Eli Lilly and Co. v. Novopharm Ltd.
T-734-96
Dubé J.
15/10/97
17 pp.
Motion for order declaring detailed statement and allegations dated February 7, 1996 provided by Novopharm with respect to drug cefaclor void, of no effect as not provided in compliance with Regulations-Regulations prohibit Minister from granting NOC until all relevant product and use patents of brand name company expired-Also permit applicant (inventor and legal representatives) to submit patent number, expiration date of all relevant drug patents-Minister required to maintain public registry of patent information-Where generic drug makers file NOC applications, must certify status of all patents listed for earlier approved drug-If allege some of patents listed by earlier NOC applicant invalid or will not be infringed, must give notice of allegations to owner of any contested patent-Patent owner having 45 days from notice to file suit against subsequent applicants to enforce patent-Novopharm provided notice of allegation alleging non-infringement of Eli Lilly's patents-Eli Lilly commencing proceeding seeking prohibition order (first proceeding)-Subsequently Novopharm denied leave to amend notice of allegation to change legal issue to Eli Lilly's patents not containing claims to medicine itself or claims for use of medicine-On February 7, 1996 Novopharm providing Eli Lilly with document entitled "detailed statement of legal and factual basis" alleging patents not belonging on Eli Lilly's patent list-Prohibition order issued on first proceeding-Application dismissed-Multiple notices of allegations may be filed, and Minister may grant NOC even when prohibition order still in effect, provided prohibition made in particular context, new allegations separate and distinct from previous ones: Apotex Inc. v. Canada (Minister of National Health and Welfare), [1997] F.C.J. No. 1251 (C.A.) (QL)-Prohibition order herein issued on basis no evidence patents would not be infringed and because of previous order excluding legal issue that patents not containing claims to medicine itself-Not precluding revival of legal issue by way of another notice of allegation as Novopharm has now done-Overwhelming, undisputed evidence patents on Eli Lilly's list either expired or not containing any claim to medicine cefaclor, but only to preparation processes-Not proper to keep generic manufacturer off market by listing patents not belonging to list-As to argument second proceeding res judicata, notice of allegation merely "piece of evidence" providing patentee with cause of action-Principle of res judicata not applicable-Novopharm entitled to serve second notice of allegation because different from first-Eli Lilly neither challenging new allegations nor adducing evidence establishing patents on list containing claims for medicine itself-Eli Lilly not first person entitled to apply for prohibition order-Patented Medicines Notice of Compliance Regulations, SOR/93-133, ss. 4, 5, 6.