AB Hassle et al. v. Genpharm Inc. et al., (2003) 243 F.T.R. 6 (FC)

• Judge: Layden-Stevenson, J.
• Court: Federal Court (Canada)
• Case Date: December 22, 2003
• Jurisdiction: Canada (Federal)
• Citations: (2003), 243 F.T.R. 6 (FC);2003 FC 1443

AB Hassle v. Genpharm Inc. (2003), 243 F.T.R. 6 (FC)

MLB headnote and full text

Temp. Cite: [2004] F.T.R. TBEd. JA.012

AB Hassle, AstraZeneca AB and AstraZeneca Canada Inc. (applicants) v. Genpharm Inc., Takeda Chemical Industries, Ltd. and the Minister of Health (respondents)

(T-2005-01; 2003 FC 1443)

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

Federal Court

Layden-Stevenson, J.

December 22, 2003.

Summary:

The applicants (AB Hassle et al.) owned patents relating to omeprazole which was an inhibitor of gastric acid secretion and marketed under the trade name "Losec". Genpharm Inc., a generic drug manufacturer, filed a notice of allegation (NOA) under s. 5 of the Patented Medicine (Notice of Compliance) Regulations, raising issues of non-infringement and invalidity. The applicants filed an application under s. 6 of the Regulations seeking an order prohibiting the Minister from issuing a notice of compliance (NOC). The primary issue was whether Genpharm Inc.'s allegations of invalidity and non-infringement were justified.

The Federal Court allowed the applicants' application. The court held that Genpharm's various allegations of invalidity and noninfringement were not justified. The court therefore issued an order prohibiting the Minister from issuing the NOC to Genpharm until after the expiry of the applicants' patents.

Food and Drug Control - Topic 1104

Drugs - New drugs - Notice of compliance - General - The Federal Court referred to the burden of proof in proceedings under s. 6 of the Patented Medicine (Notice of Compliance) Regulations (i.e., proceedings to prohibit the Minister from issuing a notice of compliance following the filing of a notice of allegation) - See paragraph 39.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for - [See Food and Drug Control - Topic 1104 ; both Patents of Invention - Topic 1589 , Patents of Invention - Topic 1605 and both Patents of Invention - Topic 2888 ].

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Federal Court referred to the test for obviousness - See paragraph 45.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - The applicants (AB Hassle et al.) owned patents, incl. patent '693, relating to omeprazole which was an inhibitor of gastric acid secretion and marketed under the trade name "Losec" - Patent '693 claimed a novel oral formulation of omeprazole (i.e., a form of omeprazole with a modified enteric coating by the addition of an alkaline compound or a subcoating) - Genpharm Inc., a generic drug manufacturer, filed a notice of allegation (NOA) under s. 5 of the Patented Medicine (Notice of Compliance) Regulations, alleging that patent '693 was invalid for obviousness - The applicants filed an application under s. 6 of the Regulations to prohibit the Minister from issuing a notice of compliance (NOC) - The Federal Court issued the order sought - The court held that patent '693 was not invalid on the ground of obviousness - See paragraphs 1 to 72.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - The applicants (AB Hassle et al.) owned patents, incl. patent '377, relating to omeprazole which was an inhibitor of gastric acid secretion and marketed under the trade name "Losec" - Patent '377 was a formulation patent consisting of an active ingredient, a basic inorganic salt stabilizing agent and an enteric coating - Genpharm Inc., a generic drug manufacturer, filed a notice of allegation (NOA) under s. 5 of the Patented Medicine (Notice of Compliance) Regulations, alleging that the invention claims in patent '377 were obvious and therefore not inventive - The applicants filed an application under s. 6 of the Regulations to prohibit the Minister from issuing a notice of compliance (NOC) - The Federal Court issued the order sought, holding that Genpharm's allegation respecting the '377 patent was not justified - See paragraphs 88 to 113.

