Date: 19990923
CORAM: MARCEAU J.A.
DESJARDINS J.A.
LÉTOURNEAU J.A.
Docket: A-276-98
(T-1273-97)
BETWEEN:
MERCK & CO., INC.,
-and-
MERCK FROSST CANADA INC.,
Appellants
(Applicants)
- and -
THE MINISTER OF HEALTH,
THE ATTORNEY GENERAL FOR CANADA,
APOTEX INC.,
-and-
APOTEX FERMENTATION INC.,
Respondents
(Respondents)
Docket: A-475-98
(T-2152-97)
IN THE MATTER OF A REFERENCE PURSUANT TO
Ss. 18.3(1) OF THE FEDERAL COURT ACT, R.S.C. 1985, C. F-7,
REGARDING A QUESTION AS TO THE APPLICATION
OF S. 7 OF THE PATENTED MEDICINES (NOTICE OF
COMPLIANCE) REGULATIONS, SOR/93-133
REASONS FOR JUDGMENT OF THE COURT
(Delivered from the Bench at Montréal, Québec,
on Thursday, September 23, 1999)
MARCEAU J.A.
[1] The two present appeals from the Trial Division which are now before the Court have been presented together as they are so interrelated that they can only be disposed of together. They both relate to the issuance by the Minister of Health, pursuant to the Food and Drugs Act, R.S.C. 1985, c. F-27, of a so-called Notice of compliance (NOC) giving Apotex Inc. leave to put on the market the drug apo-lovastatin. The first appeal is from the dismissal by the motions judge of an application brought by the appellants for an order in the nature of certiorari quashing the issued NOC on the basis that the Minister did not comply with the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133. The second appeal is from the negative answer given by the same motions judge to the reference question put forward, at about the same time, by the Director General of the Therapeutic Products Directorate on behalf of the Minister of Health. In effect, that question asked whether issuing the NOC would be in breach of the requirements of the said Regulations. The two proceedings had been allowed to proceed separately since they were not in themselves similar, but they, of course, are now analogous following their disposition by the learned motions judge.
[2] The learned motions judge, in support of his conclusions in both cases, gave long, detailed and clear reasons in which he drew a precise picture of the factual context, exposed his understanding of the requirements of the Patented Medicines (Notice of Compliance) Regulations and proceeded to a long discussion of each and every argument advanced by the appellants in support of their contentions, arguments that the appellants simply reiterated before us.
[3] We are in complete agreement with the views of the motions judge, views that are in conformity with those already expressed by this Court and acted upon in several decisions of the Trial Division, and we see no reason to repeat what the motions judge wrote or to try to add to his comments.
[4] We will, however, restate in our own words the basic propositions on which the whole reasoning is built. The Patented Medicines (Notice of Compliance) Regulations recently adopted pursuant to the Patent Act, R.S.C. 1985, c. P-4, ought not to be interpreted rigidly, without regard to their true intent and scope. The judicial process they introduced a few years ago following the abolition of the compulsory licencing system, with a view to bringing some protection to patent holders whose proprietary rights might be inadvertently but too easily affected, is separate and distinct from the long-standing administrative process imposed by the Food and Drug Regulations, C.R.C., c. 870, adopted pursuant to the Food and Drugs Act, whose purpose is to satisfy the requirements of safety and efficacy. Of course, both processes can only be triggered by a drug manufacturer who contemplates marketing a new product. But nothing requires that they be both set in motion at the same time. The judicial process has nothing to do with the administrative one and vice versa. These are parallel processes. Matching them is achieved only through their results: the Minister cannot issue a NOC without regard to the findings established by the two processes.
[5] Having therefore nothing to add that could significantly complete or clarify the views expressed by the motions judge in the two similar sets of reasons he delivered in disposing of the two proceedings before him, we will simply dismiss the appeals with costs.
"Louis Marceau"
J.A.
Date: 19990923
CORAM: MARCEAU J.A.
DESJARDINS J.A.
LÉTOURNEAU J.A.
Docket: A-276-98
(T-1273-97)
BETWEEN:
MERCK & CO., INC.,
-and-
MERCK FROSST CANADA INC.,
Appellants
(Applicants)
- and -
THE MINISTER OF HEALTH,
THE ATTORNEY GENERAL FOR CANADA,
APOTEX INC.,
-and-
APOTEX FERMENTATION INC.,
Respondents
(Respondents)
Docket: A-475-98
(T-2152-97)
IN THE MATTER OF A REFERENCE PURSUANT TO
Ss. 18.3(1) OF THE FEDERAL COURT ACT, R.S.C. 1985, C. F-7,
REGARDING A QUESTION AS TO THE APPLICATION
OF S. 7 OF THE PATENTED MEDICINES (NOTICE OF
COMPLIANCE) REGULATIONS, SOR/93-133
Heard at Montréal, Québec, on Wednesday, September 22 and Thursday, September 23, 1999.
Judgment rendered from the Bench on Thursday, September 23, 1999.
REASONS FOR JUDGMENT OF THE COURT BY: MARCEAU J.A.
IN THE FEDERAL COURT OF APPEAL
Date: 19990923
Docket: A-276-98
(T-1273-97)
BETWEEN:
MERCK & CO., INC.,
-and-
MERCK FROSST CANADA INC.,
Appellants
(Applicants)
- and -
THE MINISTER OF HEALTH,
THE ATTORNEY GENERAL FOR CANADA,
APOTEX INC.,
-and-
APOTEX FERMENTATION INC.,
Respondents
(Respondents)
Docket: A-475-98
(T-2152-97)
IN THE MATTER OF A REFERENCE PURSUANT TO Ss. 18.3(1) OF THE FEDERAL COURT ACT, R.S.C. 1985, C. F-7, REGARDING A QUESTION AS TO THE APPLICATION OF S. 7 OF THE PATENTED MEDICINES (NOTICE OF COMPLIANCE) REGULATIONS, SOR/93-133
REASONS FOR JUDGMENT
OF THE COURT