Aventis Pharma Inc. et al. v. Apotex Inc. et al., (2005) 283 F.T.R. 171 (FC)

JudgeTremblay-Lamer, J.
CourtFederal Court (Canada)
Case DateNovember 04, 2005
JurisdictionCanada (Federal)
Citations(2005), 283 F.T.R. 171 (FC);2005 FC 1504

Aventis Pharma Inc. v. Apotex Inc. (2005), 283 F.T.R. 171 (FC)

MLB headnote and full text

Temp. Cite: [2005] F.T.R. TBEd. NO.030

Aventis Pharma Inc. and Aventis Pharma Deutschland GmbH (applicants) v. Apotex Inc. and the Minister of Health (respondents)

(T-2459-03; 2005 FC 1504)

Indexed As: Aventis Pharma Inc. et al. v. Apotex Inc. et al.

Federal Court

Tremblay-Lamer, J.

November 4, 2005.

Summary:

Aventis Pharma Inc. applied for a declaration that a letter from Apotex Inc. was not a Notice of Allegation under the Patented Medicines (Notice of Compliance) Regulations and, alternatively, an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex in respect of ramipril capsules until after the expiration of the Canadian patent '457. Apotex submitted that the '457 patent was invalid on the basis of anticipation, obviousness and obvious double patenting.

The Federal Court dismissed the application. The '457 patent was invalid for obviousness.

Estoppel - Topic 381.1

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - In intellectual property 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 - Aventis Pharma Inc. owned the '457 patent for ramipril capsules - Apotex Inc. served a notice of allegation (NOA) and detailed statement alleging invalidity - Aventis argued that the doctrine of issue estoppel and abuse of process precluded Apotex from serving its NOA where Apotex's allegations related to the same product and the same patent in prior prohibition proceedings where Apotex had alleged non-infringement of the patent - The Federal Court rejected the argument - Apotex was entitled to serve the second NOA because the second allegation was separate and distinct from the first one - While the first dealt with non-infringement, the second alleged that the patent was invalid based on anticipation, obviousness and double-patenting - The issue of invalidity of the '457 patent did not give rise to the doctrine of abuse of process - See paragraphs 26 to 47.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - Aventis Pharma Inc. applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex in respect of ramipril capsules until after the expiration of the Canadian patent '457 - Apotex submitted that the '457 patent was invalid on the basis of obviousness - Apotex submitted that by the priority date of the '457 patent (1984), the idea and effectiveness of ACE inhibitors (including ramipril) for the treatment of heart failure were known by skilled persons - The Federal Court accepted the argument and held that the '457 patent was invalid for obviousness - It was clear from the prior art that, as of 1984, a skilled person would have known that vasodilators were useful in the treatment of heart failure, that ACE inhibitors acted as vasodilators and that the prior patents and prior publications showed that ACE inhibitors as a class were useful in the treatment of heart failure - There was extensive literature at the time which referred to the use of ACE inhibitors for the treatment of heart failure - Apotex referred to 94 pieces of prior art - See paragraphs 85 to 133.

Patents of Invention - Topic 1584

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Chemical processes - [See Patents of Invention - Topic 1582 ].

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - [See Patents of Invention - Topic 1582 ].

Patents of Invention - Topic 1602

Grounds of invalidity - Anticipation - Test for - Aventis Pharma Inc. applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex in respect of ramipril capsules until after the expiration of the Canadian patent '457 - Apotex submitted that the '457 patent was invalid on the basis of anticipation - Apotex submitted that the invention embodied by the '457 patent was anticipated by four pieces of prior art - The Federal Court rejected the argument - None of the prior art documents contained a direction so clear that a skilled person would in every case and without possibility of error be led to the claimed invention - In every case, the skilled person had to make assumptions or read in details that the publication did not mention explicitly - See paragraphs 57 to 84.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - [See Patents of Invention - Topic 1602 ].

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - [See Patents of Invention - Topic 1602 ].

Patents of Invention - Topic 1653

Grounds of invalidity - Anticipation by prior patent - What constitutes anticipation - [See Patents of Invention - Topic 1602 ].

