Apotex Inc. v. Canada ( Minister of National Health and Welfare )
A-339-97
Marceau J.A.
29/9/97
14 pp.
Appeal from Trial Division decision ([1997] 2 F.C. D-63) allowing respondent's application for mandamus, declaratory relief-Nature, scope of Patented Medicines (Notice of Compliance) Regulations at issue-Appellants (Eli Lilly) marketing pharmaceutical preparation of active chemical nizatidine (used to treat peptic ulcers) pursuant to notice of compliance (NOC) issued by Minister of National Health and Welfare on December 31, 1987-In April 1993, respondent Apotex, Canadian manufacturer of generic products, submitted application to Minister for NOC in respect of own brand of nizatidine compositions-In June 1993, Eli Lilly commenced application for prohibition under Regulations, s. 6(1)-McGillis J. allowing judicial review application-Following issuance of McGillis J.'s order, Apotex submitted second notice of allegation, served copy thereof on Eli Lilly-Latter did not respond-Apotex applied to F.C.T.D. for declaratory relief, mandamus compelling Minister to process Apotex's new drug submission-Different Trial Judge seized with application allowed it-Motions Judge finding no abuse of process for Apotex to have filed second notice of allegation, in so far as second notice based on different grounds than first-Eli Lilly having failed to commence application for prohibition order within 45 days of service of second notice of allegation, Minister free to process Apotex's request-Whether Motions Judge could order Minister to proceed when McGillis J.'s prohibition order still in force-Court, in clear situation, could proceed to assessment of scope, meaning of order of type issued by McGillis J., and attach to it effect which is not absolute-Possible only exceptionally when order clearly made in particular context, rendered to give effect to stated reasons, wording in general terms can be explained-Unique nature of proceeding leading to order here involved, proceeding grafted onto administrative process of issuing NOC-In imposing special set of rules, legislator could not have contemplated that issuance of order of prohibition on finding particular allegation unjustified would be absolute, deemed to cover any future allegation, however new, distinct-Summary procedure would have effect going beyond meaning, object-Successive allegations possible, each one must be treated independently provided separate, distinct from others, bringing before Court not abuse of process-Substantive argument advanced by counsel for Eli Lilly in support of appeal ill-founded-Three requirements of Regulations, s. 5(3) met-Regulations providing certain protection to patent holder by allowing Court to determine summarily, on basis of evidence adduced, whether allegation of non-infringement justified-Appeal dismissed-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 5, 6.