Date: 20061221
Docket: T-1979-05
Citation: 2006 FC
1547
OTTAWA, ONTARIO, December 21, 2006
PRESENT: The Honourable Mr. Justice Hughes
BETWEEN:
SANOFI-AVENTIS CANADA INC. and
SANOFI-AVENTIS DEUTSCHLAND GmbH
Applicants
and
NOVOPHARM LIMITED and THE MINISTER
OF HEALTH
Respondents
REASONS FOR ORDER AND ORDER
[1]
This is a
motion brought by the Respondent, Novopharm, to dismiss the application in
whole or in respect of one or more of the patents at issue under the provisions
of section 6(5) of the Patented Medicines (Notice of Compliance) Regulations
SOR/93-133 as periodically amended. For the Reasons that follow, I find that
the motion is dismissed with costs in the cause.
[2]
The application at
issue is one of the now familiar Notice of Compliance (NOC) proceedings brought
before this Court in the ongoing battles between innovator drug companies and
the generics. The drug at issue is one commonly known as ramipril and sold by
the Applicant, Sanofi-Aventis, under the name ALTACE. There is no real dispute
that ramipril has been known for quite some time and has been used in the
treatment of high blood pressure (the old use). At issue here, at least until a
very few days ago, were four patents directed to new uses of ramipril. At the
hearing of this motion, I was advised by counsel for Novopharm that two of
these patents may have dropped out of consideration however, the extent to
which they are or are not in contention is not agreed by counsel. I will refer
to that matter, briefly, later in these reasons. It is sufficient to say that
Novopharm’s counsel at the outset of argument before me restricted that party’s
argument to two patents, Canadian Patent 2,023,089, the ‘089 patent, which
Sanofi-Aventis counsel agreed was directed to a new use of ramipril, namely the
treatment of cardiac hypertrophy and hyperplasia, and to Canadian Patent
2,055,948, the ‘948 patent, which Sanofi-Aventis counsel agreed was directed to
a new use of ramipril, namely the prevention and therapy of proteinuria.
[3]
The history of these
and related proceedings is complex and requires explanation for the
understanding of the issues raised in the motion. I will endeavor to present
them somewhat in chronological order:
1.
At various times in
the period from October 1993 to February 2001 Sanofi-Aventis or a predecessor,
obtained a number of Notices of Compliance (NOC) to market various forms of ramipril
in Canada. Sanofi-Aventis was, in the lingo of
these matters, the innovator drug company. It is important to note that
Sanofi-Aventis has never received an NOC for any “new” use, its NOC’s are
restricted to the “old” use only.
2.
On June 22, 2001,
Novopharm acquired some of Sanofi-Aventis’ ramipril product for the purposes of
using it as a comparator for bioequivalent studies to support its subsequent
application called an Abbreviated New Drug Submission (ANDS). It is important
to note two things, first a bioequivalent study simply addresses the scientific
issue as to the drug found in the human system after some form of
administration, it has nothing to do with the use of the drug. Second, an ANDS
means that if a generic, such as Novopharm, can demonstrate bioequivalence, it
need not perform many of the clinical studies undertaken by the innovator; it
cannot seek uses of the drug beyond those already awarded to the innovator in
its pre-existing NOC.
3.
On December 24, 2001,
Novopharm filed its ANDS for ramipril directed to the old uses, for capsules containing
ramipril in 2.5 mg, 5 mg and 10 mg strength.
4.
On November 12, 2002,
the ‘948 Patent, directed to a new use of ramipril, issued. Presumably it was
placed on the NOC patent list shortly after that. It is important to note that
this is after Novopharm filed its ANDS for the old uses and that Sanofi-Aventis
never got an NOC for this new use in the ‘948 Patent.
5.
On January 14, 2003,
the ‘089 Patent was directed to another new use of ramipril. Presumably, it
also was placed on the NOC patent but shortly after
Novopharm filed its ANDS. Sanofi-Aventis never got an NOC for this new use.
6.
On March 15, 2005, yet another patent, the ‘549, was issued
and presumably listed by Sanofi-Aventis shortly thereafter. It is directed to
yet another new use called by the acronym HOPE. Again this was after the
Novopharm ANDS was filed. Sanofi-Aventis never got an NOC for this use.
