Date:
20130114
Docket:
T-689-11
Citation:
2013 FC 28
Ottawa, Ontario,
January 14, 2013
PRESENT: The
Honourable Mr. Justice Barnes
BETWEEN:
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ELI LILLY CANADA INC.
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Applicant
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and
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TEVA CANADA LIMITED AND
THE MINISTER OF HEALTH
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Respondents
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and
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ELI LILLY AND COMPANY AND
TAKEDA PHARMACEUTICAL COMPANY LIMITED
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Respondent Patentees
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REASONS FOR
JUDGMENT AND JUDGMENT
[1]
This
application was brought by Eli Lilly Canada Inc. (Lilly) under the Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133 (Regulations),
seeking an Order prohibiting the Minister of Health (Minister) from issuing a Notice
of Compliance (NOC) to Teva Canada Limited (Teva) with respect to a generic
version of Lilly’s injectable pemetrexed disodium compound (Alimta) until the
expiry of Canada Letters Patents 1,340,794 (the 794 Patent) and 2,400,155 (the
155 Patent). The application was initiated in response to a Notice of
Allegation (NOA) delivered by Teva on March 11, 2011.
[2]
Subsequent
to the filing of this application, Teva established to the satisfaction of
Lilly that its product would not infringe the 155 Patent. On the basis of that
acknowledgement no Order of prohibition can be issued and the claim to relief with
respect to the 155 Patent is moot.
[3]
Between
December 2011 and February 2012, Teva was granted three extensions to file its
evidence in support of its allegation of invalidity concerning the 794 Patent.
Teva failed to file its evidence and on March 5, 2012 it advised Lilly and the
Court that it had withdrawn its NOA and Detailed Statement. Lilly, in turn,
took the position that it was entitled to rely on the statutory presumption of
the validity of the 794 Patent – a position that Teva does not dispute.
[4]
The
only remaining issue before the Court concerns the appropriate disposition of
this application in the face of the above-described history. Lilly contends
that it is entitled to an Order prohibiting the Minister from issuing a NOC to
Teva until the expiry of the 794 Patent. Teva maintains that the application
should be dismissed for mootness.
Analysis
[5]
Lilly
argues that the Regulations are a complete code of procedure for dealing with
applications of this type and that they do not authorize or contemplate the
withdrawal of a NOA except in the limited circumstances provided for in
subsection 5(6). According to Lilly, Teva is not entitled to maintain its
submission to the Minister for a NOC in the face of the withdrawal of its NOA
and it must also cancel that submission. Alternatively, it can amend its
submission by advising the Minister that it will await the expiry of the 794 Patent.
[6]
It
seems to me that Lilly is over-reading subsection 5(6) of the Regulations.
That provision requires a second person to revoke its NOA and for the judicial
application to be discontinued in the face of either a notice from the Minister
that the submission is non-compliant with the Food and Drug Regulations,
CRC, c 870, or where the second person’s submission to the Minister is
cancelled. The provision does not imply that the second person cannot unilaterally
withdraw its NOA subject, of course, to the right of the Court to dispose of
the proceeding before it on appropriate terms including an award of costs.
Indeed, the practice of withdrawing NOAs has been acknowledged many times by
this Court, albeit with appropriate concerns about relitigation and abuse of
process. This point was well expressed by Justice Marshall Rothstein in Merck
Frosst Canada Inc v Canada, [1997] FCJ no 347 at para 23, (1997) 72 CPR
(3d) 468, in the following passage:
23 Here, a second allegation is based upon what
is said to be a different non-infringing process. While the Court must guard
against abuse of its process, and clearly the successive filing and subsequent
withdrawal of allegations could in some circumstances be abusive, I am not
prepared to say that the mere withdrawing of an allegation is, for all
purposes, abusive. Each case must be determined on its own facts and, in this
case, it has not been argued and I have no reason to believe that the second
notice of allegations is a duplication of the first. Therefore, I am not
satisfied this is a case of abuse and that the matter is one of public
importance which requires resolution of a moot application.
[7]
In
Eli Lilly v Novopharm, 2007 FC 596, [2007] FCJ no 800, Justice Roger
Hughes also recognized that a second person may, in some circumstances,
withdraw its NOA and proceed under another. There Justice Hughes relied, in
part, on the Federal Court of Appeal decisions in Pharmascience v Canada,
2007 FCA 140, [2007] FCJ no 506, and in AstraZeneca v Apotex, 2005 FCA
183, [2005] FCJ no 842.
