PATENTS |
Practice |
Toba Pharma Inc. v. Canada (Attorney General)
T-93-02
2002 FCT 927, Blais J.
3/9/02
13 pp.
Judicial review of Minister of Health's refusal to list Canadian patent 2278133 (133 patent) relating to drug Sevoflurane on patent register--Patent granted in 2001 after issuance of notices of compliance based on new drug submission (NDS) for "Sevorane", supplement to new drug submission (SNDS) (for change of name) for "Sevorane AF"--But expired pursuant to Patented Medicines (Notice of Compliance) Regulations, s. 4(4) as information not filed with Minister within 30 days of grant of patent--Applicant attempted to have 133 patent included on register by filing it with further SDNS submitted to record change in manufacturer's name, product name (to "Evotane")--Minister deciding Regulations not permitting such inclusion-- Application dismissed--Process for inclusion of information on patent register beginning with submission of patent list in accordance with Regulations, s. 4(1)--Patent list must set out certain prescribed information pursuant to s. 4(2)--Strict time requirements set out in s. 4(3), (4), (6)--Patent list eligible for inclusion on register only if submitted (a) where submission made after patent granted, either at time of submission of relevant NDS or within 30 days of Regulations coming into force, or (b) where submission made before patent granted, within 30 days of granting of new patent--As applicant not submitting patent information at any one of these three points in time, patent not included in register--Patent list filed in respect of drug "Sevoflurane" ("Sevorane" or "Sevorane AF")--Patent list for Evorane therefore eligible for inclusion on register only if filed within 30 days after grant of "Evorane" product--As not done, timing requirements of Regulations, s. 4 not met--Also, SNDS not appropriate opportunity to file patent list--Filing of patent list on basis of NOC for change in manufacturer's name, product name in accordance with policy contrary to scheme of s. 4, which provides only for addition of patent to be made within time requirements reflected in s. 4(3), (4), (6)--Within Minister's discretion to refuse this means of presenting patent list--Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General) (2001), 10 C.P.R. (4th) 318 (F.C.T.D.) applied--Regulations cannot have intended patent list be eligible for inclusion on register where no comparison possible to drug to which relates--Patent list cannot be added on basis of SNDS filed for "Evotane"--Similarly cannot be added on basis of NDS filed for 133 patent because out of time--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 4 (as am. by SOR/98-166, s. 3).