7.
On October 14, 2003,
the Minister approves Novopharm’s ANDS meaning that Novopharm has met the
Minister’s requirements but the application put on “patent hold” until NOC
matters such as this one are completed.
8.
On June 21, 2005, a
final patent (for those purposes), the ‘387 patent issues and was listed by
Sanofi-Aventis shortly thereafter. This patent is directed to a new HOPE use.
Again, this patent issued well after Novopharm filed its ANDS and, in this
case, after approval of that ANDS. Sanofi-Aventis never got an NOC for this
use.
9.
On February 12, 2005,
Novopharm sent a Notice of Allegation to Sanofi-Aventis alleging that a ‘206 patent,
not at issue here, but apparently also listed in respect of ramipril, was invalid.
This allegation became the subject of other proceedings before this Court,
T-1965-05, and a decision of Justice Tremblay-Lamer to be discussed later.
10.
On August 25, 2005,
Novopharm filed a Supplementary ANDS (SANDS) to add a lower strength capsule to
its list, a 1.25 mg strength. That SANDS was approved, subject to “patent hold”
on August 3, 2006.
11.
On September 14,
2005, Novopharm sent a Notice of Allegation to Sanofi-Aventis respecting its ramipril
capsules in 1.25 mg, 2.5 mg, 5 mg and 10 mg strengths. That Notice addressed each
of the ‘089, the ‘948, the ‘549 and the ‘387 patents. It alleged that Novopharm
was seeking approval only for the old uses and no other use and that those
patents would not be infringed. Invalidity was also alleged in respect of the
‘549 and ‘387 patents.
12.
On November 2, 2005,
this application now the subject of this motion was filed with the Court.
Sanofi-Aventis challenged Novopharm’s allegations in respect of all four
patents. Affidavits have been filed by all parties, a schedule was agreed to,
some but not all cross-examinations have been conducted and a trial date fixed
for June 2007.
13.
On October 27, 2005,
this Court, in proceedings between Sanofi-Aventis and another generic, Apotex,
held that the applicant did not establish that the allegation of
non-infringement was not justified (Aventis
Pharma Inc. v. Apotex Inc., 2005 FC 1461).
14.
On July 10, 2006,
this Court made the same finding in respects of another generic, Pharmascience,
as to the ‘089 patent (Aventis Pharma Inc. v. Pharmascience Inc., 2006
FC 861).
15.
On July 18, 2006, this
Court made a similar finding in respect of Pharmascience as to the ‘948 patent
(Aventis Pharma Inc. v. Pharmascience Inc., 2006 FC 898).
16.
On September 25,
2006, Justice Danièle Tremblay-Lamer of this Court found that Sanofi-Aventis’
proceeding against Novopharm in respect of the ‘206 patent was an abuse of
process, in that, in an earlier NOC proceeding, Justice Anne L. Mactavish of
this Court had found that patent to be invalid for exactly the same reasons as
alleged in the proceedings before Justice Tremblay-Lamer (Sanofi-Aventis
Canada Inc. v. Novopharm Limited, 2006 FC 1135; Justice Mactavish, Aventis
Pharma Inc. v. Apotex Inc., 2005 FC 1283). That decision is under appeal
and scheduled to be heard in January 2007.
17.
On October 5, 2006,
the NOC Regulations were amended. Some of these amendments will be discussed
later but they include amendments as to what constitutes infringement and put a
freeze on adding new patents in certain circumstances. The amendments addressed
in particular whether patents directed to uses not approved in an innovator’s
NOA could be listed.
18.
October 18, 2006,
this motion was filed to be heard October 23, 2006. Various adjournments were
sought in the result that this motion was not heard until December 19, 2006.
19.
On November 3, 2006,
the Supreme Court of Canada delivered its decision in AstraZeneca Canada
Inc. v. Canada (Minister of Health), 2006 SCC 49. This is a significant
decision dealing with many NOC matters and will be discussed more fully later.
20.