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention - Aventis Pharma Inc. applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex in respect of ramipril capsules until after the expiration of the Canadian patent '457 - In the '457 patent, Aventis claimed the use of ramipril capsules for the treatment of cardiac insufficiency - In addition to the '457 patent, Aventis owned Canadian patent '087, which specifically claimed ramipril and disclosed the use of the compound as an ACE inhibitor and for the treatment of hypertension - Apotex submitted that the '457 patent was invalid on the basis of obvious double patenting - The Federal Court rejected the argument - Hypertension and cardiac insufficiency were distinct clinical disorders - The '457 patent was a new use for a known compound, the subject matter of which one could properly obtain a patent over - There was no double patenting - See paragraphs 134 to 140.

Cases Noticed:

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88, refd to. [para. 17].

Free World Trust v. Électro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150, refd to. [para. 18].

Danyluk v. Ainsworth Technologies Inc. et al., [2001] 2 S.C.R. 460; 272 N.R. 1; 149 O.A.C. 1, refd to. [para. 27].

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. 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. 27].

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.), leave to appeal refused [1998] 1 S.C.R. viii; 226 N.R. 400, refd to. [para. 41].

Bayer AG et al. v. Canada (Minister of National Health and Welfare) et al. (1997), 142 F.T.R. 130; 77 C.P.R.(3d) 129 (T.D.), refd to. [para. 41].

Bayer AG et al. v. Apotex Inc. et al. (1998), 156 F.T.R. 303; 84 C.P.R.(3d) 23 (F.C.T.D.) affd. (2001) , 278 N.R. 178; 14 C.P.R.(4th) 263 (F.C.A.), refd to. [para. 41].

Bayer Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1998), 154 F.T.R. 192; 82 C.P.R.(3d) 359 (T.D.), refd to. [para. 41].

AstraZeneca AB et al. v. Apotex Inc. et al. (2005), 335 N.R. 1; 2005 FCA 183, refd to. [para. 41].

Procter and Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health) et al. (2003), 313 N.R. 380; 33 C.P.R.(4th) 193 (F.C.A.), dist. [para. 42].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2005), 341 N.R. 330 (F.C.A.), refd to. [para. 48].

AB Hassle v. Canada (Minister of Health and Welfare) (2000), 256 N.R. 172; 7 C.P.R.(4th) 272 (F.C.A.), refd to. [para. 48].

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. 51].

SmithKline Beecham Pharma Inc. et al. v. Apotex Inc. et al., [2001] 4 F.C. 518; 208 F.T.R. 105 (T.D.), affd. [2003] 1 F.C. 118; 291 N.R. 168 (F.C.A.), refd to. [para. 51].

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

Janssen-Ortho Inc. v. Novopharm Ltd. et al. (2004), 264 F.T.R. 202 (T.D.), refd to. [para. 51].

Proctor & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al., [2005] 2 F.C.R. 269; 328 N.R. 149 (F.C.A.), refd to. [para. 52].

Bayer Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 258 N.R. 238; 6 C.P.R.(4th) 285 (F.C.A.), refd to. [para. 52].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130, refd to. [paras. 53, 124].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2005), 279 F.T.R. 164 (F.C.), refd to. [para. 54].

General Tire & Rubber Co. v. Firestone Tyre & Rubber Co., [1972] R.P.C. 457 (C.A.), refd to. [para. 66].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 8 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 67].

Reeves Brothers Inc. v. Toronto Quilting and Embroidery Ltd. (1978), 43 C.P.R.(2d) 145 (F.C.T.D.), refd to. [para. 68].

SmithKline Beecham Pharma Inc. et al. v. Apotex Inc. et al., [2003] 1 F.C. 118; 291 N.R. 168 (F.C.A.), leave to appeal refused (2003), 312 N.R. 200 (S.C.C.), refd to. [para. 81].

Windsurfing International Inc. v. Bic Sports Inc. (1985), 63 N.R. 218; 8 C.P.R.(3d) 241 (F.C.A.), refd to. [para. 93].

Diversified Products Corp. and Brown Fitzpatrick Lloyd Patent Ltd. v. Tye-Sil Corp. (1991), 125 N.R. 218; 35 C.P.R.(3d) 350 (F.C.A.), refd to. [para. 93].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al. (2005), 271 F.T.R. 159; 39 C.P.R.(4th) 202; 2005 FC 390, refd to. [para. 95].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd. (1998), 145 F.T.R. 161; 79 C.P.R.(3d) 193 (T.D.), affd. [2001] 1 F.C. 495; 262 N.R. 137; 10 C.P.R.(4th) 65 (F.C.A.), affd. [2002] 4 S.C.R. 153; 296 N.R. 130; 21 C.P.R.(4th) 499 (S.C.C.), refd to. [para. 96].

