Date: 20070427
Docket: A-607-06
Citation: 2007 FCA 167
CORAM: NADON
J.A.
SHARLOW
J.A.
RYER
J.A.
BETWEEN:
NOVOPHARM LIMITED
Appellant
and
SANOFI-AVENTIS CANADA INC.,
SANOFI-AVENTIS DEUTSCHLAND GmbH, and
THE MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT
SHARLOW J.A.
[1]
Novopharm
Limited has appealed a Federal Court order dismissing its motion under
paragraph 6(5)(b) of the Patented Medicines (Notice of Compliance)
Regulations, SOR/93-133 (the NOC Regulations) to dismiss a
prohibition application by the respondents Sanofi-Aventis Canada Inc. and
Sanofi-Aventis Deutschland GmbH (collectively, “Sanofi”). The reasons for the
order under appeal are reported as Sanofi-Aventis Canada Inc. v. Novopharm
Ltd., 2006 FC 1547.
[2]
Paragraph
6(5)(b) permits the Federal Court to dismiss a prohibition application
that is “redundant, scandalous, frivolous or vexatious or is otherwise an abuse
of process.” A decision on a motion to dismiss a proceeding is a discretionary
one. It will not be reversed on appeal unless there is an error of law or
principle, or a failure to exercise the discretion judicially: see Sanofi-Aventis
Canada Inc. v. Novopharm Ltd., 2007 FCA 163, at paragraph 13.
[3]
The
medicine in issue is ramipril. The respondent Sanofi-Aventis Canada Inc. has a
number of notices of compliance permitting it to market ramipril under the name
“Altace” for certain uses. It was approved in Canada in 1993 for
use in the treatment of hypertension. Later, other uses were approved, but
those other approved uses are not relevant to this appeal. It is not alleged in
this case that there is any patent for ramipril itself, or for the use of
ramipril in the treatment of hypertension.
[4]
Canadian
Patent Number 2,023,089 (the 089 patent) and Canadian Patent Number 2,055,948
(the 948 patent) contain claims for the use of ramipril for certain “new uses”
(that is, uses other than those for which ramipril has been approved in Canada). Sanofi has
no notice of compliance that permits it to sell ramipril for any of the new
uses claimed in the 089 patent or the 948 patent.
[5]
The
089 patent and the 948 patent are listed on the patent register in relation to
Altace. Paragraph 6(5)(a) of the NOC Regulations permits the
propriety of a listing to be challenged by a motion. No such motion was before
the Federal Court in this case. Therefore, this appeal has been decided on the
basis that the 089 patent and the 948 patent are properly listed.
[6]
In
2001, before the 089 patent and the 948 patent were issued, and before they
were listed in respect of Altace, Novopharm filed an abbreviated new drug
submission to obtain a notice of compliance for a generic version of ramipril
for use in the treatment of hypertension. Altace is named as the comparator
product. Novopharm proposes to market its generic product only for use in the
treatment of hypertension. Novopharm is not seeking a notice of compliance that
would permit it to market its generic product for any of the new uses claimed
in the 089 patent or the 948 patent. Indeed, it could not do so because none of
the new uses are approved for Altace.
[7]
In
the notice of allegation that led to this prohibition application by Sanofi,
Novopharm alleges that its proposed ramipril product will not infringe the 089
patent or the 948 patent because its product will not be made or sold for any
of the uses claimed in those patents. Novopharm also says in its notice of
allegation that it will not make any representations about its proposed product
that will induce infringement by others. Sanofi’s position is that the
non-infringement allegations made by Novopharm are not justified.
[8]
There
were two main grounds for the motion of Novopharm to dismiss the prohibition
application. The Judge’s decision rejected both grounds. Novopharm submits that
the Judge was wrong on both points. In my view, it is necessary to consider
only one of the grounds for Novopharm’s motion, and that is the ground based on
Pharmascience Inc. v. Sanofi-Aventis Canada Inc., 2006 FCA 229, leave to
appeal to the Supreme Court of Canada refused, [2007] S.C.C.A. No. 362 (QL) and
Sanofi-Aventis Canada Inc. v. Apotex Inc., 2006 FCA 357, leave to appeal
to the Supreme Court of Canada refused, [2007] S.C.C.A. No. 5 (QL).
