Docket:
T-1151-12
Citation: 2013 FC 1165
Toronto, Ontario, November 15, 2013
PRESENT: Kevin
R. Aalto, Esquire, Case Management Judge
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BETWEEN:
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ALLERGAN INC. AND ALLERGAN, INC.
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Applicants
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and
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THE MINISTER OF HEALTH AND
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APOTEX INC.
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Respondents
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REASONS FOR ORDER AND ORDER
[1]
This proceeding is an application under the Patented
Medicines (Notice of Compliance) Regulations (Regulations). There
is a partial reversal of evidence. The patent in suit relates to the drug
bimatoprost ('691 Patent).
[2]
As is the approach in proceedings under the Regulations,
the Respondent, Apotex Inc. (Apotex) in its NOA provided a detailed statement
of the positions it was taking regarding the '691 Patent. As is often the approach
of the patent holder, the notice of application in this case is bereft of any
real detail as to the positions being taken to support the validity of the '691
Patent.
[3]
Apotex has brought this motion pursuant to Rule
312 of the Federal Courts Rules for leave to file Reply Affidavits of three
of their experts: Dr. Arthur Kibbe (Kibbe Reply); Dr. Ian Grierson (Grierson
Reply); and, Ms. Lea Katsanis (Katsanis Reply)(collectively the Replies).
[4]
Prior to the hearing of the motion, the
Applicant (Allergan) advised that it was not opposing Apotex’s motion with
respect to the Katsanis Reply and limited parts of the other Replies. Essentially,
the Katsanis Reply responds to issues raised by Allergan relating to the
LUMIGAN RC™ market, provincial formulary listings and, the data source used.
[5]
The portions of the other Replies which Allergan
does not oppose relate to another patent referred to by an Allergan expert and
preservative free preparations. However, Apotex argues that the remainder of
the Replies should also be permitted.
[6]
Allergan opposes primarily on the grounds that,
objectively, Apotex should have known and understood that the three documents
referred to by Allergan’s experts were ”available” and known to Apotex at the
time it filed its evidence and it should therefore have referred to those
documents. Those documents are: the 004 Study; the '289 Patent (apparently a
teaching away patent); and, the '233 Patent (the Documents). While Allergan argued
during the hearing that it was opposed to Apotex’s Reply to the '289 Patent, in
fact, the letter of October 21, 2013 states that Allergan does not oppose
paragraphs 1 – 11 of the Kibbe Reply of which paragraphs 4 – 6 deal with the '289
Patent. In any event, whether Reply to the '289 Patent is or is not opposed, it
does not matter as for the reasons that follow I am of the view that the
Replies are proper.
[7]
This was an application in which there was an
agreed partial reversal of evidence. Thus, Apotex put in its evidence without
knowing the case of Allergan and did not comment or refer to the Documents.
Thus, the request to serve the Replies.
[8]
Allergan argues that the Documents all were
known to and could have and should have been referred to by Apotex in its
initial affidavit evidence. Allergan argues that because two other generic
companies, Mylan and Cobalt, referred to the Documents in their NOA’s or
evidence then it is axiomatic that Apotex could and should have known about
them and therefore referred to them. As argued by Allergan: “The conduct of
similarly-placed generics in respect of the same patent for the same drug at
the same time is the best objective evidence available and disproves Apotex’s
assertion that reliance on the study could not be anticipated”. Thus, it is
argued that on an objective basis Apotex could have anticipated Allergan’s
responding evidence and that while Apotex was aware of the Documents it chose
not to refer to them in support of their case and that by now trying to reply
they are splitting their case.
[9]
Quite apart from the prescience of other
generics in referring to the Documents, Allergan also points to bits and pieces
of the expert affidavits and the Apotex NOA to argue that Apotex would have had
to have known that the Documents should be dealt with.
