Janssen-Ortho Inc. et al. v. Apotex Inc. et al., (2009) 392 N.R. 71 (FCA)

• Judge: Nadon, Layden-Stevenson and Trudel, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: April 28, 2009
• Jurisdiction: Canada (Federal)
• Citations: (2009), 392 N.R. 71 (FCA);2009 FCA 212

Janssen-Ortho Inc. v. Apotex Inc. (2009), 392 N.R. 71 (FCA)

MLB headnote and full text

Temp. Cite: [2009] N.R. TBEd. JL.052

Apotex Inc. (appellant) v. Janssen-Ortho Inc. and Daiichi Sankyo Company, Limited (respondents) and The Minister of Health (respondent)

(A-373-08; 2009 FCA 212)

Indexed As: Janssen-Ortho Inc. et al. v. Apotex Inc. et al.

Federal Court of Appeal

Nadon, Layden-Stevenson and Trudel, JJ.A.

June 22, 2009.

Summary:

Apotex Inc., a generic drug manufacturer, sought a notice of compliance (NOC) respecting the antimicrobial drug, known as levofloxacin, in the form of 250, 500 and 700 mg tablet strengths until the expiry of Canadian Patent No. 1,304,080 ('080 patent). Daiichi Sankyo Co. (patent owner) and Janssen-Ortho Inc. (licensee) (the applicants) sought an order prohibiting the Minister of Health from issuing the NOC. Apotex alleged that the '080 patent was invalid or that its tablets would not infringe the '080 patent. The applicants claimed that the issues raised by Apotex were substantially similar to the issues and evidence on obviousness and anticipation previously submitted to the court in earlier litigation involving the same patent (the Novopharm proceedings).

The Federal Court, in a decision reported 332 F.T.R. 1, held that the patent was valid and that Apotex's tablets would infringe the patent. The court therefore issued the prohibition order sought by the applicants. The court held, subsequent to its analysis of the infringement and validity issues, and applying Sanofi-Aventis v. Novopharm (2007 FCA), that it agreed with the applicants' abuse of process argument. Apotex appealed.

The Federal Court of Appeal, Layden-Stevenson, J.A., dissenting, allowed the appeal. The court held that the trial judge misunderstood the Sanofi-Aventis decision and therefore erred on the abuse of process issue. The court expressed doubt as to whether the judge in fact conducted an assessment of the facts independent of the Novopharm proceedings. The court returned the matter to the trial judge for a redetermination of the issues on the basis that there was no abuse of process on the part of Apotex in making the allegations found in its notice of allegation and in contesting the application for a prohibition order commenced by the applicants. The court also instructed the judge to assess the evidence before him independently of any findings made by the judge in the Novopharm trial.

Courts - Topic 583

Judges - Duties - Re reasons for decisions - The Federal Court of Appeal opined that it would "be advisable for a judge who intends to adopt a substantial part of a party's written submissions to say so explicitly. Where a judge is confronted with a complex factual case such as the one before us [i.e., a notice of compliance (patented medicine) case], the adoption of a party's written submissions without an acknowledgment may lead to the impression that the judge has not done the work which he is called upon to do, namely, to examine all of the evidence before him and to make the appropriate findings" - See paragraph 77.

Courts - Topic 584

Judges - Duties - To determine issues - [See Courts - Topic 583 ].

Courts - Topic 2015

Jurisdiction - General principles - Controlling abuse of its process - [See Food and Drug Control - Topic 1108.2 ].

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - [See Food and Drug Control - Topic 1108.2 ].

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Apotex Inc., a generic drug manufacturer, sought a notice of compliance (NOC) respecting the antimicrobial drug, known as levofloxacin ('080 patent) - Janssen-Ortho Inc. (licensee) and Daiichi Sankyo Co. (patent owner), the applicants, sought a prohibition order - Apotex alleged that the '080 patent was invalid or that its tablets would not infringe the '080 patent - The applicants claimed that the issues raised by Apotex were substantially similar to the issues dealt with in litigation by another generic drug manufacturer (i.e., the Novopharm trial) involving the same patent - The trial judge relying on Sanofi-Aventis v. Novopharm (2007 FCA) held that a second person challenging a patent on grounds similar to those put forward in a prior litigation by another generic had to establish, as a condition precedent to the pursuance of its case, that it had either "better evidence or a more appropriate legal argument" to offer than that offered in the previous litigation - The court concluded that Apotex had not met the requirements set out in Sanofi-Aventis and thus it was an abuse of process for Apotex to relitigate the issues dealt with in the Novopharm trial - Apotex appealed - The Federal Court of Appeal allowed the appeal, holding that the trial judge erred in his understanding of the Sanofi-Aventis v. Novopharm case - The judge therefore erred in his conclusion on the issue of abuse of process.

Cases Noticed:

Janssen-Ortho Inc. et al. v. Novopharm Ltd. et al. (2004), 264 F.T.R. 202; 35 C.P.R.(4th) 353; 2004 FC 1631, refd to. [para. 12].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. et al. (2005), 337 N.R. 259; 2005 FCA 6, refd to. [para. 12].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 2006 FC 1234, refd to. [para. 13].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2007), 366 N.R. 290; 2007 FCA 217, refd to. [para. 15].

Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al., [2008] 1 F.C.R. 174; 364 N.R. 325; 2007 FCA 163, consd. [para. 27].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 9 C.P.R.(4th) 129, refd to. [para. 86].

Housen v. Nikolaisen et al., [2002] 2 S.C.R. 235; 286 N.R. 1; 219 Sask.R. 1; 272 W.A.C. 1; 211 D.L.R.(4th) 577; 2002 SCC 33, refd to. [para. 86].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 88].

Apotex Inc. v. Pfizer Canada Inc. et al. (2009), 74 C.P.R.(4th) 141 (F.C.A.), refd to. [para. 103].

I.G. Farbenindustrie A.G.'s Patents, Re (1930), 47 R.P.C. 289 (Ch. D.), refd to. [para. 105].

Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd., [1985] R.P.C. 59 (C.A.), refd to. [para. 112].

Pozzoli SPA v. BDMO SA, [2007] EWCA Civ 588, refd to. [para. 112].

Bourgault Industries Ltd. v. Flexi-Coil Ltd. (1999), 237 N.R. 74; 86 C.P.R.(3d) 221 (F.C.A.), refd to. [para. 127].

Counsel:

Andrew Brodkin, Richard Naiberg and Belle Van, for the appellant;

Neil Belmore and Lindsay Neidrauer, for the respondent, Janssen-Ortho Inc.;

Michael E. Charles and Andrew I. McIntosh, for the respondent, Daiichi Sankyo Company, Ltd.

Solicitors of Record:

Goodmans LLP, Toronto, Ontario, for the appellant;

Gowling Lafleur Henderson LLP, Toronto, Ontario, for the respondent, Janssen-Ortho Inc.;

Bereskin & Parr, Toronto, Ontario, for the respondent, Daiichi Sankyo Company, Ltd.

This appeal was heard in Ottawa, Ontario, on April 28, 2009, before Nadon, Layden-Stevenson and Trudel, JJ.A., of the Federal Court of Appeal. The decision of the court was delivered on June 22, 2009, including the following opinions:

Nadon, J.A. (Trudel, J.A., concurring) - see paragraphs 1 to 80;

Layden-Stevenson, J.A., dissenting - see paragraphs 81 to 128.