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Procter & Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health)
T-1970-99
2003 FC 911, Snider J.
24/7/03
13 pp.
Applicant Procter & Gamble (P&G) seeking order quashing Notice of Compliance (NOC) issued by Minister of Health to Genpharm Inc. for Gen-Etidronate oral dosage tablets containing etidronate disodium--P&G owner of patent for invention of pharmaceutical regimen used in treatment of osteoporosis, consisting of kit containing 400 mg of etidronate or etidronate disodium tablets and tablets of 1250 mg calcium carbonate (Didrocal)--P&G also making and selling Didronel, containing 200mg of etidronate disodium, used for treatment of Paget's Disease and hypercalcemia of malignancy--No Canadian patent for Didronel at this time--P&G won lawsuit against Genpharm with respect to Didrocal, obtaining order prohibiting Minister from issuing NOC to Genpharm in connection with 400 mg tablets and also 200 mg tablets Genpharm proposed to manufacture--In June 2003, Minister issued NOC to Genpharm for 200mg oral dosage tablets of etidronate disodium for Paget's disease and hypercalcemia of malignancy, to be marketed as Gen-Etidronate--Issues whether prohibition order should be varied to make clear prohibition applicable to Gen-Etidronate; whether NOC, if issued contrary to order, should be quashed--Motion dismissed--For P&G to be able to use Federal Court Rules, 1998, r. 399(2) (Court may set aside or vary order by reason of matter that arose or was discovered subsequent to making of order), must meet threefold test established in Annacis Auto Terminals (1997) Ltd. v. Cali (The) (1999), 178 F.T.R. 40 (F.C.T.D.); Saywack v. Canada (Minister of Employment and Immigration), [1986] 3 F.C. 189 (C.A.): new matter arising or discovered subsequent to order; new matter could not have been discovered sooner with reasonable diligence; if new matter had been brought forward, would probably have resulted in different original order--On facts, Court could not conclude P&G could not, with reasonable diligence, have discovered matter sooner--As to whether original order would probably have been different, in effect Court asked to step into minds of Trial Division, Court of Appeal Judges who heard matter and determine what they would have done if Gen-Etidronate had been before them--Not certain that, faced with facts, Court of Appeal would have prohibited Minister from issuing NOC for Gen-Etidronate--Had Trial Division Judge been aware of Genpharm's intention to file new ANDS for 200 mg tablets related to Paget's disease and hypercalcemia, making reference to non-patented Didronel, Court not convinced Trial Division Judge's order would have been different--Finally, given differences between August 2002 ANDS and that considered by Courts in context of original order, would be highly speculative to attempt to predict outcome--Court cannot conclude order would probably have been different--Federal Court Rules, 1998, SOR/98-106, r. 399(2).