Syntex ( U.S.A. ) Inc. v. Novopharm Ltd.
T-293-95
Noël J.
23/1/96
17 pp.
Application by Syntex for order prohibiting Minister of National Health and Welfare from issuing notice of compliance to Novopharm in respect of medicine ketorolac tromethamine until after expiration of three Canadian patents-Application allowed with respect to first patent-As to issue of burden in proceedings under Regulations: (1) second person master of its allegation and Court cannot compel it to provide further and better statement thereof: Bayer AG v. Canada (Minister of National Health and Welfare) (1995), 60 C.P.R. (3d) 129 (F.C.A.)-(2) facts asserted by second person in support of allegation presumed to be true until contrary can be shown by first person: Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.)-(3) While legal burden on first person as initiator of proceedings, evidential burden placed on second person requiring it to present facts to justify allegation made in notice of allegation: see two cases supra and AB Hassle v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 323 (F.C.T.D.)-(4) Despite difficult position in which first person placed in having to disprove second person's allegation, neither statutory presumption contained in Patent Act, nor common law presumption casting upon party having knowledge of facts burden of proving them, come to its assistance: Pharmacia Inc. v. Canada (Minister of National Health and Welfare), [1995] F.C.J. No. 1558 (C.A.) (QL); conf. (1995), 60 C.P.R. (3d) 328 (F.C.T.D.)- Isolated assertion to effect process used by second person not same as that used by first person without more not giving rise to presumption to that effect-Whether process same or not matter for Court to decide and while facts underlying conclusion can be presumed, conclusion itself cannot-Indeed, if presumption attached without disclosure of any fact relating to process per se, applicants could not challenge affirmation as having no knowledge of process and Court would have to conclude respondent's allegation made out-As respondent herein has alleged no facts to which regulatory presumption can attach and by reference to which decision favourable to it could be reached, and as it has otherwise advanced no evidence in support of its allegation, in so far as first patent concerned, allegation made not justified-Conclusion same based on plain and unaided reading of specification and claims of first patent-With respect to second and third patents, order issued declaring no claim for medicine ketorolac tromethamine itself would be infringed in light of recognition by applicants patents contain no such claim.