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

• Jurisdiction: Federal Jurisdiction (Canada)
• Court: Federal Court (Canada)
• Judge: Near, J.
• Citation: 2011 FC 1444,(2011), 401 F.T.R. 259 (FC)
• Date: 13 October 2011

Takeda Can. Inc. v. Can. (2011), 401 F.T.R. 259 (FC)

MLB headnote and full text

Temp. Cite: [2011] F.T.R. TBEd. DE.032

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

(T-2044-10; 2011 FC 1444)

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

Federal Court

Near, J.

December 9, 2011.

Summary:

The Minister of Health, through the Office of the Patented Medicines and Liaison (OPML), refused to list Takeda's Canada Inc.'s drug, DEXILANT, on the Register of Innovative Drugs (Register) 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 dismissed the application.

Food and Drug Control - Topic 1102

Drugs - New and innovative drugs - Legislation, re - [See second Food and Drug Control - Topic 1103 and Statutes - Topic 1660 ].

Food and Drug Control - Topic 1103

Drugs - New and innovative drugs - What constitute - The Health Minister refused to list Takeda's drug, DEXILANT, on the Register of Innovative Drugs and provide data protection (Food and Drug Regulations) because it was not an "innovative drug" as defined by s. C.08.004.1(1) of the Regulations since it was a "variation" of a previously approved medicinal ingredient - Takeda applied for judicial review - The Federal Court dismissed the application - The Minister correctly interpreted the definition of "innovative drug" to exclude DEXILANT as a variant - Dexlansoprazole, the medicinal ingredient in DEXILANT, was an enantiomer of a previously-approved medicinal ingredient lansoprazole (PREVACID) - It therefore fell under one of the recognized variations within s. C.08.004.1(1), irrespective of the extent of the data collected by Takeda for the New Drug Submission - Data protection was only intended to apply to "new chemical entities" falling under the definition of an "innovative drug" and that did not constitute variations - See paragraphs 24 to 44.

Food and Drug Control - Topic 1103

Drugs - New and innovative drugs - What constitute - Section C.08.004.1 of the Food and Drug Regulations defined an "innovative drug" as meaning "a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph" - The Federal Court interpreted the definition of "innovative drug" and the word "variation" within that definition - See paragraphs 31 to 42.

Food and Drug Control - Topic 1115

Drugs - New and innovative drugs - Judicial review - Scope of - At issue on judicial review was the Minister of Health's interpretation of the phrase "innovative drug" in s. C.08.004.1 of the Food and Drug Regulations - The Federal Court held that the Minister's expertise was confined to scientific assessments as opposed to legal interpretation - The legal question was also one of general application to the drug listing determination process - A standard of correctness therefore had to be applied by the Court in reviewing the interpretation of the "innovative drug" definition and exclusion of variations - See paragraphs 15 to 23.

Statutes - Topic 1660

Interpretation - Extrinsic aids - Legislative history - Regulatory Impact Analysis Statements - In interpreting the meaning of the word "variation" in the definition of "innovative drug" in s. C.08.004.1(1) of the Food and Drug Regulations, the Federal Court looked to the Regulatory Impact Analysis Statement - See paragraphs 34 to 36.

Statutes - Topic 5356

Operation and effect - Delegated legislation - Regulations - Interpretation - General - The Federal Court briefly reviewed the principles applicable in the interpretation of regulations - See paragraphs 27 to 30.

Words and Phrases

Innovative drug - The Federal Court 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 30 to 40.

Words and Phrases

Variation - The Federal Court discussed the meaning of the word "variation" as used in s. C.08.004.1(1) of the Food and Drug Regulations, C.R.C. 1978, c. 870 - See paragraphs 30 to 40.

Cases Noticed:

Epicept Corp. v. Canada (Minister of Health) (2010), 377 F.T.R. 29; 2010 FC 956, refd to. [para. 17].

Teva Canada Ltd. v. Canada (Minister of Health) et al. (2011), 390 F.T.R. 1; 2011 FC 507, refd to. [para. 18].

Celgene Corp. v. Canada (Attorney General), [2011] 1 S.C.R. 3; 410 N.R. 127; 2011 SCC 1, refd to. [para. 19].

Smart & Biggar v. Canada (Attorney General) et al. (2008), 377 N.R. 173; 291 D.L.R.(4th) 660; 2008 FCA 129, refd to. [para. 20].

Scott Paper Ltd. v. Canada (Attorney General) - see Smart & Biggar v. Canada (Attorney General) et al.

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. 21].

Khosa v. Canada (Minister of Citizenship and Immigration) (2009), 385 N.R. 206; 2009 SCC 12, refd to. [para. 23].

Minister of National Revenue v. Canada Trustco Mortgage Co., [2005] 2 S.C.R. 601; 340 N.R. 1; 259 D.L.R.(4th) 193; 2005 SCC 54, refd to. [para. 27].

Németh v. Canada (Minister of Justice), [2010] 3 S.C.R. 281; 408 N.R. 198; 2010 SCC 56, refd to. [para. 29].

Bayer Inc. v. Canada (Attorney General) et al. (1999), 243 N.R. 170; 87 C.P.R.(3d) 293 (F.C.A.), refd to. [para. 34].

Canadian Generic Pharmaceutical Association v. Canada (Minister of Health) et al. (2010), 413 N.R. 89; 2010 FCA 334, refd to. [para. 38].

Statutes Noticed:

Food and Drugs Act Regulations (Can.), Food and Drug Regulations, C.R.C. 1978, c. 870, sect. C.08.004.1(1) [para. 11].

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

Authors and Works Noticed:

Canada Gazette, Part II, vol 140, no. 21, (Regulatory Impact Analysis Statement) [para. 33].

Sullivan, Ruth, Sullivan on the Construction of Statutes (5th Ed. 2008), pp. 223, 300, 301 [para. 28].

Counsel:

Christopher Van Barr and Jane Clark, for the applicant;

John L. Syme, for the respondents.

Solicitors of Record:

Gowling Lafleur Henderson, Ottawa, Ontario, for the applicant;

John L. Syme, Department of Justice, Ottawa, Ontario, for the respondents.

This application was heard in Ottawa, Ontario, on October 13, 2011, before Near, J., of the Federal Court, who delivered the following decision on December 9, 2011.