Date: 19990204
Dossier: A-215-98
Coram : DESJARDINS J.A.
DÉCARY J.A.
NOËL J.A.
Between :
APOTEX INC.
Appellant
(Respondent)
- and -
MERCK FROSST CANADA INC.
and MERCK & CO., INC.
Respondents
(Applicants)
- and -
THE MINISTER OF HEALTH
Respondent
(Respondent)
Heard at Montreal, Quebec on Thursday, February 4, 1999
Judgment delivered from the Bench at Montreal, Quebec
on Thursday, February 4, 1999
REASONS FOR JUDGMENT OF THE COURT BY: NOËL J.A.
Date: 19990204
Docket: A-215-98
CORAM: DESJARDINS J.A.
DÉCARY J.A.
NOËL J.A.
BETWEEN:
APOTEX INC.
Appellant
(Respondent)
- and -
MERCK FROSST CANADA INC.
and MERCK & CO., INC.
Respondents
(Applicants)
- and -
THE MINISTER OF HEALTH
Respondent
(Respondent)
REASONS FOR JUDGMENT OF THE COURT
(Delivered from the Bench at Montreal, Quebec
on Thursday, February 4, 1999)
NOËL J.A.
[1] This is an appeal by Apotex Inc. ("Apotex") from an interlocutory Order issued by Pinard J. dated March 27, 1998, whereby he declined to strike the references to Canadian Patent No. 1,161,380 ("patent 380") from the Originating Notice of Motion for prohibition filed by Merck Frosst Canada Inc. and Merck & Co., Inc. ("Merck") pursuant to the Patented Medicines (Notice of Compliance) Regulations SOR/98-166. ("Regulations").
[2] By Notice of Motion dated March 13, 1998, Merck initiated the within proceeding seeking to prohibit the Minister of Health (the "Minister") from issuing a Notice of Compliance to Apotex in respect of the medicine simvastatin until the expiry of patent 380 and patent 322. Merck is the owner of Canadian Patent No. 1, 199, 322 ("patent 322") which includes a claim both for the making of a compound known as simvastatin and the compound itself whenever made by the methods and processes particularly described and claimed therein. Merck is also the owner of patent 380, which contains a claim for a process for making a compound known as lovastatin and for the compound itself whenever made by that process. In its Originating Notice of Motion, Merck alleges that lovastatin is an intermediate compound used in the process for making simvastatin and that lovastatin is itself a medicine as defined in section 2 of the Regulations .1
[3] By Notice of Motion dated March 20, 1998, Apotex sought an Order pursuant to subsection 6(5) of the Regulations dismissing Merck"s application for prohibition only in respect of the 380 patent. The basis for this motion was that the 380 patent contained no claims for the medicine simvastatin or its use and that as an intermediate it was improperly on the patent list for simvastatin and not eligible for inclusion in the register. Apotex alleged that the application in respect of patent 380 was scandalous, frivolous, vexatious and an abuse of process.2
[4] Subsection 6(5) reads:
| In a proceeding in respect of an application under subsection (1), the court may, on the motion of a second person, dismiss the application |
| (a) if the court is satisfied that the patents at issue are not eligible for inclusion on the register or are irrelevant to the dosage form, strength and route of administration of the drug for which the second person has filed a submission for a notice of compliance; or |
| (b) on the ground that the application is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process. [emphasis added] |
[5] The Motion Judge dismissed Apotex"s motion holding that given the plain language of subsection 6(5), a second person is not permitted to move for the dismissal of only part of an application pursuant to the Regulations . He further found that even if it was open to the Court to dismiss only part of an application, that this was not a plain and obvious case justifying this result. Merck"s contention that lovastatin, the subject of the 380 patent, although used as an intermediate in the manufacture of simvastatin, is a medicine within the definition of that term in section 2 of the Regulations , could not be characterized as so clearly futile as not having the slightest chance of succeeding.3
[6] In our view, the Motion Judge was correct in holding that subsection 6(5) does not permit a court to dismiss only part of an application for prohibition. The "application" under subsection 6(1) is for an order prohibiting the Minister from issuing a Notice of Compliance to a second person in respect of a drug. The subject-matter of the application is whether any of the patents on the patent list would be infringed by the making, construction, using or selling by that person of the drug for which the Notice of Compliance is sought. A single application may therefore involve several patents, as is made clear by the language of subsection 6(5) which contemplates the dismissal of "the application" where "the patents in issue" are ineligible for inclusion on the register.
