Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al., (2007) 364 N.R. 325 (FCA)

• Judge: Nadon, Sexton and Sharlow, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: April 23, 2007
• Jurisdiction: Canada (Federal)
• Citations: (2007), 364 N.R. 325 (FCA);2007 FCA 163

Sanofi-Aventis Can. v. Novopharm (2007), 364 N.R. 325 (FCA)

MLB headnote and full text

Temp. Cite: [2007] N.R. TBEd. AP.047

Sanofi-Aventis Canada Inc. (appellant/applicant) v. Novopharm Limited and The Minister of Health (respondents/respondents) and Schering Corporation (respondent/respondent/patentee)

(A-413-06; 2007 FCA 163)

Indexed As: Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al.

Federal Court of Appeal

Nadon, Sexton and Sharlow, JJ.A.

April 23, 2007.

Summary:

In 2003, Apotex (generic drug manufacturer) served a Notice of Allegation (NOA) on Sanofi-Aventis alleging that its '206 patent for ramipril was invalid. Sanofi-Aventis applied under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations for an order that the allegations were unjustified. That application was dismissed and affirmed on appeal. Another generic drug manufacturer (Novopharm) sent its own NOA to Sanofi-Aventis which, like the Apotex NOA, alleged that the '206 patent was invalid on the basis of lack of sound prediction. Sanofi-Aventis brought a second application under s. 6(1) for an order that the allegations in Novopharm's NOA were unjustified. Novopharm applied under s. 6(5)(b) of the Regulations to dismiss the application on the ground that it was redundant, scandalous, frivolous or vexatious or otherwise an abuse of process because of the earlier dismissal of the same application respecting Apotex's NOA. A Prothonotary dismissed the application, finding that res judicata, issue estoppel and abuse of process required a final decision and the Apotex decision was not yet final. Novopharm appealed.

The Federal Court, in a judgment reported (2006), 306 F.T.R. 56, allowed the appeal on the ground of abuse of process. The court dismissed Sanofi-Aventis' application that the allegations were unjustified.  Sanofi-Aventis appealed.

The Federal Court of Appeal, Nadon, J.A., dissenting, dismissed the appeal.

Courts - Topic 2015

Jurisdiction - General principles - Controlling abuse of its process - [See Food and Drug Control - Topic 1105 ].

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - A generic drug manufacturer (Apotex) served a Notice of Allegation (NOA) alleging that a drug manufacturer's '206 patent was invalid - The manufacturer unsuccessfully applied under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations for a prohibition order (i.e., allegations unjustified) - That decision was affirmed on appeal - Another generic drug manufacturer (Novopharm) sent its own NOA to the manufacturer, alleging invalidity of the '206 patent on the same grounds as the Apotex NOA - The manufacturer applied under s. 6(1) for an order that Novopharm's NOA contained unjustified allegations - Novopharm applied under s. 6(5)(b) of the Regulations to dismiss the application on the ground that it was redundant, scandalous, frivolous or vexatious or otherwise an abuse of process because of the earlier dismissal of the same application respecting Apotex's NOA (i.e. application had no chance of success) - The Federal Court of Appeal affirmed the dismissal of the manufacturer's application notwithstanding that it disagreed with the trial judge that it was "plain and obvious" that the second application would not succeed because of the dismissal of the first application - The court noted that subsequent judges would not be bound by the first judge's fact findings - However, it was an abuse of process to relitigate an allegation of invalidity that was previously rejected respecting another generic drug manufacturer - The court held that (1) Novopharm was not required to allege abuse of process and the factual basis for that allegation in its NOA; (2) the allegations in both NOA's were materially the same; and (3) the application initiated by the manufacturer was scandalous, frivolous, vexatious or otherwise an abuse of process within the meaning of s. 6(5)(b) - The court stated that permitting re-litigation of the same issues "poses a severe threat to the integrity of the adjudicative process, the principle of finality, and the efficiency of the judicial system" - Permitting potential inconsistent decisions would threaten the integrity of the adjudicative process - The second application constituted a collateral attack on the first judge's decision.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Dismissal of application for - [See Food and Drug Control - Topic 1105 ].

