Eli Lilly and Co. v. Apotex Inc.
T-1444-93
McGillis J.
9/2/95
14 pp.
Judicial review applications to prohibit Minister of National Health and Welfare from issuing notices of compliance to Apotex Inc. and Novopharm for marketing of medicine nizatidine in Canada -- Whether formulation by Apotex Inc. of capsules of nizatidine from bulk material sold to it under compulsory licence held by Novopharm Limited constitute act of infringement for purposes of proceedings under Patented Medicines (Notice of Compliance) Regulations -- Whether Eli Lilly established, on balance of probabilities, allegation of Apotex in notice of allegation dated April 28, 1993 not justified within meaning of Regulations, s. 6(2) -- Application for prohibition under Regulations, s. 6(1) judicial review proceeding intended to determine, in expeditious manner, whether Minister of National Health and Welfare may issue notice of compliance to permit generic pharmaceutical company to market drug in Canada -- In proceedings conducted under Regulations, s. 6, applicant required to establish, on balance of probabilities, none of allegations in notice of allegation justified -- No issue arising herein as to whether generic pharmaceutical company has evidential burden in proceedings under s. 6, as evidence adduced by Apotex to substantiate allegation -- Agreement dated November 27, 1992 between Novopharm and Apotex not sublicence in breach of terms of licence -- According to president of Apotex, actions of Apotex in making capsules not act of infringement as bulk material supplied by Novopharm under terms of licence -- Only case directly addressing question recent decision of MacKay J. in Merck & Co. v. Apotex Inc. (1994), 59 C.P.R. (3d) 133 (F.C.T.D.) -- MacKay J. rightly concluding formulation by Apotex Inc. of capsules from bulk material purchased from licensed supplier infringement of patent rights of Merck & Co. Inc. -- Unlicensed third party purchaser acquiring none of exclusive rights granted to patentee merely by purchasing bulk material from licensed supplier -- Intended activities of Apotex infringement of patent rights of Eli Lilly -- Eli Lilly, Eli Lilly of Canada having established, on balance of probabilities, allegation of Apotex in notice of allegation dated April 28, 1993 not justified within meaning of s. 6(2) -- Application allowed -- Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6(1),(2).