Date: 19990923
Docket: A-423-95
CORAM: DÉCARY J.A.
MacKAY J.
McDONALD J.A.
BETWEEN:
NOVOPHARM LIMITED
Appellant
(Respondent)
- and -
THE MINISTER OF NATIONAL HEALTH AND WELFARE
Respondent
(Respondent)
-and-
AB HASSLE and ASTRA PHARMA INC.
Respondents
(Applicants)
Heard at Toronto, Ontario, Thursday, September 23, 1999
Judgment delivered orally from the Bench
at Toronto, Ontario on Thursday, September 23, 1999
REASONS FOR JUDGMENT BY: DÉCARY J.A.
Date: 19990923
Docket: A-423-95
CORAM: DÉCARY J.A.
MacKAY J.
McDONALD J.A.
BETWEEN:
NOVOPHARM LIMITED
Appellant
(Respondent)
- and -
THE MINISTER OF NATIONAL HEALTH AND WELFARE
Respondent
(Respondent)
-and-
AB HASSLE and ASTRA PHARMA INC.
Respondents
(Applicants)
REASONS FOR JUDGMENT
(Delivered orally from the Bench at Toronto, Ontario on
Thursday, September 23, 1999)
DÉCARY J.A.:
[1] Having filed with the Minister of National Health and Welfare (the "Minister") a submission for a notice of compliance in respect of the medicine omeprazole pursuant to the Food and Drug Regulations , the appellant (Novopharm), as required by the Patented Medicines (Notice of Compliance) Regulations, 1993 (the "Regulations"), served the co-respondents, Astra Pharma Inc. and AB Hassle ("Astra") with a Notice of Allegation on July 30, 1993 alleging, with respect to six patents, that no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling of the drug by Novopharm.
[2] In a detailed statement of fact and law served on Astra on September 10, 1993 pursuant to section 5(3) of the Regulations, Novopharm reaffirmed its allegation of non-infringement. The statement was amended on January 17, 1994.
[3] On September 15, 1993, Astra commenced a prohibition application seeking an Order prohibiting the Minister from issuing a Notice of Compliance (NOC) to Novopharm in respect of omeprazole, until after the expiration of the six patents.
[4] On February 6, 1995, Novopharm advised the Minister that Novopharm was withdrawing its Notice of Allegation, reserving its rights to re-serve another Notice at a later date when appropriate. Novopharm sent a copy of that letter to Astra"s counsel on February 8, 1995. The hearing had been set for May, 1995.
[5] There being no evidence that Novopharm had withdrawn its new drug submission, Astra decided to proceed with its prohibition application.
[6] There is some confusion as to what precisely was withdrawn. The notice of allegation, clearly, was withdrawn, but the new drug submission was not and there is no evidence that it was amended to withdraw the allegation it contained. At the hearing of the application, however, as noted by the Motions Judge, "counsel for Novopharm confirmed that it was the allegation itself which was withdrawn, not only the notice".
[7] At the hearing of the prohibition application, Novopharm asserted that, absent a notice of allegation, the Court was without jurisdiction to hear the application and offered to pay the respondents" costs on a solicitor-client basis.
[8] Richard J. (as he then was), in his decision dated June 23, 1995 ((1995), 62 C.P.R. (3d) 3), found that as the allegation of non-infringement contained in the submission for the new drug made by Novopharm to the Minister, and which had given rise to the application before the Court, had not been withdrawn, Astra was entitled to have its prohibition application heard and disposed of by the Court. He then went on to decide that Novopharm"s allegation was not justified, as he was of the view that it was open to him, given that the notice of the allegation had been withdrawn but not the allegation itself, to interpret the withdrawal of the notice only as an admission by Novopharm that none of its allegations were justified. He further found that the Minister would have no jurisdiction to issue a notice of compliance to Novopharm as the requirements of subsection 5(1) of the Regulations - i.e. either a statement that Novopharm accepts that the notice of compliance will not issue until the patent expires, or an allegation of non-infringement - had not been met.
[9] Mootness was not argued before the Motions Judge, as it eventually was before Nadon J. in AB Hassle v. Canada (Minister of National Health and Welfare), (1997) 72 C.P.R. (3d) 318 (F.C.T.D.) and Rothstein J. (as he then was) in Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), (1997) 72 C.P.R. (3d) 468 (F.C.T.D.) and the applications were dismissed on the ground of mootness.
