Takeda Canada Inc. v. Canada (Health), 2013 FCA 13 (2013)

Parts:Takeda Canada Inc. v. Canada (Health)
Reporting Judge:PELLETIER J.A.
Docket Number:A-9-12
 
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Federal Court of Appeal - Takeda Canada Inc. v. Canada (Health) [Anonymoused]

Source: http://decisions.fca-caf.gc.ca/en/2013/2013fca13/2013fca13.html

Date: 20130118

Docket: A-9-12

Citation: 2013 FCA 13

CORAM: PELLETIER J.A.

DAWSON J.A.

STRATAS J.A.

BETWEEN:

TAKEDA CANADA INC.

Appellant and

THE MINISTER OF HEALTH and

ATTORNEY GENERAL OF CANADA

Respondents

Heard at Ottawa, Ontario, on June 11, 2012.

Judgment delivered at Ottawa, Ontario, on January 18, 2013.

REASONS FOR JUDGMENT BY: DAWSON J.A.

CONCURRED IN BY: PELLETIER J.A.

DISSENTING REASONS BY: STRATAS J.A.

Date: 20130118

Docket: A-9-12

Citation: 2013 FCA 13

CORAM: PELLETIER J.A.

DAWSON J.A.

STRATAS J.A.

BETWEEN:

TAKEDA CANADA INC.

Appellant and

THE MINISTER OF HEALTH and

ATTORNEY GENERAL OF CANADA

Respondents

REASONS FOR JUDGMENT

STRATAS J.A. ( Dissenting reasons)

[1] The appellant, Takeda Canada Inc., appeals from the judgment dated September 12, 2011 of the Federal Court ( per Justice Near): 2011 FC 1444. The Federal Court dismissed Takeda’s application for judicial review of a decision of the respondent Minister.

[2] The Minister refused to list Takeda’s drug, DEXILANT, on the Register of Innovative Drugs and provide data protection under section C.08.004.1 of the Food and Drug Regulations , C.R.C. c. 870, as amended by the Regulations Amending the Food and Drug Regulations (Data Protection) , SOR/2006-241.

[3] The Minister refused to list DEXILANT based on her interpretation of the definition of “innovative drug” in subsection C.08.004.1(1) of the Regulations. The Federal Court agreed with the Minister’s interpretation, found that DEXILANT was not an “innovative drug” under the subsection, and dismissed Takeda’s application for judicial review. Takeda appeals to this Court.

[4] For the reasons set out below, I find that the Minister wrongly interpreted the term “innovative drug” under subsection C.08.004.1(1) of the Regulations. Properly interpreted, the definition of “innovative drug” under the subsection can include a drug such as DEXILANT.

[5] Therefore, I would allow Takeda’s appeal, with costs, and remit to the Minister for redetermination the issue whether DEXILIANT is an “innovative drug” entitled to data protection.

A. The data protection regulations: section C.08.004.1 of the Regulations

[6] The provisions contained in Section C.08.004.1 of the Regulations are frequently described as the “data protection regulations.” The data protection regulations protect an innovator who submits undisclosed data in support of an application for approval to market certain drugs in certain circumstances, described below. For a period of time, it prevents others from using the innovator’s data in support of their own submissions for drug approval.

[7] Before the enactment of the data protection regulations, one of the impediments to a generic drug manufacturer’s ability to obtain approval of the right to market a generic drug was the existence of an unexpired patent. After the enactment of the data protection regulations, generic drug manufacturers cannot obtain approval for their generic drug until the period of market exclusivity of the innovative drug has expired, even where there is no patent protection for that drug.

[8] The data protection regulations read as follows:
C.08.004.1 (1) The following definitions apply in this section.

