A suite of amendments to the Patent Act and the Patented Medicines Regulations (the Regulations) will soon require holders of Certificates of Supplementary Protection (CSPs) to report information to the Patented Medicine Prices Review Board (PMPRB

Pharma in Brief team
Proposed amendments to the PM(NOC) Regulations: Patents claiming different salt forms of medicinal ingredients eligible for inclusion on the Patent Register
On April 23, 2021, Proposed PM(NOC) Amendments [1] were published in the Canada Gazette, Part I. These amendments permit patents claiming different forms of a medicinal ingredient (e.g., salt forms) to be listed on the patent register and are intended…
New Proposed Amendments to the Federal Courts Rules: Proportionality, Abuse of Process, and Motions Before the Federal Court of Appeal
On April 10, 2021, the Rules Committee of the Federal Court of Appeal and the Federal Court (the Rules Committee) launched a consultation on amendments to the Federal Courts Rules (the Rules) on proportionality, abuse of process, and…
Federal Court upholds patent validity and issues declarations of infringement against two generic apixaban tablets
In one of its first patent decisions of 2021, the Federal Court tackled arguments regarding the relevant date for insufficiency allegations and the level of disclosure required for demonstrated utility. The Court resolved these and other issues in the…
Pharma in Brief: The 2020 Year in Review
In this article, the Pharma in Brief team has curated and provided updates on the most significant topics we covered in 2020.
Introduction
The Canadian pharma and life sciences space saw many developments in 2020, despite and in some cases…
Canada amends CSP Regulations, adding UK to list of “timely submission requirement” countries
Canada has added the UK to the list of countries that must be considered for the “timely submission requirement” in an application for a Certificate of Supplementary Protection (CSP). The change was implemented by an amendment to the…
Divided success in PM(NOC) actions regarding glatiramer acetate
The Federal Court has decided two infringement actions concerning glatiramer acetate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations of anticipation based upon “speculative” prior art and rejected an argument that there…
Prosecution history cannot be invoked against patent licensees
The Federal Court has found that prosecution history evidence is inadmissible to rebut representations made by a patent licensee (as opposed to the patentee) on claims construction. The Court also considered the issues of “essential elements”, infringement, and obviousness in…
NOC issued after Federal Court overturns Minister’s decision on effective date of consent letter under the PM(NOC) Regulations
On October 29, 2020, the Federal Court ordered the Minister of Health to immediately issue a notice of compliance (NOC) for a biosimilar drug following a dispute about the effective date of a consent letter under the Patented …
Finality, finally: Adir and Servier Canada Inc. confirm their perindopril win
The 14 year perindopril litigation in Canada is over, with Adir and Servier Canada Inc. (collectively “Servier”) emerging victorious against Apotex Inc. and Apotex Pharmachem Inc. (collectively “Apotex”). The end was marked by the Supreme Court…