On December 8, 2006,
the Minister issued a letter to Novopharm advising that as a result of the
Supreme Court decision, Novopharm no longer needed to address the ‘549 or ‘387
patents in its ANDS but still needed to address the ‘089 and ‘948 patents. As a
result, Novopharm did two things:
a)
On December 15, 2006,
it filed an application with this Court challenging the decision that the ‘089
and ‘948 patents are to remain for NOC purposes; and
b)
Wrote to
Sanofi-Aventis abandoning its Notice of Allegation respecting the ‘549 and ‘387
patents.
21.
On December 13, 2006,
another generic, Apotex, received an NOC in respect of ramipril. Sanofi-Aventis
has brought an application to this Court to quash that NOC. The background
appears to be that Apotex received a letter from the Minister similar to the
one received by Novopharm wherein apparently, impediments were lifted from a
patent point of view.
22.
On December 13, 2006,
another generic, Ratiopharm, also received an NOC for ramipril. Sanofi-Aventis
has not challenged this NOC. Novopharm calls Ratiopharm an “authorized” generic
but I have no evidence as to this.
23.
On December 6, 2006,
Sanofi-Aventis moved requesting that I remove myself from this proceeding on
the grounds of alleged apprehension of bias, a matter which I rejected by Order
dated December 8, 2006. Sanofi-Aventis have appealed, requesting that I
postpone hearing the motion until the appeal was determined. I rejected that
request.
24.
On December 19, 2006,
this motion was heard and taken under reserve.
[4]
The motion then, as
presented by Counsel for Novopharm, was to dismiss this proceeding in whole or
in part in respect of the ‘089 and ‘948 patents or one of them under the
provisions of section 6(5)(b) of the NOC Regulations on the ground that the
proceeding is redundant, scandalous, frivolous or vexatious or otherwise and
abuse in respect of one or both patents.
[5]
A
preliminary objection was raised by Counsel for Novopharm as to the propriety
of the affidavit of Junyi Chen sworn 27th October, 2006, filed by
Sanofi-Aventis in support of its position in this motion. The objection, with
which I agreed, was that the affidavit, while attesting to factual matters, did
so in an argumentative manner such that, when viewed as a whole, it clearly
resembled a memorandum of argument and not a simple factual recital. There is
clear precedent that an affidavit from a member of a firm of solicitors arguing
a motion, particularly one submitting evidence as to contested matters or opinion,
should not be permitted (Cross-Canada Auto Body Supply (Windsor) Ltd. v.
Hyundai Auto Canada, 2006 FCA 133). Counsel for
Sanofi-Aventis appear to have agreed, reluctantly, with this observation. I
suggested, and the parties agreed, that in order to get on with the matter, the
affidavit would remain on the file and could be referred to, if needed, but
only as to factual, non-contentious matters, and that the argument and
contentious matters would be ignored.
[6]
Novopharm
based its motion, on either of two independent grounds; either or both of which,
Counsel argues, would result in a dismissal of these proceedings in respect of
the two patents. They are:
1.
The
decision of the Supreme Court of Canada in AstraZeneca, supra, results
Novopharm argues in the ‘089 and ‘948 patents being irrelevant to Novopharm’s
ANDS and thus the proceedings brought by Sanofi-Aventis are irrelevant; or
2.
The
evidence as to infringement by Novopharm is inadequate to demonstrate that
Novopharm’s allegation of non-infringement is not justified and it would be an
abuse of the proceedings to continue.
[7]
Counsel
for Sanofi-Aventis take the position that while the Minister may have stated
to Novopharm that does not have to address the ‘549 and ‘387 patents and while
Novopharm has written to Sanofi-Aventis abandoning those portions of the its
Notice of Allegation addressing those patents, this Application brought by
Sanofi-Aventis still addresses those two patents. As I understand it,
Sanofi-Aventis does not yet wish to take a position as to whether those two
patents remain at issue in this Application. Novopharm takes the position that
they are not, and for the purpose of this motion has abandoned them. I
will make no determination at this time as to the status of this Application in
respect of these two patents.
[8]
I will
consider each of the two grounds raised by Novopharm upon which they argue that
the proceeding should be dismissed in respect of the ‘089 and ‘948 patents.
First, however, it is important to consider what is the meaning of section
6(5)(b) of the NOC Regulations.