[10] The following comments by Nadon J., at pages 324 and 326, are particularly appropriate:
| On the facts before me I find that this proceeding is moot. Astra, as Applicant, is seeking an order of prohibition against the Minister. Astra gained the standing to bring such an application under s. 6(1) because Novopharm served it with a notice of allegation pursuant to paragraph 5(3)(b) of the Regulations. However, at the time of the hearing of the application, Novopharm had withdrawn that allegation. Section 7 of the Regulations stipulates that the Minister shall not issue a notice of compliance if there is a patent on the patent list which has not expired and which is not the subject of an allegation. Thus, if the 449 patent is on the list, the withdrawal of the allegation by Novopharm prevents the Minister from issuing the NOC. An order from this court prohibiting the Minister from doing that which he is already prohibited from doing according to the Regulations would add nothing and is unnecessary. (at page 324) |
| I will not issue an order of prohibition against the Minister at this stage because to do so will have no practical effect on the rights of the parties as their rights and obligations are fully identified and clarified in the Regulations themselves and an order of prohibition will add nothing. There is no indication that the Minister intends to knowingly step outside of the jurisdiction conveyed on him by the provisions of the statute. (at page 326) |
[11] The Motions Judge having found that the Minister would have no jurisdiction in the circumstances of this case to issue a notice of compliance, we are quite confident that he would have reached the same conclusion as Nadon J. and Rothstein J. had the issue of mootness been put to him. The facts, admittedly, vary from one case to the other, but the essential fact, which is common throughout, is that at the date of the hearing of the application (which is the relevant date, as found by the Supreme Court of Canada in Merck & Co. Inc. v. Apotex Inc. [1998] 3 S.C.R. 400), the Minister is simply not in a position to issue a notice of compliance since the conditions set out in subsection 5(3) of the Regulations are no longer met. Absent evidence in a given case that the Minister is prepared to ignore his legal duties and exceed his jurisdiction, the Court should not embark in the hearing of a prohibition application. The time of the Court is better spent deciding live issues.
[12] The appeal will therefore be allowed, but the order as to costs on a solicitor-client basis payable to the applicants in the Trial Division should remain. The application for a prohibition order will be dismissed.
[13] There will be no costs on this appeal.
"Robert Décary"
J.A.
FEDERAL COURT OF CANADA
Names of Counsel and Solicitors of Record
DOCKET: A-423-95
| STYLE OF CAUSE: NOVOPHARM LIMITED |
| Appellant |
(Respondent)
- and -
| THE MINISTER OF NATIONAL HEALTH AND WELFARE |
| Respondent |
(Respondent)
- and -
AB HASSLE and ASTRA PHARMA INC.
Respondents
(Applicants)
DATE OF HEARING: THURSDAY, SEPTEMBER 23, 1999
PLACE OF HEARING: TORONTO, ONTARIO
| REASONS FOR JUDGMENT BY: DÉCARY J.A. |
Delivered at Toronto, Ontario
on Thursday, September 23, 1999
APPEARANCES: Mr. Douglas Deeth
| For the Appellant |
Novopharm
Mr. Gunars Gaikis
For the Respondents
AB Hassle & Astra Pharma Inc.
| SOLICITORS OF RECORD: Deeth Williams Wall |
Barristers & Solicitors
National Bank Building
400-150 York St.,
Toronto, Ontario
M5H 3S5
| For the Appellant |
Novopharm
Morris Rosenberg
Deputy Attorney General of Canada
For the Respondent
| Minister |
Smart & Biggar
Barristers & Solicitors
1500-438 University Ave.,
Toronto, Ontario
M5G 2K8
For the Respondents
AB Hassle & Astra Pharma Inc.
FEDERAL COURT OF APPEAL
Date: 19990923
Docket: A-423-95
BETWEEN:
NOVOPHARM LIMITED
Appellant
(Respondent)
- and -
| THE MINISTER OF NATIONAL HEALTH AND WELFARE |
Respondent
(Respondent)
- and -
AB HASSLE and ASTRA PHARMA INC.
Respondents
(Applicants)
REASONS FOR JUDGMENT