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This special edition reports on three separate new decisions: (i) the first subsequent entry biologic decision under the Patented Medicines (Notice of Compliance) Regulations, (ii) a Federal Court of Appeal decision, finding that generic manufacturers ratiopharm and Sandoz fell within the PMPRB’s jurisdiction regarding certain medicines, and (iii) a Federal Court decision, finding that data protection can be triggered by post-filing regulatory amendments.
First biologic decision under PMNOC Regulations: Amgen’s prohibition application dismissed
by Urszula Wojtyra
On November 10, 2015, the Federal Court dismissed Amgen’s application for an order prohibiting the issuance of a notice of compliance (NOC) to Apotex for its proposed filgrastim product, which relied on a comparison to Amgen’s NEUPOGEN: Amgen Canada Inc v Apotex Inc, 2015 FC 1261. This is the first decision on a subsequent entry biologic (SEB) product in an application brought under the Patented Medicines (Notice of Compliance) Regulations. Apotex was successful in its allegation of obviousness.
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Federal Court of Appeal finds that Sandoz and ratiopharm are subject to jurisdiction of PMPRB in relation to certain drug sales
by Abigail Smith
As previously reported, on May 27, 2014, Justice O’Reilly of the Federal Court overturned decisions of the Patented Medicine Prices Review Board (PMPRB or the Board), finding that the Board had no jurisdiction to review the prices set by ratiopharm or Sandoz. On November 6, 2015, the Federal Court of Appeal overturned Justice O’Reilly’s decisions, finding that Sandoz and ratiopharm are “patentees” within the meaning of subsection 79(1) of the Patent Act (the Act) and are therefore subject to the jurisdiction of the PMPRB: Canada (Attorney General) v Sandoz Canada Inc, 2015 FCA 249. The matters were returned to the Federal Court so that outstanding issues could be addressed.
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Federal Court confirms data protection correctly triggered by Hospira’s post-filing NDS amendment making a comparison to ELOXATIN
by Paul Jorgensen
On November 6, 2015, the Federal Court dismissed an application for judicial review of the Minister of Health’s decision to not issue a Notice of Compliance (NOC) for Hospira’s OXALIPLATIN FOR INJECTION pending expiry of the data protection term for ELOXATIN: Hospira Healthcare Corp. v Canada (Health), 2015 FC 1205. Hospira’s new drug submission (NDS) was filed before Sanofi-Aventis’s NDS for ELOXATIN was filed. The Court found that the Minister was correct that post-filing amendments to a NDS can trigger data protection under the Food and Drug Regulations, s. C.08.004.1.
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