AB Hassle v. Apotex Inc. (2003), 27 C.P.R.(4th) 465 (F.C.T.D.), affd. [2004] N.R. Uned. 200; 2004 FCA 369, refd to. [para. 97].

Illinois Tool Works Inc. et al. v. Cobra Anchors Co. (2002), 221 F.T.R. 161 (T.D.), affd. (2003), 312 N.R. 184; 2003 FCA 358 (F.C.A.), refd to. [para. 97].

AB Hassle et al. v. Genpharm Inc. et al. (2003), 243 F.T.R. 6 (T.D.), refd to. [para. 98].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 56 C.P.R.(2d) 145, refd to. [para. 130].

Authors and Works Noticed:

Fox, Harold G., The Canadian Law and Practice Relating to Letters Patent for Inventions (4th Ed. 1969), generally [para. 18].

Lange, Donald J., The Doctrine of Res Judicata in Canada (2000), pp. 347, 348 [para. 29].

Counsel:

Gunars A. Gaikis and Kavita Ramamoorthy, for the applicants;

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

Solicitors of Record:

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

Goodmans LLP, Toronto, Ontario, for the respondent, Apotex;

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

This application was heard on September 20 to 22, 2005, at Toronto, Ontario, by Tremblay-Lamer, J., of the Federal Court, who delivered the following judgment on November 4, 2005.

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12 practice notes
  • AstraZeneca AB et al. v. Apotex Inc. et al., 2007 FC 688
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    ...v. Abbott - see Abbott Laboratories et al. v. Canada (Minister of Health) et al. Aventis Pharma Inc. et al. v. Apotex Inc. et al. (2005), 283 F.T.R. 171; 44 C.P.R.(4th) 108 ; 2005 FC 1504 , refd to. [para. 16]. Merck & Co. et al. v. Apotex Inc. (2003), 305 N.R. 68 ; 227 D.L.R.(4th) ......
  • Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al., 2006 FC 1135
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    ... (2003), 239 F.T.R. 32 ; 29 C.P.R.(4th) 350 ; 2003 FC 1055 , refd to. [para. 24]. Aventis Pharma Inc. et al. v. Apotex Inc. et al. (2005), 283 F.T.R. 171; 2005 FC 1504 , refd to. [para. Glaxo Group Ltd. et al. v. Canada (Minister of Health) et al., [2001] F.T.R. Uned. 29 ; 2001 FCT 16 ......
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    ...10, 2003 (invalidity) December 29, 2003/T-2459-03 Tremblay-Lamer J. dismisses on November 4, 2005 ( Aventis Pharma Inc v Apotex Inc , 2005 FC 1504, 283 FTR 171 [ 44 C.P.R. (4th) 108 ] [ Ramipril NOC #3 (FC) ]) '089 Patent November 17, 2003 January 5, 2004/T -11-04 von Finckenstein J. dis......
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12 cases
  • AstraZeneca AB et al. v. Apotex Inc. et al., 2007 FC 688
    • Canada
    • Canada (Federal) Federal Court (Canada)
    • April 2, 2007
    ...v. Abbott - see Abbott Laboratories et al. v. Canada (Minister of Health) et al. Aventis Pharma Inc. et al. v. Apotex Inc. et al. (2005), 283 F.T.R. 171; 44 C.P.R.(4th) 108 ; 2005 FC 1504 , refd to. [para. 16]. Merck & Co. et al. v. Apotex Inc. (2003), 305 N.R. 68 ; 227 D.L.R.(4th) ......
  • Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al., 2006 FC 1135
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    • September 5, 2006
    ... (2003), 239 F.T.R. 32 ; 29 C.P.R.(4th) 350 ; 2003 FC 1055 , refd to. [para. 24]. Aventis Pharma Inc. et al. v. Apotex Inc. et al. (2005), 283 F.T.R. 171; 2005 FC 1504 , refd to. [para. Glaxo Group Ltd. et al. v. Canada (Minister of Health) et al., [2001] F.T.R. Uned. 29 ; 2001 FCT 16 ......
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    • March 14, 2014
    ...10, 2003 (invalidity) December 29, 2003/T-2459-03 Tremblay-Lamer J. dismisses on November 4, 2005 ( Aventis Pharma Inc v Apotex Inc , 2005 FC 1504, 283 FTR 171 [ 44 C.P.R. (4th) 108 ] [ Ramipril NOC #3 (FC) ]) '089 Patent November 17, 2003 January 5, 2004/T -11-04 von Finckenstein J. dis......
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