[9]
Section
6(5)(b) of the NOC Regulations did not exist in any form when the Regulations
were introduced in 1993. There did exist the Federal Court Rules which
provided, as Rule 419, that an action could be dismissed for grounds including
the litany of words now found in section 6(5)(b). In a case that has become
classic in the area, David Bull Laboratories (Canada) Inc. v. Pharmacia Inc.,
[1995] 1 F.C. 588, the Federal Court of Appeal refused to strike out an NOC
application on the basis that the Rules, including Rule 5, which directed that
the court may adopt analogous situations, did not contemplate the striking out
of applications of this kind. The court said at pages 597-598:
“The contrast between
actions and motions in this Court is even more marked where the motion involved
is for judicial review, as these applications for prohibition under Patented
Medicines (Notice of Compliance) Regulations, subsection 6(1) have been held to
be. Unlike the rules pertaining to actions, the rules governing judicial review
provide a strict timetable for preparation for hearing and a role for the Court
in ensuring that there is no undue delay. The focus in judicial review is on
proceeding to the hearing as quickly as possible, with objections to the
originating notice being disposed of promptly in considering the merits of the
case.”
[10]
In 1998,
the Regulations were amended to include, among other things, section 6(5)(b).
The commentary appearing in the Canada Gazette, Part II, Vole 132, No. 7 at
page 1057 states simply that a generic manufacturer will be able to seek
dismissal of the patentee’s case, at an early stage, in certain circumstances.
Thus the provision is remedial, it overcomes the David Bull objection
and puts NOC Applications on a similar footing with actions under Rule 419 of
the Federal Court Rules, as they then were, and Rule 221 as it presently
stands.
[11]
Taking
section 6(5)(b) on an equal footing with old Rule 419 or present Rule 221 we
must start with the well entrenched proposition as stated by the Supreme Court
in Hunt v. Carey Canada Inc., [1990] 2 S.C.R. 959 that a party should
not be driven from the judgment seat at an early stage before trial unless it
is “plain and obvious” that the matter cannot succeed. In dealing with an
application not an action, the Federal Court of Appeal in Norton v. Via Rail
Canada (2005), 255 D.L.R. (4th) 311, at paragraph 15, states
that striking out an application before hearing is an extraordinary remedy,
granted only in narrowly defined circumstances. Finally, another classic
decision of this Court should be cited, Creaghan Estate v. The Queen,
[1972] F.C. 732 at 736:
(3) Finally, in my
view, a statement of claim should not be ordered to be struck out on the ground
that it is vexatious, frivolous or an abuse of the process of the Court, for
the sole reason that in the opinion of the presiding judge, plaintiff's action
should be dismissed. In my opinion, a presiding judge should not make such an
order unless it be obvious that the plaintiff's action is so clearly futile
that it has not the slightest chance of succeeding, whoever the judge may be
before whom the case could be tried. It is only in such a situation that the
plaintiff should be deprived of the opportunity of having “his day in Court”.
[12]
With the
general principles in mind some cases in which section 6(5)(b) of the NOC
Regulations have been considered by this Court should be reviewed.
1.
Hoffman
LaRoche Ltd. v. Canada, (1999), 87 C.P.R. (3rd)
251 (FC). The Court dismissed an application where it was demonstrated that
the applicant, the innovator, failed to take the appropriate steps in the
appropriate sequence in respect of filing its NOC. The Application was
dismissed as failure to follow the correct sequence was fatal.
2.
There are
several cases where there had been previous NOC litigation between the same parties.
Subsequent NOC litigation between the same parties respecting the same patents
was dismissed as being an abuse. Among these are Janssen-Ortho Inc. v.
Novopharm Limited, (2005), 46 C.P.R. (4th) (FC); AB Hassle v.
Apotex Inc., (2005), 38 C.P.R. (4th) and Glaxo Group Ltd. v.
Canada, 2006 FCT 16.
3.
These are
two cases where in a previous NOC decision a patent had been held to be invalid
and another generic in a subsequent application involving the same patent
sought the dismissal on the basis of the prior invalidity finding. The Federal
Court of Appeal in Pharmascience Inc. v. Sanofi-Aventis Canada Inc.,
(2006) FCA 210 held that where the generic in the subsequent proceeding was
alleging invalidity on a ground different from the basis upon which invalidity
had previously been found, the proceeding should not be dismissed. In the
second case, Tremblay-Lamer, J. of this Court held that where the patent was
held invalid in the first proceeding on the same ground of invalidity raised by
the generic in the second proceeding, it would be an abuse to continue the
second proceeding and thus it was dismissed, see Sanofi-Aventis Pharma Inc.
v. Novopharm Limited, 2006 FC 1135. That decision is under appeal.
