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AB Hassle v. Canada ( Minister of National Health and Welfare )

T-366-98

Tremblay-Lamer J.

18/12/98

22 pp.

Confidential information-Appeal from Morneau P.'s ruling certain documents filed on behalf of respondent RhoxalPharma Inc. not confidential and not subject to protective order issued in this proceeding in April 1998-Applicants (Astra) hold patent on omeprazole tablets, gastric reduction medicine sold under trade name "Losec"-RhoxalPharma generic drug manufacturer and distributor of drugs intending to market version of omeprazole allegedly not infringing applicants' patent-Andrx Pharmaceuticals (Andrx), not party to action, generic drug company who developed "novel and innovative pharmaceutical formulation" of omeprazole tablets not infringing Astra patents-Andrx has agreed to sell non-infringing formulation to RhoxalPharma-Fact Andrx supplier of RhoxalPharma entered as evidence in public record and no longer confidential-Astra obtained NOC from MNHW with respect to patented omeprazole tablets-Astra considered first person under Patented Medicines (Notice of Compliance) Regula tions-RhoxalPharma second person-Latter filed two affidavits and designated them as confidential information-Astra challenged designation, as permitted by protective order-Issue whether Morneau P. erred in law in interpreting and applying terms of protective order-Appeal granted-Two steps involved for protective order: one subjective, one objective-Based on reasoning in Apotex Inc. v. Wellcome Foundation Ltd. (1993), 51 C.P.R. (3d) 305 (F.C.T.D.), protective order will issue in relation to information to be produced if moving party believes its proprietary, commercial and scientific interests would be seriously harmed by producing information upon which those interests based-In present case, Teitelbaum J. found evidence sufficient to satisfy test and protective order issued in April 1998-Protective order specifically providing in event of challenge, party asserting confidentiality shall have burden of proving on balance of probabilities information in fact confidential-In effect, objective test-Morneau P. erred when agreed that subjective test (asserting party's belief) proper test to apply when determining confidentiality of information under protective order-Test cannot be limited to requiring moving party to prove information not type contemplated by paragraph 18 (broad provision which merely states type of information that should generally be excluded from assessment)-Protective order specifically allowing party to submit challenged information to objective evaluation-Scheme under protective order providing appropriate safeguards and emphasizing balance between openness of process and bona fide interests of parties-Proper test at this stage twofold: (1) whether information has been treated by party at all relevant times as confidential; (2) whether asserting party has demonstrated that on balance of probabilities, its proprietary, commercial and scientific interests could reasonably be harmed by disclosure of information-Evidence establishing RhoxalPharma has treated information as confidential-Morneau P. erred in not finding evidence has demonstrated RhoxalPharma could reasonably be harmed by disclosure of challenged information-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133.

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