Date:
20080428
Docket:
T-1941-07
Citation:
2008FC541
Ottawa, Ontario, Monday, this 28th
day of April 2008
PRESENT: MADAM PROTHONOTARY
MIREILLE TABIB
BETWEEN:
NYCOMED CANADA INC. and
NYCOMED GmbH
Applicants
-and-
THE MINISTER OF HEALTH and
SANDOZ CANADA INC.
Respondents
REASONS
FOR ORDER AND ORDER
[1]
The Respondent, Sandoz Canada Inc. (“Sandoz”), brings this motion to
dismiss the present application on the basis that it is redundant, frivolous or
vexatious or otherwise an abuse of process, pursuant to sub-section 6(5)(b) of
the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 (the “Regulations”).
[2]
This application was instituted by the Applicants, Nycomed Canada Inc.
and Nycomed GmbH (collectively referred to as “Nycomed”) pursuant to section
6(1) of the Regulations, and seeks a prohibition order against the
issuance by the Minister of an NOC to Sandoz in relation to its proposed
pantoprazole tablets until after the expiration of Canadian Patent 2,089,748
(‘748 Patent). Another relevant patent, the 2,092,694 Patent (‘694 Patent), is
being separately litigated under the Regulations between the same
parties in Court file T-1942-07. A similar motion to dismiss was heard
concurrently in that matter, and is disposed of in a separate order.
Preliminary objection as to
jurisdiction
[3]
Nycomed raised, as a preliminary matter, the issue of a prothonotary’s
jurisdiction to hear and determine the present motion. Nycomed recognizes that
that very issue was considered and determined in AB Hassle v. Apotex Inc.,
[2003] F.C.J. No. 1601, followed and applied in Pfizer Canada Inc. v. Canada
(Minister of Health), 2007 FC 452, the Court concluding that a prothonotary
does have jurisdiction to hear and determine such motions. However, Nycomed
submits that the circumstances herein command further consideration of these
decisions, particularly with respect to the statutory requirement, found in sub-section
46(1)(h) of the Federal Courts Act, that jurisdiction conferred upon
prothonotaries pursuant to the Rules be exercised “subject to the supervision
of the Court”:
|
“46(1) Subject to the approval
of the Governor in Council and subject also to subsection (4), the rules
committee may make general rules and orders:
(…)
(h)
empowering a prothonotary to exercise any authority or jurisdiction, subject
to supervision by the Federal Court, even though the authority or
jurisdiction may be of a judicial nature.”
|
« 46(1) Sous
réserve de l’approbation du gouverneur en conseil et, en outre, du paragraphe
(4), le comité peut, par règles ou ordonnances générales :
(…)
(h) donner pouvoir aux protonotaires
d'exercer une autorité ou une compétence — même d'ordre judiciaire — sous la
surveillance de la Cour fédérale. »
|
[4]
It is understood that the “supervision” mentioned in sub-section
46(1)(h) is exercised by way of appeal to a judge of the Federal Court, and in
no other fashion. Bearing that in mind, Nycomed submits that because Sandoz’
submission for an NOC is currently on “patent hold”, orders dismissing both
this and the other pending prohibition applications in respect of Sandoz’
proposed pantoprazole sodium tablets would clear the way for Sandoz to obtain
its NOC within a matter of days. Nycomed submits that any appeal of these
orders it might then bring would be moot and the orders would therefore never be
subject to the supervision of the Court. Nycomed stated in argument that a
prothonotary’s jurisdiction to hear and determine a motion pursuant to section
6(5)(b) would not be questionable so long as an effective right of appeal
cannot be curtailed by becoming moot. Following that reasoning, I would have
jurisdiction to hear and dismiss the motion, but not to hear and grant it if
the pending motion in T-1942-07 is also granted; I would also have jurisdiction
to hear and grant the motion if I had dismissed the pending motion in
T-1942-07, or, if both motions being granted, I also stayed the effect of one
or both of them pending appeal.