[13]
There
appears to be no precedent directly on point in respect of the grounds for
dismissal raised in the present motion which I will now discuss substantively.
Ground 1 – Effect of Supreme Court
Decision in AstraZeneca
[14]
The
situation which confronted the Supreme Court of Canada in AstraZeneca, supra,
was succinctly put in the head note provided by the Court which I repeat here:
In 1989, the respondent,
Astra, an innovator manufacturer, obtained from the Minister of Health a notice
of compliance (“NOC”) enabling it to market its drug omeprazole for use in the
treatment of acidic stomach conditions. It was sold in Canada as Losec 20 from 1989 until
1996, when Astra decided to remove it from the market and replace it with
another formulation. Astra’s patent for omeprazole then expired in 1999. In
2002, despite the absence of Losec 20 from the market, Astra obtained and
registered with the Minister of Health two more patents associated with Losec
20, but did not incorporate this new technology into any of its products. In
1993, Apotex filed an abbreviated new drug submission for a NOC for its generic
version of omeprazole, comparing its product to Astra’s 1989 version of Losec
20. The Minister determined that Apotex was not required to address the
after-issued patents and granted Apotex the NOC in 2004. Astra applied for
judicial review of this decision, and the motions judge upheld the Minister’s
decision. The Federal Court of Appeal overturned this judgment and quashed
Apotex’s NOC.
[15]
The
Supreme Court allowed the appeal, reversing the Federal Court of Appeal. It is
important to note that the two patents at issue dealt with physical
characteristics of the drug, one addressed a particular formulation, the other
addressed a particular crystaline form. Neither patent dealt with new uses. The
innovator was able to list those patents via a Supplementary New Drug
Submission (SNDS) which it filed which SNDS was directed to a new use even
though the patents were not directed to the new use. The generic wanted to
copy the old form of the drug for the old use. As Binnie, J. said at paragraph
21:
21 I emphasize the words
in s. 4(5) that in the case of patents added afterwards, "the first person
must identify the submission to which the patent list or the amendment relates,
including the date on which the submission was filed". In addition, s.
3(3) provides that "[n]o information submitted pursuant to section 4 shall
be included on the register until after the issuance of the notice of
compliance in respect of which the information was submitted". These
provisions, it seems to me, provide an important key to understanding the
scheme. Entry of the "Patent list" does not destroy the linkage
between the patent and the submission(s) to which it relates, nor to the NOC to
which the submission(s) are directed. Specific patents are associated with one
or more NDS, ANDS or SNDS, which in turn (if approved) give rise to specific
NOCs, which in turn approve a specific manufacturer's product, which a generic
manufacturer may seek to copy. There is no linkage between the 037 and 470
patents and the submissions that lead to the Losec 20 product copied by Apotex.
Those after-acquired patents were listed in relation to a SNDS dated January
22, 1999 by AstraZeneca for a new medical use for Losec 20 (treatment of H.
Pylori), a use for which the Apotex product is not approved, and to an
administrative SNDS submitted by AstraZeneca dated July 12, 2000, which
submission has nothing at all to do with the technology incorporated in Losec
20.
[16]
Binnie, J.
recited the argument of the innovator and the Federal Court of Appeal at
paragraph 23:
23 AstraZeneca relies on
Eli Lilly Canada Inc. v. Canada (Minister of Health), [2003] 3 F.C. 140, 2003
FCA 24, for the proposition that a patent list is submitted in respect of a
drug and not in respect of any particular submission. This is also the view
taken by the majority judgment of the Federal Court of Appeal in this case. On
this view a "first person" could carry on "evergreening"
its product indefinitely by the addition of new patents of marginal significance
which would trigger an indefinite series of 24-month statutory freezes even
though such subsequently listed patents are not the subject of "early
working" by the generic manufacturer, and from which (as in the
circumstances here) the generic manufacturer derives no advantage. As this case
further illustrates, AstraZeneca even managed to piggy-back the 037 and 470
patents onto an administrative SNDS. An interpretation that would freeze the
generic product out of the market vacated by AstraZeneca in 1996 for a further
two years or more in these circumstances flies in the face of the limited
purpose authorized by s. 55.2(4) of the Act. It is not to be presumed that s.
