PRACTICE |
Stay of Proceedings |
Bristol-Myers Squibb Co. v. Canada (Attorney General)
T-1898-01
2002 FCT 1319, Noël J.
20/12/02
10 pp.
Respondent, Biolyse Pharma Corporation (Biolyse), moving for order that decision of Blanchard J. of Federal Court Trial Division be stayed pending disposition of appeal-- Biolyse small pharmaceutical company which has developed new way of making paclitaxel from novel source--Paclitaxel drug used in treatment of cancer tumours--Minister of Health (Minister) advised respondent to file new drug submission (NDS) rather than abbreviated New Drug Submission (ANDS) --On September 20, 2001, Minister issued notice of compliance (NOC) to respondent, in relation to 6mg/ml paclitaxel for injection--Minister determined Patented Medicines (NOC) Regulations, 1994, (Regulations), s. 5 not engaged; as result did not require Biolyse to send notice of allegation (NOA) to Bristol-Myers Squibb (BMS)--Granting of NOC permitted Biolyse to start selling and advertising paclitaxel--On November 22, 2002, Blanchard J. allowed BMS' application for judicial review of Minister's decision granting NOC--Blanchard J. found Minister had failed to require Biolyse to comply with Regulations, s. 5; as result, quashed NOC issued to respondent--Effects on Biolyse of immediate quashing of NOC: Biolyse must stop manufacturing and selling paclitaxel in Canada, must submit ANDS relating to paclitaxel to Minister, must serve NOA to BMS--In RJR--MacDonald Inc. v. Canada (Attorney General), [1994] 1 S.C.R. 311, Supreme Court of Canada set out test for granting stay: serious question to be tried; irreparable harm; balance of convenience--Main issue concerns proper interpretation of Regulations, s. 5(1.1)-- Blanchard J., in decision, held Regulations, s. 5(1.1) engaged even if no comparison between one drug and another drug as basis for approval of first drug--Regarding second step of test, harm considered irreparable based not on magnitude, but on whether court hearing appeal will be able, by award of damages, to correct damages if order not stayed--Reference made to decision RJR--MacDonald, indicating permanent loss of market share and irrevocable damage to party's business reputation constituting irreparable harm--Not only will Biolyse probably go bankrupt if stay not granted, but would also suffer other damages--For example, stockpiled raw materials for production of paclitaxel would be spoiled-- Biolyse's reputation on pharmaceutical market will be negatively affected and consequently be detrimental for future business with potential clients--If stay not granted, respondent will suffer irreparable damage--Moreover, if Biolyse falls out of business, Biolyse would be unable to repay creditors and investors--If judgment of Blanchard J. not stayed, appeal will probably be pointless because Biolyse won't have financial means to pursue appeal--Quashing of NOC will cause irreparable harm to respondent and will place Biolyse's existence in jeopardy--Regarding test for balance of convenience, Biolyse will undoubtedly suffer greater harm from refusal of motion for stay, pending decision from Court of Appeal--Balance of convenience clearly in favour of maintaining situation in order to allow Biolyse chance to stay in business--Considering factual situation and immediate concerns needing to be addressed in timely manner for stay and appeal to be effective--Biolyse required to file motion requesting expedited hearing--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 5 (as am. by SOR/98-166, s. 4; 99-379, s. 2).