Tag archives: PM(NOC) Regulations

FCA upholds selection patent protecting apixaban and rejects that a second patented invention was obvious to try

The Federal Court of Appeal (FCA) has dismissed an appeal concerning four actions related to the molecule apixaban under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The Federal Court (FC) found the patents at issue to be valid. Background Bristol-Myers Squibb Canada Co. (BMS) markets ELIQUIS® (apixaban) in Canada for the treatment of thrombosis. … Continue reading

Proposed amendments to the PM(NOC) Regulations: Patents claiming different salt forms of medicinal ingredients eligible for inclusion on the Patent Register

By Corey McClary, David Yi and Kristin Wall on April 25, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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 to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers … Continue reading

Two PM(NOC) Actions Dismissed After Common Trial on Validity of Treatment Regimen Patent

By Paul Jorgensen, David Yi and Daniel Daniele on June 1, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has dismissed two infringement actions brought against defendants under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations), following a common trial on the validity of Canadian Patent No. 2,562,277 (277 Patent). The Court found that all the asserted claims – to uses for treating multiple sclerosis (MS) – were … Continue reading

Patent owner files its own pleading in a PM(NOC) action

By Colin Hyslop, Daniel Daniele and Brian R. Daley on January 29, 2020 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court granted leave to the United States of America (USA), in its capacity as co-owner of a patent, to file its own pleading in an action under s 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations). The USA was permitted to respond to the defendant’s (Apotex Inc.) allegations of invalidity, … Continue reading

Federal Court dismisses motion for determination of an issue of law under the new PM(NOC) Regulations

By Colin Hyslop and Judith Robinson on November 29, 2019 Posted in Pharmaceuticals and life sciences

The Federal Court dismissed Pharmascience Inc.’s (Pharmascience) motion to determine a question of law on the issue of whether a first person can commence an action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) for a drug for which there are no patents listed on the patent register. The Court … Continue reading

Top Headlines of 2018

By Kristin Wall on January 14, 2019 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

Last year ushered in a number of changes to the Canadian pharmaceutical and life sciences sector. 2018 also served as a year to explore the impacts of major intellectual property decisions and regulatory changes from 2017 including the impact of the Supreme Court’s decision in NEXIUM striking down the Promise Doctrine and the implementation of … Continue reading