[7] The promulgation of subsection 6(5) follows in time the decision of this Court in David Bull Laboratories (Canada) Inc. v. Pharmacia Inc.4 which held that the proper way to demonstrate that an application for a prohibition is wholly without merit is to appear and argue the matter on the main application. On that occasion the Court stated:
| This [motion to strike] well illustrates the waste of resources and time in adding on to what is supposed to be a summary judicial review proceeding the process of an interlocutory motion to strike. This motion to strike has involved a hearing before a trial judge and over one-half day before the Court of Appeal, the latter involving the filing of several hundred pages of material, all to no avail.5 |
[8] Consistent with the policy objective that proceedings under the Regulations be dealt with in a summary manner, subsection 6(5) now provides that an application may be dismissed at an early stage. However, it seems clear that this new remedy can only facilitate the timely disposition of proceedings under the Regulations if it leads to the dismissal of the application in its entirety.6 This explains why subsection 6(5) contemplates a dismissal only where all the patents in issue7 can be shown to be ineligible.
[9] As it is the Regulations themselves which provide for this result, there is no basis for Apotex"s invocation of this Court"s implied jurisdiction to control its process and order that patent 380 be struck from the original Notice of Motion.
[10] Having regard to the conclusion we have reached on the first ground, it is not necessary to express an opinion on the Motion Judge"s alternative ground for dismissing the motion to strike.
[11] The appeal will be dismissed with costs.
Marc Noël
J.A.
FEDERAL COURT OF APPEAL
Date: 19990204
Docket: A-215-98
Between :
APOTEX INC.
Appellant
(Respondent)
- and -
MERCK FROSST CANADA INC.
and MERCK & CO., INC.
Respondents
(Applicants)
- and -
THE MINISTER OF HEALTH
Respondent
(Respondent)
REASONS FOR JUDGMENT
[12] FEDERAL COURT OF CANADA
APPEAL DIVISION
NAMES OF COUNSEL AND SOLICITORS OF RECORD
COURT NUMBER: A-215-98
STYLE OF CAUSE: APOTEX INC.
Appellant (Respondent)
- and -
MERCK FROSST CANADA INC.
and MERCK & CO., INC.
Respondents (Applicants)
- and -
THE MINISTER OF HEALTH
Respondent (Respondent)
PLACE OF HEARING: Montreal, Québec
DATE OF HEARING: February 4, 1999
REASONS FOR JUDGMENT OF THE COURT (DESJARDINS, DÉCARY, NOËL, JJ.A.) DELIVERED FROM THE BENCH BY:
Noël J.A.
DATED: February 4, 1999
APPEARANCES:
Mr. David Scrimger for the Appellant
Mr. Patrick E. Kierans/ for the Respondents
Ms. Judith Robinson (Merck Frosst Canada Inc. and Merck & Co. Inc.)
Page: 2
SOLICITORS OF RECORD:
Goodman, Phillips & Vineberg for the Appellant
Toronto, Ontario
Ogilvy, Renault for the Respondents
Montreal, Quebec (Merck Frosst Canada Inc. and Merck & Co. Inc.)
Morris Rosenberg for the Respondent
Deputy Attorney General of Canada (The Minister of Health)
Ottawa, Ontario
__________________
3 Order and Reasons for Order of Mr. Justice Pinard, dated March 27, 1998, Appeal Book, Tab 2.
6 Allowing for a partial disposition of an application would recreate the very situation which this Court went to great lengths to avoid in David Bull Laboratories , supra note 5.