Date: 19990204
Dossier: A-178-98
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 NATIONAL HEALTH AND WELFARE
and KYORIN PHARMACEUTICAL CO., LTD.
Respondent
(Respondent)
Heard at Montreal, Quebec on Tuesday and Wednesday, February 2 and 3, 1999
Judgment delivered from the Bench at Montreal, Quebec
on Thursday, February 4, 1999
REASONS FOR JUDGMENT OF THE COURT BY: DÉCARY J.A.
Date: 19990204
Docket: A-178-98
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 NATIONAL HEATH AND WELFARE
and KYORIN PHARMACEUTICAL CO., LTD.
Respondents
(Respondents)
REASONS FOR JUDGMENT OF THE COURT
(Delivered from the Bench at Montreal, Quebec
on Thursday, February 4, 1999)
DÉCARY J.A.
[1] The determination that was to be made by the trial judge was whether the allegation of non-infringement made by Apotex under subparagraph 5(1)(b)(iv) of the Patented Medicines (Notice of Compliance) Regulations, 19931 respecting the process by which it will have norfloxacin produced is justified. More specifically, the question to be resolved was whether the Apotex process using protected piperazine differed from the process disclosed and claimed in Canadian Patent No. 1,178,961 (the '961 process) using unprotected piperazine, in such a way as not to amount to an obvious chemical equivalent of the patented process.
[2] The trial judge found2 that the Apotex process using protected piperazine did not add any particular advantage and was an obvious chemical equivalent of the '961 process. While that finding would normally have been sufficient to dispose of the application and to grant the prohibition order against the Minister, the trial judge was persuaded by counsel for Apotex that as the process used by Apotex was itself disclosed and claimed in a patent issued to Torcan Chemical Ltd. under Canadian Patent No. 1,326,239 (the Torcan process or the '239 Patent), the Court was precluded because of the presumption of validity of a patent set out in section 45 of the Patent Act3 ("the Act") from concluding that the Torcan process was an obvious chemical equivalent of the process disclosed in the '961 Patent. The argument had been summarized as follows by the trial judge: "as the '239 Patent must be presumed to be valid, the Torcan process cannot be found to be an obvious chemical equivalent of the process disclosed in the '961 Patent, i.e. if it was an obvious chemical equivalent it would infringe the '961 Patent and the '239 Patent never would have issued" (at paragraph 17 of the Reasons for Judgment).
[3] The trial judge then went on to examine whether the Torcan process, as an improved patent, could be found under section 32 of the Act to infringe the '961 Patent. He concluded that if it was a patent on an improvement, the new process as a whole incorporated using the original patented process or an obvious equivalent of that original process. He, therefore, decided that Apotex's allegation of non-infringement was not justified and he granted Merck's application for prohibition in any event.
[4] The trial judge, in our view, erred in adopting Apotex's argument to the effect that the presumption of validity of the '239 Patent precluded any finding that the process to be used by Apotex was an obvious chemical equivalent of the '961 Patent. The validity of the '239 Patent is not at issue in these proceedings and the presumption of validity that attaches to that patent under the Patent Act can be of no more assistance to Apotex than it would have been if we had before us an action for infringement of the '961 Patent4.
[5] In the end, however, the trial judge examined and construed the '961 Patent. He also examined the Torcan process and had before him as part of the evidence the '239 Patent. Expert witnesses on both sides had filed affidavits which compared at great length the '961 process and the Torcan process and which also referred to the '239 Patent. The trial judge weighed that evidence and reached the conclusion that the process to be used by Apotex was an obvious chemical equivalent of the '961 process. He made no reviewable error in law or in fact in doing so. He needed not go further.
[6] The appeal will be dismissed with costs.
Robert Décary
J.A.
FEDERAL COURT OF APPEAL
Date: 19990204
Docket: A-178-98
Between :
APOTEX INC.
Appellant
(Respondent)
AND:
MERCK FROSST CANADA INC.
and MERCK & CO. INC.
Respondents
(Applicants)
-and-
THE MINISTER OF NATIONAL HEALTH
AND WELFARE and KYORIN PHARMACEUTICAL
CO., LTD.
Respondent
(Respondent)
REASONS FOR JUDGMENT
FEDERAL COURT OF CANADA
APPEAL DIVISION
NAMES OF COUNSEL AND SOLICITORS OF RECORD
COURT NUMBER: A-178-98
STYLE OF CAUSE: APOTEX INC.
Appellant (Respondent)
AND:
MERCK FROSST CANADA INC.
and MERCK & CO. INC.
Respondents (Applicants)
-and-
THE MINISTER OF NATIONAL HEALTH AND
WELFARE and KYORIN PHARMACEUTICAL
CO., LTD.
Respondent (Respondent)
PLACE OF HEARING: Montreal, Québec
DATE OF HEARING: February 2 and 3, 1999
REASONS FOR JUDGMENT OF THE COURT (DESJARDINS, DÉCARY, NOËL, JJ.A.) DELIVERED FROM THE BENCH BY:
Décary J.A.
DATED: February 4, 1999
APPEARANCES:
Mr. H.B. Radomski/ for the Appellant
Mr. David Scrimger
Mr. J. Nelson Landry/ for the Respondents
Mrs. 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 (Minister of National Health and Welfare)
Ottawa, Ontario
__________________
1 SOR/93-133.
2 Merck Frosst Canada Inc. et al v. Canada (Minister of National Health and Welfare) (1998), 80 C.P.R. (3d) 110; (1998), 144 F.T.R. 299.
3 R.S.C. 1985, c. P-4, as amended.
4 See Tweedale v. Ashworth (1890), 7 R.P.C. 426 at 432 (Ch.), Chitty J.; R.H. Barrigar, Canadian Patent Act Annoted, 2d ed. (Aurora: Canada Law Books, 1998) at 54: 150.
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