PATENTS |
Practice |
Bayer AG v. Apotex Inc.
T-2052-01
2003 FC 1199, Gibson J.
17/10/03
50 pp.
Applicants seeking order prohibiting Minister of Health from issuing notices of compliance to respondent Apotex in connection with ciprofloxacin hydrochloride tablets until after expiration of Canadian Patent 1218067 (067 patent) (drug itself, process to produce it)--Notice of allegation giving rise to proceeding alleging that certain claims of patent invalid on basis of obviousness; lack of inventiveness--Application allowed in part--While legal burden resting with Bayer, question is whether Apotex has proved, on balance of probabilities by evidence supporting its allegations in its notice of allegation, that 067 patent invalid by reason of obviousness--Application of test for obviousness as summarized in Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2002), 22 C.P.R. (4th) 466 (F.C.T.D.)--In absence of evidence of invention date, relevant date for purposes of assessing obviousness of claims priority filing date identified in patent, here, October 29, 1981--For purposes of present matter, person of ordinary skill in art highly trained, experienced scientist--Ciprofloxacin, new substance, has, since its introduction in market, demonstrated unexpected usefulness--Ciprofloxacin has solved long-felt need , has been commercial success, commanding industry praise--Hoechst v. Halocarbon (Ontario) Ltd. et al., [1979] 2 S.C.R. 929 applied as to obviousness--Much of expert testimony on behalf of Apotex on which Apotex' argument for invalidity of product-by-process claims of patent based amounting to hindsight analysis--On totality of evidence before Court, Bayer successfully refuted allegation claims of patent obvious on relevant date when viewed through eyes of person of ordinary skill in relevant art--Process claimed in other claims of patent valid as not obvious at relevant date in that, in context of patent, process produced new, useful substance, ciprofloxacin, which possessed utility that could not have been expected by person of ordinary skill in art at that date.