Date: 20050104
Docket: A-630-04
Citation: 2005 FCA 2
Present: RICHARD C.J.
BETWEEN:
JANSSEN-ORTHO INC. and
DAIICHI PHARMACEUTICAL CO., LTD.
Appellants
(Applicants)
and
NOVOPHARM LIMITED and
THE MINISTER OF HEALTH
Respondents
(Respondents)
Dealt with in writing without appearance of parties.
Order delivered at Ottawa, Ontario, on January 4, 2005.
REASONS FOR ORDER BY: RICHARD C.J.
Date: 20050104
Docket: A-630-04
Citation: 2005 FCA 2
Present: RICHARD C.J.
BETWEEN:
JANSSEN-ORTHO INC. and
DAIICHI PHARMACEUTICAL CO., LTD.
Appellants
(Applicants)
and
NOVOPHARM LIMITED and
THE MINISTER OF HEALTH
Respondents
(Respondents)
REASONS FOR ORDER
[1] By way of the original motion filed November 29, 2004, the appellants seek the following relief:
(a) an order staying the Judgment and Order of Justice Mosley dated November 19, 2004 dismissing the appellants' application for an Order of Prohibition pending the final disposition of the appeal;
(b) leave to file the motion on short notice;
(c) an expedited hearing of the appeal to take place such that the Court of Appeal may make its decision prior to February 7, 2005.
[2] By way of the supplementary motion filed December 6, 2004, the appellants seek the following relief:
(a) an order staying the effect of, and/or quashing the Notice of Compliance numbered 8427-NO454-456 dated November 29, 2004 issued by the Minister of Health to Novopharm Limited for NOVO-LEVOFLOXACIN until the result of the appeal is determined;
(b) a declaration that s. 7(4) of the Patented Medicines (Notice of Compliance) Regulations ("PMNOC Regulations") be read such that the terms "the court hearing the application" is defined as the Federal Court of Appeal, once an appeal is issued and a motion for a stay of the Federal Court's decision is filed;
(c) in the alternative, a declaration that s. 7(4) of the PMNOC Regulations is inoperative as it is beyond the jurisdiction of the Governor in Council to promulgate, as it violates the right of appeal granted to first persons by s. 27 of the Federal Courts Act.
[3] By way of a separate motion filed on December 13, 2004, the respondent Novopharm Limited seeks an order dismissing the appeal on the ground of mootness. This motion must be decided by a panel of three judges and will proceed by way of written representations under Rule 369 of the Federal Courts Rules.
[4] The respondent, the Minister of Health, disputes the relief sought by the appellants in the supplementary motion.
[5] All the parties have responded in writing to the original motion and to the supplementary motion brought by the appellants and the matter can be disposed on the basis of those written representations.
[6] The circumstances surrounding these two motions can be briefly stated as follows:
In December 2002, Novopharm filed an Abbreviated New Drug Submission ("ANDS") with Health Canada seeking the issuance of a Notice of Compliance ("NOC") for NOVO-LEVOFLOXACIN. Concurrent with the filing of the ANDS, Novopharm served on Janssen-Ortho Inc. a Notice of Allegation pursuant to s. 4 of the Patented Medicines (Notice of Compliance) Regulations ("PMNOC Regulations").
On February 7, 2003, Janssen-Ortho Inc. commenced an Application in the Federal Court pursuant to s. 5 of the PMNOC Regulations, seeking an order prohibiting the Minister of Health from issuing an NOC to Novopharm for NOVO-LEVOFLOXACIN.
On November 25, 2003, Health Canada issued to Novopharm a "patent hold" letter advising that it had approved Novopharm's ANDS and that the NOC would be issued upon resolution of the Application commenced by Janssen-Ortho Inc.
By Order of Mr. Justice Mosley dated November 19, 2004, Janssen-Ortho's Application was dismissed.
On November 23, 2004, Novopharm was informed by Health Canada that the NOC would be issued as soon as Health Canada had reviewed the Product Monograph for NOVO-LEVOFLOXACIN to ensure no changes were required to the monograph as a result of the ANDS being on patent hold for greater than 6 months. Health Canada advised Novopharm that this review would likely take a few days, and that the NOC would likely issued by the end of that week (i.e., by November 26, 2004).
