As we reported, Apotex Inc. applied for judicial review of the Minister’s decisions to disclose information from Apotex’s abbreviated new drug submission in response to an access to information request. The Federal Court of Appeal upheld an order adding
Hard to believe, but we are halfway through 2017 already! It has been a busy six months, with major developments, including Canada preparing to implement CETA and the Supreme Court of Canada abolishing the “Promise Doctrine.” Below, Pharma in Brief
On July 12, 2017, section 5 and subsections 6(3) and 6(4) of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) came into force. These sections amend the Food and Drugs Act to require healthcare institutions to report
Innovators’ growing use of the Patent Register is highlighted in the annual statistical report on the Patented Medicines (Notice of Compliance) Regulations and Data Protection issued by the Therapeutic Products Directorate (TPD) on July 14, 2017. This
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