[10]
For its part, Apotex points to the paucity of
any real information that Allergan puts forward regarding its case in its
notice of application. In all, the notice of application, as is often the
case, is a collection of denials of the positions in Apotex’ NOA without any
detail or substantive information about why Apotex’ NOA is wrong. Some
examples are illustrative: “none of the references cited by Apotex to support
its allegation of obviousness formed part of the common general knowledge or
were disclosed made available to the public prior to the relevant date”;
“Apotex’s allegation regarding the identification of the inventive concept of
the claims of the '691 Patent are incorrect and not justified and are premised
on an incorrect application of the law”; and, “Each and every allegation of
obviousness is unjustified . . .”. There is no detail to support any of these
allegations.
[11]
By comparison, Allergan knows with exactitude
the position of Apotex regarding the '691 Patent as it is spelled out in detail
in the NOA. In light of this, Apotex argues it could not know what Allergan
believes is relevant and it is idle speculation to try and divine what Allergan
will argue and what prior art or other documents its experts might rely upon.
This is particularly so as the Documents are not specifically referred to
anywhere in the NOA or the notice of application. Allergan was only able to point
to the most oblique references in the NOA to suggest that it was obvious that
Apotex not only knew about them but should have referred to them.
[12]
In large part, the position of Allergan is
putting the cart before the horse. How can one know what the other side
believes relevant until they put it in play? If the expectation is that if any
piece of prior art or document is known to a party and they do not refer to it
in their evidence then they cannot reply because they knew of it – this is an
invitation for a party to include every single piece of known prior art and
document so as not to be prevented from commenting on it. Such an approach
will only lengthen and complicate what are already very complex proceedings. Precision,
not guesswork is required in these proceedings. However, that is not the way
the litigation plays out.
[13]
This motion raises issues that frequently haunt
Rule 312 motions. The allegation of the opposing party usually revolves around
the “availability” of the evidence and that the Reply is, in effect, a
“splitting” of the case. The “availability” argument flows from the well-known
Federal Court of Appeal case of Atlantic Engineering Ltd. v. Lapointe
Rosenstein, 2002 FCA 503.
[14]
Rule 312(a) of the Federal Courts Rules
permits this Court to grant leave to “file additional affidavits to those
provided for in Rules 306 and 307”. In Atlantic Engraving, the Federal
Court of Appeal described four requirements that must be met before this Court
may permit additional affidavits:
[8] Pursuant
to Rule 306 of the Federal Court Rules, 1998, an applicant has thirty
days from the filing of its notice of application to file its supporting
affidavits and exhibits (appeals under section 56 of the Trade-marks Act
fall within Part 5 of the Rules entitled "Applications" (Rules 300 to
334) and therefore must be commenced by way of a notice of application). By
exception, rule 312 allows a party, with leave of the Court, to file additional
affidavits. Under that rule, the Court may allow the filing of additional
affidavits if the following requirements are met:
i) The evidence to be adduced
will serve the interests of justice;
ii) The evidence will assist the
Court;
iii) The evidence will not cause
substantial or serious prejudice to the other side (see Eli Lilly and Co. v.
Apotex Inc. (1997), 76 C.P.R. (3d) 15 (T.D.); Robert Mondavi Winery v.
Spagnol's Wine & Beer Making Supplies Ltd. (2001), 10 C.P.R. (4th)
331 (T.D.)).
[9] Further,
an applicant, in seeking leave to file additional material, must show that the
evidence sought to be adduced was not available prior to the cross-examination
of the opponent's affidavits. Rule 312 is not there to allow a party to
split its case and a party must put its best case forward at the first
opportunity (see Salton Appliances (1985) Corp. v. Salton Inc. (2000),
181 F.T.R. 146, 4 C.P.R. (4th) 491 (T.D.); Inverhuron &
District Ratepayers Assn. v. Canada (Min. of Environment) (2000), 180
F.T.R. 314 (T.D.)). [emphasis added]
[15]
