PATENTS |
GlaxoSmithKline Inc. v. Canada (Attorney General)
T-644-02
2004 FC 1302, Lemieux J.
23/9/04
29 pp.
Applicant GlaxoSmithKline Inc. (GSK) seeking to quash notice of compliance (NOC) issued by Minister of Health for Canada to respondent Apotex Inc.--Apotex' NOC in respect of inhalation product Apo-Salvent CFC Free containing medicine salbutamol sulphate--GSK arguing same medicine contained in GSK's Ventolin, delivered by same route of oral administration--Minister arguing Apotex' submission for NOC mere administrative submission, arising out of Apotex' licensing agreement with 3M Canada to market medicine salbutamol sulphate administered through inhalation--3M has NOC for Airomir, meaning approved for safety, efficacy, covered by patent on patent list--Apotex arguing Patented Medicines (Notice of Compliance) Regulations, s. 5(1.1) not applicable because subject to s. 5(1), which applies--Apotex, in cross-referenced submission for NOC, compared its product with 3M's Airomir; said its product identical thereto-- Whether Minister properly interpreted Patented Medicines (Notice of Compliance) Regulations in determining s. 5(1) had no application to circumstances of case, could issue NOC to Apotex without Apotex having to serve notice of allegation (NOA) on GSK--Purpose of Regulations to protect research and development initiatives of innovator pharmaceutical companies--Purposive approach adopted to interpretation of Regulations, s. 5(1.1)--Minister's policy for changes in manufacturer's name, product solidly anchored in Food and Drug Regulations, s. C.08.003--Regulations linked to Food and Drug Regulations through definition in Regulations, s. 2 of term "notice of compliance"--Because of such linkage, administrative new drug submission filed pursuant to policy not submission for notice of compliance within meaning of words in Regulations, ss. 5(1), (1.1)--Court applying interpretation by McGillis J. in Apotex Inc. v. Canada (Minister of Health) (1999), 87 C.P.R. (3d) 271 (F.C.T.D.) to words "submission for a notice of compliance" as found in Regulations, s. 4--Minister correct in issuing NOC to Apotex without requiring Apotex to serve NOA on GSK--But if Regulations do apply to administrative new drug submission, provisions of s. 5(1.1) not applicable because s. 5(1) applies since Apotex compared its drug with, or made reference to 3M's Airomir for purpose of demonstrating bioequivalency on basis of pharmaceutical characteristics--Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 2 "notice of compliance", 4 (as am. by SOR/98-166, s. 3), 5(1) (as am. idem, s. 4; 99-379, s. 2), 5(1.1) (as enacted idem)--Food and Drug Regulations, C.R.C., c. 870, s. C.08.003 (as am. by SOR/95-411, s. 6).