The Federal Court of Appeal has reaffirmed the constitutionality of the excessive price provisions of the Patent Act that ground the jurisdiction of the Patented Medicine Prices Review Board (PMPRB) over patented medicines.
In 2015, the PMPRB
On December 14, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal the decision finding that Health Canada does not owe a duty of care to drug manufacturers in reviewing drug submissions.
Case: Apotex Inc v Canada (Minister
The first court action under the newly amended Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) was commenced on December 11, 2017. Genentech, Inc. and Hoffmann-La Roche Limited v Amgen Canada Inc. (T-1921-17) addresses allegations of infringement
On December 12, 2017, Bill 160 passed third reading and received Royal Assent. Included in Bill 160 is the Health Sector Payment Transparency Act (the “Act”). This Act will come into force at a later date to be
On Monday, December 11, 2017, the Patented Medicine Prices Review Board (PMPRB) released a scoping paper providing a high-level overview of how a new, risk-based approach to its mandate could function under revised Guidelines following forthcoming amendments to
The Pharmaceutical Advertising Advisory Board (PAAB) has announced an updated Code of Advertising Acceptance (Code). The new Code will be implemented beginning on January 1, 2018.
The primary change is to the Code’s format. It will
The Federal Court of Appeal has provided additional guidance on the framework for analyzing obviousness. In dismissing an appeal from the Federal Court, the Court of Appeal identified the search for an inventive concept as an “unnecessary satellite debate” and
On Friday, December 1, 2017, the government revealed proposed amendments to the Patented Medicines Regulations (the Regulations) conferring new powers on the Patented Medicine Prices Review Board (PMPRB) and setting the stage for revised Guidelines from the
We provide an update of developments in recent PMPRB cases below. Notably, the PMPRB has ordered Alexion Pharmaceuticals Inc. to pay $4,245,329.60 in excess revenues earned on sales of SOLIRIS (eculizumab) to Her Majesty in right of Canada and has
The Federal Court found that the PMPRB wrongly asserted jurisdiction over Differin® pricing based on an incorrect application of the patent-pertaining analysis. The Court allowed an application for judicial review by Galderma Canada Inc. (Galderma) from the