4(5) of the NOC Regulations insisted on linking particular patents to
particular submissions for no purpose.
[17]
Their
argument was found to be wrong. Without reciting the whole of the remainder of
the decision, the following paragraphs illustrate the view of the Supreme
Court:
35 In my opinion, the
rules governing acceptable "comparator" drugs give a further
important clue to the legislative intention. If, as subs. (b) says, a drug
cannot be used as a comparator unless acceptable to the Minister "because
it is no longer marketed in Canada", it seems obvious that a drug cannot be used as a
comparator if it has never been marketed in Canada. That is the significance of the fact
that AstraZeneca has never had a product on the market based on AstraZenaca's
later submissions in relation to which the 037 and 470 patents were listed.
36 Viewed in this light,
it seems to me inescapable that the expression "another drug" in s.
5(1) refers to the actual comparator drug - not a drug that never became
available for comparison -- and that the words "with respect to each
patent on the register in respect of the other drug" carries the same
meaning.
37 The whole obligation
incurred by the generic manufacturer under the NOC Regulations is based on its
"early working" of patents embodied in "another drug for the
purpose of demonstrating bio-equivalence". The only drug that fits the
description is the version of Losec 20 approved in the June 19, 1989 NOC.
H. The Broader Statutory
Purpose
38 I repeat that
Parliament's stated purpose in authorizing the NOC Regulations was to permit
the early working of the patented invention (s. 55.2(4)). As Apotex did not
make use of the patented inventions taught by the 037 and 470 patents, Apotex
is not on this occasion within the mischief aimed at by the NOC Regulations.
39 By imposing the
24-month delay called for by the NOC Regulations, the decision of the Federal
Court of Appeal undermines achievement of the balance struck by Parliament
between the objectives of the FDA and regulations thereunder (making safe and
effective drugs available to the public) and the Patent Act and its regulations
(preventing abuse of the early working exception to patent infringement). Given
the evident (and entirely understandable) commercial strategy of the innovative
drug companies to evergreen their products by adding bells and whistles to a
pioneering product even after the original patent for that pioneering product
has expired, the decision of the Federal Court of Appeal would reward
evergreening even if the generic manufacturer (and thus the public) does not
thereby derive any benefit from the subsequently listed patents. In my view, s.
5(1) of the NOC Regulations requires a patent-specific analysis, i.e. the
generic manufacturer is only required to address the cluster of patents listed
against submissions relevant to the NOC that gave rise to the comparator drug,
in this case the 1989 version of Losec 20.
40 If AstraZeneca had
brought to market a Losec 20 product pursuant to the later NOCs and if Apotex
had made reference to that modified product for the purpose of demonstrating
bioequivalence, Apotex would have been required to file a notice of allegation
with respect to the 037 and 470 patents.
41 However, it is clear
that AstraZeneca did not market any product pursuant to the subsequent NOCs and
that the preconditions to any obligations of Apotex under s. 5(1) were
therefore not triggered.
[18]
In the
present proceeding we have a case where the physical drug is the same,
ramipril. For the purpose of bioequivalence all that is important is how the
drug of the generic behaves in the human body compared to that of the
innovator, a new use is immaterial.
[19]
As far as
new use is concerned, the innovator, Sanofi-Aventis, never got approval, it never
got an NOA, for the new use as claimed in the patents at issue. It never sold
its ramipril drug in Canada for the new uses. The only
purpose of the new use patents seemingly, is to act as an impediment to early
entry by a generic into the old use marketplace. Novopharm argues that the
Reasons of the Supreme Court at paragraph 35 and 42 are significant in
determining that a patent which does not pertain to a product that has been
marketed by the innovator, need not be engaged by the generic:
35 In my opinion, the
rules governing acceptable "comparator" drugs give a further
important clue to the legislative intention. If, as subs. (b) says, a drug
cannot be used as a comparator unless acceptable to the Minister "because
it is no longer marketed in Canada", it seems obvious that a drug cannot
be used as a comparator if it has never been marketed in Canada. That is the significance of
the fact that AstraZeneca has never had a product on the market based on
AstraZenaca's later submissions in relation to which the 037 and 470 patents
were listed.
