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Fournier Pharma Inc. v. Apotex Inc.

T-601-99

Richard A.C.J.

15/9/99

26 pp.

Motion for interlocutory injunction-To restrain defendant from using colour orange in association with sale and distribution of 200 mg fenofibrate capsule and from using word "micro" as part of trade mark or name in association with which 200 mg fenofibrate products sold or distributed, until issues in present action finally disposed of in trial on merits-Plaintiff Fournier Industrie registered owner of patent for fenofibrate used for treatment of hyperlipidemia and hypercholesterolemia-Also owner of trade mark for "Lipidil Micro" in association with pharmaceutical preparation called "hypolipidémiant"-Also applied for registration of trade mark for orange capsule design in association with pharmaceutical preparation for treatment of hypercholester-olemia, hypertriglyceridemia and mixed dyslipidemia-In March 1999, Apotex received notice of compliance (NOC) for fenofibrate pharmaceutical composition marketed in association with name "Apo-Feno Micro"-NOC certified Apo-Feno Micro bioequivalent of Lipidil Micro-In April 1999, Motions Judge dismissed plaintiffs' application for interim injunction on basis insufficient evidence to demonstrate serious issues to be tried and imminent irreparable harm-Appeal therefrom still pending-Plaintiffs amended statement of claim, removing allegations of patent infringement, and pleading Competition Act, s. 52(1) and Trade-marks Act, s. 7(b), (d)-Following dismissal of interim injunction and pursuant to licence agreement with generic company Pharmascience, latter began to market and sell micronized fenofibrate drug, PMS Fenofibrate micro, identical to Lipidil Micro and produced by plaintiff-Essentially plaintiffs claim defendant infringing its trade mark and misleading public by using "micro" in name given to its drug and by using colour orange on its capsule-Application dismissed-Application of three-stage test in RJR-MacDonald Inc. v. Canada (Attorney General), [1994] 1 S.C.R. 311-(1) Serious issue-No likelihood of confusion related to orange colour of capsule-Based on material before Court, plaintiffs' claim based on Competition Act, s. 52(1) not raising serious question to be tried; no evidence use of word "micro" affected purchasing decision of physicians, pharmacists or patients-Therefore, plaintiffs have not established serious question to be tried in respect of colour orange and Competition Act, s. 52(1)-(2) Irreparable harm-Much of evidence relied on by plaintiffs identified financial impact on plaintiffs of introduction of generic version on market-Evidence directed at patent infringement, issue not before Court on present motion, or describing observed result of lawful introduction of generic equivalent in market, result of competition and not unfair practices-As in Syntex Inc. v. Novopharm Ltd. (1991), 36 C.P.R. (3d) 129 (F.C.A.), loss of market share cannot be attributable to infringement of trade mark, but rather caused by regulatory regime coupled with reality of lower pricing of generics-Further, product would suffer loss of volume as result of licence agreement with Pharma-Plaintiffs have not established irreparable harm through any loss of market share attributable to use of word "micro" or colour orange by defendant-No clear evidence of loss of distinctiveness or loss of goodwill-Damages claimed can be quantified, even though may be difficult to do so-(3) Balance of convenience-Based on evidence, defendant would suffer greater harm than plaintiffs if interlocutory injunction granted-Defendant would have to remove word "micro" from its label and colour orange from capsules and have to reapply for listing with provincial formularies-Licence agreement with Pharmascience would guarantee its exclusive entry into generic market, to exclusion of defendant and would be out of market for critical period of time-Costs awarded to defendant.

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