Eli Lilly Co. v. Novopharm Ltd.
T-890-94
Cullen J.
2/2/95
14 pp.
Application for order, pursuant to Patented Medicines (Notice of Compliance) Regulations, s. 6(1), prohibiting Minister from issuing notice of compliance (NOC) to respondent with respect to drug until after expiration of patents -- Applicants owning patents-In support of procedure to obtain NOCs for drug, respondent filing notices of allegation in relation to relevant patents-Respondent basing allegation of non-infringement on grounds: (1) certain patents containing neither claim for "medicine itself" nor claim for use of medicine, thus not validly included on patent list; and (2) respondent not using processes set out in applicant's patents -- Regulation, s. 4(2) patent list can only rightly include product claims and product-by-process claims; Parliament not intending to include process claims in regulatory scheme -- Patent for "chromatographic purification process", being solely process patent, not proper subject of prohibition order -- Patent for improvement in processing of drug using precipitation process, being solely a process patent, not proper subject of prohibition order -- With respect to burden of proof regarding allegations, legal burden resting on applicants and evidential burden resting on respondents -- Applicants must prove infringement of their patents in event of NOC issuance on preponderance of evidence -- Respondent must ensure sufficient evidence on record to satisfy Court applicant's patents not infringed; burden discharged by evidence falling short of proof -- Neither Patent Act, s. 55.1 presumption nor equivalent common law presumption, substance of same chemical composition and constitution deemed to be produced by patented process in absence of contrary proof, not applicable: presumptions only applicable in proceeding pursuant to action for infringement-Applicant must satisfy legal burden of proof irrespective of inability to either compel respondent to disclose information, or to rely on presumption -- Respondent only required to satisfy evidential burden after applicants having proved infringement of their patents -- Requiring respondent to discharge evidential burden, rather than requiring applicants to satisfy legal burden contrary to statutory language and common law rules of evidence-Applicants not satisfying legal burden -- Application dismissed-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 4(2), 6(1) -- Patent Act, R.S.C., 1985, c. P-4, s. 55.1 (as enacted by S.C. 1993, c. 2, s. 4).