[5]
Nycomed’s argument is ill-founded. Jurisdiction to hear and determine a
motion seeking a particular relief is either conferred or it is not. It cannot
depend on the outcome of the motion, or on external circumstances such as the
status of other litigation or the imminence of the issuance of an NOC. At
most, Nycomed’s argument might be considered in the context of deciding whether
the effect of an order dismissing the application should be stayed, or of deciding
whether an appeal of such an order should be heard even if moot. As I have
concluded that Nycomed’s application herein should not be dismissed, the issue
of a stay does not arise.
Overview
[6]
The drug at issue, pantoprazole sodium, is an old drug, marketed and
sold in Canada since the mid-1990’s. It is classified as a proton pump
inhibitor (“PPI”) or a H+K+- ATPase Inhibitor, and has long been known to
inhibit the secretion of gastric juice or acid in the stomach. Its use as such
is no longer protected by patent. For the purpose of this motion, it is fair
to say that the relevant portions of the ‘748 patent claim a composition of
pantoprozole and a Helicobacter Inhibiting Anti-Microbial Agent (“HIAMA”) for
use in the treatment of gastrointestinal diseases caused or exacerbated by H.
Pylori and secreted gastric acid. In other words, the relevant claims of
the patent for the purpose of this motion are for the use of pantoprazole in
combination therapy where the disease is caused or exacerbated by an H.
Pylori infection.
[7]
Sandoz’ Notice of Allegation alleges that if it is issued an NOC in
respect of its proposed pantoprazole product, its using or selling the product
will not infringe the ‘748 patent since it only seeks approval and will only
sell, market and promote its product for use in monotherapy, for the treatment
of conditions not caused by H. Pylori, where reduction of gastric acid
secretion is required.
[8]
It is common ground between the parties that in order to succeed in its
prohibition application, Nycomed must establish that Sandoz’ allegation of
non-infringement is not justified, in that Sandoz will, if issued an NOC,
induce others (such as physicians, pharmacists, patients or provincial
formulary authorities) to make infringing use of the product.
[9]
In addition to the above-mentioned allegations of non-infringement,
Sandoz’ NOA alleges that the ‘748 patent does not contain claims to the
medicine or the use of the medicine, and that it was improperly listed against
the relevant Nycomed NOCs. On November 7, 2007, Nycomed filed the within
application, contesting all of Sandoz’ allegations as improper, insufficient or
unjustified.
Sandoz’ motion
[10]
Sandoz’ motion is exclusively based on sub-section 6(5)(b) of the Regulations,
which permits the Court, on motion, to dismiss an application, in whole or in
part, on the ground that it is redundant, scandalous, frivolous or vexatious or
otherwise an abuse of process. This motion does not invoke sub-section 6(5)(a)
of the Regulations, pursuant to which an application may be dismissed on
the ground that a patent is not eligible for inclusion on the register. In
fact, Sandoz served and filed, concurrently with the present motion, a separate
notice of motion specifically based on sub-section 6(5)(a), which is now
scheduled to be heard on May 28, 2008.
[11]
Sandoz’ contention that the present application constitutes an abuse of
process is based on the following grounds:
1)
That the ‘748 patent has been held to contain no claims for the use of
the medicine at issue, and that there are therefore no relevant claims against
which an allegation may be considered, by judgment issued on March 6, in
Solvay Pharma Inc. v. Apotex Inc., [2008] F.C.J. No. 378, 2008 FC 308
(the “Apotex” case).
2)
That the ‘748 patent has been held to be ineligible for listing against
the relevant NOCs in the Apotex case.
3)
That the same or a similar allegation of non-infringement has been found
to be justified, again, in the Apotex case, and that Nycomed’s
application for a prohibition order in respect of the same allegation of
non-infringement of the ‘748 Patent, against another generic, has since been
dismissed as an abuse of process in Nycomed Canada Inc. v. Novopharm Ltd.,
2008 FC 454 (the “Novopharm” case).
[12]
Sandoz thus submits that for Nycomed to pursue the present application
in the circumstances constitutes an attempt to re-litigate issues that have
already been finally determined against it, and is an abuse of process, as per
the principles applied by the Court of Appeal in Sanofi-Aventis Canada Inc.
v. Novopharm Ltd., 2007 FCA 163.
