AstraZeneca AB et al. v. Apotex Inc. et al., 2007 FC 688

• Judge: Barnes, J.
• Court: Federal Court (Canada)
• Case Date: April 02, 2007
• Jurisdiction: Canada (Federal)
• Citations: 2007 FC 688;(2007), 314 F.T.R. 177 (FC)

AstraZeneca AB v. Apotex Inc. (2007), 314 F.T.R. 177 (FC)

MLB headnote and full text

Temp. Cite: [2007] F.T.R. TBEd. JL.012

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

(T-985-05; 2007 FC 688)

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

Federal Court

Barnes, J.

June 28, 2007.

Summary:

AstraZeneca sought an order under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a notice of compliance to Apotex, a generic drug manufacturer, for the production of omeprazole for use in a combination therapy to treat Helicobacter pylori infections (ulcers).

The Federal Court dismissed the application.

Courts - Topic 2015

Jurisdiction - General principles - Controlling abuse of its process - AstraZeneca owned two patents for omeprazole, a drug used to treat Helicobacter pylori (Hp) infections (ulcers) - In earlier proceedings, Apotex, a generic drug manufacturer, obtained permission to sell Apo-omeprazole for non Hp indications (i.e., it could be used to treat an ulcer by suppressing gastric acid to allow an ulcer to heal but not as a single dose therapy to eradicate bacteria) - In those proceedings Apotex did not challenge the patents' validity and limited its non-infringement argument to a single issue (i.e., Apotex's particular use of the drug) - Subsequently, Apotex sought a notice of compliance (NOC) for the production of omeprazole for use in a combination therapy to treat Hp infections, raising issues of invalidity and non-infringement - AstraZeneca applied for an order to prevent the Minister of Health from issuing the NOC, alleging an abuse of process - AstraZeneca claimed that because of the earlier proceedings involving the same patents, it was an abuse of process to allow Apotex to litigate new issues of non-infringement and invalidity - The Federal Court rejected the abuse of process argument, holding that it was open to Apotex to adopt a multiple notice of allegation approach - Here Apotex had a legitimate basis for limiting its initial allegations to a single issue on non-infringement and AstraZeneca offered no evidence of actual prejudice to its commercial interests - See paragraphs 4 to 18.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for - Notice of allegation - Multiple notices respecting same drug - [See Courts - Topic 2015 ].

Food and Drug Control - Topic 1111.1

Drugs - New drugs - Notice of compliance - Practice - Multiple notices of allegation respecting same drug - [See Courts - Topic 2015 ].

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - AstraZeneca owned a patent ('668 patent), entitled "Use of Omeprazole as an Antimicrobial Agent" - The patent claimed to be a new use patent based on the inventor's discovery that omeprazole had antimicrobial activity and could, therefore, be used effectively in the treatment of Campylobacter infections (Hp infections or ulcers) - Omeprazole had been previously used in the treatment of ulcers caused by Hp but only because of its known anti-acid or antisecretory effects and it was understood that it was not a cure - Apotex, a generic drug manufacturer, sought a notice of compliance (NOC) for the production of omeprazole for use in a combination therapy to treat Hp infections - Apotex argued that the '668 patent should be read as relating only to the use of omeprazole as a form of monotherapy to treat Hp - Apotex asserted that its proposed use of omeprazole would be in combination with antimicrobial medicines, and as such, there would be no infringement of any of the claims of the '668 patent - AstraZeneca sought to prohibit issuance of the NOC, arguing that the patent was not limited to the use of omeprazole as a single drug therapy - The Federal Court construed the '668 patent, agreeing with the construction advanced by AstraZeneca - See paragraphs 20 to 33.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - AstraZeneca owned a patent ('762 patent), entitled "Synergistic Combination of a Substance with Gastric Acid Secretion Inhibiting Effect and an Acid Degradable Antibiotic" - The invention was that the combined use of acid-suppressant compounds like omeprazole (a drug used to treat ulcers) with an acid degradable antibiotic led to an increase in the bioavailability of the antibiotic - Apotex, a generic drug manufacturer, sought a notice of compliance (NOC) for the production of Apo-omeprazole for use in a combination therapy to treat Helicobacter pylori (Hp) infections (ulcers) - Apotex alleged that the '762 patent was invalid as it was anticipated by a letter published on July 25, 1992, which disclosed the results of a clinical trial involving the combination of omeprazole and clarithromycin for the treatment of Hp - An issue arose as to whether the letter was citable prior art because its publication fell between two potentially relevant priority filing dates for the '762 patent - Apotex argued that the operative filing date was June 8, 1993, so the letter was prior citable art - AstraZeneca argued that the "subject matter" of its patent was reasonably inferable from the first priority application made in Sweden on April 24, 1992, and therefore the letter was not citable - The Federal Court held that the language of the first Swedish priority application was not sufficient to support an inference that it included clarithromycin - The court accepted Apotex's argument as to the operative filing date and, therefore, the letter was citable art - See paragraphs 61 to 68.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - AstraZeneca owned a patent ('762 patent), entitled "Synergistic Combination of a Substance with Gastric Acid Secretion Inhibiting Effect and an Acid Degradable Antibiotic" - The invention was that the combined use of acid-suppressant compounds like omeprazole (a drug used to treat ulcers) with an acid degradable antibiotic led to an increase in the bioavailability of the antibiotic - Apotex, a generic drug manufacturer, sought a notice of compliance for the production of Apo-omeprazole for use in a combination therapy to treat Helicobacter pylori (Hp) infections (ulcers) - Apotex claimed that the '762 patent was invalid on the ground of anticipation - In this context an issue arose as to the meaning of "bioavailability" as used in the patent claims - The Federal Court construed the claims accordingly - See paragraphs 69 to 79.

