT 1143, 22 C.P.R. (4th) 503 at paragraphs 40-43, he was of the view that
AstraZeneca had the onus to demonstrate:
a. The request for disclosure was
made in a timely manner.
b. The information already
provided is not sufficient to deal with the issues at stake.
c. The disclosure of the required
information is necessary because it is relevant to the disposition of the
issues in the proceeding, and is required and important.
[9]
Although
that decision was affirmed by the Court of Appeal, 2003 FCA 406, 29 C.P.R.
(4th) 129, in speaking for the Court, Mr. Justice Nadon did not set out a
formal tri-partite test. He held that relevancy is the prime consideration.
This point was taken by Prothonotary Aalto since he noted that while relevance
of the information is a condition precedent to the Court exercising its
discretion to direct disclosure, it was not necessary for the purposes of the
disposition of the motion to determine whether the information was also required
and important. Put another way, the court will not order disclosure of
documents it considers irrelevant, but on the other hand it may not order the
production of relevant documents that are not necessary to a determination of
the case on its merits
[10]
Prothonotary
Aalto was of the view that sufficient information had been provided to allow
AstraZeneca to file its record. He left the door open that following production
of Apotex’s record, a fresh motion for production could be filed. He said:
“Suffice it to say that once evidence has been filed in this proceeding, if
there is information that AstraZeneca still requires that it is both relevant,
required and important, they may be able to pursue it.”
DISCUSSION
[11]
Prothonotary
Aalto’s decision, whatever it might have been, could not have been vital to the
outcome of the case. His decision was discretionary and is only to be disturbed
if the exercise of that discretion was based on a wrong principle or
misapprehension of the facts (Merck & Co. v. Apotex Inc., 2003 FCA
488, 30 C.P.R. (4th) 40).
[12]
AstraZeneca
submits that Prothonotary Aalto erred both in fact and in law. The flaw in his legal
reasoning is said to be that he should not have effectively adjourned the
motion. I see no merit in this submission as there is nothing in s. 6.(7) which
fetters a decision maker’s discretion to adjourn.
[13]
As to
factual error, it is submitted that the Prothonotary could not have given
proper consideration to the facts. The prime fact relied on is that one of
Apotex’s suppliers appears, on its face, to begin its process with something
that falls squarely within one of the patent claims. If that is so, it must be
borne in mind that Dr. Byrn’s complaint is that the Notice of Allegation does
not give him sufficient information to assess possible water content and
crystalline forms. If that is ultimately found to be so, then Apotex’s Notices
of Allegation may not be a detailed statement as contemplated by the
Regulations, as indeed AstraZeneca alleges in its own applications. If the Applications
Judge finds that the patent is valid and interpreted the way AstraZeneca would
like, and if the products supplied at an earlier stage constitute a claim for
the medicine itself, then Apotex is in considerable difficulty, as per the
decision of the Court of Appeal in Abbott Laboratories v. Canada (Minister
of Health) 2006 FCA 187, 56 C.P.R. (4th) 387.
[14]
Given
schedules and given deadlines, Prothonotary Aalto’s order was not clearly
wrong; it was eminently reasonable. There is no basis to interfere (Sawridge
Band v. Canada, 2001 FCA 338, [2002] 2 F.C. 346 and Apotex Inc. v.
Lundbeck Canada Inc., 2008 FCA 265).
[15]
It must be
borne in mind that parties to an application, as opposed to an action, are
under no obligation to voluntarily produce documentation which may be relevant.
Indeed, this was also the situation in actions before the former Court Rules
were amended in 1991. Under former Rule 447, a party needed only to disclose
documents that might be used in evidence to assist in establishing any of its allegations
of fact, or to assist in rebutting any allegation of fact of an opposing party.
The rationale therefor, which I think still applies in applications which are
intended to be summary in nature, was set out by Chief Justice Jackett in the “Little
Red Book” (Manual of Practice) issued in 1971:
…The reason for thus curtailing the ambit
of discovery as of right is the purely practical one that while, on the one
hand, it is felt that there are relatively few cases where a party can be
building his case on documents that he hopes to get from his opponent, on the
other hand it is very onerous, tedious and a difficult task, involving
considerable expense and delay, to prepare a list of documents that would,
conceivably, be of aid to one’s opponent… On balance, it seems probable that
the costs and delays of making such discovery outweigh, in most cases, the
theoretical advantages obtained from it.
[16]
The old
rules had a fallback position in that the Court could nevertheless order full
discovery under Rule 448. Currently, apart from s. 6(7) of the PM (NOC)
Regulations, Rule 313 of the Federal Courts Rules also permits the
Court to require the filing of additional material if it considers the record
is incomplete.
[17]
As a
matter of caution, should I have erred and the circumstances require me to
exercise my discretion de novo, for the reasons given above, I would
have done exactly what Prothonotary Aalto did.
ORDER
THIS COURT ORDERS that:
1.
The appeal
of the order of Prothonotary Aalto is dismissed.
2.
Apotex
shall have its costs, calculated on the basis of a single motion in appeal.
“Sean Harrington”
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