Date: 20061208
Docket: T-1979-05
Citation: 2006
FC 1473
OTTAWA, ONTARIO, December 8, 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
ORDER AND REASONS FOR ORDER
[1]
The
Applicants have brought a motion within the context of this Notice of
Compliance proceeding requesting that I recuse myself from hearing a
forthcoming motion brought by the Respondent to dismiss these proceedings and
from any other involvement in these proceedings. For the Reasons that follow,
I have determined that I will not recuse myself.
[2]
These are
Notice of Compliance (NOC) proceedings. In accordance with the Patented
Medicines (Notice of Compliance) Regulations, such proceedings are to be
made by way of application, to proceed in a summary fashion, and to be
concluded within twenty-four (24) months from when they are instituted. This
seemingly simple model has not proven successful in practice. The issues include
those of patent validity and infringement which are complex issues,
particularly in the field of drugs and medicines, requiring sophisticated
expert evidence. The stakes are usually very high. An innovator drug company
may find that a successful generic has entered the market eroding substantially
the market position and profitability of the innovator. More than one generic
may enter the market, the order in which they enter and the marketing strength
of the generic may be critical. It is not unusual to find that millions of
dollars may be at stake and that every single day that a generic is prevented
from entering the market can be critical to each of the innovator and the
generic.
[3]
As a
result, NOC proceedings in this Court are usually hotly contested, many
procedural motions and issues arise, tactics and strategy abound. Both the
innovator and the generic instigate and participate in such matters. So much
is at stake. If, at the end of the day, the innovator is successful, the
generic is prevented from marketing the product at issue. If the generic is
successful, it may enter the market but be subject to possible patent
infringement actions respecting the same or other patents. Res judicata
does not apply in such actions so that the result of the NOC proceedings cannot
be applied to the patent infringement action. The Regulations provide a
further tool to the generic to sue the innovator for damages if it can be shown
that the innovator, in some improper way, used the NOC proceedings to delay
entry by the generic into the market.
[4]
Here we
have a motion by the innovator, that I recuse myself on the basis of alleged
reasonable apprehension of bias. One hesitates to, in effect, judge oneself,
but that appears to be the process. The judge in question decides if it is
appropriate that he or she be recused. The test for recusal is not in issue,
it is that set out in the recent decision of the Supreme Court of Canada in Wewaykum
Indian Band v. Canada, [2003] 2 S.C.R. 259 at paragraph 60 of the decision
of the Court:
60 In Canadian law, one
standard has now emerged as the criterion for disqualification. The criterion,
as expressed by de Grandpré J. in Committee for Justice and Liberty v. National Energy Board,
supra, at p. 394, is the reasonable apprehension of bias: [page289]
... the apprehension of bias
must be a reasonable one, held by reasonable and right minded persons, applying
themselves to the question and obtaining thereon the required information. In
the words of the Court of Appeal, that test is "what would an informed
person, viewing the matter realistically and practically -- and having thought
the matter through -- conclude. Would he think that it is more likely than not
that [the decision-maker], whether consciously or unconsciously, would not
decide fairly."
[5]
There is
no question of actual bias, the issue is that of reasonable apprehension of
bias. The Applicants have fairly stated their position in paragraphs 35 and 36
of their Memorandum:
35. In the present case,
Sanofi-Aventis does not suggest that there is actual bias, but rather, suggests
that there is a reasonable apprehension of bias. Certainly, the personal
integrity of Justice Hughes is not at issue.
36. The question is whether,
having regard to the totality of the circumstances, confidence in the integrity
of the administration of justice would be undermined if Justice Hughes decides
the present motion. The test is whether reasonable, right-minded and properly
informed persons would think that Justice Hughes, whether consciously or
unconsciously, would not decide the motion fairly.
[6]
At this
stage, it is appropriate to review these proceedings and other proceedings.
[7]
Prior to
the institution of these proceedings the Respondent, Novopharm, sent a letter,
called a Notice of Allegation under the Regulations, stating that it intended
to obtain permission to market a drug containing ramipril in Canada.
Novopharm alleged that certain patents, which for brevity I will call the ‘089,
the ‘948, the ‘549 and the ‘387 patents would not be infringed if Novopharm
were to market its drug in Canada. Novopharm further alleged
that two of these patents, the ‘549 and the ‘387 were, in addition, invalid. As
a result, the Applicants instituted these proceedings stating that such
allegations were not justified.
[8]
Sanofi-Aventis
has also been engaged in other NOC proceedings in this Court respecting many of
the same patents. In Aventis Pharma Inc. v. Pharmascience Inc., 2006 FC
898, this Court held that Aventis (a predecessor of Sanofi-Aventis) had not
proven that Pharmascience’s allegation of non-infringement was not justified in
respect of the ‘948 patent. In other words, Sanofi-Aventis failed to show
infringement by the generic Pharmascience of the ‘948 patent. In Aventis Pharma
Ltd. v. Apotex Inc. 2005 FC 1461, affirmed by the Federal Court of Appeal
on November 2, 2006, 2006 FCA 357, it was held that Sanofi-Aventis had failed
to show infringement by the generic Apotex of the ‘089 patent.
[9]
Waiting in
the wings are two further NOC proceedings involving yet another generic Laboratoire
Riva Inc. In these proceedings one of the issues is whether Sanofi-Aventis can
prove whether Riva’s allegation of non-infringement of a number of patents,
among them the ‘089 and the ‘948 patents which were previously the subject of
decisions of this Court respecting other generics, Pharmascience and Apotex is
justified.