…
42 Apotex acknowledges
that its NOC dated January 27, 2004 does not permit Apotex to produce a product
formulated or manufactured in accordance with the 037 and 470 patents, nor to
claim that the Apotex product is indicated for the treatment of H. Pylori. This
opinion deals only with the obligations of Apotex under the NOC Regulations.
AstraZeneca seemed to suggest at various points during the oral hearing that
Apotex is indeed infringing AstraZeneca patents. If this be so (and there is no
evidence before us either way), then of course AstraZeneca retains all its
remedies under the Patent Act, including, in appropriate circumstances, an
interlocutory injunction. The only patent-related consequence of the present
decision is to deny AstraZeneca the benefit of a 24-month freeze without any
proof of patent infringement.
[20]
Sanofi-Aventis
argues that AstraZeneca must be confined to a situation where the drug
in its patented physical form has never been marketed. It says that here, the
drug is in its physical form and has been marketed; it was purchased by
Novopharm and used as a comparator for bioequivalent studies. The “new” use
patents are not immaterial.
[21]
Perhaps
this difference in interpretation of the Supreme Court decision could be
resolved on a motion such as this. However, there is a complication. The
Minister, in his letter of December 8, 2006, to Novopharm, disagrees with Novopharm’s
view, at least to the extent that it affects the ‘089 and ‘948 patents at issue
here, so much so that Novopharm has instituted other proceedings in this Court
to quash the Minister’s decision. I will not repeat the whole of the
Minister’s view of the decision because of its length, however, a portion
states:
While the AstraZeneca decision
arose from an unusual factual basis, namely the addition of a patent list for a
drug that was no longer marketed, it appears that Mr. Justice Binnie, for the
court, entertained a broader discussion as to the assessment of which patents
must be addressed by a second person under section 5 of the PM(NOC) Regulations.
He held, at paragraph 39, that a “patent-specific” analysis” is necessary in
order to determine which patents on the Patent Register must be addressed by a
second person under the PM(NOC) Regulations. He went on to determine that a
second person “is only required to address the cluster of patents listed
against submissions relevant to the NOC that gave rise to the comparator drug.”
…
If, at the end of the
patent-specific analysis, it is determined that a second person is not required
to address a given patent, the OPML will consider whether the Minister if
statutorily barred from issuing the relevant NOC due to an order of prohibition
granted to the first person under section 6 of the PM(NOC) Regulations or due
to the requirements for the issuance of an NOC under section 7. The OPML will
not issue an NOC if it is statutorily barred from doing so.
[22]
A motion
to dismiss should not be used as a vehicle to resolve important, controversial
points of law. This is particularly so in an area which the law is currently
evolving (Daniels v. Canada, [2002] 4 F.C. 550). For this reason I will
not dismiss the proceeding in respect of the ‘089 and ‘948 patent on this
ground.
Ground 2: Is there Sufficient Evidence on the
Non-Infringement Issue
[23]
The issue of infringement in NOC proceedings is expressed in a
convoluted way. Once a generic, in its Notice of Allegation, has stated that
there will not be infringement of a patent, the innovator, in NOC proceedings
before this Court, has the burden to show that such an allegation is not
justified. (e.g. Abbott Laboratories Limited v. Novopharm Limited, 2006
FC 1411 at paragraph 10).
[24]
The parties concede that the jurisprudence as to use by a
generic, after a controversial start, is now quite well settled. The mere sale
by a generic of an old drug for an old use will not constitute infringement of
a patent directed to a new use for that drug unless “something more” than sale
is shown in the evidence. That something more would include the procuring or
inducing others to infringe (Sanofi-Aventis Canada Inc. v.
Apotex Inc., 2006 FCA 357). Evidence showing that “off label” uses of a
drug would occur in that physicians may prescribe, pharmacists may dispense and
patients may consume old drugs for new uses is not sufficient to implicate the
generic in infringement as defined by the NOC Regulations unless the generic is
shown to do “something more” than simply make the drug available for the old
use.