[13]
Sandoz does not rely on any expert evidence at all. It relies on the
decision of the Court in the Apotex case and on a comparison between the
Notices of Allegations, Notices of Application and Product Monographs in the Apotex
case and the present case. Sandoz has not tendered a copy of the affidavits
filed in the Apotex case or in the subsequent Novopharm case.
Nycomed has yet to serve its evidence on the merits of this application. In
fact, a scheduling order made on consent of both parties provides that Nycomed
has until May 15, 2008 to serve its evidence on the merits of the application.
While Nycomed has filed the evidence of four experts in opposition to this
motion, going to issues of claims construction, ineligibility for listing and
inducing infringement, the evidence also makes it clear that it is brought
solely for the purpose of responding to Sandoz’ motion, and that it is not
intended to constitute the whole of the evidence to be brought on the merits of
the application or on the eventual 6(5)(a) motion. More particularly, Nycomed
indicates that more fulsome evidence is intended to be filed on the merits of
the application and in opposition to the 6(5)(a) motion.
Prior ligitation involving
the ‘748 Patent
[14]
As mentioned above, Sandoz’ motion is entirely premised on its
contention that the issues raised in this application have already been finally
determined in a manner adverse to Nycomed, such that re-litigation would
constitute an abuse of process. While Sandoz principally invokes the Apotex
case as a prior determination, it also relied at the hearing on the subsequently
issued decision of Prothonotary Lafrenière in the Novopharm case. The
‘748 Patent was, however, the subject of another motion to dismiss, both under sub-sections
6(5)(a) and 6(5)(b) of the Regulations, resulting in the decision of
Prothonotary Milczynski in Nycomed Canada Inc. v. Genpharm Inc., 2008 FC
330 (the “Genpharm” case).
[15]
A brief review of the facts, circumstances and conclusions of each case
is useful before considering Sandoz’ arguments.
[16]
The Apotex case was decided on March 3, 2008 by Justice Gauthier,
on the merits of Nycomed’s application for a prohibition order (although the
case is reported under the names Solvay Pharma and Altana Pharma, the identity
of the Applicants is in fact the same as in the present case, as the Applicants
changed their respective names to Nycomed designations in the course of those
proceedings). The application covered two patents, the ‘694 and ‘748 Patents.
In respect of the ‘748 Patent, Apotex had made in its NOA, in addition to
allegations of invalidity, allegations that the patent contains no claims for
the medicine itself, that claims 15 and 16 are irrelevant because Apotex’s ANDS
does not involve the early working of the use claims (early working issue),
that the patent was improperly listed, and that Apotex would not infringe the
use claims of the patents. No motion had been brought by Apotex for dismissal
of the application pursuant to sub-section 6(5)(a) on grounds of ineligibility
for listing. Nycomed objected to the determination of the eligibility issue on
the merits of the application. It is not clear from the decision whether
Nycomed had adduced substantive evidence on the eligibility issue. In any
event, Nycomed brought evidence on the motion before me to the effect that it
had adduced no specific expert evidence before Justice Gauthier in respect of
listability, and had otherwise limited evidence at its disposal on that issue.
[17]
Justice Gauthier’s decision, as it relates to the ‘748 Patent, was as
follows:
[18]
As to eligibility for listing, she held that the Court had no
jurisdiction to consider or determine the eligibility for listing of patents on
the merits of an application for a prohibition order, and that the only process
by which this issue could be resolved is by way of a motion brought pursuant to
sub-section 6(5)(a) of the Regulations (see discussion at paragraphs 53
to 66, ratio decidendi at paragraph 66). Although she went on to
comment on eligibility issues, it is plain that the discussion is entirely obiter,
and included solely in the event her finding of lack of jurisdiction was
overturned on appeal (see paragraph 69). In any event, as regards to the ‘748
Patent, it is unclear whether she reached any definitive conclusion on
eligibility, or merely raised concerns as to the potential consequences of
accepting Nycomed’s submissions, for ulterior determination.
