Date: 20100120
Dockets: T-371-08
T-372-08
Citation: 2010 FC 65
Toronto, Ontario, January 20,
2010
PRESENT: The Honourable Mr. Justice Hughes
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
REASONS FOR ORDER AND ORDER
[1]
This
is a motion brought by the Applicants, AstraZeneca et al. by way of an appeal
from the Order of Prothonotary Aalto dated December 18, 2009, in each of these
two proceedings. In particular, the Applicants seek to set aside that Order in
which:
1. The
Prothonotary refused to strike out the Affidavit of John Hems and portions of
Apotex’s evidence listed in Schedule A, or, in the alternative, for leave to
argue the propriety of this evidence at the hearing of these applications;
2. The
Prothonotary refused to permit the Applicants to file, by way of reply
evidence, a further affidavit of Dr. Stephen Davies in each of these two
proceedings.
[2]
The
Prothonotary provided eight pages of Reasons for his decision in these
respects.
[3]
It
is well understood, having regard to appeals of this kind, that this Court
should not disturb an Order of a Prothonotary unless the matter is vital to a
final issue in the proceeding, or that the Order was clearly wrong as being
based upon a wrong principle or misapprehension of the facts (Merck &
Co. v. Apotex Inc. (2003), 30 C.P.R. (4th) 40 (F.C.A.)).
[4]
As
to the facts, the Applicants chose to place before the Prothonotary only an
affidavit from a law clerk which provided copies of certain correspondence
between the solicitors for the parties and copies of some of the materials in
the Court Record in these proceedings. There is no substantive affidavit
attesting to any factual basis for striking the Hems’ affidavit or allowing the
further Davies’ affidavit to be filed. Counsel for the Applicant relies on
argument and inferences drawn from the Record in these proceedings to
substantiate a basis for the request to strike Hems and allow Davies.
[5]
As
to the law, there is no provision, as such, in the Federal Courts Rules for
striking out evidence before the hearing of an application or for allowing
evidence to be filed in reply to evidence filed by a respondent in application
proceedings. In similar instances, Orders to such effect have been granted but
an exceptional basis for doing so must be established on a case- by-case basis.
[6]
First,
in respect of striking out the Hems’ affidavit and related portions of the
Apotex evidence, the Applicants’ position, notwithstanding complex arguments of
Counsel, is that these portions constitute a withdrawal of certain statements
made in Apotex’s Notice of Allegation and that somehow, AstraZeneca is
prejudiced, particularly should events transpire in certain ways in respect of
any section 8 claim Apotex may wish to make under the Patented Medicines (Notice
of Compliance) Regulations. S.O.R./93-133, as amended. Essentially, the
situation is that, in its Notice of Allegation, Apotex stated that it would be
obtaining the essential ingredient for its medicine either from supplier A or
supplier B, each of which made the ingredient in a somewhat different way.
Hems’ affidavit says that Apotex will not be seeking to obtain the ingredient
from supplier A, but only from supplier B.
[7]
The
Applicants argue that they “might” not have launched these proceedings if only
supplier B was to be the source of the ingredient and, if they were to persist
in the present proceedings only with respect to supplier B, they may lose and
be exposed to a section 8 claim. All of this is speculative. There is no
evidence to support these speculations. Apotex is not changing its Notice of
Allegation; it is removing one of the grounds for the allegations as to
non-infringement. There will be less for the Applicants and the Court to
address – it is not a different matter, just less. Any ramifications as to
section 8 can be argued, if necessary, at a later time. I agree with the
Prothonotary’s conclusions at page 5 of his Reasons:
With respect, there is no provision in
the Regulations which prevents a party from changing a fact such as this. In
effect, Apotex is simplifying the case and narrowing the issues. To take
AstraZeneca’s position to extreme, Apotex would be compelled to deal with a
factual premise upon which they no longer rely in the course of the hearing and
argue it as if they were going to use Nosch as a supplier. This would be a
wasteful and useless exercise. Apotex have now committed to a position
regarding the Nosch material from which it cannot resile. If AstraZeneca is
prejudiced by virtue of having prepared its expert affidavits on the basis of
the use of the Nosch material, such prejudice can be compensated for in costs
at the time of the hearing.
[8]
With
respect to the proposed Davies’ reply affidavit, Applicants’ counsel argues
that the affidavit addresses two matters. The first is the propriety of
certain tests, said to replicate prior art, put in evidence by Apotex; the
second is addressed to what has been characterized as an “optical purity”
issue, which AstraZeneca argues was not put into play in Apotex’s Notice of
Allegation.
[9]
As
to the propriety of the replication by Apotex’s affiants of certain prior
art, the Applicants argue that they were caught by surprise and could not have
anticipated this evidence at an earlier time when they put in their evidence in
chief. There are two reasons why this assertion is not appropriate. First,
the order in which evidence was to be provided by the parties was the subject
of a previous Order of the Prothonotary, which was upheld on appeal by this
Court. Applicants were well aware as to how evidence was to be presented and in
which order. Second, if the Applicants were caught by surprise, there was no
evidence to this effect before the Prothonotary. Therefore, the Prothonotary
was not in error when he concluded, at page 7 of his Reasons:
[1] Since the three affidavits are
not being struck, is AstraZeneca entitled to file reply evidence? The tests
for permitting reply evidence are well-known:
(a)
the
evidence to be adduced will serve the interests of justice;
(b)
the
evidence will assist the Court;
(c)
the
evidence will not cause substantial prejudice to the other side;
(d)
the
evidence was not available at an earlier date.
(See, Atlantic Engraving v. Lapointe
Rosenstein (2002), 23 C.P.R. 4th) 5 (F.C.A.)
In this case I am not
satisfied that any compelling case has been made out to satisfy these tests.
There is nothing in the Apotex affidavits that is new in the sense that it was
unanticipated or could not have been dealt with initially nor will the evidence
assist the Court. AstraZeneca cannot rationally believe that having had their
clinicians conduct the tests in Examples 4 and 5 that Apotex would not also
undertake a similar proves. The evidence of Dr. Davies in the proposed reply
affidavit, while relatively short, in large part is speculative, repeats
information that is already in the record, or can be dealt with in
cross-examination. In my view, reply is not warranted in this case.
[10]
As
to whether Apotex has gone beyond the allegations made in its Notice of
Allegation, the Applicants are free to make this argument, if appropriate, at
the hearing of these applications on their merits. There is no need for
Davies’ affidavit in this regard, as the argument is one of law.
[11]
Therefore,
the appeal is dismissed with costs to Apotex. The Minister of Health did not
appear and no costs for or against the Minister are awarded.
ORDER
THIS COURT
ORDERS that:
1.
The
motion, by way of an appeal in each of these proceedings from Prothonotary
Aalto’s decision dated December 18, 2009, is dismissed; and
2.
Apotex
is entitled to costs of each motion as against the Applicants.
"Roger T. Hughes"
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