Zeneca Pharma Inc. v. Canada ( Minister of National Health and Welfare )
T-1454-93 / T-1968-93
Richard J.
26/5/95
15 pp.
Application for order prohibiting Minister of National Health and Welfare from issuing notice of compliance to Apotex Inc. in respect of medicine lisinopril, until expiration of Canadian Letters Patent 1,275,350 ('350 patent) and 1,288,351 ('351 patent) -- Applicant Zeneca licensee of patentee Merck -- Respondent, Apotex, generic manufacturer -- Merck owner of '350 patent issued on October 16, 1990 and '351 patent issued on September 3, 1991 -- Both patents relating to lisinopril, chemical compound useful in treatment of medical conditions and disorders -- Notice of allegation forwarded by Apotex to Zeneca by letter dated April 29, 1993 -- Proceeding commenced in file T-1454-93 by filing of originating notice of motion by Zeneca dated June 15, 1993 in respect of letter of April 29, 1993 -- Applications raising two principal issues: 1) with respect to both '350 and '351 patents, whether Patent Act, s. 56 supports respondent's allegations of non-infringement; 2) with respect to '351 patent only, whether respondent's claim in first notice of allegation that it will not sell composition for use for congestive heart failure supports allegation of non-infringement -- S. 56(1) must be given liberal interpretation -- Protection offered by s. 56 limited to quantity acquired before issuance of patent and to scope of invention disclosed in patent -- With respect to both patents, evidential burden required under s. 56 met by Apotex -- Evidence establishing composition of matter acquired before issuance of patent-Respondent acquiring scope of invention disclosed in '350 patent in limited quantity before issuance of patent -- Not acquiring scope of invention described in '351 patent prior to grant of said patent-Only if Apotex used lisinopril for purpose of prolonging survival of mammalians with congestive heart failure could be said to have acquired invention or novel subject matter of '351 patent -- Only intended use of lisinopril in '350 patent for treating hypertension-No evidence Apotex used lisinopril for purpose of prolonging survival of mammalians with congestive heart failure prior to grant of '351 patent -- S. 56 providing immunity from liability for what would otherwise be infringing activity -- Designed to be invoked as defence in action for declaration of infringement where damages claimed by patentee -- Purpose of both prior common law remedy and statutory provision protection of prior purchaser -- S. 56 not providing support for allegation of non-infringement -- Protection provided immunity from suit or liability for infringement -- Limited quantity protected by s. 56 cannot provide justification for allegation of non-infringement for entire life of patent -- Only utility of invention in '350 patent stated to be use in treating hypertension -- Lisinopril tablets intended by Apotex and capable of being used for treatment of congestive heart failure -- Application allowed -- Patent Act, R.S.C., 1985, c. P-4, s. 56 (as am. by S.C. 1993, c. 44, s. 194).