Digests

RhoxalPharma Inc. v. Canada (Minister of Health)

T-655-01

2001 FCT 1036, Lemieux J.

20/9/01

19 pp.

Appeal from Prothonotary's refusal to order reattendance of RhoxalPharma Inc.'s affiant to answer questions asked and refused during cross-examination on affidavit--AstraZeneca has eight listings for omeprazole and omeprazole magnesium on Patent Register, maintained pursuant to Patented Medicines (Notice of Compliance) Regulations, under Canadian patent 2133762 (762 patent)--RhoxalPharma requested removal of 762 patent on ground should have been listed as combination product (in respect of which would not have to make notice of allegation), not under omeprazole alone--Minister rejected request--Rhoxal-Pharma commenced application for judicial review directing Minister to remove 762 patent from Register for all strengths, dosage forms of AstraZeneca's medicines--In affidavit, Director of Regulatory Affairs asserted RhoxalPharma filed Abbreviated New Drug Submission (ANDS) under Food & Drug Regulations, in order to obtain notice of compliance (NOC) which would allow it to sell omeprazole--On cross-examination, asserted RhoxalPharma filed ANDS for 20 mg omeprazole tablets--Refused to answer questions regarding three other products AstraZeneca listed on Register associated with 762 patent--Refusals falling into three categories: (1) those related to whether RhoxalPharma filed new drug submission (NDS) or ANDS for these omeprazole products, including strengths for which submissions filed; (2) relating to status with Minister of Health of any submissions filed by RhoxalPharma; and (3) relating to identity of omeprazole product to which RhoxalPharma compared its proposed omeprazole product for each of AstraZeneca's products--Prothonotary not providing reasons for refusal--Appeal based on ground answers refused relevant to RhoxalPharma's standing to seek delisting of patent, particularly if RhoxalPharma not having NDS or ANDS for particular formulation or strength in which case may not be directly affected by presence of 762 patent on Register--AstraZeneca also argues questions relating to current status of NDS relevant to whether RhoxalPharma "directly affected" under Federal Court Act, s. 18--As discretionary, not vital to final issue of case, appropriate test whether Prothonotary's decision clearly wrong--Rules of relevance more limited on cross-examination in context of judicial review proceeding--Relevance either formal or legal--Formal relevance determined by reference to issues of fact, as defined by affidavits in application for judicial review--Thus cross-examination limited to facts sworn to by deponent--Fact has legal relevance only if existence or non-existence can assist in determining whether or not remedy sought can be granted--Determination of relevance depending upon examination of legislative scheme, nature, scope of proceedings before Trial Division--AstraZeneca arguing relevance primarily on basis may affect RhoxalPharma's standing to obtain remedies seeks--Argument based on incorrect view of nature of proceedings which RhoxalPharma launched against Minister of Health--Fundamental premise of RhoxalPharma's judicial review application that Minister erred in listing 762 patent in eight different ways--Astra Zeneca says needs to know for purposes of RhoxalPharma's standing whether RhoxalPharma has live and pending approvable submissions for other drug strengths, dosage forms against which 762 patent listed--Such knowledge not advancing debate in determining whether scope of Minister's alleged error equates remedy sought--RhoxalPharma established filed ANDS, seeking NOC--As directly affected by Minister's decision, questions have no legal relevance on outcome of litigation--Appeal dismissed--Issues of: whether notice of allegation required, form NOA might take, whether proper submission to Minister by RhoxalPharma supporting NOA, propriety of comparison between drug in RhoxalPharma's submission and AstraZeneca's listed drug, whether Minister might issue NOC without NOA, not relevant as either anticipatory and premature or trench upon Minister's mandate under Food and Drugs Act--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133--Food and Drugs Act, R.S.C., 1985, c. F-27--Food & Drug Regulations, C.R.C., c. 870--Federal Court Act, R.S.C., 1985, c. F-7, s. 18 (as am. by S.C. 1990, c. 8, s. 5).