Date: 20070502
Docket:
T-1171-06
Citation: 2007FC452
Ottawa, Ontario, Wednesday, this 2nd day of May
2007
PRESENT: MADAM PROTHONOTARY MIREILLE TABIB
BETWEEN:
PFIZER CANADA INC. and
WARNER-LAMBERT COMPANY, LLC
Applicants
-
and -
THE MINISTER OF HEALTH,
RANBAXY LABORATORIES LIMITED and
RANBAXY INC.
AMENDED REASONS FOR ORDER
[1]
I am seized of a motion by the Respondents
Ranbaxy Laboratories Limited (“Ranbaxy”), to dismiss the within application
pursuant to section 6(5)(b) of the Patented Medicines (Notice of Compliance)
Regulations, SOR/93-133 (as amended) (the “Regulations”).
Preliminary issue as to jurisdiction
[2]
The Applicants have argued, as a preliminary
point, that a Prothonotary is without jurisdiction to hear and determine a
motion brought under section 6(5)(b) of the Regulations.
[3]
That same question arose and was determined by
Justice Marc Nadon, then of the Federal Court, in AB Hassle v. Apotex Inc.,
[2000] F.C.J. No. 1767 as follows:
“4 With respect to the jurisdiction issue, I am of
the view that the prothonotary has jurisdiction to hear and dispose of the
motions before him, and more particularly Apotex's motion for an order
dismissing the applicants' application under subsection 6(1) of the Regulations
on the ground that the application is redundant, scandalous, frivolous or
vexatious or is otherwise an abuse of process. Rule 50(1)(a) and (c) of the
Federal Court Rules, 1998 (the "Rules") provides as follows:
50. (1) A prothonotary may hear, and make any necessary
orders relating to, any motion under these Rules other than a motion
(a) in respect of which these
Rules or an Act of Parliament has expressly conferred jurisdiction on a judge;
…
(c) for summary judgment in a
proceeding other than an action referred to in subsection (2);
* * *
50. (1) Le protonotaire peut
entendre toute requête présentée en vertu des présentes règles -- à l'exception
des requêtes suivantes -- et rendre les ordonnances nécessaires s'y rapportant
:
a) une requête pour laquelle un juge a compétence expresse
en vertu des présentes règles ou d'une loi fédérale ;
…
c) une requête pour obtenir un jugement sommaire dans une
instance autre que celle visée au paragraphe (2) ;
5 The applicants' submission is that the motions
before the prothonotary, and more particularly Apotex's motion for dismissal,
are not motions brought under the Rules, but motions brought pursuant to the
Regulations. Paragraph 6(5)(b) of the Regulations reads as follows:
6. (5) In a proceeding in respect of an application under
subsection (1), the court may, on the motion of a second person, dismiss the
application
…
(b) on the ground that the application is redundant,
scandalous, frivolous or vexatious or is otherwise an abuse of process.
* * *
6. (5) Lors de l'instance relative à la demande visée au
paragraphe (1), le tribunal peut, sur requête de la seconde personne, rejeter
la demande si, selon le cas :
…
(b) il conclut qu'elle est inutile, scandaleuse, frivole ou
vexatoire ou constitue autrement un abus de procédure.
6 In my view, the position taken by the applicants
cannot be correct. I agree entirely with the submission which Apotex makes at
paragraph 27 of its written representations:
27. Second, the Applicants' contention that Apotex' motion
is not "a motion brought under the Federal Court Rules", as specified
by Rule 50, is plainly incorrect. The motion was initiated by Notice of Motion,
in accordance with Rule 359. In accordance with Rule 362, the Notice of Motion
was served and filed at least two days before the date set out for the hearing
of the motion. Similarly, Apotex filed evidence on the motion in accordance
with Rule 363, and filed a Motion Record pursuant to Rule 364. It is
accordingly clear that Apotex' motion is a motion under the Rules.
