Eli Lilly and Co. v. Apotex Inc.
T-1144-97
Teitelbaum J.
25/9/97
8 pp.
Application for leave to submit reply evidence-Issue in proceeding to quash issuance of notice of compliance to Apotex Inc. for drug nizatidine whether synthetic process forming subject-matter of Apotex's allegation same process as that set out in Apotex's new drug submission (NDS)-Process referred to in allegation provided to applicants by letter dated November 29, 1995-At start of proceedings, applicants not including in evidence details of synthetic process set out in November 29, 1995 letter because Apotex claiming confidentiality in details-Demonstrated by Apotex filing motion to strike portions of originating notice of motion, affidavits on basis applicants improperly using confidential information by referring to November 29, 1995 letter-That motion dismissed and on August 22, 1997, Apotex providing evidence including affidavits to which applicants now seeking to reply evidence, and November 29, 1995 letter-Letter filed without confidentiality order-Apotex submitting contents of letter no longer confidential-Furthermore, Apotex for first time producing portions of Torcan's Drug Master file setting out full details of process in NDS-Torcan having patent application on purported improvement to method of manufacturing nizatidine-Process disclosed in patent application part of Apotex's NDS and will be used to make Apotex's nizatidine-Application allowed-When evaluating applicants' request to file reply evidence must consider: (1) would it serve interests of justice; (2) would it assist Court in making final determination; (3) would it cause substantial or serious prejudice to respondents-Introduction of evidence would serve interests of justice, assist Court in making final determination-Whether synthetic process detailed in November 29, 1995 letter as subject-matter of Apotex's allegation same process set out in Apotex's NDS important issue to be determined-Now that November 29 letter no longer confidential, and applicants have access to Torcan Drug Master File, should be allowed to provide evidence based on it-No substantial or serious prejudice to respondents as safeguards incorporated into order-Discovery not completed so unlikely effect on respondents serious.