PATENTS
Infringement
Application for order under Patented Medicines (Notice of Compliance) Regulations, s. 6(1) prohibiting Minister of Health from issuing notice of compliance (NOC) to Novopharm Limited (Novopharm) regarding 250 mg tablets for oral administration of azithromycin until after expiration of Canadian Letters Patent No. 1314876 (′876 patent)— Applicants seeking “grave consequence order” in alternative— ′876 patent entitled “Azithromycin Dihydrate” respecting applicants’ Zithromax azithromycin product in 250 mg— Product claim 1 of ′876 Patent directed to crystalline azithromycin dihydrate; composition claim 5 directed to pharmaceutical composition comprising antibiotic effective amount of non-hygroscopic crystalline azithromycin dihydrate —In notice of allegation (NOA), Novopharm alleging product (Novopharm Azithromycin) not infringing product claim 1, composition claim 5 of ′876 patent—Alleging product free of crystalline azithromycin dihydrate because product is azithromycin monohydrate, alleging stability of product and absence of risk of conversion to azithromycin dihydrate— Novopharm proposing to import azithromycin monohydrate in bulk into Canada and formulate “Novopharm Product” therefrom—(1) Sufficiency of NOA, evidential burden—NOA silent as to “use” by Novopharm in Canada of imported product—Detailed statement also silent as to whether dihydrate used or formed in manufacturing of Novopharm’s azithromycin product, ultimately resulting in depriving applicants of advantage of ′876 patent—“Saccharin Doctrine” applying in Canada in patent infringement cases turning on “use” (when patented process used in manufacturing of article produced)—Term “use” in Patent Act, s. 42 judicially interpreted as applying both to patented products and processes —Expansive doctrine only applying if patent playing important part in production—Law holding infringement occurring when defendant manufacturing, seeking to use, or using patented part contained within something not patented, provided part significant or important—Novopharm having evidential burden to “put into play” all aspects of issue of non-infringement flowing from issuance of NOA and detailed statement—On face, NOA inadequate since not addressing issue of potential infringement of ′876 patent by use of bulk azithromycin monohydrate in off-shore production process— Use of azithromycin monohydrate central part in production of Novopharm product—(2) Adequacy of samples provided for analysis—Evidentiary value of testing evidence doubtful since materials provided to applicant, respondent’s own experts for testing different—Issue of whether Novopharm’s tableted material potentially converting into azithromycin dihydrate not determined—“Grave consequence order” to issue if conversion taking place in future—Applicants not meeting legal burden of establishing on balance of probabilities bulk azithromycin monohydrate containing or converting to azithromycin dihydrate—Novopharm’s NOA inadequate and inadequacy fully addressed in notice of application initiating this proceeding—Not open to Novopharm to “patch up” NOA with evidence, but if it were, Novopharm failed to do so with evidence filed—Application allowed—Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6(1) (as am. by SOR/98-166, s. 5)—Patent Act, R.S.C., 1985, c. P-4, s. 42 (as am. by R.S.C., 1985 (3rd Supp.), c. 33, s. 16).
Pfizer Canada Inc. v. Novopharm Ltd. (T-74-03, 2004 FC 1633, Gibson J., order dated 22/11/04, 32 pp.)