PATENTS |
Abbott Laboratories v. Canada (Minister of Health)
A-49-04, A-50-04, A-51-04
2004 FCA 154, Richard C.J.
19/4/04
16 pp.
Appeals from Motions Judge's (2004 FC 465) determination underlying Supplemental New Drug Submission (SNDS) insufficient to support listing of Abbott's Canadian Patent No. 2261732 (732 patent) on Patent Register --Whether Motions Judge properly interpreted and applied provisions of Patented Medicines (Notice of Compliance) Regulations (NOC Regulations) concerning listing of patent in respect of pharmaceutical product-- After making factual determinations, Motions Judge stated SNDS without substance--In her estimation, fact Abbott's product monograph amendment related to use of Biaxin (clarithromycin) in triple therapy for eradication of Helicobacter pylori bacteria, an established use, meant there was no new indication--Although not defined in Food and Drug Regulations (FD Regulations), indication essentially purpose for which pharmaceutical product used--For purposes of filing SNDS, indication does not have to be new or novel, in sense this term used in patent law--However, if manufacturer proposes to use its pharmaceutical product for purpose for which it has no prior approval, SNDS required--This is what occurred in present case--Thus, Motions Judge correct in stating SNDS related to eradication of Helicobacter pylori bacteria and Abbott had no prior authorization to sell or market specific combination of Biaxin (clarithromycin), amoxicillin and lansoprazole to combat Helicobacter pylori bacteria infection--Fact TAP Pharmaceuticals had previously obtained approval for this combination immaterial, as TAP different manufacturer-- SNDS filed by Abbott falls within FD Regulations, s. C.08.003(2)(h)(iii), as relating to new claim made for Biaxin--In filing SNDS, Abbott complied with regulatory requirement--SNDS in respect of new indication, because Abbott required Ministerial approval to sell or market combination of Biaxin (clarithromycin), amoxicillin and lansoprazole in Canada--As stated by Motions Judge, this was not an attempt by Abbott to circumvent time limitations set out in NOC Regulations--SNDS in current appeal necessary in order for Abbott to comply with FD Regulations, and Abbott entitled to file 732 patent for listing--Not for this Court to alter patent benefits to which manufacturer entitled after validly complying with various requirements set out in FD Regulations--Appeals allowed-- Food and Drug Regulations C.R.C., c. 870, s. C.08.003(2)(h)(iii) (as am. by SOR/95-411, s. 6--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133.