PATENTS
Practice
Judicial review of Minister’s refusal to list two patents on ground out of time under Patented Medicines (Notice of Compliance) Regulations when Supplementary New Drug Submission (SNDS) filed regarding two patents owned by Genetech, Inc.—Genetech, Inc. owning patent number 1218613 (′613) entitled “Recombinant Immunoglobin Preparations” and patent number 1321082 (′082) entitled “Method of Treating Tumour Cells by Inhibiting Growth Factor Receptor Function”—Applicant previously filing New Drug Submission (NDS) for Herceptin (′613) in 1998 and receiving notice of compliance (NOC) but not submitting patent list with NDS—Applicant filing SNDS for approval of additional manufacturing site for Herceptin—Health Canada considering patent list for ‘613 patent should have been filed with 1998 NDS under Regulations, s. 4(3) and within 30 days after ′082 patent granted under s. 4(4)—“Notice of compliance” defined in Regulations as notice issued under Food and Drug Regulations, s. C.08.004—S. C.08.004 providing Minister required to issue NOC if warranted after examining new drug submission—Food and Drug Regulations, s. C.08.003 stating manufacturer needing approval to continue to sell drug in respect of which NOC has been issued if manufacturer proposing changes—Manufacturer of drug having to file supplement to NDS to cover changes—To submit patent list, manufacturer must be owner, have exclusive licence, or have patent owner’s consent—Only evidence applicant eligible to apply for SNDS is patent list— Genetech, American corporation, not eligible to submit patent list since only manufacturer of medicine in Canada eligible— Bona fides of applicant in applying for approval of new manufacturing site not questioned by Minister—1998 amendments to Patented Medicines (Notice of Compliance) Regulations providing balance between effective enforcement of patent rights; ensuring generic drug products enter market as soon as possible—Case law establishing submission for NOC supporting patent list within meaning of Regulations, s. 4 need not be new drug submission or abbreviated new drug submission, but may be application supplementary to either— Abbott Laboratories v. Canada (Minister of Health) (2004), 239 D.L.R. (4th) 627 (F.C.A.) dealing with SNDS for new purpose for which pharmaceutical product could be used— Federal Court of Appeal holding person may submit patent list with SNDS as long as SNDS relating to drug or use of drug—Applicant’s SNDS for additional manufacturing site not relating to drug (Herceptin) or use of drug and patent list not supported—Brand names, manufacturing sites incidental to drug and purpose thereof—Abbott referring to bona fides as warning concocted SNDS for new indication may not serve as basis of patent listing if real purpose to circumvent timing requirements of Regulations—Minister correctly refusing to list applicant’s patents—Possible applicant not submitting two patents for listing earlier because applicant not having exclusive licence from consent of patent owner—No evidence when applicant obtaining Genetech’s consent to file patent list —Application dismissed—Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 4 (as am. by SOR/98-166, s. 3)—Food and Drug Regulations, C.R.C., c. 870, ss. C.08.003 (as am. by SOR/95-411, s. 6), C.08.004 (as am. idem).
Hoffmann-LaRoche Ltd. v. Canada (Minister of Health) (T-2133-03, 2004 FC 1547, Harrington J., order dated 3/11/04, 14 pp.)