Hoffmann-La Roche Ltd. v. Canada ( Minister of National Health and Welfare )
T-2309-98
Evans J.
7/4/99
13 pp.
Apotex seeking competitive advantage when Hoffmann-La Roche's (HL) patent on naproxen sustained release 750 mg tablets expires in 2003-In 1996, Reed J. (Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1996), 67 C.P.R. (3d) 484 (F.C.T.D.)) granted HL order prohibiting Minister from issuing notice of compliance to Apotex after concluding Apotex's allegation would not infringe HL's patent not supportable on evidence-In 1996, Apotex filed second notice of allegation raising issue of validity of HL's patent-HL applied for second order prohibiting issuance of notice of compliance-MacKay J. (AB Hassle v. Canada (Minister of National Health and Welfare) (1997), 71 C.P.R. (3d) 129 (F.C.T.D.)) found first and second allegations essentially similar and ordered stay of further proceedings in file, with result first prohibition order remained in effect-In October 1998, Apotex advised Minister 30-month period from making of second prohibition application would expire following month and Minister issued notice of compliance on basis of MacKay J.'s order-However, after careful reading of MacKay J.'s reasons for order, Minister later informed parties considered notice void-In meantime, HL had filed present application for judicial review requesting Court to set aside notice of compliance, to declare it invalid and to order Minister to withdraw it-While issue moot as notice withdrawn, would be appropriate for Court to exercise discretion and determine issues in dispute between HL and Apotex-Although proceeding taking form of public law litigation, unrealistic not to recognize litigation has important bearing on legal rights of patent holders and commercial competitors-Also, since all parties present before Court, and counsel made full written and oral submissions on all issues, would be wasteful of time and resources if proceeding were dismissed as moot-Issue whether, in interpreting MacKay J.'s order disposing of HL's second application for prohibition, Court entitled to go behind order itself and consider reasons given for it-Court entitled to look to reasons and, if necessary, to entirety of record before Court to examine context from which order arose in order to better understand its scope and significance-Difficulty arising from fact MacKay J. appears to have considered only allegation of non-infringement, and not allegation HL's patent invalid-Right or wrong, however, MacKay J.'s order made issue of similarity between second and first notices of allegation res judicata-In result, Reed J.'s order of prohibition applies to both elements contained in Apotex's second notice of allegation-Hence, Minister prohibited from issuing notice of compliance to Apotex until expiry of HL's patent on naproxen sustained release 750 mg tables-Choice as follows: (1) dismiss application on ground prohibition issued by Reed J. could only apply to allegation of non-infringement-Accordingly, in absence of either order of prohibition issued by MacKay J. with respect to allegation of invalidity, or order extending 30-month statutory stay, Apotex became entitled to notice of compliance by virtue of its allegation of invalidity-However, this would inevitably sacrifice important principle that, subject to reversal on appeal, order of Court final and should be given effect according to clear terms-Or (2) allow application and prefer advantages offered by res judicata, thereby giving judgment of Court effect it could not have been intended to have, and exhibit preference of form over substance-Lesser evil to find in favour of applicant, and thereby uphold values underlying res judicata doctrine-Order setting aside Minister's issue of notice of compliance to Apotex, and declaring it to have been beyond jurisdiction of Minister and consequently invalid, necessary to prevent Apotex from instituting application for judicial review alleging Minister obliged in law to issue to it notice of compliance on basis of allegation of invalidity patent contained in second notice of allegation.