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 89.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - AstraZeneca owned a patent ('762 patent), entitled "Synergistic Combination of a Substance with Gastric Acid Secretion Inhibiting Effect and an Acid Degradable Antibiotic" - The invention was that the combined use of acid-suppressant compounds like omeprazole (a drug used to treat ulcers) with an acid degradable antibiotic led to an increase in the bioavailability of the antibiotic - Apotex, a generic drug manufacturer, sought a notice of compliance (NOC) for the production of Apo-omeprazole for use in a combination therapy to treat Helicobacter pylori (Hp) infections (ulcers) - Apotex claimed that the '762 patent was invalid on the ground of obviousness - The Federal Court agreed - See paragraphs 89 to 107.

Patents of Invention - Topic 1602

Grounds of invalidity - Anticipation - Test for - The Federal Court referred to the test for anticipation - See paragraph 34.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - AstraZeneca owned a patent ('668 patent), entitled "Use of Omeprazole as an Antimicrobial Agent" - The patent claimed to be a new use patent based on the inventor's discovery that omeprazole had antimicrobial activity and could, therefore, be used effectively in the treatment of Campylobacter infections (Hp infections or ulcers) - Apotex, a generic drug manufacturer, sought a notice of compliance for Apo-omeprazole and claimed that the '668 patent was invalid for anticipation - The Federal Court held that the '668 patent was anticipated by a previously published abstract and a prior patent - The court stated that the '668 patent was a classic case of evergreening and it was invalid - See paragraphs 34 to 48.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - AstraZeneca owned a patent ('762 patent), entitled "Synergistic Combination of a Substance with Gastric Acid Secretion Inhibiting Effect and an Acid Degradable Antibiotic" - The invention was that the combined use of acid-suppressant compounds like omeprazole (a drug used to treat ulcers) with an acid degradable antibiotic led to an increase in the bioavailability of the antibiotic - Apotex, a generic drug manufacturer, sought a notice of compliance for the production of Apo-omeprazole for use in a combination therapy to treat Helicobacter pylori (Hp) infections (ulcers) - Apotex claimed that the '762 patent was anticipated by prior art publications - The Federal Court examined the prior art and agreed that the '762 patent was invalid for anticipation - See paragraphs 80 to 88.

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - [See second Patents of Invention - Topic 1032 ].

Words and Phrases

Bioavailability - The Federal Court discussed the meaning of this word as it was used in a patent claim respecting 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. 13].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 362 N.R. 91; 2007 FCA 140, affing. (2006), 289 F.T.R. 139; 2006FC 341, refd to. [para. 15].

Pharmascience 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) 106; 25 C.P.R.(4th) 289; 2003 FCA 234, refd to. [para. 18].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 361 N.R. 308; 2007 FCA 153, refd to. [para. 19].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 2007 FCA 209, refd to. [para.19].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC 67, refd to. [para. 22].

Free World Trust v. Électro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 22].

Wyeth-Ayerst Canada Inc. et al. v. Faulding (Canada) Inc. et al. (2002), 223 F.T.R. 189; 2002 FCT 969, refd to. [para. 22].

Ranbaxy v. Warner, [2006] EWCA Civ. 876 (C.A.), refd to. [para. 30].

Abbott Laboratories Ltd. et al. v. Canada (Minister of Health) et al. (2006), 304 F.T.R. 104; 2006 FC 1411, refd to. [para. 33].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 2006 FC 1234, refd to. [para. 34].

Astra Aktiebolag et al. v. Andrx Pharmaceuticals Inc. et al. (2002), 222 F. Supp.2d 423 (S.D.N.Y.), affd. (2003), 84 Fed. App'x. 76 (Fed. Cir.), refd to. [para. 45].

Aventis Pharma Inc. v. Apotex Inc. et al. (2006), 349 N.R. 183; 46 C.P.R.(4th) 401 (F.C.A.), refd to. [para. 49].

Searle (G.D.) & Co. et al. v. Novopharm Ltd. et al. (2007), 296 F.T.R. 254; 2007 FC 81, refd to. [para. 62].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2006), 350 N.R. 242; 2006 FCA 187, refd to. [para. 87].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2007), 366 N.R. 290; 2007 FCA 217, refd to. [para. 89].

Procter & Gamble Co. v. Bristol-Myers Canada Ltd. (1979), 39 C.P.R.(2d) 145 (F.C.T.D.), refd to. [para. 99].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 307 F.T.R. 271; 2006 FC 1558, affd. (2007), 370 N.R. 109; 2007 FCA 187, refd to. [para. 106].

Counsel:

Ms. Kang, Ms. Ing and Mr. Gaikis, for the applicants;

Mr. Radomski, Mr. Brodkin, Ms. Simmons and Mr. Tuzi, for the respondents.

Solicitors of Record:

Smart & Biggar, for the applicants;

Goodmans LLP, for the respondents.

This application was heard at Ottawa, Ontario, on April 2, 2007, before Barnes, J., of the Federal Court, who delivered the following judgment on June 28, 2007.