AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al., 2002 FCA 421

• Judge: Linden, Sexton and Evans, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: November 01, 2002
• Jurisdiction: Canada (Federal)
• Citations: 2002 FCA 421;(2002), 298 N.R. 323 (FCA)

AB Hassle v. Can. (2002), 298 N.R. 323 (FCA)

MLB headnote and full text

Temp. Cite: [2002] N.R. TBEd. NO.070

AB Hassle and AstraZeneca Canada Inc. (appellants/applicants) v. The Minister of National Health and Wel­fare and Apotex Inc. (respondents/respondents)

(A-716-01; 2002 FCA 421)

Indexed As: AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al.

Federal Court of Appeal

Linden, Sexton and Evans, JJ.A.

November 1, 2002.

Summary:

AB Hassle, owner of the patent for "Use of Omeprazole as an Anti-Microbial Agent", applied under s. 6 of the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the issuance of a Notice of Compliance (NOC) to Apotex to manufac­ture and sell omeprazole. AB Hassle's patent claims were limited to Campylobacter infec­tions. Apotex submitted that its generic drug would not be made, used or sold for that purpose and that, accordingly, granting an NOC would not infringe AB Has­sle's patent. AB Hassle submitted that it need not estab­lish direct infringement by Apotex. It was sufficient to prove third party in­fringement (i.e., that notwithstanding Apo­tex's state­ments, patients would use Apotex's drug for Campylobacter infections). Apotex submitted that AB Hassle had to establish direct in­fringement or an induce­ment to third parties to infringe the patent.

The Federal Court of Canada, Trial Divi­sion, in a judgment reported 213 F.T.R. 161, dismissed AB Hassle's application to pro­hibit issuance of the NOC. The infringe­ment re­ferred to in s. 5(1)(b)(iv) ("by that person") was limited to direct infringement by the generic drug manufacturer or indirect in­fringement by third parties that was induced or procured by the generic drug manufac­turer. AB Hassle failed to prove direct in­fringement by Apotex and there was no evidence that infringement of the patent by third parties would occur if an NOC was granted. AB Hassle appealed.

The Federal Court of Appeal dismissed the appeal.

Evidence - Topic 7012

Opinion evidence - Expert evidence - Basis for opinion - The Federal Court of Appeal stated that "a party tendering expert evi­dence has 'the obligation of establishing, through properly admissible evidence, the factual basis on which such opinions are based. Before any weight can be given to an expert's opinion, the facts upon which the opinion is based must be found to exist'." - See paragraph 45.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compli­ance - Intervention on application for (incl. notice of allegation) - Section 5(1)(b)(iv) of the Patented Medicines (Notice of Compliance) Regulations required a gen­eric drug manufacturer seeking a Notice of Compliance (NOC) to allege that "no claim for the use of the medicine would be infringed by the mak­ing, constructing, using or selling by that person of the drug for which the sub­mission for the notice of compliance is filed" - The issue was whether "by that person" meant that an NOC was to be issued unless there was direct infringement by the generic drug manufacturer or whether indirect infringe­ment by third parties would suffice to preclude issuance of an NOC (i.e., "by that person" meant "by anyone") - The trial judge held that the in­fringement referred to in s. 5(1)(b)(iv) ("by that person") was limited to direct in­fringement by the gen­eric drug manufac­turer or indirect in­fringe­ment by third parties (such as patients) that was induced or procured by the generic drug manufac­turer - The Federal Court of Appeal agreed - See paragraphs 26 to 60.

