Date: 20070222
Docket: T-507-05
Citation: 2007
FC 205
Ottawa, Ontario, February 22, 2007
PRESENT: The Honourable Mr. Justice Phelan
BETWEEN:
PFIZER CANADA INC. and
WARNER-LAMBERT COMPANY, LLC
Applicants
and
THE MINISTER OF HEALTH and
RANBAXY LABORATORIES LIMITED
Respondents
REASONS FOR ORDER AND ORDER
I. OVERVIEW
[1]
This is an
appeal of a decision of the Learned Prothonotary granting leave to Pfizer to
serve and file a further Fresh As Amended Notice of Application and extending
the 24-month stay under section 7(1)(e) of the Patented Medicines (Notice of
Compliance) Regulations (the Regulations).
[2]
The issues
in this appeal are:
(a) whether
a part of a NOC proceeding which had been discontinued can be re‑instituted;
and
(b) whether
the Learned Prothonotary had properly exercised the jurisdiction to extend
time.
[3]
Ranbaxy
Laboratories Limited’s (Ranbaxy) principal argument is that once a proceeding
in respect of one patent has been discontinued, the 24-month stay in respect of
that patent expires and the Regulations create an absolute bar to reviving the
proceeding in respect of that patent. Ranbaxy submits that no matter the reason
for the discontinuance, even fraud, deception or misrepresentation, the bar is
absolute and the only remedies may be in an infringement action.
II. FACTS
[4]
By letter
dated January 31, 2005 (the NOA), Ranbaxy made allegations under the
Regulations with respect to the six (6) patents then listed by Pfizer for its
atorvastatin calcium tablets. Specifically Ranbaxy made allegations of
non-infringement and invalidity in respect of the 018 and 455 Patents.
[5]
In
Pfizer’s Notice of Application dated March 17, 2005, Pfizer attacked Ranbaxy’s
allegations in respect of the two patents.
[6]
Even
before the Application was filed, there was an exchange of information in March
between the parties including the “March Spectra” data which Ranbaxy says
should have alerted Pfizer to what patents and processes would be in issue.
[7]
Nevertheless,
on March 30, 2005, Pfizer sought reassurances that the March data was intended
to comprise the full details of the relevant Ranbaxy product, formulation and
manufacture.
[8]
Ranbaxy
gave that reassurance on April 4, 2005 that “the documents enclosed with the
letter of March 11th comprise everything that we have at present
that is relevant to the Ranbaxy product, formulation and manufacture”.
[9]
As a
result of this reassurance and the productions which had been delivered by
Ranbaxy, Pfizer amended its application and discontinued its contentions in
respect to the 018 and 455 Patents. It was the unchallenged evidence of an
officer of Pfizer that this would not have occurred but for the actions and
assurances of Ranbaxy.
[10]
In another
later and related proceeding, Ranbaxy’s productions showed that the assurances
given to Pfizer were not correct. Ranbaxy has acknowledged that certain
statements made by it to Pfizer were not accurate due to a miscommunication
between the company and its then counsel.
[11]
When
Pfizer became aware of the true state of affairs, that the assurances received
were not entirely accurate, it sought to amend its Notice of Application to
bring the two patents back into this proceeding.
[12]
The
parties are, in addition to this proceeding, also involved in two other
proceedings related to atorvastatin calcium such that the 24-month statutory
stay in those proceedings will not expire until May or June 2008.
[13]
The
Learned Prothonotary allowed Pfizer to amend its application to include again
allegations in respect of the 018 and 455 Patents, as well as extending the
24-month stay.
III. ANALYSIS
A. Standard of
Review
[14]
As the
decision in respect of the amendment to the Application is an issue of law and
would, if overturned, be final and dispositive in respect of the issues related
to the two patents, the standard of review is correctness as to the Court’s
jurisdiction. (See Housen v. Nikolaisen, [2002] 2 S.C.R. 235)
[15]
Further,
if the Court has jurisdiction, the exercise of that jurisdiction is so
important and so final as regards the two patents, it should be considered de
novo. The decision to extend the statutory stay is not so vital or
dispositive and therefore should only be reviewed if there has been a wrong
principle applied, based on a misapprehension of facts or clearly wrong.
B. Jurisdiction
[16]
With the
greatest respect, I do not accept Ranbaxy’s submissions that the Regulations
are a complete code which imports nothing of the Rules or principles in the
Rules. I also do not accept the strict constructionist approach taken that
would deprive the Court of jurisdiction to remedy a deprivation of rights
caused by the actions of the other party particularly by a misrepresentation which
caused the loss of those rights.
[17]
The
Regulations are not a complete code. There are numerous aspects of NOC
proceedings which are governed either by the Federal Courts Act or its
Rules. The Regulations enjoy supremacy only in respect of matters which
conflict with the more general provisions found in the Act or the Rules.
[18]
The
fundamental requirement under the Regulations is that an application to the
Court must be commenced within 45 days of the notice of allegation. The Court
has no jurisdiction to extend the 45 days because the general rule on
extensions would be in direct conflict with Regulation s. 6(1). (Merck
Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1997),
72 C.P.R. (3d) 453)
[19]
However,
once the matter is commenced within the statutory time limits, the Federal
Courts Rules apply except where there is a conflict. The Act and Rules
apply to a number of matters not specifically addressed in the Regulations
including the right to appeal. (Bayer AG et al v. Canada (Minister of Health
and Welfare) (1993), 51 C.P.R. (3d) 329 (F.C.A.) at 336)
[20]
The
applicable rule in this instance is Rule 77:
|
77.
