Takeda Canada Inc. v. Canada (Minister of Health) et al., (2013) 440 N.R. 346 (FCA)

• Judge: Pelletier, Dawson and Stratas, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: June 11, 2012
• Jurisdiction: Canada (Federal)
• Citations: (2013), 440 N.R. 346 (FCA);2013 FCA 13

Takeda Can. Inc. v. Can. (2013), 440 N.R. 346 (FCA)

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[French language version follows English language version]

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Temp. Cite: [2013] N.R. TBEd. JA.029

Takeda Canada Inc. (appellant) v. The Minister of Health and Attorney General of Canada (respondents)

(A-9-12; 2013 FCA 13; 2013 CAF 13)

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

Federal Court of Appeal

Pelletier, Dawson and Stratas, JJ.A.

January 18, 2013.

Summary:

The Minister of Health, through the Office of the Patented Medicines and Liaison, refused to list Takeda's Canada Inc.'s drug, DEXILANT, on the Register of Innovative Drugs and provide data protection in accordance with s. C.08.004.1 of the Food and Drug Regulations. Takeda applied for judicial review.

The Federal Court, in a decision reported 401 F.T.R. 259, dismissed the application. Takeda appealed.

The Federal Court of Appeal, Stratas, J.A., dissenting, dismissed the appeal.

Food and Drug Control - Topic 1103

Drugs - New and innovative drugs - What constitute - The Minister of Health refused to list Takeda's drug, DEXILANT, as an "innovative drug" (Food and Drug Regulations, s. C.08.004.1(1)), because its medicinal ingredient, dexlansoprazole, was an enantiomer of lansoprazole, a medicinal ingredient previously approved by the Minister - In the Minister's view, a previously approved medicinal ingredient (here an enantiomer) could never be an "innovative drug" regardless of the innovator's effort in developing the drug - That is, any drug containing a medicinal ingredient that was an enantiomer of a previously approved medicinal ingredient was automatically a "variation" - Thus DEXILANT could not qualify as an "innovative drug" and receive data protection - The Federal Court agreed with the Minister's interpretation - Takeda appealed - The Federal Court of Appeal held that both the Minister and the Federal Court correctly interpreted the definition of "innovative drug" - See paragraphs 109 and 117 to 136.

Food and Drug Control - Topic 1115

Drugs - New and innovative drugs - Judicial review - Scope of - The Minister of Health refused to list Takeda's Canada Inc.'s drug, DEXILANT, on the Register of Innovative Drugs and provide data protection in accordance with s. C.08.004.1 of the Food and Drug Regulations - The Minister's refusal was based on her interpretation of the definition of "innovative drug" in s. C.08.004.1(1) - On judicial review, the Federal Court agreed with the Minister's interpretation - Takeda appealed - The Federal Court of Appeal discussed the standard of review, holding that the standard of review to be applied to the Minister's interpretation of the data protection provisions of the Regulations was correctness - See paragraphs 26 to 34 and 111 to 116.

Words and Phrases

Innovative drug - The Federal Court of Appeal discussed the meaning of the phrase "innovative drug" as used in s. C.08.004.1(1) of the Food and Drug Regulations, C.R.C. 1978, c. 870 - See paragraphs 117 to 136.

Cases Noticed:

Teva Canada Ltd. v. Canada (Minister of Health) et al. (2012), 431 N.R. 185; 2012 FCA 106, refd to. [para. 27].

Alberta Teachers' Association v. Information and Privacy Commissioner (Alta.) et al., [2011] 3 S.C.R. 654; 424 N.R. 70; 519 A.R. 1; 539 W.A.C. 1; 2011 SCC 61, refd to. [paras. 28, 112].

Canada (Fisheries and Oceans) v. Suzuki (David) Foundation - see Georgia Strait Alliance et al. v. Canada (Minister of Fisheries and Oceans) et al.

Georgia Strait Alliance et al. v. Canada (Minister of Fisheries and Oceans) et al. (2012), 427 N.R. 110; 2012 FCA 40, refd to. [paras. 29, 112].

Sheldon Inwentash and Lynn Factor Charitable Foundation v. Minister of National Revenue (2012), 432 N.R. 338; 2012 FCA 136, refd to. [para. 29].

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. 30].

AstraZeneca Canada Inc. v. Canada (Minister of Health) et al., [2006] 2 S.C.R. 560; 354 N.R. 88; 2006 SCC 49, refd to. [paras. 30, 115].

Purdue Pharma v. Canada (Attorney General) et al. (2011), 417 N.R. 223; 2011 FCA 132, refd to. [para. 30].

Minister of National Revenue v. Craig (2012), 433 N.R. 111; 2012 SCC 43, refd to. [para. 33].

