AB Hassle et al. v. Apotex Inc. et al., (2005) 271 F.T.R. 30 (FC)

JudgeLayden-Stevenson, J.
CourtFederal Court (Canada)
Case DateFebruary 14, 2005
JurisdictionCanada (Federal)
Citations(2005), 271 F.T.R. 30 (FC);2005 FC 234

AB Hassle v. Apotex Inc. (2005), 271 F.T.R. 30 (FC)

MLB headnote and full text

Temp. Cite: [2005] F.T.R. TBEd. FE.052

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

(T-1878-02; 2005 FC 234)

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

Federal Court

Layden-Stevenson, J.

February 14, 2005.

Summary:

AstraZeneca owned a patent (the '693 patent) for an enteric coated dosage form of omeprazole tablets used for treating gastric and duodenal ulcers. The invention disclosed an acid resistant enteric coating and an inert subcoating covering the core of the tablet, which allowed the tablet to pass through the stomach unaltered and to dissolve in the neutral to alkaline environment found in the small intestine. The product was marketed under the name LOSEC. Apotex served correspondence, stating to be a notice of allegation (NOA), on AstraZeneca, alleging that the '693 patent was invalid, and, in any event, its generic version of omeprazole, did not infringe the '693 patent because the Apotex tablet did not have a subcoating between the core and the enteric coating. AstraZeneca applied for a declaration that Apotex's correspondence was not a NOA as contemplated by the Patented Medicines (Notice of Compliance) Regulations, and alternatively, an order prohibiting the Minister of Health from issuing a notice of compliance (NOC) to Apotex until after the expiry of the '693 patent.

The Federal Court held that it would not go so far as to grant the declaration sought but ruled that the NOA was deficient in that Apotex could not add to the contents of its NOA by purporting to establish noninfringement by evidence presented during the proceedings for which there was no basis stated in the NOA. In any event, the court ruled that Apotex was estopped from alleging noninfringement and invalidity in light of prior prohibition proceedings dealing with the same issues or wherein the issues raised in this case could have been dealt with.

Courts - Topic 2015

Jurisdiction - General principles - Controlling abuse of its process - [See Estoppel - Topic 386 ].

Estoppel - Topic 381.1

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - In intellectual property proceedings - Prohibition and notice of allegation proceedings - [See Estoppel - Topic 386 ].

Estoppel - Topic 386

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - Issues decided in prior proceedings - AstraZeneca owned a patent (the '693 patent) for magnesium omeprazole tablets (LOSEC) - Apotex served a notice of allegation (NOA) and detailed statement alleging invalidity and non-infringement - AstraZeneca applied for an order prohibiting the Minister of Health from issuing a notice of compliance (NOC) - AstraZeneca argued that the doctrine of issue estoppel applied to preclude Apotex from alleging noninfringement and invalidity in view of prior prohibition proceedings which allegedly also turned on the construction of the same patent claim - The Federal Court held that issue estoppel applied and Apotex was estopped from alleging noninfringement and invalidity in its NOA - The court held further that this case did not fall within the special circumstances exception such that the court should exercise its discretion not to apply the doctrine - The court opined that even if it was wrong on the estoppel issue, then the doctrine of abuse of process would operate to preclude Apotex from alleging noninfringement and invalidity - See paragraphs 53 to 90.

Estoppel - Topic 398

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - Exceptions - Special circumstances - [See Estoppel - Topic 386 ].