[19]
As to relevance, she notes that Apotex had not alleged in its NOA that
claims 15 and 16 of the ‘748 Patent did not contain claims for the medicine
itself or for the use of the medicine, such that the argument could not be
considered. As to irrelevance on grounds of early working arguments, which was
the argument specifically raised by Apotex in respect of those claims, she held
that such arguments were akin to eligibility issues and also fell to be
determined exclusively by way of motion pursuant to sub-section 6(5)(a)
(paragraphs 65 and 66).
[20]
Finally, after discussing at length the evidence submitted by both
parties, Justice Gauthier concluded that Nycomed had failed to meet its burden
of establishing that Apotex’s allegations of non-infringement were unjustified.
[21]
No appeal was taken from the decision in the Apotex case,
presumably because Apotex was issued an NOC shortly thereafter and that any
appeal would likely have been declared moot.
[22]
The Genpharm case was heard well before the judgment in Apotex
was issued, but determined on March 10, 2008, merely a week after the decision
in Apotex. Nycomed filed evidence before me showing that the Apotex
decision was brought to Prothonotary Milczynski’s attention by the parties,
Genpharm urging that the decision in respect of eligibility for listing and
non-infringement justified its motion being granted and the dismissal of
Nycomed’s application.
[23]
As mentioned above, the matter before Prothonotary Milczynski was a
motion to dismiss on the grounds of ineligibility for listing of the relevant
patents (both the ‘748 and the ‘694 Patents) pursuant to sub-section 6(5)(a),
and on grounds that the application was redundant, frivolous, vexatious or an
abuse of process, pursuant to sub-section 6(5)(b). The argument on that latter
sub-section was that it was obvious on the face of the evidence that both
patents were invalid or not infringed. On the 6(5)(a) portion of the motion,
Genpharm had filed specific expert evidence. It is unclear from the decision
whether the evidence relied upon for the 6(5)(b) portion was that as
constituted on the merits of the application or whether either party had filed
specific evidence for that purpose.
[24]
On the evidence before her, and having been apprised of the Court’s
earlier decision in Apotex, Prothonotary Milczynski found that Genpharm
had not established that the ‘748 Patent was ineligible for listing (paragraph
73).
[25]
As regards the 6(5)(b) motion in respect of that patent, she held that
on the evidence before her, Genpharm had not established that Nycomed’s
position on infringement was so clearly futile that the inevitable conclusion
was that it had no chance of success (paragraph 78). She did not discuss the incidence
of the decision in Apotex.
[26]
The Novopharm case came before Prothonotary Lafrenière after the
judgments in Apotex and Genpharm had been issued. In that case,
Novopharm brought a motion to dismiss Nycomed’s application in respect of both
the ‘694 and ‘748 Patents, on the basis that in light of Justice Gauthier’s
decision in Apotex on the non-infringement issues, Nycomed’s application
was clearly futile on its merits and should be dismissed. There was no issue of
invalidity or ineligibility for listing in play on that motion.
[27]
In evidence before the Court in the Novopharm matter were all the
affidavits filed on the merits of the application by both parties, and the
transcripts of all cross-examinations that had been conducted to that point
(some experts on both sides had yet to be cross-examined). Nycomed had,
additionally, filed direct evidence on the motion. Prothonotary Lafrenière
concluded that Nycomed had not adduced any materially different evidence in the
application than that which had been held insufficient in the Apotex
matter, and accordingly dismissed the application as an abuse of process. At
the time of hearing of the present motion, the delays to appeal the order of
Prothonotary Lafrenière in Novopharm had expired, with no appeal having
been taken, although Nycomed has filed a motion to reconsider. It was common
ground between the parties that Novopharm had since received its NOC.
Eligibility for listing
[28]
Sandoz’ argument that this application is an abuse of process on the
basis of a prior determination that the ‘748 Patent is not eligible for listing
relies solely on the Apotex decision. As mentioned above, the Court’s
decision in Apotex is to the specific effect that it had no jurisdiction
to consider or determine the eligibility for listing of the patent. That case
cannot therefore stand as a determination, final or otherwise, as to that
issue. Further, any comment made by the Court as to the arguments raised by
the parties on that issue are not only clearly obiter and therefore not
binding but they are, further, ambiguous as to their effective conclusion.
