New CETA regulations impacting pharmaceuticals published but not yet in force
The Canadian government has published the proposed patent term restoration / Certificate of Supplementary Protection (CSP) and Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations)
The applicant brought a judicial review application regarding the Minister of Health’s determination that it compared its product to a product with listed patents and was therefore required to address the listed patents. The Federal Court determined that the third-party
As we reported, the Canadian government has approved changes to Canada’s pharmaceutical patent regime, including the introduction of patent term restoration and the replacement of the current summary proceedings under the Patented Medicines (Notice of Compliance) Regulations with full
Health Canada is seeking input on potential changes to the Food and Drug Regulations affecting which drug products would be approvable by way of an abbreviated new drug submission (ANDS) and thus be designated therapeutically equivalent. Comments can
The “Promise Doctrine” has been conclusively rejected by Canada’s highest court as a basis for invalidating a Canadian patent. In a judgment that reverses years of jurisprudence in the lower courts, the Supreme Court of Canada today held that the
As we reported, the Canadian government has approved changes to Canada’s pharmaceutical patent regime, including the introduction of patent term restoration and the replacement of the current summary proceedings under the Patented Medicines (Notice of Compliance) Regulations with full
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
Health Canada recently released the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products (GLPP Guide). The GLPP Guide was released as part of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging
Apotex filed an application for leave to appeal the decision allowing its claim for damages for misfeasance of public office, negligence and breach of contract against Health Canada based on its review of Apotex’s drug submission for Apo-Trazodone. Apotex has
The Canadian government is requesting feedback relating to the renegotiation of the North American Free Trade Agreement. In particular, the government is asking for the public’s “views on the key areas in NAFTA that could be clarified or updated,