Bayer Inc. v. Canada ( Attorney General )
T-1154-97
Muldoon J.
2/12/98
16 pp.
Practice-Motion brought by Apotex Inc. and Novopharm Ltd., generic drug manufacturers, for order adding them as parties respondent or interveners herein as well as in appeal of judgment rendered by Evans J. on November 3, 1998 dismissing plaintiff's motion for summary judgment-Applicants also seek order varying or setting aside confidentiality order of Pinard J. dated July 13, 1998-Principal action seeking declaratory relief against defendant Minister of Health in regard to interpretation and application of Food and Drug Regulations, s. C.08.004.1-Bayer acquired right to distribute drug X and filed new drug submission (NDS) in accordance with procedure for obtaining notice of compliance (NOC) from Health Canada, Therapeutic Product Programme (TPP)-TPP informed Bayer would be issuing NOC to second manufacturer-Bayer arguing TPP's action not in accordance with North American Free Trade Agreement (NAFTA), Art. 1711 as Regulations, s. C.08.004.1(1) creating minimum 5-year period in which innovator free from competition by generic manufacturers-Art. 1711 mandating 5-year term of protection starting from date on which approval granted to market product-Defendant contending Bayer's drug not falling within scope of Regulations, and even if it did, protection sought by Bayer granted only in highly unusual situations-In July 1998, Court issued protective order effectively sealing certain documents, ensuring their confidentiality-In September 1998, Bayer brought motion for summary judgment-In November 1998, motion denied on basis X new drug within meaning of Regulations, s. C.08.001, and falling within scope of s. C.08.004.1-C.08.004.1 not affording innovators protection analogous to that of patent-Furthermore, Minister not necessarily relying on innovator's information contained in its NDS when considering abbreviated new drug submission (ANDS) for NOC; rather, information contained in ANDS forming basis of decision, and Health officials concerned mainly with ensuring it established pharmaceutical equivalence and bioequivalence of new drug to innovator's drug (called Canadian reference product)-Tests for intervention in Apotex Inc. v. Canada (Attorney General) (1994), 56 C.P.R. (3d) 261 (F.C.T.D.) and in Rothmans, Benson & Hedges Inc. v. Canada (Attorney General), [1990] 1 F.C. 84 (T.D.), confd [1990] 1 F.C. 90 (C.A.) and applied in Holiday Park Developments Ltd. v. R. (1994), 75 F.T.R. 76 (F.C.T.D.)-Outcome of main action will necessarily have impact on applicants, affecting manner in which they submit future ANDS to Minister-Litigation, involving interpretation of Regulations and NAFTA, Art. 1711, concerns very process by which manufacturers of new drugs obtain Minister's approval of their products in Canada-Applicants' position, given diverging interests from those of defendants, might not be adequately defended by defendants-Given potential far-reaching effects of outcome of action, input from applicants will further serve interests of justice, not only inter partes, but also as between drug manufacturers as class and general public-Ability of Court to hear and decide case on merits might be enhanced by applicants' intervention-Delay in bringing motion to intervene not such as to warrant its dismissal-Applicants' delay herein attributable to their lack of knowledge of action, despite their usual and customary vigilance of Federal Court database-Circumstances of case illustrate vagaries of such informal system, and cry out for implementation of more structured and formal means of notification-With applicants as limited interveners, Court could better hear and adjudicate issues of law outstanding herein-As difficult to believe Minister's minions effective guardians of public interest having consented to confidentiality order allowing Bayer to keep secret drug X, for human disease X, intervention would be beneficial to public interest-Appears too late for applicants to be accorded status at appeal of dismissal of motion for summary judgment-But that decision up to Court of Appeal-Applicants can aid Court and Minister by examining safety of Bayer's potion X and commenting on it, but only by means of specially engaged outside expert, who will be subject to confidentiality order, who must swear to keep formula secret, except in confidential depositions to Court-Applicants may intervene conditionally, if Bayer's appeal fails, and if Bayer thereafter decides to prosecute its action-Intervention may be upon formulation of drug X, and upon questions of law-One counsel only for applicants shall have carriage of discoveries, but both shall be exigible to discovery at Bayer's instance-Applicants shall be limited in total, but otherwise subject to rr. 279-281, to two expert witnesses and no other at trial-They shall file pleading, joint statement of intervention to which other parties may respond by pleading called answer to intervention-One of interveners only, or both jointly, may appeal outcome of trial, as if party thereto-They shall be exigible to costs-Confidentiality order stands, conditionally varied to cover interveners' expert or experts-Federal Court Rules, 1998, SOR/98-106, rr. 279, 280, 281-Food and Drug Regulations, C.R.C., c. 870, s. C.08.001 (as am. by SOR/95-172, Sch. I, Part II, s. 4), C.08.004.1 (as am. by SOR/95-411, s. 6)-North American Free Trade Agreement Between the Government of Canada, the Government of the United Mexican States and the Government of the United States of America, December 17, 1992, [1994] Can. T.S. No. 2, Art. 1711.