Globalive Wireless Management Corp. v. Public Mobile Inc. - see Public Mobile Inc. v. Canada (Attorney General) et al.

Public Mobile Inc. v. Canada (Attorney General) et al., [2011] 3 F.C.R. 344; 420 N.R. 50; 2011 FCA 194, leave to appeal denied (2012), 435 N.R. 388 (S.C.C.), refd to. [para. 33].

Toussaint v. Canada (Attorney General) (2011), 420 N.R. 364; 2011 FCA 213, leave to appeal denied (2012), 435 N.R. 381 (S.C.C.), refd to. [para. 33].

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. 40].

Rizzo & Rizzo Shoes Ltd. (Bankrupt), Re, [1998] 1 S.C.R. 27; 221 N.R. 241; 106 O.A.C. 1, refd to. [para. 40].

Bayer Inc. v. Canada (Attorney General) et al., [1999] 1 F.C. 553; 155 F.T.R. 184 (T.D.), affd. (1999), 243 N.R. 170; 87 C.P.R.(3d) 293 (F.C.A.), refd to. [para. 41].

Minister of National Revenue v. Canada Trustco Mortgage Co., [2005] 2 S.C.R. 601; 340 N.R. 1; 2005 SCC 54, refd to. [para. 43].

Placer Dome Canada Ltd. v. Ontario (Minister of Finance), [2006] 1 S.C.R. 715; 348 N.R. 148; 210 O.A.C. 342; 2006 SCC 20, refd to. [para. 44].

Merck & Co. et al. v. Canada (Attorney General) et al. (1999), 176 F.T.R. 21 (T.D.), affd. (2000), 254 N.R. 68; 5 C.P.R.(4th) 138 (F.C.A.), refd to. [para. 55].

Apotex Inc. v. Canada (Minister of Health) - see Canadian Generic Pharmaceutical Association v. Canada (Minister of Health) et al.

Canadian Generic Pharmaceutical Association v. Canada (Minister of Health) et al. (2010), 413 N.R. 89; 2010 FCA 334, refd to. [para. 71].

National Corn Growers' Association et al. v. Canadian Import Tribunal, [1990] 2 S.C.R. 1324; 114 N.R. 81, refd to. [para. 87].

Daniels v. White, [1968] S.C.R. 517, refd to. [para. 87].

Febles v. Canada (Minister of Citizenship and Immigration) (2012), 442 N.R. 290; 2012 FCA 324, refd to. [para. 99].

Esteban v. Canada (Ministre de la Citoyenneté et de l'Immigration) - see Medovarski v. Canada (Ministre de la Citoyenneté et de l'Immigration).

Medovarski v. Canada (Ministre de la Citoyenneté et de l'Immigration), [2005] 2 S.C.R. 539; 339 N.R. 1; 2005 SCC 51, refd to. [para. 116].

de Jong v. Canada (Minister of Citizenship and Immigration) - see Hilewitz v. Canada (Minister of Citizenship and Immigration).

Hilewitz v. Canada (Minister of Citizenship and Immigration), [2005] 2 S.C.R. 706; 340 N.R. 102; 2005 SCC 57, refd to. [para. 116].

Statutes Noticed:

Food and Drug Regulations - see Food and Drugs Act Regulations (Can.).

Food and Drugs Act Regulations (Can.), Food and Drug Regulations, C.R.C. 1978, c. 870, sect. C.08.004.1(1) [para. 8].

Authors and Works Noticed:

Canada, Regulatory Impact Analysis Statement, Canada Gazette, Part II, vol. 140, No. 21, generally [paras. 124, 127]; p. 1496 [paras. 56, 63, 75].

Driedger, Elmer A., Construction of Statutes (2nd Ed. 1983), p. 87 [para. 40].

Health Canada, Guidance for Industry: Stereochemical Issues in Chiral Drug Development (February 14, 2000), p. 2 [para. 65].

Sullivan, Ruth, Sullivan on the Construction of Statutes (5th Ed. 2008), pp. 538, 539 [para. 87].

Counsel:

Christopher Van Barr and Jane Clark, for the appellant;

John L. Syme and Leah Garvin, for the respondents.

Solicitors of Record:

Gowling Lafleur Henderson LLP, Ottawa, Ontario, for the appellant;

Myles J. Kirvan, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondents.

This appeal was heard in Ottawa, Ontario, on June 11, 2012, before Pelletier, Dawson and Stratas, JJ.A., of the Federal Court of Appeal. The following decision was delivered on January 18, 2013, including the following opinions:

Stratas, J.A., dissenting - see paragraphs 1 to 108;

Dawson, J.A. (Pelletier, J.A., concurring) - see paragraphs 109 to 136.