Wednesday, January 23, 2013


Wednesday, January 23, 2013

Last week the Federal Court of Appeal in a two to one decision affirmed the Minister of Health’s and Federal Court’s decision that DEXILANT did not qualify as an “innovative drug” under “the data protection regulations” of the Food and Drug Regulations and thus was not entitled to data protection. The full decision can be found at the following link:

Under the data protection regulations, an “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.”

There was no question that Dexlansoprazole, the medicinal ingredient of DEXILANT, had not previously been approved in a drug.  What was at issue was whether or not Dexlansoprazole was a variation of a previously approved medicinal ingredient.

Dexlansoprazole is one of two enantiomers found in the previously approved racemic mixture, lansoprazole.

As noted at paragraph 17 of the FCA decision:

In [the Minister of Health’s] view, drugs containing any of the listed variations of a previously approved medicinal ingredient (here an enantiomer) can never be an “innovative drug,” regardless of the innovator’s effort in developing the drug. Any drug containing a medicinal ingredient that is an enantiomer of a previously approved medicinal ingredient is automatically a “variation.”

The issue before the FCA was one of statutory interpretation and the applicable standard of review was that of correctness.  Namely, was the definition of “innovative drug” taken in context and with attention given to its text and purpose, interpreted correctly by both the Minister of Health and the Federal Court.

The FCA answered yes and agreed with the interpretation that all listed examples in the definition of “innovative drug” are variations and dismissed the appeal.

As an aside, Justice Stratas in his dissenting reasons provided an interesting discussion on Canada’s data protection obligations under NAFTA and TRIPS and a compelling argument that the automatic exclusion of enantiomers “will lead to results which are contrary to Canada’s NAFTA and TRIPS obligations” (see paragraph [96]).

His comments when considered together with the scientific evidence that many enantiomers have different biological and pharmalogical properties to their stereoisomers, supports the notion that the Governor in Council should revisit the definition of “innovative drug”.