Bayer Inc. v. Canada ( Attorney General )
A-679-98
Rothstein J.A.
19/5/99
11 pp.
Appeal from order dismissing appellant's motion for summary judgment ([1999] 1 F.C. 553 (T.D.))-Food and Drug Regulations, s. C.08.004.1(1), providing where manufacturer filing new drug submission, (NDS) abbreviated new drug submission (ANDS), for purpose of establishing safety, effectiveness of new drug, and Minister examining and relying upon any information filed by innovator, Minister shall not issue notice of compliance in respect of that submission earlier than five years after date of issuance to innovator-When generic manufacturer filing ANDS, safety, effectiveness of generic product may be demonstrated by showing product pharmaceutical, bioequivalent of innovator's product-If generic manufacturer able to do so solely by comparing its product with innovator's product which is being publicly marketed, Minister will not have to examine or rely upon confidential information filed as part of innovator's NDS-In such case minimum five-year market protection referred to in Regulation will not apply-If, in order to be satisfied of safety, effectiveness of generic product, Minister examining, relying upon information filed by innovator in NDS, minimum five-year market protection for innovator will apply because safety, effectiveness of generic product will only be established by reference to confidential information provided to Minister by innovator-Only this use of that confidential information by Minister on behalf of generic manufacturer gives rise to minimum five-year protection from competition for innovator-Regulation contemplating Minister may or may not examine, rely upon confidential information filed by innovator-Where Minister intending to rely on data of innovator to support safety, efficacy claims of generic manufacturer, generic manufacturer will be given option of supplying additional information to avoid Minister relying on information supplied by innovator-No implied examination or reliance-NAFTA, Art. 1711(5) requiring Canada protect against disclosure of undisclosed data submitted to determine whether use of product safe, effective when origination of data involving considerable effort-Art. 1711(6) providing that with respect to such confidential data, no person other than person submitting data shall rely on that confidential data in support of application for product approval-Intended to protect trade secrets-If confidential data not relied upon, trade secrets provisions of NAFTA not applicable-If generic manufacturer comparing its product to innovator's product solely on basis of public information, providing innovator with protection from competition for minimum of five years tantamount to granting it protection patent would provide-S. C.08.004.1(1) cannot be so construed-Where no commercial use of confidential data, s. C.08.004.1(1) not requiring innovator be protected from competition because no confidential information or trade secrets being examined, relied upon in bringing generic product to market-Appeal dismissed-Food and Drug Regulations, C.R.C., c. 870, s. C.08.004.1(1) (as enacted by SOR/95-411, s. 6)-North American Free Trade Agreement Between the Government of Canada, the Government of the United Mexican States and the Government of the United States of America, [1994] Can. T.S. No. 2, Art. 1711(5),(6).