Merck Frosst Canada Inc. v. Canada ( Minister of National Health and Welfare )
T-1312-96
Muldoon J.
27/5/97
18 pp.
Application for order prohibiting Minister of National Health and Welfare (Minister) from issuing respondent Genpharm notice of compliance (NOC) for medicine famotidine until after expiry of Canadian Patent No. 1,222,763 ('763 patent)-Patent at issue re-issue of patent issued on November 2, 1982 to Yamanouchi Pharmaceutical of Japan, expiring on November 2, 1999-Merck & Co. allegedly sole licensee under patent-Merck Frosst Canada allegedly sole sublicensee-Respondent Genpharm Inc. Canadian generic drug manufacturer obtaining compulsory licence for famotidine under Patent Act, s. 39(4) on November 18, 1989-With respect to '763 patent, compulsory licence allows Genpharm to use process to prepare claimed medicine, to import medicine prepared by process, to sell medicine-First issue whether applicants failed to prove were exclusive licensees/sublicensees of '763 patent in Canada and if so, what is effect of such failure-Where second person (usually generic drug manufacturer) wants to market new drug, it must submit to Minister notice of allegation patent at issue not valid or will not be infringed-Minister shall issue NOC if new drug complies with Food and Drug Regulations-Court must determine whether generic drug manufacturer's allegations of non-infringement justified-Prohibition proceeding under Regulations not patent infringement action, but judicial review heard in summary matter-Onus on applicant to prove allegations of non-infringement by generic drug company can be justified-Standard of proof whether, on balance of probabilities, allegation of non-infringement justified-Applicants have not demonstrated existence of any licence or sub-licence-Proof of licensing agreement not in record before Court-Applicants not relieved of burden of proving interest in patent-Proving interest requires showing authentic licence-Material interest should not be merely inferred, especially when evidence of interest must be within applicant's possession-Second issue whether time at which Court looks to determine if allegation justified when allegation made or when application heard-Court finding time for determining justification of allegation time of hearing-Once first person makes application for prohibition as provided by Regulations, legislative stay of maximum of thirty months arises under Patented Medicine (Notice of Compliance) Regulations, s. 7-NOC cannot issue until prohibition application heard or 30-month legislative stay expires-Genpharm already obtained notices of compliance for famotidine-Continues to hold compulsory licence for famotidine permitting it to use process claimed in '763 patent-Prohibited however from importing famotidine until October 7, 1996-After that date Genpharm entitled to import, sell famotidine, made by patented process in Canada, so long as acquired requisite NOC-No justifiable reason for prohibiting Minister from issuing NOC to Genpharm just because Genpharm's notice of allegations dated more than 46 days prior to earliest date upon which NOC could have issued-All of Genpharm's allegations justified-Notice of allegations not deficient-Legislative purpose of compulsory licences to permit, upon payment of royalty to patentee, profitable marketing, sale to public by licensee of reasonably priced pharmaceutical drugs-Court should not enforce narrow, unlegislated notion of prematurity in order to nullify compulsory licence-No order of prohibition against Minister should be given to thwart Genpharm from lawful exercise of compulsory licence-Foundation of prohibition application moot-Application dismissed-Patent Act, R.S.C., 1985, c. P-4, s. 39(4) (as repealed by S.C. 1993, c. 2, s. 3)-Food and Drug Regulations, C.R.C., c. 870-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 7.