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

A-804-99

Rothstein J.A.

20/4/00

14 pp.

Motion for stay of this Court's decision pending appeal to S.C.C.--Decision upholding Trial Division (T.D.) decision ([1999] F.C.J. No. 1894) notice of compliance should not have been issued to Nu-Pharm for its version of Nu-Enalapril--Court's jurisdiction grounded in Supreme Court Act, s. 65.1(1), not Federal Court Rules, 1998, r. 398(3)--T.D. stayed its judgment, thereby allowing Nu-Pharm to continue to market Nu-Enalapril pending appeal to this Court--Had found financial consequences, for Nu-Pharm, of having to withdraw from market would constitute irreparable harm--Application dismissed--On stay application pending appeal to S.C.C., applicant must demonstrate serious issue would meet criteria set out in Supreme Court Act, s. 40(1): serious question of public importance: Turf Masters Landscaping Ltd. v. T.A.G. Developments Ltd. and Dartmouth (City) (1995), 144 N.S.R. (2d) 326 (C.A.)--Interpretation of relevant regulation overtaken by amendments to Regulations--S.C.C. decision thereon would therefore have no broad importance or lasting significance--Applicant has not satisfied irreparable harm test either--T.D. granted stay so that Nu-Pharm would not have to take back product already sold and to allow it to continue to market Nu-Enalapril already in inventory, thus permitting Nu-Pharm to survive--However, since then, Nu-Pharm purchased additional $1.5 million of bulk raw material for use in making Nu-Enalapril tablets--To some degree, Nu-Pharm therefore appears to be author of its current cash crisis by action it took during period of stay granted by T.D.--Nu-Pharm's evidence (would seek to list or re-list drug in provinces where not listed or de-listed) not consistent with short-term objective of overcoming cash crisis, rather, indicative of carrying on business as usual, even in face of F.C.T.D. and F.C.A. decisions Nu-Pharm should not now be in enalapril business--Furthermore, evidence not establishing Nu-Pharm, profitable generic drug company manufacturing numerous products, must continue to market Nu-Enalapril in order not to go out of business--Nu-Pharm not sufficiently forthcoming in cross-examination on affidavits about possible sources of financing--Evidence not such as to justify inference that, on balance of probabilities, Nu-Pharm would go out of business if unable to market Nu-Enalapril--Downsizing, mentioned as means of dealing with cash-flow difficulty, not irreparable harm--Purpose of stay not to alleviate financial difficulties or sustain company in current form when other options for survival available--Balance of convenience in favour of Merck as some doubt as to whether funds put up as security for Merck by Nu-Pharm will be available (secured creditors, taxes payable, presupposing favourable business circumstances)--To allow Nu-Pharm to sell only such inventory as necessary to overcome cash crisis unacceptable, as monitoring involved too complicated--Federal Court Rules, 1998, SOR/98-106, r. 398--Supreme Court Act, R.S.C., 1985, c. S-26, ss. 40(1) (as am. by S.C. 1990, c. 8, s. 37), 65.1(1) (as enacted idem, s. 40; 1994, c. 44, s. 101)--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 5(1) (as am. by SOR/99-379, s. 2).

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