[29]
Not only is there clearly no determination in the Apotex decision
as to the eligibility for listing of the ‘748 Patent, but the subsequent
decision in Genpharm, exactly on point, issued after Apotex and
on a full record, holds that the allegations of ineligibility for listing made
in that case were not established.
[30]
Sandoz’ argument of abuse of process in respect of eligibility is
clearly ill-founded, and must be rejected.
[31]
I would add that I would, in any event, have had some difficulty in
accepting Sandoz’ argument that an application can be dismissed as an abuse of
process on an eligibility issue outside the context of a motion regularly
brought pursuant to sub-section 6(5)(a). As held by the Court in Apotex,
the issue of eligibility for listing cannot be considered and determined on the
merits of an application. A generic is required to address all patents listed
on the register even though they may be improperly listed, and the innovator
then has the right to assert that the allegations are unjustified. Unless the
Minister acts to de-list a patent, the only process to determine the issue of
whether the patents are properly listed and whether the prohibition application
must therefore proceed is by way of a motion pursuant to sub-section 6(5)(a).
Such a motion must necessarily be brought by the second person and it is the
second person, and not the innovator, who bears the burden of proof. Thus,
unless the generic brings, in a timely manner, a motion pursuant to sub-section
6(5)(a), the issue of eligibility for listing cannot and will not be
determined, and the application will proceed and may be granted on its merits.
In order, therefore, to hold that an application constitutes an abuse of
process because of a prior determination of ineligibility for listing in
another application, the Court would have to “deem” the generic to have made a
motion under section 6(5)(a), raising the same allegations of ineligibility for
listing, and supported by similar evidence. I doubt that a generic could attack
an application as an abuse of process on the basis that a motion it has not
made, and on grounds it has not properly raised, would be bound to succeed.
Relevance of the patent
claims
[32]
The issue of whether the ‘748 Patent contains relevant claims that are
required to be addressed in an NOA turns on a determination of whether it
contains a claim for the medicine itself or for the use of the medicine. That
determination is one that can properly be made on the merits of an application,
if properly alleged in the generic’s NOA (see Apotex, paragraph 66).
Sandoz’ NOA does contain an allegation to the effect that the ‘748 Patent is
not relevant as containing no claim for the medicine or the use thereof.
However, contrary to Sandoz’ assertions, it is clear that no determination has
been made in Apotex as to whether or not the ‘748 Patent contains a
claim for the use of pantoprazole sodium. Indeed, as mentioned above, the
Court specifically mentions, at paragraph 67 of the reasons, that the Apotex
NOA had not alleged the irrelevance of claims 15 and 16 of the ‘748 Patent on
the basis that they contain no claims for the use of the medicine. Neither the
Genpharm nor Novopharm decisions address that issue. As there
are simply no prior determinations to the effect that the ‘748 Patent contains
no claims for the medicine itself or the use of the medicine, Sandoz’s argument
to that effect is not supported and must consequently fail.
Non-infringement
[33]
Sandoz submits that it has made the same allegation of non-infringement
in respect of the ‘748 Patent as was made by Apotex, that the indications and
dosage regimen in its product monograph are similar to those in Apotex’s
product monograph, and that, as with Apotex’s product monograph, its own
monograph does not refer to triple therapy or use for the treatment of H.
Pylori. Sandoz then argues that, as the Court in Apotex has found
that nothing in Apotex’s product monograph would lead others to infringe, so it
must follow that Nycomed cannot succeed in establishing inducement by another
generic when its product monograph is, in those respects, similar to Apotex’s.
Sandoz argues that Nycomed’s application therefore seeks to re-litigate this
issue and must be dismissed as an abuse of process.
[34]
In my view, Sandoz’ argument improperly conflates the doctrine of abuse
of process, as applied by the Court of Appeal in Sanofi-Aventis, supra,
and the determination that, on the evidence led by an applicant on the merits
of an application, it is inevitable that the application would fail.