[25]
Novopharm asserts that the evidence in this case fails to show
“something more”. It says that Sanofi-Aventis has filed all of its affidavits
in the proceeding and none of them show “something more”. To the extent that
Sanofi-Aventis’ evidence addressed either the ‘089 or ‘948 patent that evidence
is simply that alleging that “off label” uses will occur. That is, the same
sort of evidence that the courts have found to be insufficient.
[26]
Sanofi-Aventis says that the evidence is not yet complete in that
it has not yet concluded the cross-examination of all of Novopharm’s affiants.
This, says Novopharm, is mere speculative hope that something unexpected may
arise from cross-examination. A party, Novopharm says, cannot sustain a
proceeding based merely on such a hope (Kastner v. Painblanc, [1994]
F.C.J. No. 1671 (C.A.)).
[27]
Sanofi-Aventis also argues that Novopharm has only supplied a
redacted version of a proposed product monograph and labeling. Until Sanofi-Aventis
receives verification as to the actual monograph and labeling to be used
unredacted form it says that there will not be sufficient evidence before the
Court on the infringement issue. It points to cases such as Abbott, supra,
and ABHassle v. Genpharm Inc., 2003 FC 1443 where certain information
contained in a product monograph was sufficient to constitute the “something
more” which the case law requires.
[28]
Novopharm says that the evidence is clear that the monograph and
labels are those which it intends to use and that the redactions have nothing
to do with the “new use” issue. They relate to formulations or “numbers only”
as to clinical trials. It remains puzzling as to why Novopharm, given that
there is a Confidentiality Order in this case, would not simply have turned
over an unredacted copy of the monograph and labeling. Whatever mystery existed
would have been put to rest.
[29]
Further, Sanofi-Aventis points to a passage in the Novopharm
proposed product monograph, not redacted, which says:
Recommended
Dose and Dosage Adjustment
Essential
Hypertension
Dosage of
NOVO-RAMIPRIL (ramipril) must be individualized. Initiation of therapy requires
consideration of recent antihypertensive drug treatment, the extent of blood
pressure elevation and salt restriction. The dosage of other antihypertensive
agents being used with NOVO-RAMIPRIL may need to be adjusted.
[30]
This statement, Sanofi-Aventis says, taken with the evidence of
one of its experts, may lead some patients to combine the generic ramipril with
another drug to arrive at a new use claimed by at least the ‘948 patent.
[31]
Novopharm says that such speculation is very thin evidence indeed
and wholly insufficient to support a finding that a non-infringement allegation
is not justified.
[32]
Sanofi-Aventis raises another objection to Novopharm’s motion on
this second ground. Sanofi-Aventis counsel put it on the basis that Novopharm
has “already engaged the process” such that the parties have filed their
evidence in-chief, some cross-examination has been conducted and a trial date
fixed. Being a summary proceeding, it says, a motion for dismissal at this
stage should not be entertained. Such an argument has been couched by the
courts as delay. (e.g. Sofila Canada Inc. v. Contour Optic Inc., 2005 FC
278; Inventions Armand Morin Inc. v. Risley Mfg. Ltd., 2005 FC 362).
[33]
I make no finding on the evidence presently on the record even
though I have some skepticism that a party should be allowed to proceed simply
because it might obtain something useful on cross-examination. However,
combining what little evidence there is or may be with the fact that these
proceedings were instituted over a year ago and a trial date has been fixed for
six months hence, I make the observation that the motion, on this ground, could
have been initiated at the outset of this case just after Sanofi-Aventis filed
its affidavit evidence, I find that it would be inappropriate to dismiss the
proceedings on this ground at this time. The sufficiency of evidence on the
infringement issue, now that the matter has gone this far, should be left to
the hearing at trial.
[34]
Counsel for the parties have indicated that they would co-operate
in seeking an earlier trial date than that presently fixed and I encourage them
to apply to the Office of the Chief Justice to determine if an earlier date can
be obtained.
[35]
As to costs, this is a matter best left for determination at
trial. They will be in the cause.
ORDER
FOR THE REASONS GIVEN:
THIS COURT ORDERS that:
1.
The motion
is dismissed; and
2.
Costs are
in the cause.
"Roger
T. Hughes"
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