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Notice of allegation - AstraZeneca owned a patent (the '693 patent) for magnesium omeprazole tablets (LOSEC) with an acid resistant enteric coating and an inert subcoating covering the core of the tablet to facilitate digestion in the small intestines - Apotex served a notice of allegation (NOA) and detailed statement alleging invalidity and non-infringement - Prohibition proceedings ensued wherein AstraZeneca argued that the NOA and detailed statement were not proper and did not comply with the Patented Medicines (Notice of Compliance) Regulations (i.e., that Apotex was attempting to expand by evidence and argument the position stated in the NOA) - The Federal Court agreed that Apotex could not add to the contents of its NOA and purport to establish noninfringement by evidence for which no basis was stated in the NOA - To that end, the NOA was deficient because it contained an allegation of noninfringement that turned on what had proven to be an incorrect construction of the '693 patent - Not having raised the allegation in its NOA that the reactive material in its product was not inert, continuous and polymeric, it could not do so by way of evidence or argument - Consequently, Apotex's allegation of noninfringement was not justified - See paragraphs 16 to 52.

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. 14].

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. 14].

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. 15].

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. 15].

Novartis AG et al. v. Apotex Inc. et al. (2002), 22 C.P.R.(4th) 450 (F.C.A.), refd to. [para. 96].

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. 15].

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. 15].

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.72, footnote 25].

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al. (2002), 291 N.R. 339; 20 C.P.R.(4th) 1 (F.C.A.), refd. to. [para. 33].

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

Hoffmann-La Roche Ltd. et al. v. Apotex Inc. et al. (1997), 130 F.T.R. 110; 72 C.P.R.(3d) 480 (F.C.T.D.), affd. (1998), 234 N.R. 8; 82 C.P.R.(3d) 284 (F.C.A.), refd to. [para. 33].

Bayer A.G. et al. v. Canada (Minister of National Health and Welfare) and Apotex Inc. (1995), 179 N.R. 122; 60 C.P.R.(3d) 129 (F.C.A.), refd to. [para. 33].

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. 33].

SmithKline Beecham Pharma Inc. et al. v. Apotex Inc. et al. (2001), 10 C.P.R.(4th) 338 (F.C.A.), refd to. [para. 33].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2004), 245 F.T.R. 24; 31 C.P.R.(4th) 214 (F.C.), affd. (2004), 329 N.R. 152; 2004 FCA 398, refd to. [para. 49].

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. 53].

Procter & Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health) (2003), 33 C.P.R.(4th) 193 (F.C.A.), refd to. [para. 58].

AGF Canadian Equity Fund v. Transamerica Commercial Finance Corp. Canada (1993), 14 O.R.(3d) 161 (Gen. Div.), refd to. [para. 62].

Fidelitas Shipping Co. v. V/0 Exportchleb, [1965] 2 All E.R. 4 (C.A.), refd to. [para. 73].

Maynard v. Maynard, [1951] S.C.R. 346, refd to. [para. 74].

Green v. Weatherill, [1929] 2 Ch. 213, refd to. [para. 74].

Novartis Pharmaceuticals Canada Inc. et al. v. RhoxalPharma Inc. (2004), 34 C.P.R.(4th) 218 (F.C.), refd to. [para. 77].

Toronto (City) et al. 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. 83].

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. 87].

Counsel:

Gunars A. Gaikis and J. Sheldon Hamilton, for the applicants;

H.B. Radomski, Andrew Brodkin and Rick Tuzi, for the respondents.

Solicitors of Record:

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

Goodmans LLP, Toronto, Ontario, for the respondent (Apotex Inc.);

John H. Sims, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent (Minister of Health).

This matter was heard in Vancouver, British Columbia, on December 14 to 17, 2004, by Layden-Stevenson, J., of the Federal Court, who delivered the following decision on February 14, 2005.

