Eli Lilly and Co. v. Nu-Pharm Inc.
Application for order prohibiting Minister of National Health and Welfare from issuing notice of compliance (NOC) to respondent Nu-Pharm in connection with 10 mg and 20 mg capsules and 20 mg/5 ml oral suspension of drug fluoxetine hydrochloride until patent expired-Respondent Nu-Pharm filed submission for NOC alleging making, constructing, using or selling capsules of fluoxetine would not infringe patent owned by applicants-Pursuant to new Regulations, monopoly rights of patentee of medicine preserved: no medicine can be marketed in Canada unless NOC issued-Where, as here, NOC applied for based on allegation of non-infringement, must be determined whether making or marketing of medicine pursuant to second NOC infringing patent right of person to whom first NOC issued-Applicants' right of action stems from Patented Medicines Regulations, s. 6(2)-Whether burden of proof with respect to Nu-Pharm's allegations resting with applicants or respondent Nu-Pharm-Applicants relying on Hoffmann-La Roche Ltd. v. Apotex Inc. (1983), 41 O.R. (2d) 84 (F.C.T.D.); affd by (1984), 47 O.R. (2d) 287 (F.C.A.) putting burden on respondents because where party failing to lead evidence of facts in better position to establish, Court will infer facts adverse to party's interest-As respondents not filing detailed statement of legal and factual basis, no evidence before Court respondents' allegation justified-Presumption of infringement as Patent Act, s. 55.1 shifting burden of proof on respondents once applicants establish substances "new" and identical-Medicine "new substance" within meaning of s. 55.1 and of same chemical composition and constitution as composition claimed in patent-Applicants' action under s. 6(1) for infringement of patent within meaning of Patent Act, s. 55.1; consequently, respondents' medicine deemed to have been produced by patentee's process-Application allowed-Patent Act, R.S.C., 1985, c. P-4, s. 55.1 (as enacted by S.C. 1993, c. 2, s. 4; c. 44, s. 193)-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6.