“abbreviated new drug submission” includes an abbreviated extraordinary use new drug submission. ( présentation abrégée de drogue nouvelle )

“innovative drug” means 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. ( drogue innovante )

“new drug submission” includes an extraordinary use new drug submission. ( présentation de drogue nouvelle )

“pediatric populations” means the following groups: premature babies born before the 37th week of gestation; full-term babies from 0 to 27 days of age; and all children from 28 days to 2 years of age, 2 years plus 1 day to 11 years of age and 11 years plus 1 day to 18 years of age. ( population pédiatrique )

(2) This section applies to the implementation of Article 1711 of the North American Free Trade Agreement , as defined in the definition "Agreement" in subsection 2(1) of the North American Free Trade Agreement Implementation Act , and of paragraph 3 of Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights set out in Annex 1C to the World Trade Organization Agreement, as defined in the definition "Agreement" in subsection 2(1) of the World Trade Organization Agreement Implementation Act .

(3) If a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug,

( a ) the manufacturer may not file a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission in respect of the new drug before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug; and

( b ) the Minister shall not approve that submission or supplement and shall not issue a notice of compliance in respect of the new drug before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug.

(4) The period specified in paragraph (3)( b ) is lengthened to eight years and six months if

( a ) the innovator provides the Minister with the description and results of clinical trials relating to the use of the innovative drug in relevant pediatric populations in its first new drug submission for the innovative drug or in any supplement to that submission that is filed within five years after the issuance of the first notice of compliance for that innovative drug; and

( b ) before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug, the Minister determines that the clinical trials were designed and conducted for the purpose of increasing knowledge of the use of the innovative drug in those pediatric populations and this knowledge would thereby provide a health benefit to members of those populations.

(5) Subsection (3) does not apply if the innovative drug is not being marketed in Canada.

(6) Paragraph (3)( a ) does not apply to a subsequent manufacturer if the innovator consents to the filing of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission by the subsequent manufacturer before the end of the period of six years specified in that paragraph.

(7) Paragraph (3)( a ) does not apply to a subsequent manufacturer if the manufacturer files an application for authorization to sell its new drug under section C.07.003.

(8) Paragraph (3)( b ) does not apply to a subsequent manufacturer if the innovator consents to the issuance of a notice of compliance to the subsequent manufacturer before the end of the period of eight years specified in that paragraph or of eight years and six months specified in subsection (4).

(9) The Minister shall maintain a register of innovative drugs that includes information relating to the matters specified in subsections (3) and (4).

C.08.004.1 Les définitions qui suivent s’appliquent au présent article.

« drogue innovante » S’entend de toute drogue qui contient un ingrédient médicinal non déjà approuvé dans une drogue par le ministre et qui ne constitue pas une variante d’un ingrédient médicinal déjà approuvé tel un changement de sel, d’ester, d’énantiomère, de solvate ou de polymorphe. ( innovative drug )

« population pédiatrique » S’entend de chacun des groupes suivants : les bébés prématurés nés avant la 37 e semaine de gestation, les bébés menés à terme et âgés de 0 à 27 jours, tous les enfants âgés de 28 jours à deux ans, ceux âgés de deux ans et un jour à 11 ans et ceux âgés de 11 ans et un jour à 18 ans. ( pediatric populations )

« présentation abrégée de drogue nouvelle » S’entend également d’une présentation abrégée de drogue nouvelle pour usage exceptionnel. ( abbreviated new drug submission )

« présentation de drogue nouvelle » S’entend également d’une présentation de drogue nouvelle pour usage exceptionnel. ( new drug submission )

(2) Le présent article s’applique à la mise en œuvre de l’article 1711 de l’Accord de libre-échange nord-américain , au sens du terme « Accord » au paragraphe 2(1) de la Loi de mise en œuvre de l’Accord de libre-échange nord-américain , et du paragraphe 3 de l’article 39 de l’Accord sur les aspects des droits de propriété intel lectuelle qui touchent au commerce figurant à l’annexe 1C de l’Accord sur l’Organisation mondiale du commerce, au sens du terme « Accord » au paragraphe 2(1) de la Loi de mise en œuvre de l’Accord sur l’Organisation mondiale du commerce.

(3) Lorsque le fabricant demande la délivrance d’un avis de conformité pour une drogue nouvelle sur la base...

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