AstraZeneca Canada Inc. v. Canada (Minister of Health) et al., (2006) 354 N.R. 88 (SCC)

JudgeMcLachlin, C.J.C., Bastarache, Binnie, LeBel, Deschamps, Fish, Abella, Charron and Rothstein, JJ.
CourtSupreme Court (Canada)
Case DateMay 11, 2006
JurisdictionCanada (Federal)
Citations(2006), 354 N.R. 88 (SCC);2006 SCC 49

AstraZeneca Can. Inc. v. Can. (2006), 354 N.R. 88 (SCC)

MLB headnote and full text

[French language version follows English language version]

[La version française vient à la suite de la version anglaise]

....................

Temp. Cite: [2006] N.R. TBEd. NO.001

Apotex Inc. (appellant) v. AstraZeneca Canada Inc., Minister of Health and Attorney General of Canada (respondents)

Apotex Inc. (appellant) v. AstraZeneca Canada Inc., Minister of Health and Attorney General of Canada (respondents) and Canadian Generic Pharmaceutical Association and Canada's Research-Based Pharmaceutical Companies (intervenors)

(30985; 2006 SCC 49; 2006 CSC 49)

Indexed As: AstraZeneca Canada Inc. v. Canada (Minister of Health) et al.

Supreme Court of Canada

McLachlin, C.J.C., Bastarache, Binnie, LeBel, Deschamps, Fish, Abella, Charron and Rothstein, JJ.

November 3, 2006.

Summary:

Apotex filed an abbreviated new drug sub­mission for a notice of compliance com­par­ing its proposed drug (Apo-Omeprazole 20 mg capsules) to AstraZeneca's Losec 20 mg capsules. AstraZeneca took its Losec cap­sules off the market. AstraZeneca subse­quent­ly obtained a notice of compliance pur­suant to a supplementary new drug sub­mis­sion which authorized the sale of Losec 20 mg capsules for a new therapeutic use. Astra­Zeneca had two patents (the new pat­ents) added to the patent list for Losec cap­sules. The Minister of Health issued Apotex a notice of compliance for Apo-Omeprazole capsules without Apotex having addressed the new patents. AstraZeneca brought two ju­dicial review applications, asserting that the Minister erred in issuing Apotex a notice of compliance without requiring that the new patents be addressed by Apotex (T-261-04) or by anyone (T-262-04).

The Federal Court, in a decision reported at 263 F.T.R. 161, dismissed the appli­ca­tions. AstraZeneca appealed.

The Federal Court of Appeal, Sharlow, J.A., dissenting, in a decision reported at 336 N.R. 166, allowed the appeals, set aside the decision of the Federal Court and quashed the notice of compliance that was issued to Apotex. Apotex appealed.

The Supreme Court of Canada allowed the appeal, set aside the Court of Appeal's de­cision and restored the Trial Division's decision.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for - Notice of allegation - In 1989, AstraZeneca ob­tained a notice of compliance (NOC) for its Losec 20 mg capsules - Apotex filed an abbreviated new drug submission for an NOC comparing its proposed drug (Apo-Omeprazole 20 mg capsules) to Losec 20 - AstraZeneca took Losec 20 off the market - AstraZeneca obtained an NOC pursuant to a supplementary new drug sub­mission which authorized the sale of Losec 20 for a new therapeutic use - AstraZeneca had two patents (the new patents) added to the patent list - The Minister subsequently issued Apotex an NOC for the Apo-Ome­prazole capsules without requiring a notice of allegation addressing the new patents under s. 5(1) of the Patented Medicines (NOC) Regulations - AstraZeneca chal­lenged the decision, asserting that the ref­er­ence in s. 5(1) to "another drug for the purpose of demon­strating bioequiva­lence" and "the other drug" against which pat­ents were listed was a reference to Losec 20 in any of its formulations, in­cluding formula­tions never brought to market - The Su­preme Court of Canada disagreed - Sec­tion 5(1) required a patent specific analysis, i.e., a generic manufac­turer was only re­quired to address the cluster of patents listed against submissions relevant to the NOC that gave rise to the com­para­tor drug, in this case, the 1989 version of Losec 20 - If Astra­Zeneca had brought to market a Losec 20 product pursuant to the later NOC's and if Apotex had referred to that modified pro­duct for the purpose of demonstrating bio­equivalence, Apotex would have been required to file a notice of allegation re­specting the new patents - However, Astra­Zeneca had not marketed any product pursuant to the subsequent NOC's and the preconditions to any obli­gations of Apotex under s. 5(1) were not triggered - See paragraphs 32 to 42.

Cases Noticed:

Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al., [2005] 1 S.C.R. 533; 334 N.R. 55; 2005 SCC 26, refd to. [para. 16].

Eli Lilly Canada Inc. v. Canada (Minister of Health), [2003] 3 F.C. 140; 300 N.R. 76; 2003 FCA 24, refd to. [para. 29].

Bell ExpressVu Limited Partnership v. Rex et al., [2002] 2 S.C.R. 559; 287 N.R. 248; 166 B.C.A.C. 1; 271 W.A.C. 1; 2002 SCC 42, refd to. [para. 30].

Statutes Noticed:

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

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

Counsel:

Harry B. Radomski, Andrew R. Brodkin and Miles Hastie, for the appellant;

Gunars A. Gaikis, Yoon Kang, Nancy P. Pei and Colin B. Ingram, for the respon­dent AstraZeneca Canada Inc;

Peter M. Southey and Frederick B. Woyi­wada, for the respondents the Minister of Health and the Attorney General of Can­ada;

Edward Hore and Kevin Zive, for the in­ter­vener the Canadian Generic Phar­ma­ceutical Association;

Patrick S. Smith and Henry S. Brown, Q.C., for the intervener Canada's Re­search-Based Pharmaceutical Companies.

Solicitors of Record:

Goodmans, Toronto, Ontario, for the ap­pellant;

Smart & Biggar, Toronto, Ontario, for the respondent AstraZeneca Canada Inc.;

Attorney General of Canada, Ottawa, On­tario, for the respondents the Minister of Health and the Attorney General of Can­ada;

Hazzard & Hore, Toronto, Ontario, for the intervener the Canadian Generic Phar­ma­ceutical Association;

Gowling Lafleur Henderson, Ottawa, On­tario, for the intervener Canada's Re­search-Based Pharmaceutical Companies.

This appeal was heard on May 11, 2006, by McLachlin, C.J.C., Bastarache, Binnie, LeBel, Deschamps, Fish, Abella, Charron and Rothstein, JJ., of the Supreme Court of Canada. Binnie, J., delivered the following decision for the court in both official lan­guages on November 3, 2006.

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