Hoffman-La Roche Ltd. v. Canada ( Minister of National Health and Welfare )
T-1964-93
Reed J.
20/3/96
26 pp.
Applications under Patented Medicines (Notice of Compliance) Regulations, s. 6(1) for orders prohibiting Minister of National Health and Welfare from issuing notices of compliance to respondents until expiration of patents-First patent at issue containing specific description of non-volatile organic acids and broad description of patent as whole-Second patent at issue describing weight percentages "about" or "in the range of"-First issue extent of explanation respondent must provide in notice of allegation when virtually no other information on record concerning allegation-Second issue whether Court should allow reopening of proceedings on basis parties overtaken by evolving case law-In application under s. 6(1) applicant having burden to prove "that the evidence which has been provided by the respondent does not justify the allegation"-Court has no jurisdiction to order filing and service of detailed statement or better detailed statement-Notice of allegation and detailed statement not pleadings of this Court but administrative documents filed with Minister-Respondents' interlocutory application to have status of patent claim determined should be dealt with at hearing of judicial review application and not on interlocutory application-Respondent stating in notice of allegation use or sale of its drug not infringing because patent covered composition or formulation claim and respondent did not use organic acids listed in patent claim-Established in case law facts asserted in respondent's allegation to be taken as true, until disproved-These proceedings neither infringement actions nor actions for declarations of noninfringement-Summary proceedings and if facts asserted justify allegation of non-infringement, in so far as text of patent claim concerned, allegation justified-Respondent's statement it does not use one of organic acids listed in claim therefore justifies allegation of non-infringement-Second respondent's implied assertion product does not fall within specific range of weight percentages listed in patent claim not supporting allegation of non-infringement-On procedural questions, Court refusing to substitute alternate procedure (requesting information from respondent) from one required (obtaining information from Minister)-RR. 6 and 302(b) not appropriate in this case-Also refusing to allow respondents to adduce further and better affidavit material to support allegation-R. 303 not appropriate when argument on hearing of application essentially completed-Mandatory nature of Regulations, s. 6(2) requiring Court to issue order of prohibition if allegations not justified-Patent Act, s. 55.2(5) providing Act, s. 55(2) and Regulations made thereunder prevail over any other Act of Parliament-Court therefore cannot order prohibition "without prejudice to respondent's right to file new notices of allegation"-Application with respect to first patent denied-Application with respect to second patent allowed-Patent Act, R.S.C., 1985, c. P-4, s. 55.2-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6(1),(2)-Federal Court Rules, C.R.C., c. 663, RR. 6, 302(b), 303.