On November 29, 2004, Novopharm was issued a Notice of Compliance ("NOC") by Health Canada in relation to NOVO-LEVOFLOXACIN.
On November 29, 2004, the appellants filed a Notice of Appeal from the Order of Mr. Justice Mosley. Concurrent with the filing of the Notice of Appeal, the appellants filed a notice of motion dated November 29, 2004 seeking, inter alia, an order staying the Judgment and Order of Mr. Justice Mosley pending final disposition of the appeal.
On December 6, 2004, the appellants filed a supplementary notice of motion seeking, inter alia, an order "staying the effect of, and/or quashing the Notice of Compliance" issued to Novopharm.
On December 7, 2004, Novopharm was served with a Statement of Claim filed in the Federal Court naming Janssen-Ortho Inc. and Daiichi Pharmaceutical Co., Ltd. as plaintiffs and Novopharm as defendant, alleging that Novopharm has infringed Canadian Patent No. 1,304,080 by the manufacture and sale in Canada of NOVO-LEVOFLOXACIN.
[7] The relief sought by the appellants in the original motion filed on November 29, 2004 is denied.
[8] Following the dismissal of the application for prohibition on November 22, 2004, the Director General of the Therapeutic Products Directorate signed the Notice of Compliance on November 29, 2004 and it is considered issued on that date.
[9] There was no bar to the issuance of the Notice of Compliance on that date. Accordingly, the motion to stay the issuance of a Notice of Compliance cannot succeed since the Notice of Compliance was already issued under subsection 7(1) of the Patented Medicines (Notice of Compliance) Regulations.
[10] With respect to the request for an expedited hearing, I see no reason to allow this request at this time and the matter of a place and date of hearing of the appeal can be dealt with when a Requisition for Hearing is made under Rule 347 of the Federal Courts Rules.
[11] The relief sought in the appellants' supplementary motion filed on December 6, 2004 is also denied.
[12] In effect, the appellants seek, by way of a motion, orders that would result in quashing a Notice of Compliance and a declaration that subsection 7(4) of the Regulations is invalid.
[13] The relief sought by the appellants in this supplementary motion is not available by way of a motion in these proceedings.
[14] Accordingly, both motions will be dismissed.
[15] The respondents will be entitled to their costs on these two motions in accordance with Column V of Tariff B.
"J. Richard"
Chief Justice
FEDERAL COURT OF APPEAL
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: A-630-04
STYLE OF CAUSE:
JANSSEN-ORTHO INC. and DAIICHI PHARMACEUTICAL CO., LTD. v. NOVOPHARM LIMITED and THE MINISTER OF HEALTH
MOTION DEALT WITH IN WRITING WITHOUT APPEARANCE OF PARTIES
REASONS FOR ORDER BY: RICHARD C.J.
DATED: January 4, 2005
WRITTEN REPRESENTATIONS BY:
|
Neil R. Belmore
Michael E. Charles |
FOR THE APPELLANT, JANSSEN-ORTHO INC.
FOR THE APPELLANT, DAIICHI PHARMACEUTICAL CO., LTD.
|
|
David W. Aitken
F. B. Woyiwada
|
FOR THE RESPONDENT, NOVOPHARM LIMITED
FOR THE RESPONDENT, THE MINISTER OF HEALTH |
SOLICITORS OF RECORD:
|
GOWLING LAFLEUR HENDERSON LLP Toronto, Ontario
BERESKIN & PARR Toronto, Ontario
OSLER, HOSKIN & HARCOURT LLP Ottawa, Ontario |
FOR THE APPELLANT, JANSSEN-ORTHO INC.
FOR THE APPELLANT, DAIICHI PHARMACEUTICAL CO., LTD.
FOR THE RESPONDENT, NOVOPHARM LIMITED |
|
Morris Rosenberg Deputy Attorney General of Canada Ottawa, Ontario |
FOR THE RESPONDENT, THE MINISTER OF HEALTH |