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Merck & Co., Inc. v. Canada ( Attorney General )

T-398-99

McGillis J.

06/12/99

12 pp.

Application for stay of judgment allowing application for review brought by applicants, quashing decision of Minister of Health to issue notice of compliance to Nu-Pharm for drug Nu-Enalapril, generic version of Merck's patented drug Vasotec-In order to obtain stay of judgment pending appeal, Nu-Pharm must satisfy all three branches of test applicable for issuance of interlocutory injunction-Central issue on application for review proper construction of Patented Medicines (Notice of Compliance) Regulations, s. 5(1)-Issues to be raised by counsel for Nu-Pharm on appeal of McGillis J.'s decision not frivolous, vexatious-Nu-Pharm has established serious issue to be tried on appeal-As to irreparable harm, counsel for NuPharm focussed on two areas: financial consequences to NuPharm in period of time pending disposition of appeal, consequences in marketplace-Drug Nu-Enalapril competing directly with Merck's Vasotec tablets-Minister issuing notice of compliance to Nu-Pharm for Nu-Enalapril tablets-Nu-Pharm made substantial investment in Nu-Enalapril in attempt to generate maximum possible sales revenue from such lucrative product-As of November 23, 1999, NuPharm required to stop selling Nu-Enalapril in Canada-Raw material inventory on hand presently valued at US$2,151,000, inventory of finished Nu-Enalapril tablets valued at $4,200,000, in-process, unfinished tablets worth $1,300,000-If Nu-Pharm prevented from continuing to sell Nu-Enalapril pending appeal, in-process tablets valued at $1,300,000 will spoil, be useless-Nu-Pharm profitable company prior to issuance of notice of compliance for Nu-Enalapril-Precarious financial position due to substantial investment in Nu-Enalapril, fact it may not be able to remain in market pending disposition of appeal-Nu-Pharm having established, by clear, compelling evidence, financial consequences arising from inability to remain in market in period pending appeal irreparable harm-If unsuccessful on appeal, Nu-Pharm will be required to suffer consequences of investment in Nu-Enalapril-As to balance of convenience, Nu-Pharm would suffer greater harm from refusal of stay pending determination of appeal on merits-Balance of convenience in favour of Nu-Pharm-Granting stay of judgment pending disposition of appeal on merits in interests of justice-Application allowed-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 5(1) (as am. by SOR/98-166, s. 4).

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