[9]
Those
cases establish that an allegation of non-infringement of a claim for the use
of a medicine is justified if the generic drug manufacturer is seeking a notice
of compliance only for a use that is not within the new use claim and the evidence
fails to establish that the generic drug producer will infringe the new use
claim by inducing others to prescribe or use the generic product for that new
use.
[10]
Infringement
of a use claim by a person other than a generic drug manufacturer may occur
because of the “off label” use of drug products. For example, if a notice of
compliance is issued to Novopharm to permit it to market its generic ramipril
product for use in the treatment of hypertension, and if a physician were to
prescribe the Novopharm product, or a pharmacist were to dispense it, for one
of the uses claimed in the 089 patent or the 948 patent (despite the fact that
no such use has been approved even for Altace), the physician or pharmacist may
be infringing the claims of the 089 patent or the 948 patent. However, Novopharm
would not necessarily be implicated in those acts of infringement by the
physician or pharmacist. Unless Novopharm is so implicated, the infringement by
the physician or pharmacist would not be the kind of infringement that can
support the granting of a prohibition order under the NOC Regulations.
[11]
A
generic drug manufacturer may be implicated in the infringement by others of a
claim for a new use of a medicine if the generic drug manufacturer induces that
infringement. 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.
[12]
Novopharm
argues that it is inevitable that its non-infringement allegation will be found
to be justified because Novopharm is not seeking approval to market its product
for any of the new uses claimed in the 089 patent or the 948 patent, and there
is no evidence that Novopharm will induce others to use its product for any of
those new uses. The Judge rejected this argument because the evidence on the
question of infringement is not yet complete and because, given the time
already taken to get the proceedings to this stage, Sanofi should not be
deprived of its opportunity to complete the cross-examinations on the
affidavits even though there is only a slim chance of any improvement in the
evidentiary foundation for its application.
[13]
In
my view, the Judge erred in law in rejecting Novopharm’s argument on this point.
The evidence in the prohibition proceedings consists of the affidavits filed by
Sanofi and the affidavits filed by Novopharm. An exhibit to one of the
affidavits submitted by Sanofi includes the product monograph for the proposed
Novopharm ramipril product. It is redacted, but only in respect of the
composition of the generic product and specific information about research
relating to bioavailability. All of the information in the product monograph
touching on the use of the generic product is unredacted. 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.
[14]
Novopharm
also submits that the Judge dismissed its motion for delay, and argues that
delay is not a proper basis for denying relief under paragraph 6(5)(b)
of the NOC Regulations. Whether delay by itself can be a complete answer
to a motion under paragraph 6(5)(b) to dismiss prohibition proceedings
is a question upon which I express no opinion. I agree with the Judge that
Novopharm could have brought this motion as soon as Sanofi filed its affidavits,
although at that time the issues relating to infringement through off label use
were still being debated. Also, Novopharm brought its motion soon after it
obtained a favourable result in other litigation that might have barred the
issuance of its notice of compliance. Given my conclusion that the
non-infringement allegation is justified, I see no basis for giving any weight to
delay in this case.
[15]
Novopharm
also based its motion for dismissal on AstraZeneca Canada Inc. v. Canada (Minister of
Health),
[2006] 2 S.C.R. 560. Novopharm argues that, according to AstraZeneca,
the NOC Regulations do not require Novopharm to address the 089 patent
or the 948 patent because Novopharm cannot have benefited from the early
working exception in subsection 55.2(1) of the Patent Act, R.S.C. 1985,
c. P-4, in relation to those patents. The Judge noted that there is a debate as
to the scope of the AstraZeneca decision. Given the conclusions I have
already stated, I decline to express an opinion on the meaning of AstraZeneca.
[16]
I
would allow this appeal with costs in this Court and in the Federal Court, set
aside the
order of the
Federal Court, and make an order granting the motion of Novopharm to dismiss
Sanofi’s prohibition application.
“K.
Sharlow”
“I
agree
M.
Nadon J.A.”
“I
agree
C. Michael Ryer J.A.”
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