Practice - Topic 5408.1

Judgments and orders - General - Collateral attack - [See Food and Drug Control - Topic 1105 ].

Cases Noticed:

Aventis Pharma Inc. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 43 C.P.R.(4th) 161; 2005 FC 1283, refd to. [para. 5].

Aventis Pharma Inc. v. Apotex Inc. et al. (2006), 349 N.R. 183; 46 C.P.R.(4th) 401; 2006 FCA 64, refd to. [para. 5].

Housen v. Nikolaisen et al., [2002] 2 S.C.R. 235; 286 N.R. 1; 219 Sask.R. 1; 272 W.A.C. 1; 2002 SCC 33, refd to. [para. 12].

Elders Grain Co. et al. v. Ship M/V Ralph Misener et al., [2005] F.C.R. 367; 334 N.R. 1; 2005 FCA 139, refd to. [para. 13].

AB Hassle et al. v. Apotex Inc. et al., [2006] 4 F.C.R. 513; 350 N.R. 219; 2006 FCA 51, refd to. [para. 13].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, refd to. [para. 30].

Voith (J.M.) GmbH v. Beloit Corp. (1991), 128 N.R. 54; 36 C.P.R.(3d) 322 (F.C.A.), refd to. [para. 30].

Bull (David) Laboratories (Canada) Inc. v. Pharmacia Inc. et al., [1995] 1 F.C. 588; 176 N.R. 48; 58 C.P.R.(3d) 209 (F.C.A.), refd to. [para. 32].

Pharmacia Inc. et al. v. Canada (Minister of National Health and Welfare) - see Bull (David) Laboratories (Canada) Inc. v. Pharmacia Inc. et al.

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (1999), 172 F.T.R. 81; 1 C.P.R.(4th) 358 (T.D.), refd to. [para. 33].

Hunt v. T & N plc et al., [1990] 2 S.C.R. 959; 117 N.R. 321, refd to. [para. 34].

Hunt v. Carey Canada Inc. - see Hunt v. T & N plc et al.

Bayer Inc. et al. v. Apotex Inc. et al., [1998] F.T.R. Uned. 744; 85 C.P.R.(3d) 334 (T.D.), refd to. [para. 34].

Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) et al. (1999), 164 F.T.R. 22; 87 C.P.R.(3d) 251 (T.D.), refd to. [para. 34].

GlaxoSmithKline Inc. et al. v. Apotex Inc. et al. (2003), 239 F.T.R. 32; 29 C.P.R.(4th) 350; 2003 FC 1055, refd to. [para. 34].

Toronto (City) v. Canadian Union of Public Employees, Local 79 et al., [2003] 3 S.C.R. 77; 311 N.R. 201; 179 O.A.C. 291; 2003 SCC 63, refd to. [para. 35].

Novartis AG et al. v. Apotex Inc. et al. (2002), 298 N.R. 348; 2002 FCA 440, refd to. [para. 36].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2001), 266 N.R. 371; 11 C.P.R.(4th) 245 (F.C.A.), refd to. [para. 36].

Bradford & Bingley Building Society v. Seddon, [1999] 1 W.L.R. 1482 (C.A.), refd to. [para. 42].

Glaxo Group Ltd. et al. v. Canada (Minister of Health) et al., [2001] F.T.R. Uned. 29; 2001 FCT 16, refd to. [para. 47].

Toronto (City) et al. v. Canadian Union of Public Employees, Local 79 et al. (2001), 149 O.A.C. 213; 55 O.R.(3d) 541 (C.A.), refd to. [para. 71].

Demeter v. British Pacific Life Insurance Co., Occidental Life Insurance Co. of California and Dominion Life Assurance Co. (1983), 150 D.L.R.(3d) 249 (H.C.), affd. (1984), 7 O.A.C. 143; 48 O.R.(2d) 266 (C.A.), refd to. [para. 71].

Hunter v. Chief Constable of the West Midlands Police, [1982] A.C. 529 (H.L.), refd to. [para. 71].

