Pharmacia Inc. v. Canada ( Minister of National Health and Welfare )
T-2343-93
Wetston J.
22/2/96
10 pp.
Application for order under Patented Medicines (Notice of Compliance) Regulations, s. 6(1) prohibiting Minister of National Health and Welfare from issuing Notice of Compliance (NOC) to Novopharm Limited until expiry of Canadian letters patent Nos 1,291,037 (037 patent) and 1,248,453 (453 patent)-Pharmacia S.p.A. owner of both patents-Under Regulations, s. 4, Pharmacia Inc. filed patent lists for medicine doxorubicin hydrochloride with respect to 037 and 453 patents-Respondent Novopharm Ltd. filing, serving Notices of Allegation with respect to each form of doxorubicin, alleging non-infringement of 037 and 453 patents on basis doxorubicin not coming within patents' claims-Originating notice of motion filed by applicants on September 30, 1993-Respondent required to file and serve detailed statement of legal and factual basis for allegations of non-infringement-Applicants filing motion to strike certain questions and corrected answers from respondent's supplementary record-Impugned answers relevant to issues in proceeding-No prejudice to applicants-Motion dismissed-Respondent's submission regarding powder withdrawn-No amended Notice of Allegation before Court-Construction of patent question of law-Issue of patent infringement matter of law and fact-Only one composition of respondent's liquid doxorubicin-Legal basis for allegation of non-infringement modified-No lack of truthfulness on part of respondent regarding factual information put forward-Whether respondent's allegation of non- infringement of 037 patent justified where doxorubicin purchased from licensed source-On March 20, 1991, three agreements entered into between Cetus companies of which Cetus-Ben Venue Therapeutics (CBVT) is member and Erbamont Inc.-As result of agreements, Cetus intended to sell finished doxorubicin to Novopharm in vials bearing Novopharm labels and packaging-Novopharm intending to resell finished doxorubicin in Canada-Cetus entitled to sell finished product to Novopharm, and Novopharm to resell in Canada-Settlement Agreement, License Agreement, Supply Agreement not expressly requiring product sold by Cetus to Novopharm bear Cetus label-Under Supply Agreement, Cetus could sell to Novopharm doxorubicin with Cetus label-No requirement in License agreement, Supply Agreement finished pharmaceutical specialty bear Cetus labels-Only requirement inclusion of appropriate labels-Cetus could sell finished doxorubicin with Novopharm labels at time of Cetus' first sale to Novopharm-Application dismissed-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 4, 6(1).