As we reported, Janssen Inc. et al. filed an application for leave to appeal with the Supreme Court of Canada on December 9, 2016 with respect to the Federal Court of Appeal’s decision addressing a generic manufacturer’s notice obligations when obtaining a notice of compliance (NOC) by way of a cross-referenced drug submission.

On June 22, 2017, the Supreme Court dismissed the application for leave.

Case: Janssen Inc, et al v Hospira Healthcare Corporation, et al (SCC Docket: 37342)

Drug: REMICADE® (infliximab)

Nature of case: Appeal of judicial review of a decision of the Minister of Health to not require notice under section 5 of the Patented Medicines (Notice of Compliance) Regulations (Regulations)

Successful party: Hospira Healthcare Corporation, et al (Hospira)

Date of decision: June 22, 2017

The Minister had issued NOCs for two generic products without requiring that the generics serve a notice of allegation. Because the submissions made reference to already approved generic drugs, the FCA found that the submissions did not give rise to a new or different basis for asserting that a particular product was infringing. Any potential infringement could be addressed in infringement proceedings.

Health Canada has provided notice that the FCA decision affects the application of section 5 of the Regulations with respect to administrative drug submissions (reported here).