Date:20001123
Docket:A-273-99
CORAM: STONE J.A.
ISAAC J.A.
EVANS J.A.
BETWEEN:
ELI LILLY & COMPANY and
ELI LILLY CANADA INC.
Appellants
(Applicants)
- and -
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
(Respondents)
Heard at Toronto, Ontario, Wednesday, November 22, 2000
Judgment delivered from the Bench at Toronto, Ontario,
on Wednesday, November 22, 2000
| REASONS FOR JUDGMENT OF THE COURT BY: EVANS J.A. |
Date: 20001123
Docket: A-273-99
CORAM: STONE J.A.
ISAAC J.A.
EVANS J.A.
BETWEEN:
ELI LILLY & COMPANY and
ELI LILLY CANADA INC.
Appellants
(Applicants)
- and -
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
(Respondents)
REASONS FOR JUDGMENT
(Delivered from the Bench at Toronto, Ontario
on Wednesday, November 22nd, 2000)
EVANS J.A.
| _. This is an appeal by Eli Lilly ("Lilly") from a decision of the Trial Division ((1999), 165 F.T.R. 83 (F.C.T.D.)) refusing an order of certiorari to quash a Notice of Compliance ("NOC") |
issued in April 1997 by the Minister of Health pursuant to the Patented Medicines (Notice of
Compliance) Regulations, SOR/93-133. The NOC was issued to the respondent, Apotex, in respect of the drug nizatidine, as produced by a process which is alleged not to infringe patents held by Lilly.
| _. The appellant argued that the NOC was issued in breach of the Regulations because there were discrepancies between the factual basis of the detailed statement provided by Apotex to Lilly in connection with Apotex' Notice of Allegation ("NOA"), and the content of the New Drug Submission ("NDS") filed by Apotex with the Minister in support of its application for a NOC. In particular, the appellant alleged that the detailed statement was both misleading, because it appeared to show DMF as the reagent, and incomplete, because it did not include what were in fact the reagents. |
| _. The Motions Judge found (at p. 91, para [30]) that the information disclosed by Apotex to Lilly "to say the least, was misleading." However, he refused (at p. 91, para [32]) to quash the NOC, on the ground that, whatever discrepancies there may have been in the information supplied to the Minister on the one hand, and to Lilly on the other, |
| Lilly has not convinced me that the Minister has committed any reviewable error so as to warrant the quashing of the NOC. |
He concluded that, since the underlying issue in the dispute was whether Apotex had infringed Lilly's patent, it was appropriate to leave Lilly to whatever remedies might be available to it in infringement proceedings.
| _. The appellant maintained before us that certiorari was an appropriate remedy in view of the statement by Stone J.A. in Hoffman-La Roche Ltd. v. Canada (Minister of Health and Welfare) (1996), 70 C.P.R. (3d) 206 at 213 (F.C.A.), to the effect that the information contained in a NOA is intended to be accurate and that, if it were shown to be inaccurate once the product was on the market, "the consequences for a second person could well be very grave indeed." |
| _. When invited to make submissions on whether the information supplied by Apotex to Lilly was misleading, counsel for Apotex vigorously challenged the Motions Judge's finding of fact. He maintained that no one was misled. Lilly decided not to bring prohibition proceedings in response to the NOA, not because it was misled by the detailed statement, but because it believed, erroneously as it turned out, that its interests were adequately protected by the order of prohibition issued in response to an earlier NOA. |
| _. Nor was the Minister misled, because he issued the NOC under the compulsion of an order of mandamus from this Court, and because Apotex was in compliance with the Regulations in that it was not, in the circumstances, required to issue a detailed statement. The description of the process of which the appellant complained was not contained in a detailed statement within the meaning of the Regulations, and hence any inaccuracies that it might have contained could not constitute a breach of the Regulations. |
| _. In addition, counsel for Apotex argued, the information supplied to Lilly was not misleading; it was exactly the same as that supplied to the Minister in the NDS in support of |
Apotex' application for a NOC. It referred the reader to the master drug file for further details, a document that the Minister had, but Lilly did not. If not satisfied that the information provided to it by Apotex was complete, Lilly could have requested additional information under confidentiality agreement, but it did not.