7 In my view, it cannot be disputed that the
motions before the prothonotary are motions brought under the Rules. I find
support for that view in the decision of MacKay J. in Brain Tumor Foundation of
Canada v. Starlight Foundation et al., (1999) 4 C.P.R. (4th) 192. The matter before Mr. Justice MacKay
was an appeal from a judgment rendered by prothonotary Richard Morneau on
September 1, 1999, [1999] F.C.J. No. 1444, whereby the learned prothonotary
dismissed, inter alia, the appellant's appeal from a decision, dated March 3,
1999, [1999] T.M.O.B. No. 57, of the Registrar of trademarks. One of
the issues before Mr. Justice MacKay was the authority of the prothonotary to
dismiss an appeal taken to this Court pursuant to section 56 of the Trade-marks
Act
8 At pages 201 and 202 of his decision, MacKay J.
dealt as follows with the issue of jurisdiction:
[23] On the second issue it is urged that since the
Prothonotary is expressly prohibited from determining a motion for summary
judgment (Federal Court Rules, 1998, Rule 50(1)(c)), the dismissal of the
applicant's statutory appeal is not a matter within the prothonotary's
jurisdiction. In a technical sense the motion before the Prothonotary was not
one for summary judgment. Nevertheless, it is urged that the decision to strike
is the equivalent of a summary dismissal of the appeal, despite the applicant's
statutory right to proceed to question the Registrar's decision.
[24] In my opinion, the Prothonotary had authority under
the Federal Court Act and the Court's Rules to decide on the respondent's
motion to strike the appeal. That was not a motion in respect of which the
Trade-marks Act expressly confers jurisdiction on a judge, nor was it a motion
for summary judgment, matters excluded under paragraphs (a) and (c) of Rule
51(1) from the authority of a Prothonotary. Consistent with his general
authority to deal with all motions except those expressly excluded by Rule
50(1), in my opinion, it was not beyond that authority for the Prothonotary to
deal with the motion in this case.
9 As is apparent from a reading of the
Regulations, subsection 6(5) thereof confers jurisdiction on the Court.
Therefore, the motions are not motions that a prothonotary is barred from
hearing. Further, like MacKay J. in Brain Tumour Foundation of Canada, supra, I
am of the view that Apotex's motion herein is not a motion for summary
judgment. Thus, the applicants fail on ground one.”
[4]
This decision is directly on point and is
binding upon me.
[5]
The Applicants however argue that AB Hassle
has effectively been overruled by the Court of Appeal’s decision in TMR
Energy Ltd. v. State Property Fund of Ukraine, [2005] 3 F.C.R. 111,
especially, at paragraphs [38], [41], [42] and [51] thereof, which state as
follows:
“[38] To
understand the jurisdiction of prothonotaries under the Federal
Court Rules, 1998, it is important to distinguish between actions,
applications and appeals, which are the only ways allowed by the Rules to
commence proceedings, on the one hand, and motions, on the second hand.
[…]
[41] When
read in that context, it is obvious that rule 50 does not grant to
prothonotaries any power with respect to the final disposition of applications
and appeals and grants them a limited jurisdiction with respect to the final
disposition of actions. As noted by McGillis J. in Vaughan
v. Canada (2000), 184 F.T.R. 197 (F.C.T.D.), at paragraph 14, "Rule 50 expanded the
jurisdiction of prothonotaries to permit them to hear and make orders relating
to any motion, except those specifically exempt
by the Rule, and to hear certain actions"
(my emphasis). And in First Canadians', this Court,
in paragraph 9, noted that the "distinction between 'motion' and 'action'
was clearly in the mind of the regulator." The same may be said with
respect to the distinction between "motion" and
"application." An application for registration, recognition or
enforcement of a foreign judgment is described as an "application" in
paragraph 300(h) and it is governed by rules
327-334, which are found in Part 5 of the Rules. It cannot therefore be
disposed of by a prothonotary even though motions pertaining to it may be
entertained by the prothonotary.
[42] Whatever
might have been the law or practice under the former Rules or whatever might be
the practice under the present Rules, a prothonotary does not have the
jurisdiction, under the present Rules, to determine an application brought
under rules 327-334. Jurisdiction is to be found in the Rules of the Court; it
cannot be found in mere rules of practice, even more so where such rules of
practice are inconsistent with the Rules.