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - The applicants (AB Hassle et al.) owned patents, incl. patent '693, relating to omeprazole which was an inhibitor of gastric acid secretion and marketed under the trade name "Losec" - Patent '693 claimed a novel oral formulation of omeprazole (i.e., a form of omeprazole with a modified enteric coating by the addition of an alkaline compound or a subcoating) - Genpharm Inc., a generic drug manufacturer, filed a notice of allegation (NOA) under s. 5 of the Patented Medicine (Notice of Compliance) Regulations, arguing that patent '693 was anticipated by a prior patent - The applicants filed an application under s. 6 of the Regulations to prohibit the Minister from issuing a notice of compliance (NOC) - The Federal Court issued the prohibition order, holding that Genpharm's allegation of invalidity on the basis of anticipation was not justified - See paragraphs 82 to 87.

Patents of Invention - Topic 2888

Infringement of patent - Acts constituting an infringement - Of particular patents - The applicants (AB Hassle et al.) owned patents, incl. patent '668, relating to omeprazole which was an inhibitor of gastric acid secretion and marketed under the trade name "Losec" - Patent '668 was a new use patent respecting the use of omeprazole as an antimicrobial agent directed to the treatment of a particular form of bacteria - Genpharm, a generic drug manufacturer, filed a notice of allegation (NOA) under s. 5 of the Patented Medicine (Notice of Compliance) Regulations, arguing that its drug would be used only for the "old" purpose and would not be used for antimicrobial activity; therefore, it would not infringe the '668 patent - The applicants filed an application under s. 6 of the Regulations to prohibit the Minister from issuing a notice of compliance (NOC) - The applicants argued that physicians and pharmacists would prescribe and distribute the generic form of omeprazole for antimicrobial purposes without regard to the fact that it was not formally approved for that purpose - The Federal Court issued the prohibition order - The court concluded that if a NOC issued and Genpharm were to sell its omeprazole, patients would infringe the applicants' new use patent - The court was satisfied, on a balance of probabilities, that Genpharm's allegation of noninfringement was not justified - See paragraphs 114 to 156.

Patents of Invention - Topic 2888

Infringement of patent - Acts constituting an infringement - Of particular patents - The applicants (AB Hassle et al.) owned patents, incl. patent '762, relating to omeprazole which was an inhibitor of gastric acid secretion and marketed under the trade name "Losec" - Patent '762 was a new use patent relating to a combination of a substance which inhibited gastric acid secretion (e.g., omeprazole) and an acid-degradable antibacterial compound - Genpharm, a generic drug manufacturer, filed a notice of allegation (NOA) under s. 5 of the Patented Medicine (Notice of Compliance) Regulations, arguing that its drug would be used only for the "old" purpose and would not be used for antimicrobial activity or mixed with an antibacterial compound; therefore, it would not infringe the '762 patent - The applicants filed an application under s. 6 of the Regulations to prohibit the Minister from issuing a notice of compliance (NOC) - The Federal Court issued the prohibition order finding that Genpharm's allegation of noninfringement was not justified - See paragraphs 157 to 192.

Cases Noticed:

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. 8].

Novartis Pharmaceuticals Canada Inc. et al. v. Abbott Laboratories Ltd. et al. (2000), 258 N.R. 105; 7 C.P.R.(4th) 264 (F.C.A.), refd to. [para. 8].

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. 10].

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. 10].

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

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; 80 C.P.R.(3d) 368, refd to. [para. 11].

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. 11].

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. 11].

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 (F.C.A.), refd to. [para. 11].

Novartis AG et al. v. Apotex Inc. et al. (2002), 298 N.R. 348 (F.C.A.), refd to. [para. 11].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2002), 225 F.T.R. 1; 22 C.P.R.(4th) 466; 2002 FCT 1138 (F.C.), refd to. [para. 39].

GlaxoSmithKline Inc. et al. v. Genpharm Inc. et al. (2003), 241 F.T.R. 42 (F.C.), refd to. [para. 40].

Canamould Extrusions Ltd. et al. v. Driangle Inc. (2003), 229 F.T.R. 104; 25 C.P.R.(4th) 343 (T.D.), refd to. [para. 40].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 9 C.P.R.(4th) 168, refd to. [para. 40].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 67; 263 N.R. 88; 9 C.P.R.(4th) 129, refd to. [para. 40].

Dableh v. Ontario Hydro, [1996] 3 F.C. 751; 199 N.R. 57 (F.C.A.), refd to. [para. 43].