Food and Drug Control - Topic 1106

Drugs - New drugs - Notice of compli­ance - Issuance of - AB Hassle, owner of the patent for "Use of Omeprazole as an Anti-Microbial Agent", applied under s. 6 of the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the issuance of a Notice of Compliance (NOC) to Apotex to manufac­ture and sell omepra­zole - AB Hassle's patent claims were limited to one type of infection - Apotex sub­mitted that its gen­eric drug would not be made, used or sold for that infection and that, accordingly, granting an NOC would not directly in­fringe AB Hassle's patent - AB Hassle submitted that it need not establish direct infringement by Apotex - It was sufficient to prove third party infringement (i.e., that notwithstanding Apotex's statements, patients would use Apotex's drug for the same infec­tion) - Apotex sub­mitted that AB Hassle had to establish direct infringe­ment or an induce­ment to third parties to infringe the patent - The trial judge dis­missed AB Hassle's applica­tion to pro­hibit issuance of the NOC - The infringe­ment referred to in s. 5(1)(b)(iv) ("by that per­son") was limited to direct infringement by the gen­eric drug manufac­turer or indirect infringement by third parties that was induced or procured by the generic drug manufacturer - AB Hassle failed to prove direct infringement by Apotex and there was no evidence that infringement by third parties would occur if an NOC was granted - The Federal Court of Appeal affirmed the decision - See paragraphs 26 to 60.

Patents of Invention - Topic 2890

Infringement of patent - Acts constituting an infringement - Inducing infringement - The Federal Court of Canada, Trial Divi­sion, stated that "a party who induces or procures another to infringe a patent is itself responsible for infringement of the patent. In this manner, the infringing actions of a third party can become rel­evant under the NOC Regulations where the applicant (first person) can demonstrate that the second person has induced or procured another to infringe the patent in question. A patentee wishing to rely on the doctrine of induced infringement must allege and prove each of the following elements: (a) that the act of infringement was completed by the direct infringer; (b) the completed act of infringement was influenced by the seller, to the point where without said influence, infringement by the buyer would not otherwise take place; and, (c) the influence must knowingly be exer­cised by the seller, such that the seller knows that his influence will result in the completion of the act of infringement." - The Federal Court of Appeal agreed - See paragraphs 26 to 60.

Practice - Topic 8820

Appeals - General principles - Duty of appellate court re findings of credibility by trial judge - The Federal Court of Appeal stated that "an appellate court is not entitled to re-assess expert evidence and substitute its own view. These limits on the scope of appellate review apply equally to docu­mentary expert evidence. ... it is wrong for an appeal court to second-guess the trial judge's assessment of the credibil­ity of experts, unless an egregious error can be demonstrated." - See paragraphs 29 to 30.

Cases Noticed:

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al. (2002), 291 N.R. 339 (F.C.A.), dist. [para. 26].

N.V. Bocimar S.A. v. Century Insurance Co. of Canada, [1987] 1 S.C.R. 1247; 76 N.R. 212, refd to. [para. 30].

Kirin-Anger Inc. et al. v. Hoffmann-La Roche Ltd. (2000), 267 N.R. 150 (F.C.A.), refd to. [para. 30].

Housen v. Nikolaisen et al. (2002), 286 N.R. 1; 219 Sask.R. 1; 272 W.A.C. 1 (S.C.C.), refd to. [para. 31].

Hoffmann-La Roche Ltd. et al. v. Canada (Minister of National Health and Wel­fare) et al. (1996), 205 N.R. 331; 70 C.P.R.(3d) 206 (F.C.A.), refd to. [para. 35].

R. v. Abbey, [1982] 2 S.C.R. 24; 43 N.R. 30, refd to. [para. 45].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 55.2(4)(e) [para. 28].

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Reg­ulations, SOR/93-133, sect. 2, sect. 5(1), sect. 6 [para. 27].

Patented Medicines (Notice of Compli­ance) Regulations - see Patent Act Reg­ulations (Can.).

Authors and Works Noticed:

Hughes and Woodley on Patents (Loose­leaf Ed.) (July 2002), Issue 52, p. 413 [para. 35].

Sopinka, John, Lederman, Sidney N., and Bryant, Alan W., The Law of Evidence in Canada (2nd Ed. 1999), p. 623 [para. 44].

Counsel:

Gunars Gaikis and Sheldon Hamilton, for the appellants;

Harry Radomski and Andrew Brodkin, for the respondent, Apotex Inc.

Solicitors of Record:

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

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

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

This appeal was heard on September 17, 2002, at Ottawa, Ontario, before Linden, Sexton and Evans, JJ.A., of the Federal Court of Appeal.

On November 1, 2002, Sexton, J.A., delivered the following judgment for the Court of Appeal.