K.F. et al. v. White (2001), 142 O.A.C. 116; 53 O.R.(3d) 391 (C.A.), refd to. [para. 71].

Bomac Construction Ltd. et al. v. Stevenson et al., [1986] 5 W.W.R. 21; 48 Sask.R. 62; 1986 CarswellSask 221 (C.A.), refd to. [para. 71].

Bjarnarson (H.R.) v. Manitoba (1987), 48 Man.R.(2d) 49; 38 D.L.R.(4th) 32 (Q.B.), affd. (1987), 50 Man.R.(2d) 178; 21 C.P.C.(2d) 302 (C.A.), refd to. [para. 71].

R. v. Power (E.), [1994] 1 S.C.R. 601; 165 N.R. 241; 117 Nfld. & P.E.I.R. 269; 365 A.P.R. 269, refd to. [para. 72].

R. v. Conway, [1989] 1 S.C.R. 1659; 96 N.R. 241; 34 O.A.C. 165, refd to. [para. 72].

R. v. Scott, [1990] 3 S.C.R. 979; 116 N.R. 361; 43 O.A.C. 277; 61 C.C.C.(3d) 300, refd to. [para. 72].

Danyluk v. Ainsworth Technologies Inc. et al., [2001] 2 S.C.R. 460; 272 N.R. 1; 149 O.A.C. 1; 2001 SCC 44, refd to. [para. 73].

Johnson v. Gore Wood & Co., [2001] 2 W.L.R. 72 (H.L.), refd to. [para. 75].

Bragg v. Oceanus Mutual Underwriting Association (Bermuda), [1982] 2 Lloyd's Rep. 132 (C.A.), refd to. [para. 77].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 2006 FC 1234, refd to. [para. 88].

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. 88].

Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) et al. (1999), 164 F.T.R. 22; 87 C.P.R.(3d) 251 (T.D.), refd to. [para. 96].

Hoffmann-La Roche Ltd. et al. v. Canada (Minister of National Health and Welfare) et al. (1998), 158 F.T.R. 135; 85 C.P.R.(3d) 50 (T.D.), refd to. [para. 97].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2001), 213 F.T.R. 161; 16 C.P.R.(4th) 21 (F.C.A.), affd. (2002), 298 N.R. 323; 22 C.P.R.(4th) 1; 2002 FCA 421, refd to. [para. 102].

AB Hassle et al. v. RhoxalPharma Inc. et al. (2002), 222 F.T.R. 48; 21 C.P.R.(4th) 298 (T.D.), refd to. [para. 102].

Glaxo Group Ltd. et al. v. Canada (Minister of National Health and Welfare) et al. (2001), 188 F.T.R. 1 (T.D.), affd. (2001), 273 N.R. 166; 2001 FCA 96, refd to. [para. 114].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 5(1)(b), sect. 5(3), sect. 6(1), sect. 6(2), sect. 6(5)(b) [para. 10].

Patented Medicines (Notice of Compliance) Regulations - see Patent Act Regulations (Can.).

Counsel:

Gunars A. Gaikis, J. Sheldon Hamilton and Mark Biernacki, for the appellant;

Jonathan Stainsby and Mark Davis, for the respondent, Novopharm Ltd.;

Anthony Creber, for the respondent, Schering Corp.

Solicitors of Record:

Smart & Biggar, Toronto, Ontario, for the appellant;

Heenan Blaikie LLP, Toronto, Ontario, for the respondent, Novopharm Ltd.;

John H. Sims, Q.C., Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, Minister of Health;

Gowling Lafleur Henderson LLP, Ottawa, Ontario, for the respondent, Schering Corp.

This appeal was heard on January 9, 2007, at Toronto, Ontario, before Nadon, Sexton and Sharlow, JJ.A., of the Federal Court of Appeal.

On April 23, 2007, the judgment of the Court was delivered and the following opinions were filed:

Sexton, J.A. (Sharlow, J.A., concurring) - see paragraphs 1 to 51;

Nadon, J.A., dissenting - see paragraphs 52 to 120.