[10]
With
respect to the two Riva proceedings, I acted as solicitor of record for a time
for Riva and signed one of the Notices of Allegation. I took no active part in
respect of the examinations of Sanofi-Aventis’ witnesses. A year and a half
has passed since I was sworn in as a judge of this Court.
[11]
The common
thread, if any, between Riva and this current Novopharm proceeding, is the same
as that in the decided cases of this Court respecting Pharmascience and Apotex
namely, has the allegation of the particular generic in question that it would
not infringe the ‘089 or ‘948 patent been shown not to be justified?
[12]
It is
important to note that there is, in respect of the forthcoming motion, which is
among the matters from which I am asked to recuse myself, no issue as to validity
of any patent. Patent validity can, in some circumstances, be in rem
proceedings. This however, is only in an ordinary patent action where the
Court may in fact impeach a patent or some of its claims in a judgment that is in
rem and effective against the patent itself and not just the parties.
[13]
Infringement
on the other hand requires a factual examination as to what the alleged
infringer does or says it will do. This is a determination of fact to be made
upon the evidence as determined by the Court in each case. That determination
of fact is then applied to the claims of the patent at issue, as construed by the
Court, to determine if an allegation of non-infringement is justified.
[14]
The
question of infringement, therefore, is a mixed question of fact (what the
alleged infringer does or will do) and the law (construction of the claim) see Whirlpool
Corp. v. Camco Inc. [2000] 2 S.C.R. 1067 at para.67.
[15]
The claim
at issue of the ‘089 Patent has previously been considered by the Federal Court
in the Apotex case, supra, at paragraph 25 of the reasons as
being a claim for use of ramipril in treating Hypertrophy. That construction
was undisputed. The judgment was affirmed on appeal.
[16]
In Pharmascience,
supra, the Federal Court has previously construed the ‘948 Patent at
paragraph 3 of the Reasons as the use of ramipril in combination with a calcium
antagonist to prevent and treat pneumonia. Again this construction was
undisputed.
[17]
I have
read the Memorandum of Argument filed by Sanofi-Aventis in respect of the
forthcoming motion to dismiss and note at paragraph 23 that the construction of
the claims of the ‘089 and ‘948 Patents urged there is not inconsistent with the
finding of this Court, in those prior Apotex and Pharmascience
decisions. I also note that Sanofi-Aventis in that Memorandum, argues, in
paragraphs such as 60 and 92, that findings as to infringement are “fact-intensive”
and that each case is to be considered separately.
[18]
Thus the
findings that I will be asked to make in the present proceeding, particularly
on the forthcoming motion, to the extent that there would be any commonality
with Riva, would be fact intensive findings unique to each circumstance for
each generic.
[19]
While
Courts have often been circumspect when issues as to possible bias arise and
have as a matter of expediency, assigned a different Judge to hear a matter
when even the merest suggestion as to apprehension of bias arise, that is a
matter of expediency only and does not establish jurisprudential precedent. In
this case, the Applicants’ only raised the suggestion of a bias issue by letter
sent to the Court in the middle of the afternoon of the day before several
motions were due to be heard by me, having been set down for hearing several
weeks previously.
[20]
Turning to
the jurisprudence, the Arsenault-Cameron v. PEI case in the Supreme
Court of Canada, reported at [1999] 3 S.C.R. 851 is instructive. The court
states at paragraph 2 that:
“The test for apprehension of
bias takes into account the presumption of impartiality. A real likelihood of
bias must be demonstrated.”
[21]
In Samson
Indian Nation and Band v. Canada, [1998] 3 F.C. 3, Justice Teitelbaum of
this Court at paragraph 73 to 75 reminds the reader as to the solemnity of the
judicial oath and the impartiality that it brings with it.
[22]
In Wewaykum,
supra, the Supreme Court at paragraph 59 of its decision invokes one of its
earlier decisions in Bertram stating that the law should not carelessly
evoke the possibility of bias in a Judge. As set out earlier in these Reasons
in quoting from paragraph 60 of Wewaykum, there must be a “reasonable”
apprehension of bias held by “reasonable and right minded persons.” One does
not view such matters through the mind of a cynical, capricious, excessively
suspicious, paranoid or perfectionist person as MacKinnon ACJO stated at page
679 of Re Currie (1984), 14 D.L.R. (4th) 651 (Ont CA).
[23]
Here the
position of Sanofi-Aventis as to the alleged “reasonable” apprehension of bias
is that somehow I would make findings in this case on the facts and in law that
might benefit a former client at the time when I was practicing law, which
former client has pending cases involving two of the same patents. As I have
already pointed out, factual findings as to infringement are case specific, and
there is no controversy as to construction of the claim. Such allegations are
more like those recited by MacKinnon ACJO than those of a reasonable person.
[24]
Judges
should be allowed to do their job free from unreasonable allegations of bias.
They have taken an oath to execute their powers and trusts duly and faithfully.
Lawyers practicing before the Courts have their own duties to their client and
the Court. Lawyers should be encouraged, at the appropriate time, to put that
career behind them and assume new duties as a Judge serving the public duly and
faithfully. As the Supreme Court stated in Arsenault-Cameron, supra at
paragraph 4 in referring to a decision of the Constitutional Court of South
Africa: “No recusal application could be founded on a relationship of
advocate unless the advocacy was regarding the case to be heard”.
[25]
The motion
for recusal is dismissed with costs.
ORDER
FOR THE REASONS ABOVE:
1.
The motion
is dismissed; and
2.
The
Respondent is entitled to its costs of the motion.
"Roger
T. Hughes"
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