[35]
The Court of Appeal in Sanofi-Aventis made it quite clear that
the abuse of process in that case arose because the same allegation of
invalidity of a patent had already been litigated unsuccessfully by Sanofi-Aventis,
and that while it could not be said that Sanofi-Aventis could not
possibly succeed on the same allegation in a subsequent proceeding, allowing it
to do so would create the risk of contradictory judgments on the same issue,
which was impermissible in the context of NOC litigation (see paragraph 31 of Sanofi-Aventis).
That approach assumes that different, better evidence could be tendered in the
subsequent proceeding and that the application could thus succeed. The policy
ground that then operates to foreclose the applicant from that opportunity is
the risk that there will indeed be contradictory judgments, such that “one
generic would receive an NOC because of invalidity based on lack of sound
prediction while another would be refused an NOC even though its NOA raised the
same allegation” (par. 36). For that policy consideration to even come into
play, the allegations must be the same, otherwise, they could not give rise to
contradictory judgments.
[36]
The allegation that was held to be justified in Apotex was that Apotex
would not sell, promote or market its tablets for use in combination therapy,
and would not induce others to do so. The allegation made in the present
matter is that Sandoz will not sell, promote or market its tablets for
infringing use and would not induce others to do so. A judgment holding that
Apotex would not induce infringement would, on its face, not contradict a
judgment finding that Sandoz would induce infringement. To the extent the
Court has to consider various factors to determine whether inducement would
occur, and that the existence or incidence of these factors have already been
considered in other cases, these consideration would not dictate the outcome,
but would be taken into account by the Court, as judicial comity requires.
[37]
In the end, allowing Nycomed, through different or better evidence, to
attempt to establish that Sandoz will induce infringement cannot be an abuse of
process, since that issue was not determined in Apotex and could
therefore not give rise to contradictory judgments.
[38]
In contrast, the other cases relied upon by Sandoz as instances where
the Court has dismissed applications pursuant to sub-section 6(5)(b) on
allegations of non-infringement were cases where the Court was satisfied that
the applicant could not possibly succeed in establishing that the allegations
were not justified.
[39]
The first such cases were Hoffman-La Roche Ltd. v. Pro Doc Ltée,
(1998), 85 C.P.R. (3d) 50 and Hoffman-La Roche Ltd. v. Pharmascience Inc.,
(1999), 87 C.P.R. (3d) 251. In the Pro Doc case, the Court reviewed the
evidence filed by Hoffman on the merits of the application, and found that it
“adds nothing new to assist in the construction of the relevant words of the
patent”. In view of the fact that prior determinations had turned on that
construction and that Hoffman could not bring any evidence of the composition
of the proposed drug as direct evidence of infringement (the disclosure
requirements of section 6(7) of the Regulations not yet being in
effect), the Court concluded that the application was simply re-litigation on
the same evidence and was an abuse of process (see paragraphs 10 and 14). In Pharmascience,
the Court held that it was bound by the interpretation of the patent in the earlier
decisions; as the Notice of Allegation stated that the medicine would contain
none of the acids claimed, with no opportunity for Hoffman to bring evidence to
the contrary, the application could not possibly succeed on that ground (see
paragraphs 8 and 9).
[40]
In Sanofi-Aventis v. Novopharm, 2007 FCA 167 (a decision
subsequent to the Sanofi-Aventis decision earlier cited), the Court of
Appeal granted a motion to dismiss pursuant to sub-section 6(5)(b), not on the
basis of an earlier decision, but on the basis that the evidence already filed
by the applicant in the main application on the non-infringement issue could
not possibly succeed. As stated by the Court of Appeal (at paragraph 13):
“13 There
is nothing in the redacted product monograph, or any of the other documents in
the record, that is capable of establishing that Novopharm will infringe
the 089 patent or the 948 patent, either directly or by inducing infringement
by others. Sanofi does not contend that there is such evidence, but
argues that something might emerge on cross-examination. In my view, that
argument should have been rejected as entirely speculative. Once the
speculative possibility of additional evidence is set aside, it is inevitable
that the prohibition application in this case would fail because Novopharm's
non-infringement allegation is justified.”
