PATENTS |
Practice |
AstraZeneca Canada Inc. v. Canada (Minister of Health)
T-261-04, T-262-04
2004 FC 1277, Kelen J.
20/9/04
30 pp.
Judicial review of Minister of Health's decision to issue notice of compliance (NOC) to Apotex for 20 mg omeprazole capsules without requiring respondent Apotex to address patents added to patent list after applicant ceased marketing drug in Canada--Applicant marketing "Losec" brand omeprazole since 1989--Withdrew 20 mg capsules from Canadian market in 1996, but continued to list new patents in association with capsules--Two new patents added to patent register in 2002 with respect to "Losec" capsules--Prior to September 1996, while new patents pending, Apotex' abbreviated new drug submission for 20 mg capsules approved--No allegation made re: new patents since not in effect at that time--Minister decided Apotex not required to address new patents, as applicant not fulfilling prerequisites of Patented Medicines (Notice of Compliance) Regulations, s. 5(1), and applicant failing to market "Losec" 20 mg capsules pursuant to NOC for which new patents listed--Standard of review correctness re: proper interpretation of "marketed" in Regulations, s. 5, patent unreasonableness re: whether "Losec" capsules marketed in Canada after 2002--Two determinations Minister must make under s. 5(1): whether relevant drug "marketed" in Canada by applicant; whether "marketing", if any, carried out pursuant to NOC issued to applicant "in respect of which a patent list has been submitted"--No requirement of relevant time period as to when drug "marketed"--Regulations only requiring drug marketed pursuant to a NOC for which a patent list submitted--Patented drug must be on market, available for comparative purposes--Here, drug not manufactured, sold pursuant to patents listed on register after applicant stopped marketing "Losec" 20 mg omeprazole capsules--Words in s. 5 referring to drug marketed in Canada pursuant to NOC in respect of which patent in question listed--Applicant's "Losec" capsules not marketed in Canada because marketing ceased in 1996, NOCs issued after 1996, patents added to register after 1996--Generic drug not expected to compare itself to drug not on Canadian market--Allowing patent drug company to delay generic drug by listing new patents for drug no longer sold in Canada abuse of Regulations--Minister's decision marketing of "Losec" 20 mg not resumed in 2002 not patently unreasonable based on evidence--Marketing requiring more than mere sales--Minister not breaching duty of fairness, applicant fully aware of facts, issues-- Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 5(1) (as am. by 98-166, s. 4; SOR/99-379, s. 2).