The Federal Court dismissed Apotex’s application for judicial review of the Minister of Health’s withdrawal of a notice of compliance (NOC) granted to Apotex Inc. for Apo-omeprazole. Health Canada withdrew the NOC because Apotex had not demonstrated bioequivalence.
Bill 148, An Act to regulate generic medication procurement by owner pharmacists and to amend various legislative provisions, was tabled in the National Assembly on October 5. It will amend An Act respecting Prescription Drug Insurance, introducing the Regulation
In its 2016 Annual Report, the Patented Medicine Prices Review Board (PMPRB) provides a detailed summary and analysis of its findings concerning the 1,435 patented drug products under its jurisdiction. These products represent $15.5 billion in sales and
As we reported, Ontario has introduced legislation that will require pharmaceutical and medical device manufacturers to disclose financial relationships with healthcare professionals and organizations to the government.
The legislation has passed second reading and has been referred to committee.
Pfizer Canada Inc. successfully resisted Apotex’s appeal of the Federal Court’s dismissal of Apotex’s motion for summary judgment for invalidity based on a failure to pay the correct “final fee” owing prior to patent grant. The Federal Court of Appeal
The applicant brought a judicial review of Health Canada’s decision that its new drug submission triggered the PM(NOC) Regulations, and moved for a confidentiality order. The Federal Court has now upheld a decision requiring notice of the motion to
The Patented Medicine Prices Review Board (PMPRB) has issued an excessive-pricing order against Alexion Pharmaceuticals Inc. (Alexion) in respect of SOLIRIS (eculizumab) based on the application of a Lowest International Price Comparison (LIPC) test.
Following a consultation, legislation was introduced in the Ontario Legislature on September 27, 2017 that will require pharmaceutical and medical device manufacturers to disclose financial relationships to healthcare professionals and organizations.
The Health Sector Payment Transparency Act is one
As we reported, amendments to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) took effect on September 21, 2017, as part of the broader roll-out of measures implementing the Comprehensive Economic and Trade Agreement (CETA)
The impact of the Supreme Court’s landmark ruling in AstraZeneca Canada Inc. v Apotex Inc., 2017 SCC 36 (NEXIUM decision) rejecting the “Promise Doctrine” is taking shape in the Federal Court. As we reported, the SCC