Federal Court of Appeal upholds decision invalidating claims to multiple sclerosis treatment regimen

The Federal Court of Appeal (FCA) has dismissed appeals concerning two actions brought under the Patented Medicines (Notice of Compliance) Regulations (Regulations), confirming the Federal Court (FC) holding that claims to uses of the molecule fampridine were invalid. The FCA’s decision provides guidance on claims construction and analyzing obviousness, while pointedly refusing to endorse the FC’s … Continue reading

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

By Pardeep Heir, Christopher A. Guerreiro and Kristin Wall on August 15, 2022 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

2022 Guide to Canada’s Pharmaceutical Intellectual Property Regime

By William Chalmers and Kristin Wall on July 25, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

Our 2022 Guide to Canada’s Pharmaceutical Intellectual Property Regime is a convenient all-in-one reference to the important legal and regulatory regimes governing pharmaceuticals in Canada. The Guide provides a detailed review of the key regimes, including: Data protection market exclusivity; The Patented Medicines (Notice of Compliance) Regulations (PMNOC), linking generic market access to patent rights; … Continue reading

Federal Court finds generic would induce infringement of combination therapy patent

By Colin Hyslop, Christopher A. Guerreiro and Kristin Wall on July 18, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has allowed a second infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court found that the defendant would induce infringement of claims relating to combination treatment if it were allowed to market its macitentan product. Background Janssen Inc. markets OPSUMIT® (macitentan) to treat patients … Continue reading

Government of Canada invests in clinical trial development in Canada through the Clinical Trials Fund

By Sarah Pennington, Christopher A. Guerreiro and Kristin Wall on June 26, 2022 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On June 22, 2022, the Canadian Institutes of Health Research (CIHR) announced the launch of the Clinical Trials Fund (CTF), which will inject funding into Canada’s clinical trials environment. The government’s goals include reinforcing Canada’s clinical trials infrastructure so as to improve the health and safety of all Canadians while also ensuring that Canada is … Continue reading

Federal Court finds a combination therapy patent valid and infringed

By Colin Hyslop, Christopher A. Guerreiro and Kristin Wall on June 14, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has allowed an infringement action concerning a macitentan product under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations that the asserted patent claims were invalid for obviousness, lack of utility, overbreadth, and insufficiency of disclosure. Background Janssen Inc. (Janssen) markets OPSUMIT® in Canada for the treatment of pulmonary arterial … Continue reading

Overview of IP Law in Canada – The Intellectual Property Review, 11th Edition

By Caroline Henrie and Kristin Wall on May 18, 2022 Posted in Intellectual property

The recently published Eleventh Edition of the Intellectual Property Review (the Review) includes a Canadian chapter. Readers are invited to learn more on the various forms of IP protection available in Canada, and highlights of important changes in Canadian IP law over the past year. The chapter was authored by members of the Pharma in Brief team. The chapter … Continue reading

Federal Court finds salt patent valid in a PM(NOC) action regarding sitagliptin

By Colin Hyslop, Christopher A. Guerreiro and Brian R. Daley on April 19, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court has allowed an infringement action concerning sitagliptin phosphate monohydrate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations of obviousness and insufficiency, and it found the asserted claims to be valid and infringed. In reaching its decision, the Court provided substantive guidance on hearsay evidence in infringement … Continue reading

Federal Court sends NOC dispute concerning data protection provisions back to the Minister for a second redetermination

By Colin Hyslop, Christopher A. Guerreiro and Kristin Wall on March 23, 2022 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court (FC) has granted an application for judicial review involving the data protection provisions in section C.08.004.1 of the Food and Drug Regulations in a case involving new drug submissions (NDSs) for two different amifampridine products. This is the second time that the FC has set aside a decision to issue a notice … Continue reading

New interim order continues expedited authorization pathway for COVID-19 medical devices

By Sarah Pennington, John Greiss and Kristin Wall on March 21, 2022 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Minister of Health has issued a new interim order regarding expedited authorizations for COVID-19-related medical devices. Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 3) maintains all of the flexibilities of its predecessor, including the consideration of urgent public health needs (UPHN). … Continue reading