Digests

Patents

Practice

Appeal from Federal Court decision (2009 FC 494) dismissing appellant’s action for damages under Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (Regulations), s. 8—Judge finding 1993 (rather than 1998) version of Regulations applying to action, but that Regulations, s. 8 applicable at the time not triggered—Respondents successfully seeking in 1996 order prohibiting issuance of notice of compliance (NOC) to appellant with respect to naproxen slow release tablets until expiry of 1204671 patent ('671 patent)—That patent found to be invalid in 1999—However, Minister refusing to issue NOC to appellant on basis prohibition order continuing in effect—Appellant successfully seeking order setting aside prohibition order—This order foundation for appellant’s claim for damages—NOC subsequently issued to appellant for naproxen slow release tablets—1998 version effecting number of changes to Regulations, including amendments to s. 8—1998 version of Regulations applying to proceedings which were pending at time it came into force—Judge determining that prohibition proceedings at issue herein not pending at relevant time within meaning of transitional provisions, 1993 version of Regulations thus applicable—Judge correctly interpreting transitional provisions—Court’s inherent jurisdiction to set aside orders on basis of changed circumstances not intended to make prohibition proceedings permanently pending—Judge correctly interpreting 1993 version of Regulations—Under 1993 version, innovator commencing proceeding for prohibition order obtaining interlocutory injunction prohibiting issuance of NOC for up to 30 months—S. 8 intended to provide redress to generic where innovator failing to establish that generic’s allegation of invalidity or non-infringement unjustified—Not intended to provide redress where innovator prevailing in prohibition proceeding, even if generic later successful in patent litigation—Not possible for appellant to reach back, apply finding of invalidity in action so as to argue '671 had expired with meaning of 1993 version of Regulations, s. 8—Appeal dismissed.

Apotex Inc v. Syntex Pharmaceuticals International Inc. (A-238-09, 2010 FCA 155, Dawson J.A., judgment dated June 10, 2010, 15 pp.)