PATENTS |
Practice |
Janssen-Ortho Inc. v. Canada (Minister of Health)
T-2216-00
2003 FCT 286, Heneghan J.
7/3/03
15 pp.
Judicial review of Minister of Health's decision removing Canadian Patent 1245983 (983 patent) from Patent Register relative to "Duragesic" fentanyl patch formulation--983 patent entitled "Transdermal Administration of Fentanyl and Device Therefor"--Applicant manufacturer of pharmaceutical products--Whether "Duragesic" patches medicine-- Definition of "medicine" including compositions of active and inactive ingredients--In particular, release membrane, drug reservoir and backing cannot be considered "medicine" according to Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1995), 62 C.P.R. (3d) 58 (F.C.T.D.)--Patch not medicine--Whether words of patent indicating "Duragesic" patches medicine--Person skilled in art would identify 983 patent as describing patch, but does not mean such patch falling within definition of "medicine" for purposes of Regulations--None of 65 claims in 983 patent for medicine fentanyl itself or for use of fentanyl-- Consequently, patent not falling within Regulations, s. 4(2)(b), providing patent list submitted in respect of drug must set out any Canadian Patent containing claim for medicine itself or claim for use of within medicine--As "Duragesic" patches not falling within definition of medicine and since 983 patent not making any claims to fentanyl or use of fentanyl, 983 patent not eligible to be included in patent list--Not appropriate to stretch definition of "medicine" as provided in Regulations in order to comply with policy document having no bearing on interpretation of 983 patent--In conclusion, 983 patent not medicine within meaning of Regulations--983 patent does not meet requirements for inclusion on register, having regard to definition in ss. 2, 4(2)(b)--Whether or not respondent erred in using term "device" to refer to patch not determinative in case at bar--Consequently, decision to delist patent not offending principles of patent law--983 patent remaining valid and enforceable throughout its life notwithstanding decision to delist, as do patents related to drug fentanyl itself--Judicial review dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/193-133 (as am. by SOR/98-66) ss. 2 (as am. by SOR/99-379, s. 1), 3, 4(2)(b) (as am. by SOR/98-166, s. 3).