Pharmacia Inc. v. Canada ( Minister of National Health and Welfare )
T-2991-93
Wetston J.
20/3/95
20 pp.
Application for order, pursuant to Regulations, s. 6(1), to prohibit Minister from issuing notice of compliance (NOC) in respect of medicine used in treatment of cancer until after expiration of patents at issue -- Applicants, owner and licensee of patents at issue, marketing and distributing medicine in Canada -- In seeking regulatory approval, pursuant to Regulations, s. 5(1), to market and distribute competitive product, respondent company submitting notice of allegation asserting making, using and selling of product not infringing claims of patents at issue -- Issue whether respondent's allegation of non-infringement with respect to patent at issue "justified" -- New patent legislation creating regulatory scheme taking into account both public rights and private rights -- Regulatory scheme providing for delay in approval Minister's process by allowing patentee opportunity to determine whether manufacture or marketing of competitive product infringing its patent rights -- Regulations recognizing existing private commercial patent rights but not private rights of action -- Regulations pertain to public law i.e. patentee's right to bring application for prohibition against Minister, rather than private rights of action (David Bull Laboratories (Canada) Inc. v. Pharmacia Inc., [1995] 1 F.C. 588 (C.A.)) -- Regulations, s. 6(1) application, constituting proceeding by way of judicial review, to be determined expeditiously pursuant to procedures outlined in Part V.1 of Federal Court Rules -- Legislation not having any unusual bearing on burden of proof (Bayer AG v. Canada (Minister of National Health and Welfare) (1993), 51 C.P.R. (3d) 329 (F.C.A.)): party moving under s. 6 bearing legal burden of proving generic's allegations other than "justified", while generic company carrying evidential burden of proof requiring it to adduce sufficient evidence to justify its allegations -- Applicants arguing: (1) evidential burden resting on respondent; (2) where subject-matter of allegation lying particularly within knowledge of one party, common law requiring that party to prove allegation -- Initial allegation made by generic company must be supported by detailed statement of legal and factual basis -- Federal Court Rules and applicants' legal burden requiring patentee's grounds for challenging notice of allegation be advanced in originating notice of motion filed pursuant to Regulations, s. 6(1) -- Patentee also should present evidence to support its grounds, whether such grounds based on fact, law, mixed fact and law or opinion evidence -- Evidential burden on respondent consisting of opportunity to file evidence supporting its detailed statement at stage prior to Minister raising issue of non-infringement -- Common law presumption regarding burden of proof inapplicable -- Applicants' originating notice of motion and supporting affidavit providing no grounds for granting prohibition order -- Applicants not demonstrating respondent's product infringing claims of patent in issue: applicants not demonstrating respondent's non-infringement allegation to be other than "justified" -- Discharge of applicant's legal burden of proof generally requiring evidence particularly as Court starting from proposition allegations of fact in notice of allegation true except in face of contrary evidence shown by applicants -- As respondent not filing allegation with respect to second competitive product, order prohibiting Minister from issuing NOC premature -- Court cannot order allegation be filed with Minister -- Applicant contending respondent, as Canadian subsidiary to Australian parent company, not correct "second person" within meaning of Regulations -- Reasonable basis existing for Minister to address request for allegation to Canadian subsidiary requiring NOC to market and distribute in Canada; Canadian subsidiary valid "second person" -- Application dismissed -- Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 5(1), 6(1) -- Patent Act Amendment Act, 1992, S.C. 1993, c. 2, s. 4 -- Federal Court Rules, C.R.C., c. 663, Part V.1 (as enacted by SOR/92-43, s. 19).