PATENTS |
Practice |
Novartis AG v. Abbott Laboratories Ltd.
A-525-99
Rothstein J.A.
19/6/00
10 pp.
Appeal from Motions Judge's refusal to order disclosure ((1999), 4 C.P.R. (4th) 379)--Abbott serving notice of allegation--Patent holder, Novartis, applying for prohibition to prevent Minister from issuing notice of compliance (NOC)--In order to pursue question of infringement, Novartis seeking disclosure of information in Abbott's abbreviated new drug submission, part of application for NOC--Patented Medicines (Notice of Compliance) Regulations, s. 6(7) permitting court to order production of any portion of submission for NOC relevant to disposition of issues--Motions Judge ordered partial disclosure, but with respect to balance not persuaded applicants discharging heavy onus of showing compelling evidence information essential or necessary--Prior to passing of s. 6(7) on March 12, 1998, Court had formulated stringent standard for disclosure of information--Appeal allowed--Unlike ordinary civil litigation where obligation on party to produce relevant information, under s. 6(7) establishing relevancy only condition precedent to court exercising discretion as to whether or not to order production--As no criteria specified to limit, guide Court in exercise of discretion under s. 6(7), open to Court to assess which criteria appropriate--Nature, context of proceedings under Regulations providing some guidance as to considerations generally guiding Court in exercise of discretion under s. 6(7)--Regulatory impact analysis statement indicating Governor in Council intending fuller disclosure than previously ordered by Court, reduction of unnecessary litigation--No reference to heavy onus or requirement for compelling evidence, even though that had been requirement prior to enactment of s. 6(7)--Necessary implication intended change in direction of less restrictive approach to disclosure than previously applied--SmithKline Beecham Pharma Inc. v. Apotex Inc. (1999), 3 C.P.R. (4th) 22 (F.C.T.D.) (whether disclosure required and is important); Procter & Gamble Pharmaceuticals Canada, Inc. v. Canada (Minister of Health), [2000] F.C.J. No. 511 (F.C.T.D.) (inadequate disclosure in notice of allegations) examples of appropriate considerations in exercise of discretion under s. 6(7)--In exercising discretion, Court should consider evidence in respect of disclosure on balance of probabilities standard, rather than more restrictive prior standard of imposing on first person heavy onus of showing compelling evidence justifying disclosure--That Motions Judge exercised discretion having regard to erroneous standard of proof error of law--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6(7) (as am. by SOR/98-166. s. 5).