Date:
20071023
Docket:
A-274-07
Citation: 2007 FCA 329
Present: SEXTON
J.A.
BETWEEN:
ELI LILLY
CANADA INC.
Appellant
(Applicant)
and
NOVOPHARM
LIMITED
Respondent
(Respondent)
and
THE MINISTER OF HEALTH
Respondent
(Respondent)
and
ELI LILLY AND COMPANY LIMITED
Respondent/Patentee
(Respondent/Patentee)
REASONS FOR ORDER
SEXTON J.A.
[1]
This
appeal concerns a NOC proceeding in which inter alia an allegation of
insufficiency of disclosure was made by Novopharm with respect to a selection
patent owned by the appellant, Eli Lilly. The trial judge held that Eli Lilly
had failed to demonstrate that such allegation was unjustified. As a result a
NOC was issued to Novopharm which has precipitated a motion by Novopharm to
dismiss the appeal as being moot.
[2]
Four
parties seek intervener status in this appeal and on the motion to dismiss the
appeal as being moot. They are outlined below.
[3]
The
Canadian Chamber of Commerce with a membership of 170,000 businesses from every
sector and region in Canada, supports the appellant, Eli Lilly, and seeks to
intervene claiming that it can bring to the appeal the perspective of Canadian
businesses as to how the decision negatively affect businesses and innovation
in Canada.
[4]
BIOTECanada
– a national biotechnology industry association committed to ensuring the
sustainable commercial development of biotechnology in Canada supports the
appellant, Eli Lilly. BIOTECanada acts as an advocate for its members on
intellectual property protection, and,
in particular, patent protection available
in Canada, and wishes
to intervene in the appeal as well as on the motion by Novopharm to quash the
appeal as being moot.
[5]
Canada's Research-Based
Pharmaceutical Companies (Rx&D) is the incorporated trade associate for
innovative pharmaceutical manufacturers in Canada which claims
to foster the discovery, development and availability of new medicines and
vaccines, and seeks to intervene to support the appellant, Eli Lilly.
[6]
The
Canadian Generic Pharmaceutical Association is a trade associate whose members
include most generic drug manufacturers in Canada, seeks to
intervene in Novopharm's motion with respect to mootness and on the appeal
also. CGPA supports the position of Novopharm.
[7]
To
succeed on these motions, the proposed interveners must demonstrate how their
participation in the proceedings will assist in the determination of a factual
or legal issue related to the proceeding.
[8]
This
Court has set forth the factors to be considered on a motion to intervene.
See
CUPE v. Canadian Airlines [2000] F.C.J. No. 220
Those factors
are:
a)
Is
the proposed intervener directly affected by the outcome?
b)
Does
there exist a justiciable issue and a veritable public interest?
c)
Is there
an apparent lack of any other reasonable or efficient means to submit the
question to the Court?
d)
Is the
position of the proposed intervener adequately defended by one of the parties
to the case?
e)
Are the
interests of justice better served by the intervention of the proposed third
party?
f)
Can the
Court hear and decide the case on its merits without the proposed intervener?
[9]
In
the present case:
a)
None
of the interveners are directly affected.
b)
While
there may be a justiciable issue, it is not clear that there is a veritable
public interest.
c)
There is
no apparent lack of efficient means to submit the question to the Court. It is
apparent that the appellant and respondents, through their memoranda of fact
and law which have been filed, are quite able to adequately present the issues
to the Court.
d)
Three of
the interveners wish to support the appellant. One of the interveners wishes to
support the respondent, Novopharm. It appears to me, from their actions, that the
appellant and the respondent, Novopharm, are quite able to defend their respective
positions.
e)
I cannot
see how the interests of justice are better served by the interventions. Indeed
the proceedings will certainly be lengthened with no apparent justification.
f)
The Court
is quite able to decide the appeal without the proposed interveners. The issues
have been clearly framed by the appellant and the respondent, Novopharm.
[10]
As
mentioned previously, this appeal arises out of a proceeding under the NOC
regulations. The issue is a narrow one – was the trial judge wrong in holding
that the disclosure in the patent was insufficient. It has been said on a
number of occasions that proceedings under the NOC regulations are intended to
be summary and of short duration. Thus allowing interventions in NOC
proceedings should be done only in the clearest of cases and only where it is
obviously warranted. Such is not the case here. Sharlow J.A. in AB Hassle v.
Apotex Inc. 2006 FCA 51 at paragraph 2 described what NOC proceedings are
supposed to be:
These are summary proceedings,
intended to facilitate a relatively quick determination by the Federal Court of
certain issues of patent construction, infringement and validity, but only for
the limited purpose of making (or declining to make) an order prohibiting the
Minister of Health from approving the sale in Canada of a new generic drug for
which approval is sought on the basis of a comparison to an existing product
whose producer has certain patent rights.
[11]
It
has not escaped the attention of this Court that litigants are ignoring the
intended summary nature of NOC proceedings. As Noel J.A. recently stated in Abbott
Laboratories v. Canada (Minister of Health) 2007 FCA 187
at paragraph 28:
…[the 24-month statutory stay
period provided in paragraph 7(1)(e) of the NOC Regulations] was no doubt
intended to focus the minds of the parties and the Court on the summary nature
of the proceedings and the need for their expeditious prosecution. It is the
absence of focus on this time frame which has given these summary proceedings
over time the ponderous character of patent infringement actions commonly known
to last numerous days and sometimes weeks. The end result is that judicial
resources are increasingly being consumed by these so called summary
proceedings at the expense of other jurisdictions which advance more obvious
public policy concerns.
[12]
In
considering whether to allow the motions to intervene, it is worth noting that the
appellant has commenced an infringement action in the Federal Court where the
same issues, relating to the sufficiency of its disclosure in the patent, may
be raised. It has been held that decisions with respect to infringement and
validity in NOC proceedings are not ultimately adjudicative of the scope or
validity of a patent. Actions for infringement still lie.
Novartis
AGC v. Apotex Inc. (2002) 22 C.P.R. (4th) 450 (C.A.) at
paragraph 9
AB
Hassle,
supra., at paragraphs 28-29.
[13]
I
am therefore of the view that the interests of justice would not be well served
by allowing these interventions. I emphasize, however, that these reasons are
not to be taken as expressing any view on whether the appeal is moot or
whether, if the appeal is moot, the Court should agree to hear it anyway.
[14]
For
these reasons, all the applications for intervention will be dismissed.
"J.
Edgar Sexton"
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