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Eli Lilly and Co. v. Novopharm Ltd.

T-187-95

Joyal J.

11/8/97

5 pp.

Application for order prohibiting Minister of National Health and Welfare from issuing to respondent manufacturer, Novopharm Ltd., notices of compliance in connection with 500mg, 1g, 10g powder form of drug vancomycin hydrochloride for intravenous administration, until after expiration of patent owned by applicants-Reference of medicine in one dosage form on new drug submission not sufficient to comply with requirements of regulations and protect other dosage forms of product-Generic companies should not have approval for other dosage forms of drugs for which notice of compliance already issued-If respondent wants to include other dosage forms in new drug submission, Food and Drug Regulations already provides it with proper mechanism-Minister can only issue notice of compliance for 500mg product-Applicants have not satisfied legal burden of proof-Insufficient evidence adduced in affidavits-Failed to prove patent contains claim to medicine itself and would be infringed if Minister issued notice of compliance to respondent-Prohibition order granted for 1g, 10g product forms, denied for 500mg dosage form-Food and Drug Regulations, C.R.C., c. 870.

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