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     Date: 19990420

     Docket: T-751-98

BETWEEN:

     BRISTOL-MYERS SQUIBB COMPANY and

     BRISTOL-MYERS SQUIBB CANADA INC.

     Plaintiffs

     - and -

     APOTEX INC.

     Defendant

     REASONS FOR ORDER AND ORDER

McGILLIS J.

[1]      The defendant Apotex Inc. ("Apotex") has brought a motion for summary judgment in this patent infringement action.

[2]      I am satisfied, following my review of the materials filed and the oral submissions made by counsel, that the motion for summary judgment ought to be granted on the basis that the action presently raises no genuine issue for trial. In particular, the uncontradicted evidence establishes that any quantities of the drug nefazodone and nefazodone hydrochloride ("nefazodone") held by Apotex have been and will be used solely for purposes related to research and development, within the meaning of the exception contained in subsection 55.2(1) of the Patent Act, R.S.C. 1985, c. P-4, as amended [See Dableh v. Ontario Hydro (1996), 68 C.P.R. (3d) 129 at 149 (F.C.A.)]. Furthermore, on the basis of the evidence adduced on the motion, any other alleged infringement by Apotex of the process for making nefazodone outlined in Canadian Letters Patent 1,298,436 is presently speculative in nature. Finally, even though Apotex intends to market the drug nefazodone in the future, it has not filed a new drug submission, as of the date of the hearing. It therefore cannot be said that any alleged infringement is "imminent", in that the lengthy regulatory process to approve the marketing of nefazodone by Apotex has not even commenced. In the circumstances, to the extent that the action is brought on a quia timet basis, it is clearly premature and speculative [See Dableh v. Ontario Hydro, supra at 151; Merck & Co. v. Apotex Inc. (1997), 74 C.P.R. (3d) 202 (F.C.T.D.)].

[3]      I am also satisfied that, for the purposes of the present motion, the material facts are not in dispute, and that there are no real issues of credibility involved.

[4]      For these reasons, I have concluded that there is no genuine issue for trial at present [See Feoso Oil Ltd. v. Ship Sarla, [1995] 3 F.C. 68 at 80-82 (C.A.)]. The motion for summary judgment is therefore granted with costs. The action is dismissed with costs on the basis that it is premature.

                                         D. McGillis
                                     ______________________
                                             Judge

OTTAWA

April 20, 1999

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