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    ...62, 585, 619, 659 A.V. v. iParadigms, LLC, 2008 WL 728389 (E.D.Va. 2008) ............................... 562 AB Hassle v. Apotex Inc., 2005 FC 234, 38 C.P.R. (4th) 216 , 271 F.T.R. 30 , aff’d 2006 FCA 51 , [2006] 4 F.C.R. 513 , [2006] F.C.J. No. 203 .................. 604 Abadía Retuert......
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    ...the use of the drug omeprazole - See paragraphs 69 to 79. Cases Noticed: AB Hassle et al. v. Apotex Inc. et al., [2005] 4 F.C.R. 229 ; 271 F.T.R. 30; 38 C.P.R.(4th) 216 ; 137 A.C.W.S.(3d) 613 ; 2005 FC 234 , affd. (2006), 350 N.R. 219 ; 47 C.P.R.(4th) 329 ; 2006 FCA 51 , dist. [para. ......
  • Grenon v. Canada Revenue Agency et al., 2016 ABQB 260
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    • Court of Queen's Bench of Alberta (Canada)
    • May 6, 2016
    ...is no suggestion that it does not have the authority to assert control over its own process. See, for example, AB Hassle v Apotex Inc , 2005 FC 234, [2005] 4 FCR 229 and Tractor Supply Co of Texas, LP v TSC Stores LP , 2009 FC 154, 341 FTR 157, aff'd 2009 FCA 352, 399 NR 1. Accordingly, iss......
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17 cases
  • Aventis Pharma Inc. et al. v. Apotex Inc. et al., (2005) 283 F.T.R. 171 (FC)
    • Canada
    • Canada (Federal) Federal Court (Canada)
    • November 4, 2005
    ... [2003] 3 S.C.R. 77 ; 311 N.R. 201 ; 179 O.A.C. 291 ; 2003 SCC 63 , refd to. [para. 27]. AB Hassle et al. v. Apotex Inc. et al. (2005), 271 F.T.R. 30; 38 C.P.R.(4th) 216 ; 2005 FC 234 , not folld. [para. Apotex Inc. v. Canada (Minister of National Health and Welfare) et al. (1997), 21......
  • AstraZeneca AB et al. v. Apotex Inc. et al., 2007 FC 688
    • Canada
    • Canada (Federal) Federal Court (Canada)
    • April 2, 2007
    ...the use of the drug omeprazole - See paragraphs 69 to 79. Cases Noticed: AB Hassle et al. v. Apotex Inc. et al., [2005] 4 F.C.R. 229 ; 271 F.T.R. 30; 38 C.P.R.(4th) 216 ; 137 A.C.W.S.(3d) 613 ; 2005 FC 234 , affd. (2006), 350 N.R. 219 ; 47 C.P.R.(4th) 329 ; 2006 FCA 51 , dist. [para. ......
  • Grenon v. Canada Revenue Agency et al., 2016 ABQB 260
    • Canada
    • Court of Queen's Bench of Alberta (Canada)
    • May 6, 2016
    ...is no suggestion that it does not have the authority to assert control over its own process. See, for example, AB Hassle v Apotex Inc , 2005 FC 234, [2005] 4 FCR 229 and Tractor Supply Co of Texas, LP v TSC Stores LP , 2009 FC 154, 341 FTR 157, aff'd 2009 FCA 352, 399 NR 1. Accordingly, iss......
  • AstraZeneca Canada Inc. et al. v. Apotex Inc. et al., 2010 FC 714
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    ...AB et al. v. Apotex Inc. et al. (2006), 285 F.T.R. 258 ; 2006 FC 7 , refd to. [para. 7]. AB Hassle et al. v. Apotex Inc. et al. (2005), 271 F.T.R. 30; 2005 FC 234 , refd to. AstraZeneca AB et al. v. Apotex Inc. et al. (2007), 314 F.T.R. 177 ; 2007 FC 688 , refd to. [para. 7]. AB Hassle......
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1 books & journal articles
  • Table of Cases
    • Canada
    • Irwin Books Intellectual Property Law. Second Edition
    • June 15, 2011
    ...62, 585, 619, 659 A.V. v. iParadigms, LLC, 2008 WL 728389 (E.D.Va. 2008) ............................... 562 AB Hassle v. Apotex Inc., 2005 FC 234, 38 C.P.R. (4th) 216 , 271 F.T.R. 30 , aff’d 2006 FCA 51 , [2006] 4 F.C.R. 513 , [2006] F.C.J. No. 203 .................. 604 Abadía Retuert......

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