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

Takeda Canada appealed from the
Federal Court’s decision dismissing Takeda's application for judicial review of
a decision of the Minister. The Minister refused to list Takeda’s drug
dexlansoprazole (DEXILANT) on the Register of Innovative Drugs and provide data
protection under section C.08.004.1 of the Food and Drug Regulations.

Dexlansoprazole is an enantiomer
present in lansoprazole, a racemic mixture previously approved by the Minister.
The main issue was whether dexlansoprazole is a “variation” of lansoprazole.

Appeal is dismissed.

Per Dawson J.A. (J.D. Denis Pelletier
J.A. concurring):

Salts, esters, enantiomers, solvates
and polymorphs are listed in the Regulations as examples of molecular
structures that are “variations” of a previously approved medicinal ingredient,
and are therefore not eligible for data protection. The Governor in Council
would have created an incoherent scheme if the enumerated examples of
variations are, in some unarticulated circumstances, not variations.

It was open to the Governor in
Council to decide, as a matter of policy, that salts, esters, enantiomers,
solvates and polymorphs were not sufficiently different to be “new chemical
entities.” If, as Takeda argues, the data protection regulations are under
inclusive, this is a matter for the Governor in Council to remedy. This Court
ought not to thwart the decision of the Governor in Council as expressed in the
definition of “innovative drug” and in its rejection of the request by the
innovative drug industry that data protection be extended to salts, esters,
enantiomers, solvates and polymorphs.

Per Stratas J.A. (DISSENTING):

Takeda’s appeal should be allowed
and the matter remitted to the Minister for redetermination.

A drug that contains an enantiomer
of a previously approved medicinal ingredient is not automatically excluded
from data protection under section C.08.004.1(1) of the Regulations. The
listed substances in the definition of “innovative drug” – salts, esters,
enantiomers, solvates or polymorphs – are examples of substances that may be
“variations,” depending on the circumstances, and invite special scrutiny.

Whether an enantiomer is a “variation”
of a previously approved medicinal ingredient depends on the circumstances
surrounding the data that had to be submitted to get regulatory approval. In
particular, if regulatory approval for the drug required the submission of
confidential data generated by considerable effort – e.g., new and significant
evidence bearing upon the safety and efficacy of the drug – and the medicinal
ingredient in the drug is “new” in the sense that it has qualities of safety
and efficacy materially different from a previously approved medicinal
ingredient, then it is not a “variation” of that previously approved medicinal
ingredient.