(Emphasis mine)
[41]
Likewise, it is clear from the reasons of Prothonotary Lafrenière in the
recent Novopharm case that he carefully reviewed the evidence that had
been tendered by Nycomed on the merits of the application, and, excluding the
speculative possibility that additional evidence might emerge on
cross-examinations, proceeded, in light of the decision in Apotex, to
determine whether there was any additional or materially different evidence
from that which had been considered by Justice Gauthier in Apotex.
Although the Court in Novopharm does discuss the impact of the Federal
Court of Appeal’s decision in the first Sanofi-Aventis case, it is clear
that the final determination of the Court rested on the conclusion that Nycomed
had not adduced any materially different evidence that would justify a
different result:
“56 In
light of the facts that Nycomed's position with respect to infringement was
found to be untenable in the Apotex Decision, and that Nycomed has not adduced
any materially different evidence in this proceeding, I conclude that the
application should be dismissed as an abuse of process.”
[42]
Properly understood, then, because Sandoz’ allegation that it
will not infringe or induce infringement of the ‘748 Patent has never been
determined, Sandoz’ burden on this motion is to establish that Nycomed could
not possibly succeed in establishing that the allegation is not justified. Unlike
the situation in Novopharm, however, the evidence to be adduced by
Nycomed on the merits of the application is not before the Court – it has in
fact yet to be filed. Sandoz’ burden is therefore all the heavier because it
has to show that Nycomed could not possibly adduce sufficient evidence to be
successful.
[43]
Sandoz submits, in essence, that because its product monograph is not
materially different from Apotex’s in the crucial aspects of indications,
dosage regimen and lack of reference to treatment of H. Pylori
infections by combination therapy, it would be impossible for Nycomed to bring
evidence that would show that the product monograph would induce infringement.
[44]
Sandoz’ argument that Nycomed cannot establish inducement because its
product monograph is indistinguishable from Apotex’s in its crucial aspects is
fundamentality flawed because it is premised on the incorrect assumption that
inducement can only be established on the basis of the product monograph. However,
the Court of Appeal has clearly held, in the second Sanofi-Aventis
decision, that infringement by inducement may be established by a variety of factors,
either alone or in combination, beyond mere inferences drawn from the content
of the product monograph.
“11 (…)
Infringement by inducement may be established, for example, by inferences
reasonably drawn from the contents of the product monograph for the generic
drug product, or evidence relating to the dosage form of the generic product,
or its labelling or marketing. However, an inducement to infringe
generally cannot be inferred from a mere reference to the new use in the
product monograph, for example, in the course of explaining contraindications
or drug interactions, or as part of a list of scientific references.”
(Emphasis mine)
[45]
The clear implication of this passage is that inducement may indeed be
established by a generic’s marketing practices, quite independently of the
content of the product monograph and that it is open for the Court to consider
all these factors.
[46]
Sandoz has brought no evidence to suggest – let alone establish – that
Nycomed could not possibly bring evidence as to Sandoz’ marketing or promotional
practices from which an intent to induce infringement could be inferred.
[47]
Even as concerns the inferences to be drawn from the product monograph
itself, none of the authorities referred to by Sandoz suggest that the
indications, dosage regimen and the absence of express reference to the
protected uses are the only aspects of a product monograph that can be
considered. Indeed, the Apotex decision reviews various cases where the
following were found to indicate an intent to adduce infringement: Voluntary
omissions in a generic’s monograph as compared with the innovator’s, the choice
of reference product for comparison and reference to studies relevant to the
protected use. More importantly, this discussion emphasizes that the product
monograph must be looked at as a whole. It is not a mechanical exercise involving
simply looking at the list of indications, the dosage regimen and whether the
words “H. Pylori” are used.
[48]
Yet Sandoz invites the Court to do just that. It puts before the Court
its own proposed product monograph, Apotex’s product monograph (it bears noting
that there is no evidence that Apotex’s official product monograph, now
available through Health Canada, is the same as the draft product monograph
considered by Justice Gauthier) and invites the Court to note that the
indications are essentially similar, that the dosage regimen is similar and
that apart from two instances, it does not use the words H. Pylori.
