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

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

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

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

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

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

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

Federal Court rejects motion for summary judgment in Canadian patent infringement case following voluntary dismissal of parallel US litigation

In a recently released decision, the Federal Court (FC) considered what happens when a patent infringement plaintiff agrees to resolve a dispute in a foreign jurisdiction, but continues to press parallel litigation against the same defendant in Canada. In this case, the defendant sought summary judgment based on the terms of a voluntary dismissal between the … Continue reading

Federal Court finds patent valid, but rejects infringement claims in a PM(NOC) action regarding risedronate

The Federal Court has decided an infringement action concerning risedronate products under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court dismissed allegations of anticipation based on prior art, as well as arguments that the asserted claims were invalid due to lack of demonstrated utility, insufficiency of disclosure, and/or overbreadth. However, the Court … Continue reading

CADTH advisory panel consults on framework for pan-Canadian formulary

In a recently published discussion paper, an Advisory Panel (the Panel) convened by the Canadian Agency for Drugs and Technologies in Health (CADTH) presents a proposed framework for a potential pan-Canadian formulary. The Panel is asking for feedback on the framework with an online questionnaire.  The feedback will inform a stakeholder session in spring 2022 … Continue reading

Federal Court finds inducement of infringement at summary trial under the PM(NOC) Regulations

The Federal Court has confirmed that issues of infringement, including by inducement, may be decided by summary trial in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court rejected the Defendant’s attempt to avoid infringement based on the scope of its abbreviated new drug submission and product monograph (PM). … Continue reading
LexBlog