Date: 20090129
Docket: A-565-08
Citation: 2009 FCA 24
Present: EVANS
J.A.
BETWEEN:
NOVOPHARM LIMITED
Appellant
and
ELI LILLY CANADA INC.,
ELI LILLY and COMPANY LIMITED
and THE MINISTER OF HEALTH
Respondents
REASONS FOR ORDER
EVANS J.A.
[1]
This is a motion
in writing under rule 369 of the Federal Courts Rules by the Canadian
Generic Pharmaceutical Association (CGPA) requesting leave to intervene in an
appeal by Novopharm Ltd. from a decision of the Federal Court. The motion is
supported by Novopharm, and opposed by the respondents, the Minister of Health,
and Eli Lilly Canada Inc. and Eli Lilly and Co. Ltd. (Eli Lilly).
[2]
In the
decision under appeal (2008 FC 1221), Justice Martineau dismissed a motion by
Novopharm for
(i) a declaration that
sections 2, 3, and 4 of the Regulations Amending the Patented Medicines
(Notice of Compliance) Regulations, SOR/2008-211 (2008 Amendments)
are ultra vires the enabling provision of the Patent Act, R.S.C. 1985,
c. P-4; and
(ii) an order under paragraph
6(5)(a) of the Patented Medicines (Notice of Compliance) Regulations,
SOR/93-133 (PMNOC Regulations), dismissing Eli Lilly’s application for
an order of prohibition restraining the Minister of Health from issuing a
Notice of Compliance (NOC) to Novopharm with respect to its olanzipine drug
until the expiry of Canadian Patent No. 2,214,005.
[3]
Justice
Martineau concluded that neither the NOC Regulations, nor the Patent
Act, conferred jurisdiction on the Court, a statutory court, to grant a
declaration that provisions of the PMNOC Regulations (and any
amendments) are invalid. Further, he held, even if the Court had jurisdiction
to grant the declaration sought, he would decline in his discretion to exercise
it, in part because Novopharm had a more suitable remedy available to it,
namely, an application for judicial review in which it could seek the
declaratory relief requested in its motion. Justice Martineau supported this
latter proposition (at para. 34) by reference to a recent case, Canadian
Generic Pharmaceutical Association v. Canada (Governor in Council), 2007 FCA 375 (CGPA v. Canada), in which
the CGPA had sought a declaration in an application for judicial review that
regulations were invalid.
[4]
In its
Notice of Motion, the CGPA states that the “central issue” to be decided in
Novopharm’s appeal is whether Justice Martineau erred in refusing to determine
the validity of the impugned provisions of the 2008 Amendments on the
ground that he either lacked jurisdiction in that proceeding to grant the
relief sought or, if he had jurisdiction, it was not appropriate for him to
exercise it. Novopharm goes on to say that, if the Court agrees with its
position on this point and concludes that the validity of the 2008
Amendments can properly be determined in the appeal, it must then decide if
they are invalid.
[5]
The Court
may grant leave to intervene in a proceeding under rule 109 if the proposed
intervener (i) has an interest in the outcome of the litigation, (ii) has rights
that may be adversely affected by the outcome, and (iii) will assist the court
by bringing a perspective to the proceedings different from that of the
parties: Abbott v. Canada, [2000] 1 F.C. 482 (F.C.).
[6]
CGPA is
the trade association representing manufacturers of generic drugs in Canada, including Novopharm. It has
been consulted in the NOC regulation-making process, it is very familiar with
regulatory scheme and the pharmaceutical industry in Canada, and it has been granted leave by the
Supreme Court of Canada to intervene in litigation involving the PMNOC
Regulations, including their validity.
[7]
Even if
the CGPA were to satisfy the first two branches of the Abbott test, it
has not, in my opinion, demonstrated that it will bring to the appeal a
sufficiently different perspective on the questions likely to be in issue as to
warrant being granted intervener status. I say this for two reasons.
[8]
First,
even if the Court agrees that Justice Martineau had, and should have exercised,
jurisdiction to declare the impugned sections of the 2008 Amendments to
be invalid, it is unlikely, in my view, that the Court would proceed to
determine the validity of the 2008 Amendments in this appeal. When
exercising an appellate jurisdiction, this Court is always reluctant to decide
controversial, difficult, and important questions of law at first instance,
without the benefit of a reasoned decision by the judge whose decision is under
appeal. Hence, the only question likely to be at issue in the appeal is whether
a declaration that the regulations are invalid is properly made in an
interlocutory motion under the PMNOC Regulations. The Court is unlikely
to decide the substantive question of whether the 2008 Amendments are ultra
vires the power conferred by the Patent Act, a question on which the
CGPA may have a stronger claim to an expertise that would be valuable to the
Court.
[9]
Second,
CGPA submits that it has a valuable perspective to bring to the Court even on
the remedial issue, because it was a party in one of the cases relied on by
Justice Martineau in support of the proposition that an application for
judicial review is a more suitable proceeding than an interlocutory motion
under the PMNOC Regulations for seeking a declaration that provisions of
the 2008 Amendments are invalid. Counsel argues that that case, CGPA
v. Canada, is distinguishable from the present litigation.
[10]
In my
view, CPGA is no better placed than Novopharm to present to the Court reasons
why the validity of the regulatory regime considered in CPGA v. Canada was
properly examined in the context of an application for judicial review, but the
validity of the 2008 Amendments is not.
[11]
Finally, I
would note that the limited scope of the issues likely to be decided by the
Court on Novopharm’s appeal also reduces the seriousness of any harm that the
CGPA and its members may sustain if the appeal is dismissed.
[12]
In short,
I am not persuaded that the interests of justice would be advanced by granting
leave to the CGPA to intervene in this appeal.
[13]
For these
reasons, the CGPA’s motion is dismissed. Eli Lilly shall be awarded its costs.
“John
M. Evans”
Email this Content