[51] Assuming
for the sake of discussion that the lack of authority of the prothonotary could
be described as some form of "non-compliance," such non-compliance
would be, not with the Rules, but with the Act. As noted by Jerome A.C.J. in Iscar Ltd. v. Karl Hertel GmbH, [1989] 3 F.C. 479 (T.D.), at page 484, the jurisdiction of the prothonotary
"springs from subsection 46(1) [of the Federal Court
Act]" and "does not originate in our rule or my practice note,
but in the Federal Court Act." I might add that
the jurisdiction of prothonotaries also springs from subsection 12(3) of the Federal Courts Act, which provides that "the powers,
duties and functions of the prothonotaries shall be determined by the
Rules." [page135] The Chief Justice of the Federal Court, in assigning to
the prothonotary a matter over which he has no jurisdiction, or a prothonotary,
in exercising an authority he or she does not possess, acts outside of the
Rules and fails in reality to comply with the Act.”
[6]
The Applicants take from that decision the
general proposition that Prothonotaries have no jurisdiction to make any final
disposition of any applications or appeals, even in the context of a motion,
even where the power to make a final determination of certain issues in the
application or appeal by way of the motion is specifically contemplated and
even where the express terms of Rule 50 would otherwise appear to give
Prothonotaries jurisdiction.
[7]
It seems plain to me that the only way such a
sweeping interpretation could be given to the Court of Appeal’s reasons is by
reading the first sentence of paragraph [41] in complete isolation, ignoring
the reasoning with which the Court of Appeal’s entire analysis begins, at
paragraph [38], and that which immediately follows in paragraph [41] itself.
That reasoning emphasizes the procedural distinctions between actions,
applications and appeals on the one hand, and motions on the other. In TMR,
the impugned decision of a Prothonotary was on the merits of an application for
the registration, recognition or enforcement of a foreign judgment, qua
application, and not in the context of a “motion under the Rules”. That a
Prothonotary could not determine such an application because it is neither a
motion nor an action contemplated by Rule 50(2), and that the Rules do not
otherwise grant such jurisdiction to Prothonotaries is the ratio decidendi
of the Court of Appeal. As such, it neither explicitly, nor by necessary
implication, overrules Justice Nadon’s determination, in AB Hassle, that
a motion pursuant to section 6(5)(b) of the Regulations is a motion under the
Rules, that it is not a motion for summary judgment and that Rule 50(1) of the Federal
Courts Rules applies to confer jurisdiction upon Prothonotaries to hear and
determine same.
[8]
Having concluded that I have jurisdiction to
hear and determine the motion before me, I now turn to the merits of that
motion.
The facts and procedural record
[9]
The Applicants hold several patents listed on
the Patent Register against the drug atorvastatin calcium, commercialized under
the brand name Lipitor®. Patents 2,450,111 (111 Patent), 2,521,903 (903
Patent) and 2,521,933 (933 Patent) respectively claim, inter alia,
crystalline Forms VII, X and XII of atorvastatin calcium.
[10]
In its notice of allegation (NOA), Ranbaxy
alleges, inter alia, that its proposed atorvastatin calcium would not
infringe the relevant patents, as it would neither make, use, construct or sell
crystalline Forms VII, X or XII of atorvastatin calcium if an NOC were issued
to it. In response to Ranbaxy’s NOA, the Applicants filed the within
application, alleging, inter alia, that Ranbaxy’s allegations of
non-infringement are not justified.
[11]
There is evidence before me on this motion and
in the substantive record on this application, that Ranbaxy has developed two
processes for producing Ran-Atorvastatin. Both processes allegedly produce, as
a final product, an amorphous form of atorvastatin calcium, rather than any
patented crystalline form. Only one of these two processes has been filed with
Health Canada as part of
Ranbaxy’s Abbreviated New Drug Submission. The other process has not been
filed and the evidence before me indicates that Ranbaxy has no intention of
filing it “until after” an NOC is issued in respect of Ran-Atorvastatin. As to
whether Ranbaxy has a formed intention to file for a change of process in
favour of the second one once the NOC is issued, the parties disagree: the
Applicants submit the evidence on record permits such an inference, Ranbaxy
submits that all the evidence shows is that Ranbaxy “has not closed the door”
to such an eventuality.
