Merck Frosst Canada Inc. v. Canada ( Minister of Health )
A-223-98
Décary, J.A.
2/7/98
8 pp.
Appeal pertaining to procedural matters under Patented Medicines (Notice of Compliance) Regulations-Appellants (Merck) filing Patent List in respect of simvastatin tablets Canadian Patents Nos. 1,161,380 and 1,199,322-Respondent Apotex Inc. alleging Merck Patents would not be infringed by proposed formulation of simvastatin tablets-Apotex bringing motion for protective order, order setting schedule for filing of affidavit evidence once protective order in place-Merck agreeing to terms of protective order-Motions Judge making order setting schedule for filing of affidavit evidence-Merck objecting to order on following grounds: (1) Apotex should not be allowed to disclose process to Merck without supporting disclosure with affidavit; (2) Merck should not be forced to file own affidavit evidence with respect to Apotex's process before Apotex files own affidavit evidence-Merck's first argument confusing disclosure of evidence, filing of evidence-Motions Judge's order merely allowing Apotex to disclose process to Merck once protective order in place-Disclosure completing Notice of Allegation generic company required by Regulations, s. 5(3) to serve on manufacturer and which must contain "a detailed statement of the legal and factual basis for the allegation"-Once protective order obtained, process disclosed as part of notice-Merck, as moving party in proceedings under s. 6(1), having initial evidentiary burden-Merck's second argument also ill-founded-Merck could have decided not to complete record with additional affidavits-Whatever Merck does, Apotex's process could not make its way into evidence unless Apotex itself files it as part of its application record-Introduction of presumption in Regulations, s. 6(6) irrelevant to sequence of events prescribed by Rules of Court-Presumption applies whether evidence confidential or not and, where confidential, whether confidentiality agreed to by parties or ordered by Court-Appeal dismissed-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 5(3) (as am. by SOR/98-166, s. 4), 6(1) (as am. idem, s. 5), (6) (as am. idem).