PATENTS
Practice
Appeal of Federal Court Judge’s interlocutory order requiring Minister to produce confidential information provided by Teva Pharmaceutical Industries Ltd.—Pfizer Canada Inc. and Pfizer Inc. (Pfizer) applying for order under Patented Medicines (Notice of Compliance) Regulations (Regulations), s. 6 prohibiting Minister from issuing notice of compliance (NOC) to RhoxalPharma Inc. (Rhoxal) for 250 mg azithromycin tablets—Rhoxal contracting with supplier, Teva, for manufacture of proposed product and filing abbreviated new drug submission—Teva providing Minister directly with necessary information about manufacturing process in “drug master file” (DMF) and consenting to incorporation by reference of DMF into Rhoxal’s abbreviated new drug submission—Teva submitting DMF to Minister on understanding “closed portion” of DMF to be kept completely confidential—Abbreviated new drug submission comparing Rhoxal’s proposed product to Pfizer’s patented product Zithromax, Canadian Patent No. 1314876 named as “Azithromycin Dehydrate”—Rhoxal serving Pfizer with notice of allegation under Regulations, s. 5 asserting Pfizer’s patent covering only crystalline azithromycin crystallized in presence of less than two molar equivalents of water and alleging Rhoxal’s proposed product not infringing Pfizer’s patent because crystalline azithromycin used not crystallized in less than two molar equivalents of water—Because of non-infringement allegation, Teva’s manufacturing process information needed for prohibition proceedings—In prohibi-tion proceedings, patent holder having onus of proving non-infringement allegation not justified—Regulations, s. 6(7) regarding disclosure of information by second person filing submission for notice of compliance, applying to both information in new drug submission and information incorporated by reference into new drug submission—Pfizer filing notice of motion in Federal Court seeking order under Regulations, s. 6(7)(a),(b) requiring Rhoxal to produce portions of Teva’s DMF and Minister to verify information produced corresponding to information on file—Prothonotary hearing motion concluding information from closed portion of Teva’s DMF relevant and ordering Rhoxal to make best efforts to obtain confidential information—Teva representa-tive refusing to consent to release of confidential information —Pfizer filing second notice of motion seeking order requiring Rhoxal to produce all contents of DMF or alternatively order requiring Minister of Health to produce documents needed—Prothonotary rendering second order specifying Rhoxal failed to make best efforts to obtain information and ordering Rhoxal to produce information sought—Rhoxal filing notice of motion appealing and seeking to quash Prothonotary’s second order—Federal Court Judge rendering order under appeal—Judge’s order ambiguous, not indicating whether appeal of Prothonotary’s second order allowed, dismissed, quashed either in whole or in part—Judge’s order interpreted as replacing Rhoxal’s obligation to produce Teva information with new obligation imposed on Minister alone to produce confidential information—Minister appealing Judge’s order on ground order not authorized by relevant regulations—Prohibition proceedings conducted as applica-tions under Federal Court Rules, 1998, Part 5—Rules for discovery or authorization for making order for produc-tion only appearing under Rules, Part 4—Order rendered under Regulations, s. 6(7)(a) regarding disclosure of information in second person’s new drug submission not broad enough to authorize order directed at Minister—Order under appeal based on error of law since order to provide information from Rhoxal’s abbreviated new drug submission directed at Minister—Prothonotary also erring in making second order since record not establishing Rhoxal having Teva information or access thereto—Rhoxal’s appeal of Prothonotary’s second order should have been allowed—Whether second person using best efforts to obtain drug-making process information question of fact—Rhoxal not owning or controlling Teva and having no knowledge of closed portion of DMF and no means of compelling Teva to disclose contents—If second person fails to comply with order to use best efforts to obtain third party information about manufacturing process for second person’s proposed product, appropriate remedy to deny second person any possible advantage derived from unavailability of third party information—Therefore, in prohibition application hearing, second person would have bare allegation of non-infringement and allegation likely not justified—However, if second person uses best efforts to obtain third party information and efforts unsuccessful, second person should suffer no disadvantage but be free to adduce available evidence in support of non-infringement allegation—Appeal allowed—Patented Medicines (Notice of Compliance) Regulations, s. 6(7)(a) (as am. by SOR/98-166, s. 5), (b) (as am. idem)—Federal Court Rules, 1998, SOR/98-106.
Canada (Minister of Health) v. Pfizer Canada Inc. (A-91-04, 2004 FCA 402, Sharlow J.A., order dated 1/12/04, 23 pp.)