Eli Lilly and Co. v. Apotex Inc.
T-1144-97
Teitelbaum J.
31/3/99
16 pp.
Application for certiorari quashing notice of compliance (NOC) issued to Apotex in respect of 150 mg, 300 mg capsules of nizatidine; various declarations including Minister of Health under duty to comply with Patented Medicines (Notice of Compliance) Regulations, s. 7(1) before issuing NOC, Minister failed to comply with s. 7(1)-Applicant, Eli Lilly, owner of patents for nizatidine, holds NOC to produce, market certain dosage of medicine-Apotex generic manufacturer-In 1993 Apotex provided Eli Lilly with notice of allegation (NOA) stating patents would not be infringed-Eli Lilly obtaining prohibition order, confirmed by Court of Appeal, but reversed by Supreme Court of Canada-Latter holding Apotex would not infringe patents by simply selling medicine in form contemplated by NOA-Day after prohibition order issued, Apotex issued second NOA alleging non-infringement-Eli Lilly not initiating prohibition proceedings because prohibition order, Regulations, s. 7(1)(f) preventing Minister from issuing NOC, and regulatory scheme not permitting multiple NOAs-Apotex obtained mandamus directing Minister to process its new drug submission (NDS), stating Regulations not preventing Minister from issuing NOC to Apotex-F.C.A. upholding that decision, Minister issuing NOC in 1997-Eli Lilly submitting mandamus order not binding on Minister because based on assumption facts disclosed in NDS correct, but those facts allegedly inaccurate-If order not applicable to process disclosed in NDS for which NOC issued to Apotex, Minister faced with contradictory orders at time issued NOC-Application dismissed-Minister had no choice but to issue NOC in accordance with mandamus order-Orders not contradictory, mandamus order applied to NOC issued by Minister-In issuing mandamus order Judge found scope of prohibition order issued under s. 6(1) confined to those proceedings-Eli Lilly submitting Minister ought to have ensured process underlying NDS same as that disclosed to Eli Lilly-Regulations, s. 7(1)(b) providing Minister shall not issue NOC before second person complied with Regulations, s. 5-Second person required under Regulations to file with Minister NOA as well as proof of service of allegation, detailed statement upon first person-Minister not having access to NOA, detailed statement served upon first person-Consequently unable to match documents for accuracy, and no duty imposed by Regulations, case law to inquire into adequacy of NOA, detailed statement filed on first person-Minister must only ensure office in receipt of proof of service of NOA, detailed statement on first person-Regulations not requiring second person to copy Minister with NOA, detailed statement-Eli Lilly also submitting NOA provided by Apotex inaccurate-Relying on Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1996), 70 C.P.R. (3d) 206 (F.C.A.) wherein held if detailed statement shown to be inaccurate, consequences for second person could be grave-Submitted "grave consequences" requiring NOC be quashed-"Grave consequences" may be out-of-ordinary damages, punitive damages, solicitor-client costs-Not meaning legally valid NOC granted by Minister pursuant to order of mandamus can be quashed-Certiorari proceedings not proper forum to determine inadequacies in process disclosed by Apotex-Must determine whether Minister committed reviewable error to warrant Court's intervention-Eli Lilly not establishing Minister committed reviewable error-Issue of infringement of most concern in this type of proceeding-If what was told to Eli Lilly in NOA inaccurate, Court, on infringement proceedings, will determine if Apotex infringing Eli Lilly's patent by using process other than one for which NOC issued-In such event Apotex could be subject to "grave consequences"-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 5, 6, 7(1).