Janssen Inc. v. Canada (Attorney General), 2023 FC 7
Justice Manson - 2023-01-05
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This is an application for judicial review by Janssen of the decision of the Minister of Health dated November 10, 2021, which found that SPRAVATO (esketamine hydrochloride) nasal spray was not an “innovative drug” as defined under subsection C.08.004.1(1) of the Food and Drug Regulations and therefore not entitled to data protection. ... According to Janssen, the shift in language from conferring data protection to drugs that “utilize new chemical entities” to drugs that do “not contain a chemical entity that has been previously approved” [in CUSMA], has sufficiently changed the meaning of “innovative drug” under subsection C.08.004.1(1) so as to render enantiomers of previously approved drugs within its ambit. ... I find that the OSIP reasonably interpreted Janssen’s request and did not read into the Regulations a pre-NOC timing requirement for assessing data protection eligibility. Read as a whole, the OSIP’s reasons do not stand for the proposition that in each case the Minister must only assess data protection eligibility before issuing a NOC; rather, the OSIP’s reasons support the position that the relevant state of the law when assessing data protection eligibility is as it was when the NOC issued.
Decision relates to:
- T-1867-21 - JANSSEN INC. v. ATTORNEY GENERAL OF CANADA et Al.