AstraZeneca AB et al. v. Apotex Inc. et al., 2006 FC 7

• Jurisdiction: Federal Jurisdiction (Canada)
• Judge: Layden-Stevenson, J.
• Court: Federal Court (Canada)
• Citation: 2006 FC 7,(2006), 285 F.T.R. 258 (FC)
• Date: 18 January 2006

AstraZeneca AB v. Apotex Inc. (2006), 285 F.T.R. 258 (FC)

MLB headnote and full text

Temp. Cite: [2006] F.T.R. TBEd. JA.025

AstraZeneca AB and AstraZeneca Canada Inc. (applicants) v. Apotex Inc. and The Minister of Health (respondents)

(T-766-03; 2006 FC 7)

Indexed As: AstraZeneca AB et al. v. Apotex Inc. et al.

Federal Court

Layden-Stevenson, J.

January 18, 2006.

Summary:

The applicants applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to the respondent with respect to 10 mg and 20 mg magnesium omeprazole tablets until after the expiration of their Canadian patent. The respondent alleged non-infringement and invalidity of the patent.

The Federal Court dismissed the application. The applicants failed to satisfy the court that the respondent's allegation of non-infringement was not justified.

Estoppel - Topic 377

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - When applicable - The applicants applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to the respondent with respect to 10 mg and 20 mg magnesium omeprazole tablets until after the expiration of their Canadian patent ('037 patent) - The respondent alleged non-infringement and invalidity of the patent - The applicants argued that the respondent was estopped from relitigating certain factual matters in respect of its tablet formulation where those matters were implicitly determined by the Federal Court of Appeal in a prior decision involving the same parties but in relation to a different Canadian patent - The Federal Court rejected the argument - The estoppel argument was not pleaded in the applicants' notice of application and it was not open to them to advance it for the first time in their memorandum of fact and law - They could not expand on the contents of their memorandum during the course of oral argument - Finally, estoppel did not apply where there had been no previous determination in relation to the '037 patent - See paragraphs 11 to 22.

Estoppel - Topic 381.1

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - In intellectual property proceedings - [See Estoppel - Topic 377 ].

Patents of Invention - Topic 2926

Infringement of patent - Acts not constituting an infringement - Of particular patents - The applicants applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to the respondent with respect to 10 mg and 20 mg magnesium omeprazole tablets until after the expiration of their Canadian patent - The respondent alleged non-infringement of the patent - The Federal Court dismissed the application - The applicants failed to satisfy the court that the respondent's allegation of non-infringement was not justified - The respondent's tablets did not contain an alkaline reacting compound (ARC) that was separate and distinct from the magnesium omeprazole proton pump inhibitor (PPI) - Given the construction of the patent, the respondent's tablets could not infringe the patent because the tablets did not contain both a PPI and an ARC - See paragraphs 27 to 52.

Patents of Invention - Topic 2926

Infringement of patent - Acts not constituting an infringement - Of particular patents - The applicants applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to the respondent with respect to 10 mg and 20 mg magnesium omeprazole tablets until after the expiration of their Canadian patent - The respondent alleged non-infringement of the patent because its tablets did not have the material, between the enteric coating and the core, that met the requirements of the patent - The applicants disagreed and produced expert evidence - The Federal Court dismissed the application - The applicants failed to satisfy the court that the respondent's allegation of non-infringement was not justified - The applicants' expert evidence was suspect - The respondent's theories were as plausible as the applicants' - See paragraphs 53 to 125.

Patents of Invention - Topic 2941

Infringement of patent - Chemical products and substances intended for food and medicine - General - [See both Patents of Invention - Topic 2926 ].

Cases Noticed:

Apotex Inc. v. Canada (Minister of National Health and Welfare) et al. (1997), 219 N.R. 151; 76 C.P.R.(3d) 1 (F.C.A.), refd to. [para. 8].

Bull (David) Laboratories (Canada) Inc. v. Pharmacia Inc. et al. (1994), 176 N.R. 48; 58 C.P.R.(3d) 209 (F.C.A.), refd to. [para. 8].

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. (2001), 266 N.R. 371; 11 C.P.R.(4th) 245 (F.C.A.), refd to. [para. 9].