Beloit Canada Ltd. v. Valmet Oy (1986), 64 N.R. 287; 7 C.I.P.R. 205; 8 C.P.R. (3d) 289 (F.C.A.), refd to. [para. 45].

Bayer AG et al. v. Apotex Inc. et al. (2003), 240 F.T.R. 267; 2003 FC 1199 (F.C.), refd to. [para. 45].

AB Hassle et al. v. Apotex Inc. et al., [2003] F.T.R. Uned. 741; 2003 FCT 771 (T.D.), refd to. [para. 47].

Illinois Tool Works Inc. v. Cobra Fixations Cie - see Illinois Tool Works Inc. et al. v. Cobra Anchors Co.

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. 47].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd. (1998), 145 F.T.R. 161; 79 C.P.R.(3d) 193 (T.D.), affd. (2000), 262 N.R. 137; 10 C.P.R.(4th) 65 (F.C.A.), affd. (2002), 296 N.R. 130; 21 C.P.R.(4th) 499 (S.C.C.), refd to. [para. 51].

Farbwerke Hoechst AG. v. Halocarbon (Ont.) Ltd. et al. (1979), 27 N.R. 582; 42 C.P.R.(2d) 145 (S.C.C.), refd to. [para. 51].

Airseal Controls Inc. v. M & I Heat Transfer Products Ltd. (1993), 72 F.T.R. 196; 53 C.P.R.(3d) 259 (T.D.), affd. (1997), 220 N.R. 58; 77 C.P.R.(3d) 126 (F.C.A.), refd to. [para. 76].

Procter & Gamble Co. v. Kimberly-Clark of Canada Ltd. (No. 4) (1991), 49 F.T.R. 31; 40 C.P.R.(3d) 1 (T.D.), refd to. [para. 104].

Cochlear Corp. v. Cosem Neurostim ltée (1995), 102 F.T.R. 81; 64 C.P.R.(3d) 10 (T.D.), refd to. [para. 104].

Mahurkar v. Vas-Cath of Canada Ltd. and Gambro Canada Ltd. (1988), 16 F.T.R. 48; 18 C.P.R.(3d) 417 (T.D.), affd. (1990), 105 N.R. 138; 32 C.P.R.(3d) 409 (F.C.A.), refd to. [para. 104].

Bayer Aktiengesellschaft v. Apotex Inc. (1995), 60 C.P.R.(3d) 58 (Ont. Gen. Div.), affd. (1998), 113 O.A.C. 1; 82 C.P.R.(3d) 526 (C.A.), leave to appeal dismissed [1999] 1 S.C.R. v; 239 N.R. 200; 124 O.A.C. 199, refd to. [para. 112].

AB Hassle v. Canada (Minister of National Health and Welfare) (2002), 22 C.P.R.(4th) 1 (F.C.A.), refd to. [para. 126].

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. 127].

R. v. Mohan, [1994] 2 S.C.R. 9; 166 N.R. 245; 71 O.A.C. 241, refd to. [para. 129].

Vancouver Island Peace Society et al. v. Canada (Minister of Defence) et al., [1994] 1 F.C. 102; 64 F.T.R. 127 (T.D.), affd. (1995), 179 N.R. 106 (F.C.A.), leave to appeal dismissed (1995), 192 N.R. 80 (S.C.C.), refd to. [para. 129].

Counsel:

Gunars Gaikis and Yoon Kang, for the applicants;

Roger Hughes, Q.C., Kamleh Nicola and Jeilah Chan, for the respondent, Genpharm Inc.;

Gary O'Neil and Christopher Van Barr, for the respondent, Takeda Chemical Industries Ltd.

Solicitors of Record:

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

Sim, Hughes, Ashton & McKay LLP, Toronto, Ontario, for the respondent, Genpharm Inc.;

Gowling Lafleur Henderson LLP, Ottawa, Ontario, for the respondent, Takeda Chemical Industries Ltd.;

Morris, Rosenberg, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, Minister of Health.

This application was heard at Toronto, Ontario, on October 27-31, 2003, before Layden-Stevenson, J., of the Federal Court, who delivered the following decision on December 22, 2003.