| _. While there would seem to be some merit in counsel's submissions, particularly as they relate to the allegation that the information supplied by Lilly was misleading or incomplete, it is not necessary for the purpose of this appeal to determine whether the Motions Judge erred when he found that the disclosure of information by Apotex to Lilly was misleading. |
| _. Suffice it to say that certiorari is an extraordinary remedy granted in the discretion of the Court. It will not normally issue, even when administrative action can be shown to have been vitiated by error, if there is an adequate alternative remedy available to the appellant. |
| _. In our view, even if, as Lilly alleges, the Minister issued the NOC when Apotex had not served a complete and accurate detailed statement in accordance with the Regulations, it was appropriate for the Motions Judge to conclude that Lilly should be left to resort to the private law rights and remedies available to it as a patent holder. Indeed, counsel for the appellant advised us that infringement proceedings are already under way. |
| _. If, at the end of the infringement proceeding, Apotex is found, both to have infringed Lilly's patent, and to have misconducted itself prior to the issue of the NOC, it would be open |
to the Judge to award punitive damages or solicitor-client costs, as the Motions Judge suggested. Such remedies would certainly constitute "grave consequences" of the kind contemplated by Stone J.A. in Hoffman-La Roche, supra.
| _. Quashing the NOC would effectively enjoin Apotex from marketing nizatidine manufactured by the process described in connection with the second NOA. This is a potentially drastic remedy to grant on the basis of a summary proceeding that is not expressly contemplated by the Regulations. |
| _. Moreover, as counsel for the appellant conceded, Lilly was not misled to its prejudice by any inaccuracy or incompleteness in the detailed statement. Its failure to institute prohibition proceedings was for a totally different reason, namely, its reliance on the prohibition issued with respect to Apotex' earlier NOA. To grant certiorari at this stage would give to Lilly much the same kind of relief that it might have obtained if it had instituted prohibition proceedings in a timely fashion. |
| _. We also note that Lilly does not allege that Apotex was guilty of fraud or deception. Such an allegation, if proved, might justify the grant of certiorari when a first person or the Minister had been deceived. However, the facts of the case before us do not require that the NOC be quashed in order, either to maintain the integrity of the statutory scheme created by the Regulations, or to remedy any injustice that Lilly might have suffered. |
| _. For these reasons, the appeal will be dismissed with costs. |
"John M. Evans"
J.A.
FEDERAL COURT OF CANADA
Names of Counsel and Solicitors of Record
| STYLE OF CAUSE: ELI LILLY & COMPANY and |
ELI LILLY CANADA INC.
Appellants
(Applicants)
- and -
APOTEX INC. and THE MINISTER OF
HEALTH
Respondents
(Respondents)
DATE OF HEARING: WEDNESDAY, NOVEMBER 22, 2000
PLACE OF HEARING: TORONTO, ONTARIO
| REASONS FOR JUDGMENT BY: EVANS J.A. |
Delivered at Toronto, Ontario on Wednesday, November 22, 2000
APPEARANCES: Mr. Anthony G. Creber
Mr. Patrick S. Smith
For the Appellants
Mr. Harry B. Radomski
Mr. Ivor M. Hughes
For the Respondent Apotex Inc.
Ms. Marie Crowley
| For the Respondent the Minister |
of Health
Page: 2
| SOLICITORS OF RECORD: Gowling, Strathy & Henderson |
(cont'd) Suite 2600
160 Elgin Street
Ottawa, Ontario
K1P 1C3
Goodman, Phillips & Vineberg
250 Yonge Street
Suite 2400, Box 24
Toronto, Ontario
M5B 2M6
For the Respondent Apotex Inc.
The Minister of Health
Department of Justice,
Civil Litigation Section,
2 nd Floor, East Memorial Building
284 Wellington Street
Ottawa, Ontario
K1A 0H8
For the Respondent the Minister
of Health
FEDERAL COURT OF APPEAL
Date: 20001123
Docket: A-273-99
BETWEEN:
ELI LILLY CANADA INC.
Appellants
(Applicants)
- and -
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
(Respondents)
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