Tag archives: PM(NOC) Regulations

The Ontario Superior Court dismisses a generic manufacturer’s claim for damages under section 8 of the PM(NOC) Regulations

Photo of William ChalmersPhoto of David YiPhoto of Allyson Whyte NowakBy William Chalmers, David Yi and Allyson Whyte Nowak on Posted in Damages, Intellectual property, Life sciences and healthcare
The Ontario Superior Court (ONSC) has dismissed a claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations) brought by Apotex Inc. (Apotex) for lost sales of its Apo-Atomoxetine product. The Court conducted a purposive interpretation of the Regulations and found that Apotex did not meet the statutory requirements … Continue reading

Supreme Court denies leave to appeal in generic Statute of Monopolies case

Photo of William ChalmersPhoto of Christopher A. GuerreiroPhoto of David YiBy William Chalmers, Christopher A. Guerreiro and David Yi on Posted in Damages, Intellectual property, Life sciences and healthcare
On April 27, 2023, the Supreme Court of Canada dismissed an application by Apotex Inc. and Apotex Pharmachem Inc. (Apotex) for leave to appeal from a decision of the Ontario Court of Appeal (ONCA), dismissing its claim for damages in the Ontario courts under the Statutes of Monopolies and other novel causes of action. In the Courts below, Apotex … Continue reading

Federal Court of Appeal rejects elevated standard of proof for induced infringement in paliperidone case

Photo of Fortunat Nadima NadimaPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Fortunat Nadima Nadima, Christopher A. Guerreiro and Kristin Wall on Posted in Intellectual property, Pharmaceuticals and life sciences
The Federal Court of Appeal (FCA) has allowed an appeal concerning induced infringement in an action under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The FCA found that the Federal Court (FC) had erred by applying an elevated causation requirement. The FCA also rejected an appeal by the generic from the finding that the patent was … Continue reading

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

Photo of Pardeep HeirPhoto of Christopher A. GuerreiroPhoto of Kristin WallBy Pardeep Heir, Christopher A. Guerreiro and Kristin Wall on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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

Photo of Corey McClaryPhoto of David YiPhoto of Kristin WallBy Corey McClary, David Yi and Kristin Wall on 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

Photo of Paul JorgensenPhoto of David YiPhoto of Daniel DanieleBy Paul Jorgensen, David Yi and Daniel Daniele on 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

Photo of Colin HyslopPhoto of Daniel DanielePhoto of Brian R. DaleyBy Colin Hyslop, Daniel Daniele and Brian R. Daley on 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

Photo of Colin HyslopPhoto of Judith RobinsonBy Colin Hyslop and Judith Robinson on 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

Photo of Kristin WallBy Kristin Wall on 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
LexBlog