In Deigan v. Canada (Industry) 1999
CanLII 7761 (FC), (1999), 168 F.T.R. 277 (T.D.) aff’d 1999 CanLII 7910 (FC),
(1999), 165 F.T.R. 121 (T.D.), a fifth requirement was enunciated: The
evidence will not unduly delay the proceeding. These five criteria were
applied in Merck Frosst Canada & Co. v. Canada (Minister of Health),
2003 FCT 287 at para. 12; and, Pfizer Canada Inc. v. Canada (Minister of Health), 2007 FC 168 at para. 5.
[16]
However, before slavishly applying these
criteria it is important to consider the context in which they were developed
and what the Court actually said. In Atlantic Engineering, which
appears to be the seminal case upon which all others comment, the appeal
related to a decision of the Trial Division arising from an appeal from the Registrar
of Trade-marks who had expunged the appellant’s trade-mark. The Judge who was
hearing the matter on the merits determined that the affidavit evidence of the
appellant was deficient and resulted from the ineptitude of counsel. The Hearings
Judge of his own volition then granted leave to the appellant to file a further
and better affidavit and adjourned the matter. This happened after all of the
parties’ evidence including cross-examinations had been put in.
[17]
In the circumstances, the Federal Court of
Appeal was rightly concerned with the “additional” affidavit for which the Hearings
Judge granted leave to file. It was not a “reply” affidavit. Rather, it was a
new affidavit to be provided in support of the case after all the evidence had
been put before the Court. This was obvious “case-splitting”.
[18]
Is the need to reply to the Documents raised for
the first time in Allergan’s expert affidavits “case-splitting” as argued by Allergan?
In my view, it is not.
[19]
The Documents were not discussed in the Apotex
NOA and were not referred to in the Allergan notice of application. They first
came to light in this proceeding as part of Allergan’s evidence. It can hardly
be said that this is case splitting. Allergan’s argument would have more
weight if this were a case of eliciting “fresh evidence” as opposed to reply.
[20]
It is strenuously argued by Allergan that the Documents
must have been “known” to Apotex when it served its expert reports and
therefore was “available” within the meaning of Atlantic Engraving. Thus,
as it was “available” to Apotex when they served their expert reports they
cannot now reply to it. To permit them to reply would be to “water down” the
“available” requirement. Further, it is argued that as two other generics
referred to this evidence Apotex must also have know about them.
[21]
With respect, this argument makes no sense. In
this day and age of instant internet searching virtually anything can be found.
Lawsuits are not about what is available and can be found but rather what is
relevant to make out the case of a party. Apotex may very well have known
about the Documents but made a decision based on the known Allergan evidence
that it was not required. Now, after Apotex puts in its evidence, Allergan puts
in play the Documents and they have taken on relevance. Just because Apotex
may have known about the evidence does not make it relevant until a party seeks
to put it before the Court as part of their case. Further, the fact that two
other generics referred in their evidence to one or more of the Documents is
not determinative of anything. Those generics cast their case as they saw fit
to support the allegations they were each making. Similarly, so did Apotex
without knowing what Allergan might put in play.
[22]
This does not water down the “available” part of
the Atlantic Engraving test nor will it create a “floodgate” of reply
motions as argued by Allergan. For example, a generic that does not put in
evidence prior art that is specifically referred to in its NOA in all
likelihood will not get a right of reply if the patentee chooses to use such
prior art in support of its case. Further, in Atlantic Engraving, the
Court had before it a case where all of the evidence was in and the evidence in
the new affidavit would undoubtedly be case-splitting as it is obvious that it
was available prior to cross-examinations and the hearing. Here there is no
such situation. Cross-examinations have not taken place and the hearing is several
months away and it is Allergan that has decided to make the Documents part of
its case. In this case, it is clear that Apotex should have right of reply.
[23]
Granting a party an opportunity to reply,
however, is not an invitation to that party to do a further “document dump” of
materials that are not already in the record. Such a step simply invites
sur-reply which should be avoided. Reply requires that the evidence be
directed only at that which requires clarification by the expert and does not
necessarily require any additional documentation to be referred to. Reply
should be succinct, precise and relevant only to an issue raised in the
opposite party’s evidence.
[24]
While other arguments were raised during the
course of the hearing they need not be addressed as the reasons given are
sufficient to support a right of reply to Apotex.
[25]
As Apotex was successful it is entitled to its
costs.
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