The Court may allow an amendment under rule 76 notwithstanding the expiration
of a relevant period of limitation that had not expired at the date of
commencement of the proceeding.
|
77.
La Cour peut
autoriser une modification en vertu de la règle 76 même si le délai de
prescription est expiré, pourvu qu’il ne l’ait pas été à la date du début de
l’instance.
|
The
relevant section of the Regulations is s. 7(4) which reads:
|
7.(4) Paragraph (1)(e) ceases to apply in
respect of an application under subsection 6(1) if the application is
withdrawn or discontinued by the first person or is dismissed by the court
hearing the application.
|
7.(4) L’alinéa (1)e) cesse de
s’appliquer à l’égard de la demande visée au paragraphe 6(1) si celle-ci est
retirée ou fait l’objet d’un désistement par la première personne ou est
rejetée par le tribunal qui en est saisi.
|
[21]
There is
nothing in the Regulations which suggests that they should be so strictly
construed as argued by Ranbaxy. The interpretation of the Regulations is still
subject to s. 12 of the Interpretation Act.
|
12.
Every enactment is deemed remedial, and shall be given such fair, large and
liberal construction and interpretation as best ensures the attainment of its
objects.
|
12. Tout texte est censé apporter une
solution de droit et s’interprète de la manière la plus équitable et la plus
large qui soit compatible avec la réalisation de son objet.
|
[22]
I can see
no reason in principle why Rule 77 could not be invoked in the appropriate
circumstances particularly, as in this case, to allow Pfizer to be put back in
the same position it was in initially except for the inaccurate assurances of
Ranbaxy. I see nothing in s. 7(4) which requires a Court to ignore unfairness
and injustice nor would to do so be consistent with the rules of statutory
interpretation.
[23]
The
Regulations do not prohibit directly or indirectly an amendment to an
application. It only goes so far as to prohibit the operation of a stay where
the application is withdrawn, discontinued or dismissed by the Court.
[24]
Section
7(4) cannot be interpreted to mean that discontinuances or withdrawals secured
by misrepresentation or even fraud should still have legal effect and deprive
an innocent party of its rights.
[25]
Even
applying Ranbaxy’s strict construction approach to the Regulations, the application
at issue was not discontinued, withdrawn or dismissed. I interpret the
Regulation to cover only an application as a whole and does not cover partial
amendments and re‑amendments.
[26]
Further,
as held in Abbott Laboratories v. Canada (Minister of Health) (2004), 36 C.P.R. (4th)
505, a proceeding can be reinstated. There a motion to strike was granted and
the 24-month stay fell away as per Regulation s. 7(4). However, the decision
was reversed by the Court of Appeal and the proceeding was re-instituted.
This is because, at the very least, in law the proceeding had never truly
disappeared because it had not been properly dismissed by a Court.
[27]
Likewise,
in the case at bar, but for Ranbaxy’s misrepresentation, the proceedings in
respect of the two patents never were intended to be terminated if the true
facts were known.
[28]
Therefore,
the Learned Prothonotary was correct in concluding that the Court had
jurisdiction to permit Pfizer to amend its application to re-institute
proceedings in respect of Patents 018 and 455.
C. Amendment
[29]
Whether
one considers the decision to allow the amendment as a discretionary one,
having accepted Court jurisdiction, or one that should be reviewed de novo,
the decision should stand.
[30]
The cause
of the amendment was Ranbaxy’s misrepresentation. It ought not to be allowed to
benefit from its actions. To the extent that Pfizer bears any part of the
responsibility for its amendment (of which I find none), there is no
substantial prejudice caused by allowing it to re‑amend its application.
D. Extension of Time
for Stay
[31]
Section
7(5) of the Regulations grant the Court a discretion to extend the 24-month
stay when a party has failed to reasonably cooperate in expediting the
application. This is a decision by the Learned Prothonotary that is within its
discretion and subject to review on error in law or principle or
misapprehension of the facts.
[32]
There is
no checklist of conduct which would constitute failure to cooperate or to
expedite. Dictionary definitions are of only limited use. The Court of Appeal
in Merck Frosst Canada Inc. v. Apotex Inc. (1997), 72 C.P.R. (3d) 170 at
178 has only given examples of such instances. Those examples share some common
characteristics in that they are unilateral, unjustified and have an adverse
effect on the other party and the conduct of the litigation – as in this case.
[33]
In this
instance, there was no malice or fraudulent misleading. Confusion between
counsel and clients is not uncommon, particularly where several different
counsel are acting for a client on related matters. It is not necessary to find
malice or fraud. Here the representation was wrong – in the context of the
Regulations it cannot be said that one is cooperating when one is making inaccurate
statements to induce another party to act against their interest. The effect
has been to delay the proceedings by causing an unnecessary amendment and
resisting a re-amendment to restore the status quo.
[34]
Therefore,
I can find no reason to question the Learned Prothonotary’s exercise of
discretion and to substitute my view, even if I had a different one, which I do
not.
IV. CONCLUSION
[35]
For these
reasons, this appeal is dismissed with costs.
ORDER
IT IS ORDERED THAT this appeal is dismissed with
costs.
“Michael
L. Phelan”
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