Takeda Applied: Enantiomers per se Ineligible for Data Protection

 Janssen Inc v Canada (Attorney General) 2020 FC 904 Zinn J

esketamine hydrochloride / SPRAVATO

Janssen applied for data protection for SPRAVATO, in which the medicinal ingredient is esketamine hydrochloride, an enantiomer of the ketamine hydrochloride [3]. Ketamine hydrochloride is the medicinal ingredient in the previously approved drug KETALAR [7]. A drug is only eligible for data protection if it is an “innovative drug” under section C.08.004.1(1) of the Food and Drug Regulations, which provides that a drug is not eligible if it is a variation of a previously approved drug “such as a salt, ester, enantiomer, solvate or polymorph.” In a split decision in Takeda 2013 FCA 13 the FCA interpreted this provision as providing that enantiomers are per se ineligible for data protection: see here. Relying on Takeda, the Minister refused Janssen’s application.

Janssen then sought judicial review of the Minister’s decision. In a straightforward decision, Zinn J applied Takeda to dismiss the application, on the basis that there are no factual differences which could permit him to depart from Takeda [26].