Sandoz has not filed the evidence of any expert who might have read these
32-page scientific documents and might have understood whether there might be
subtle, yet significant differences between them.
[49]
Sandoz has therefore failed to meet its burden of establishing, by
evidence or cogent argument, that no evidence whatsoever could be brought on
the merits of this application by Nycomed, outside the specific aspects of the
product monograph upon which Sandoz relies, from which the likelihood of inducement
could be found. Nycomed therefore did not need to prove, on this motion, that
it could or would lead such evidence. A motion to dismiss pursuant to
sub-section 6(5)(b) is not a motion for summary judgment where an applicant is
compelled to show the existence of a triable issue, but a motion upon which the
entire burden of persuasion rests on the moving party.
[50]
Nevertheless, Nycomed did bring some evidence of its ability to bring
different and relevant evidence, as was prudent. Without going over all the
aspects of the evidence Nycomed has tendered to show the type of evidence it
would propose to lead on the merits of this application, I note that the evidence
includes a statement from a pharmacist to the effect that, having had prior
dealings with Sandoz’ sales representatives, Sandoz’ marketing practices
include representations by sales representatives promoting and insisting upon
the complete interchangeability and equivalence “for all purposes” between
Sandoz’ product and the innovator’s product, and that he believes the same
would occur with respect to pantoprazole. Sandoz has the burden of
establishing that Nycomed cannot or even should not be permitted to bring
better evidence against Sandoz than it has led against Apotex. Yet, Sandoz has
not attempted to show that similar evidence was brought before Justice Gauthier
with respect to Apotex’s promotional practices, or even that Apotex has similar
practices which could have been put in evidence before her. Nor has Sandoz
attempted to show that, if believed, that evidence could not support a finding
that Sandoz would induce infringement or be encouraging “off label” uses. Certainly,
neither Justice Gauthier in Apotex nor Prothonotary Lafrenière in Novopharm
discussed evidence of this type, suggesting that it was not before them.
[51]
As mentioned, I refer to this evidence merely because it is a clear
example of the kind of potentially significant and different evidence which
Nycomed appears to be both capable and justified in bringing on the merits of
this application.
[52]
If it was needed, that evidence is sufficient to confirm to me that
Sandoz has not met the heavy onus upon it to show that Nycomed’s application
cannot possibly succeed, or that allowing it to proceed would be an abuse of
process.
Costs
[53]
Nycomed was successful in opposing this motion and accordingly shall
have its costs. In addition, I have found that at least two of the grounds
relied upon by Sandoz on this motion (eligibility for listing and irrelevance
of the patent) were based on a reading of the Court’s decision in Apotex
which could not reasonably be supported on the clear reasons given by the
Court. These arguments were ill-considered, ill-founded and should not have
been raised. They have unnecessarily wasted the Court’s time and the efforts
of Nycomed, at a time where Nycomed should have been concentrating on
constituting its evidence on the merits of the application. As to Sandoz’
arguments with respect to non-infringement, they were, while novel, based on
assumptions as to what evidence could be available to Nycomed that were far too
sweeping and unjustified. This lack of balance and restraint has again forced
Nycomed to disrupt the orderly preparation of its evidence on the merits to
package a “preview” of its evidence for use on this motion. The matter was not
aided by Sandoz’ inappropriate insistence, on several occasions, that this
motion should be heard urgently, its repeated requests for case management
telephone conferences and modifications to the schedule to meet its shifting
views of how quickly or advantageously its motions under 6(5)(a) and 6(5)(b)
ought to be heard. Sandoz’ precipitation and sense of urgency were driven only
by its desire to have an NOC as soon as possible, and then only because its
competitors, having filed their own Notices of Allegation years before it, were
naturally reaping the benefits of their diligence earlier than Sandoz. In all
the circumstances, the Court considers it appropriate that Nycomed be awarded
its costs of this motion, including all the case management telephone
conferences held to schedule and re-schedule it, at the high end of Column V of
Tariff B. Nycomed shall also have its costs of its counsel’s travel for the
purposes of the hearing and, of course, of its experts, all forthwith and in
any event of the cause.
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