[8]
While
I accept that the Regulations are a complete code of procedure, I do not agree
that, in the face of this Court’s jurisprudence, subsection 5(6) can be
interpreted as expansively as Lilly contends. If the provision was intended to
restrict the practice of withdrawing a NOA or to ensure the concurrency of the
ministerial and patent review processes it could easily have said so. Instead,
subsection 5(6) expressly states that a second person may file its NOA “on or
after” it makes its submission to the Minister. This does not imply any
temporal limitation on a second person once its NOC submission is filed. It is
left up to the second person to decide when to file its NOA bearing in mind
that any delay in doing so could well be financially disadvantageous.
[9]
The
question, then, is not whether Teva had the right to withdraw its NOA in this
case. Clearly it did. The issue before the Court is whether the withdrawal of
Teva’s NOA, without more, renders this application moot or alternatively
whether there remains a non-speculative and meaningful point of controversy
between the parties: see Borowski v Canada, [1989] 1 S.C.R. 342, [1989]
SCJ no 14.
[10]
Lilly
argues that it would be improper and unjust to permit a second person to
withdraw its NOA and Detailed Statement solely to overcome its failure to file
evidence. That, of course, is the kind of abuse of process concern that has
been identified in a number of previous cases including Schering Canada Inc.
v Nu-Pharm Inc., [1994] FJC no 1396 at para 22, 58 CPR (3d) 14. In this
case, however, there is no clear evidence as to what motivated Teva’s decision
and there has been no attempt by Teva to file a second NOA. At this stage it
is speculative to infer any improper or ulterior motive on the part of Teva, or
to assume that it will in the future attempt to file a second NOA. Suffice it
to say that any attempt by Teva to circumvent the unmet disclosure obligations
in this proceeding is likely to be met with some judicial scepticism.
[11]
Lilly’s
concern about its potential exposure to section 8 damages by virtue of Teva’s so-called
“manipulation” of the system is equally untenable. That risk is based on an
assumption that Teva will improperly file a second NOA that will withstand an
abuse of process challenge and that the Court will be unmindful of its
obligations under subsection 8(4) and 8(5) of the Regulations. This is the
type of concern that was rejected by the Federal Court of Appeal in Sanofi-Aventis
v Apotex, 2006 FCA 328, [2006] FCJ no 1493, as being too remote and
speculative to justify a hearing. The same reasoning applies in this case.
[12]
Lilly’s
added concern about the possibility of the Minister issuing a NOC to Teva
despite the withdrawal of its NOA is unfounded. That is not an outcome
permitted by section 7 of the Regulations. The withdrawal of a NOA renders the
second person’s submission to the Minister for a NOC non-compliant, and section
7 directs that the Minister not issue a NOC in such circumstances. This was
not lost on the Minister in this case. In a letter to Teva dated March 5, 2012
the Director of Patented Medicines and Liaison for Health Canada acknowledged the withdrawal of Teva’s NOA and stated that “[a] Notice of Compliance
(NOC) will not be issued until the requirements of the [Regulations] are met”.
This concern is not a basis for “prohibiting the Minister from doing that which
[she] is already prohibited from doing according to the Regulations”: see AB
Hassle v Canada, [1997] FCJ no 280 at para 12, (1997) 72 CPR (3d) 318. To
the same effect is the Federal Court of Appeal decision in AB Hassle v Canada,
[1999] FCJ no 1464, (1999) 3 CPR (4th) 73, where the Court stated at
paragraph 11 that “[a]bsent evidence in a given case that the Minister is
prepared to ignore his legal duties and exceed his jurisdiction, the Court
should not embark on the hearing of a prohibition application. The time of the
Court is better spent deciding live issues”. Although that case involved a
situation where the NOC submission had also been withdrawn, nothing of
significance to the outcome turned on that point. Similar comments can be
found in Bayer v Novopharm, [1997] FCJ no 1785 at para 20, 142 FTR 130.
[13]
Although
I do not doubt that this Court could issue an Order of prohibition in
circumstances similar to these, the weight of authority indicates that it is
generally undesirable to do so and that it is preferable to deal with abuse of
process concerns as and when they arise: see for example Justice Marc
Nadon’s decision in AB Hassle v Canada, [1997] FCJ no 280, (1997) 72 CPR
(3d) 318, and the cases cited therein, and the Federal Court of Appeal decision
in AB Hassle v Canada, [1999] FCJ no 1464, 3 CPR (4th) 73.
[14]
In
short, there is no live issue between the parties and the present application
is therefore moot. There is no reason to depart from the usual disposition of
moot cases, which is to dismiss the proceeding on that ground.
[15]
The
parties have requested an opportunity to address the issue of costs in light of
these reasons. Lilly will have 14 days to file a submission on costs and Teva
may reply within 7 days thereafter. Neither submission shall exceed 7 pages in
length.
JUDGMENT
THIS
COURT’S JUDGMENT is that this application is dismissed with the
issue of costs to be reserved.
"R.L.
Barnes"
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