In Janssen-Ortho Inc. v. Minister of Health and Teva Canada Limited et al. (Court File T-240-10), Janssen-Ortho Inc. (“JOI”) brought an application for judicial review challenging the Minister of Health’s decision to approve Teva Canada Limited’s (“Teva’s”) Novo-methylphenidate ER-C tablets. The Minister of Health had approved the Novo-methylphenidate ER-C tablets in early 2010 as a generic version of JOI’s CONCERTA methylphenidate tablets (the “Minister’s Decision”). Teva brought a motion to dismiss the proceeding on the basis that it was, among other things, so completely improper as to be bereft of any possibility of success. The Court agreed with Teva’s position, and JOI’s application for judicial review of the Minister’s Decision was dismissed by Prothonotary Tabib by Order dated July 19, 2010.
JOI sought judicial review of the Minister’s Decision on two broad grounds: First, on the basis that, for example, the Notice of Compliance (“NOC”) issued by the Minister of Health names the CONCERTA methylphenidate tablets as the Canadian reference product, but in JOI’s view, the NOC did not constitute a declaration of therapeutic or clinical equivalence between the Novo-methylphenidate ER-C tablets and the CONCERTA methylphenidate tablets. Second, in the alternative, JOI requested that the Court order the Minister to amend the Notice of Compliance (“NOC”) for Teva’s Novo-methylphenidate ER-C tablets by removing the reference on the NOC to JOI’s CONCERTA methylphenidate tablets.
At the hearing of the motion, JOI abandoned its request for alternative relief seeking that the Court order the Minister to amend the NOC for Teva’s Novo-methylphenidate ER-C tablets by removing the reference to JOI’s CONCERTA methylphenidate tablets. C.08.004(4) of the Food and Drug Regulations requires that an NOC for a generic drug “shall state the name of the Canadian reference product referred to in the submission.” As such, the NOC for a generic drug is required by C.08.004(4) of the Food and Drug Regulations to explicitly set out the corresponding brand version of the generic drug. As stated by the Court, the relief sought by JOI could not granted by the Court, because it would breach C.08.004(4) resulting in an NOC that would be noncompliant with the Food and Drug Regulations.
Regarding the main relief sought by JOI, as stated by the Court, JOI was not challenging the conduct of the Minister of Health in issuing the NOC, and JOI was not seeking to interfere with the Minister’s determinations of safety and efficacy in respect of the Novo-methylphenidate ER-C tablets. Furthermore, JOI was neither challenging the validity of any part of the Food and Drug Regulations, nor seeking to set them aside. As such, the Court held that JOI was not seeking relief against any action of the Minister of Health, and consequently there was no basis for judicial review of the Minister’s Decision. As a result, the Court granted Teva’s motion and struck JOI’s application for judicial review in its entirety.