SmithKline Beecham Pharma Inc. et al. v. Apotex Inc. et al. (2001), 208 F.T.R. 105; 14 C.P.R.(4th) 76 (T.D.), affd. (2002), 291 N.R. 168; 21 C.P.R.(4th) 129 (F.C.A.), refd to. [para. 9].

Novartis AG et al. v. Apotex Inc. et al. (2002), 22 C.P.R.(4th) 450 (F.C.A.), refd to. [para. 9].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al., [1998] 2 S.C.R. 193; 227 N.R. 299, refd to. [para. 9].

Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General) et al. (2001), 266 N.R. 141; 11 C.P.R.(4th) 539 (F.C.A.), refd to. [para. 12].

Danyluk v. Ainsworth Technologies Inc. et al., [2001] 2 S.C.R. 460; 272 N.R. 1; 149 O.A.C. 1; 2004 SCC 44, refd to. [para. 12].

AB Hassle et al. v. Apotex Inc. et al. (2003), 312 N.R. 288; 29 C.P.R.(4th) 23 (F.C.A.), refd to. [para. 12].

AB Hassle et al. v. Apotex Inc. et al. (2005), 271 F.T.R. 30; 38 C.P.R.(4th) 216; 2005 FC 234, refd to. [para. 15].

Amgen Inc. v. Genetics Institute Inc., 40 USPQ2d (U.S.C.A.), dist. [para. 16].

Pharmacia Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1995), 92 F.T.R. 253; 60 C.P.R.(3d) 328 (T.D.), affd. (1995), 191 N.R. 157; 64 C.P.R.(3d) 450 (F.C.A.), refd to. [para. 18].

Bayer AG et al. v. Apotex Inc. et al. (2003), 240 F.T.R. 267; 29 C.P.R.(4th) 143; 2003 FC 1199, refd to. [para. 18].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2005), 282 F.T.R. 8; 2005 FC 1421, refd to. [para. 18].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1995), 169 N.R. 342; 55 C.P.R.(3d) 302 (F.C.A.), refd to. [para. 23].

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al., [2005] 2 F.C.R. 269; 328 N.R. 149; 37 C.P.R.(4th) 289; 2004 FCA 393, refd to. [para. 23].

Genpharm Inc. v. Procter & Gamble Pharmaceuticals Canada Inc. et al. - see Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al.

Novartis Pharmaceuticals Canada Inc. et al. v. RhoxalPharma Inc. et al. (2005), 330 N.R. 303; 38 C.P.R.(4th) 193; 2005 FCA 11, refd to. [para. 37].

Dableh v. Ontario Hydro (1996), 199 N.R. 57; 68 C.P.R.(3d) 129 (F.C.A.), refd to. [para. 38].

AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 256 N.R. 172; 7 C.P.R.(4th) 272 (F.C.A.), refd to. [para. 104].

Merck Frosst Canada Inc. et al. v. Canada (Minister of Health) et al. (2001), 274 N.R. 297; 12 C.P.R.(4th) 447 (F.C.A.), refd to. [para. 104].

AstraZeneca AB et al. v. Apotex Inc. et al. (2005), 335 N.R. 1 (F.C.A.), refd to. [para. 106].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al., [2000] F.T.R. Uned. 833; 10 C.P.R.(4th) 38 (T.D.), affd. (2002), 18 C.P.R.(4th) 558 (F.C.A.), refd to. [para. 109].

Aventis Pharma Inc. et al. v. Apotex Inc. et al. (2005), 281 F.T.R. 233; 2005 FC 1381, refd to. [para. 109].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2002), 22 C.P.R.(4th) 1 (F.C.A.), refd to. [para. 111].

Counsel:

Gunars A. Gaikis and Yoon Kang, for the applicants;

Harry Radomski, Andrew R. Brodkin and Rick Tuzi, for the respondents.

Solicitors of Record:

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

Goodmans LLP, Toronto, Ontario, for the respondents.

This application was heard on November 15 to 18 and 22, 2005, at Vancouver, British Columbia, by Layden-Stevenson, J., of the Federal Court, who delivered the following reasons for judgment on January 18, 2006.