Hoffmann-LaRoche v. Canada ( Minister of National Health and Welfare )
T-2309-98
Evans J.
21/4/99
16 pp.
Application for stay of order notice of compliance issued to Apotex in respect of sustained release naproxen 750 mg tablets null and void-Tripartite test in RJR-MacDonald Inc. v. Canada (Attorney General), [1994] 1 S.C.R. 311 governing exercise of discretion to grant stay pending disposition of appeal-Parties agreed proposed appeal raising serious issue-Disruption, delays, other inconveniences likely to be caused to Apotex, physicians, pharmacists by delisting product from provincial formularies will constitute significant harm for which Apotex not having right to be compensated-As to damage to reputation, although physicians, pharmacists, other customers possibly puzzled, unsettled by removal of product from market, subsequent reintroduction, physicians, pharmacists know litigation rife in pharmaceutical industry, and from time to time this leads to uncertainty about legal status of particular medications unrelated to safety, effectiveness-Apotex able to explain situation herein such that will not result in longterm damage to general reputation as reliable supplier of pharmaceutical products-Apotex establishing irreparable harm on basis of disruption of distribution of naproxen, likely loss of substantial sales, especially in Ontario, between now, disposition of appeal-Public interest in ensuring compliance by participants with regulatory scheme, orderly administration of scheme as whole, including provisions for balancing through intellectual property rights of competing public interests in more research, cheaper pharmaceutical products-To grant stay would reward Apotex for proceeding to market naproxen when knew, or must have known, no valid notice of compliance issued to it-Apotex acting on its view of legal position with full knowledge might be proved wrong-Taking such calculated risk may not be obvious "flouting of the law", but liable to erode smooth administration of regulatory scheme, its integrity, and constituting form of self-help remedy Court should not encourage-As noted in Attorney-General v. Harris, [1961] 1 Q.B. 74 (C.A.), approved in Ontario (Attorney-General) v. Grabarchuk (1976), 11 O.R. (2d) 607 (Div. Ct.), breach with impunity by one citizen leading to breach by others, or to general feeling law unjustly partial to those who have persistence to flout it-Balance of convenience not favouring maintaining status quo pending disposition of appeal-Breach of statutory duty for Apotex to notify Minister marketing naproxen-Not reasonable for Apotex to believe Minister had agreed could continue to market, sell naproxen, without incurring any sanction, pending determination of Hoffmann-LaRoche's application for judicial review-Reed J.'s April 19, 1999 order declaring Apotex's formulation of controlled release naproxen tablets not infringing Hoffmann-LaRoche's patent, patent invalid, not determinative of motion to stay because not addressing public interest in ensuring that those who do not comply with law should not thereby benefit-Reed J.'s order may be appealed, reversed-While Apotex cleared irreparable harm hurdle, any harm that it may suffer largely result of its "eyes open" decision to market naproxen despite doubtful legal status of notice of compliance-Public interest in promoting compliance with regulatory scheme tipping balance other way.