[12]
The parties are, however, ad idem that
the Applicants have filed substantive evidence on record in this matter in
support of its submission that the second process developed by Ranbaxy (and
which is not on file with the Minister) would produce crystalline Form VII of
atorvastatin calcium as an intermediate. Thus, say the Applicants, if the
Court accepts this evidence, Ranbaxy’s allegation of non-infringement with
respect of the 111 Patent would not be justified, as Ranbaxy intends, if
an NOC is issued, to use a process which would make or use Form VII
atorvastatin calcium.
[13]
At the time this motion was heard, the time for
filing the Applicants’ evidence pursuant to Rule 306 and for filing the
Respondents’ evidence pursuant to Rule 307 had expired. Both parties filed
substantial evidence, and cross-examinations have yet to be conducted.
The issue
[14]
Ranbaxy submits, essentially, that an
application for a prohibition order pursuant to section 6(5) of the Regulations
is necessarily limited to and defined by the submission on file with Health
Canada, and that the only issues that can be considered by the Court or that
can be relevant in such an application are whether, on the basis of the
materials filed by the second party with Health Canada, the second person’s
allegations of non-infringement are justified. In any event, Ranbaxy submits
that its notice of allegation must be read as limiting its allegations of
non-infringement to the processes and data contained in its submission to
Health Canada.
Analysis
[15]
Ranbaxy concedes that there is no case law on
this specific issue, although its argues that both section 5(1) of the Regulations
and the decision in Merck Frosst Canada Inc. v. Canada (Minister of Health)
(1994) 55 C.P.R. (3d) 302, at p. 314 make it clear that the NOA is part of the
second person’s submission, and that the decision in Aventis Pharma Inc. v.
Apotex Inc. [2005] F.C.J. No. 1691 can be applied by analogy.
[16]
Both parties submitted in argument before me
that the standard to be applied on a motion under Section 6(5)(b) of the Regulations
is whether it is “plain and obvious” that the application is redundant,
scandalous, frivolous, vexatious or an abuse of process. Taking this as the
appropriate standard, I am not satisfied that it necessarily follows from the
proposition that a NOA is part of a submission that the converse must also be
true: that the submission be deemed to be part of the NOA. On the facts of this
case, Ranbaxy’s allegation of non-infringement does not specifically refer to
the process on file with Health Canada as defining its allegations.
[17]
As for the case of Aventis Pharma v. Apotex,
I note that it was concerned with an amended product monograph rather than with
an amended manufacturing process and that it was the second person, rather than
the first person, who wished to rely on the amendment. Accordingly, I am not
satisfied that that this case stands as a binding determination that the first
person is limited, in attempting to show that the allegations are not
justified, to considering only the material filed with Health Canada, or that
it is plain and obvious that it would be applied in this case by analogy. An
analogy could just as well be made with “use claims” cases (see for example Aventis
Pharma Inc. v. Pharmascience Inc. [2007] 2 F.C.R. 103; [2006] F.C.J. No.
980; 2006 FCA 229 and cases referred to therein), where evidence going well
beyond the content of the submission filed with Health Canada is considered in
determining whether the allegations of a second person are justified.
[18]
Thus, I find that it is not plain and obvious
that the application, in respect of Patent 111, is frivolous, vexatious or an abuse
of process.
[19]
Ranbaxy’s motion also addressed the Applicants’ allegations
relating to the 903 and 933 Patents, those relating to Ranbaxy’s identity as a
second person and those relating to service of the NOA. However, Ranbaxy’s
motion also sought the dismissal of the application in its entirety, rather
than in part, and these other issues are clearly secondary, involving little or
no evidence, let alone controversial evidence. As the application will go ahead
on the issue of the 111 Patent, I decline to exercise my discretion to consider
whether the application should be dismissed in part in respect of those other
patents and arguments. Ranbaxy’s motion is therefore dismissed, with costs to the
Applicants in the cause.
“Mireille Tabib”
Email this Content