Federal Court of Appeal Restores Suspension Period

By Jordana Sanft, Allyson Whyte Nowak, Kristin Wall and Brian R. Daley on April 26, 2021 Posted in Uncategorized

On April 21, 2021, the Federal Court of Appeal (FCA) announced that it will restore the Suspension Period by default for all new matters and begin reinstating the Suspension Period on existing matters by removing them from its Selected Files List. Selected Files As previously reported in June 2020 (June 2020 Update), the FCA began … 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

New Proposed Amendments to the Federal Courts Rules: Proportionality, Abuse of Process, and Motions Before the Federal Court of Appeal

By Morgan Westgate and Jordana Sanft on April 20, 2021 Posted in Intellectual property

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 of Appeal motions. In the Regulatory Impact Analysis Statement (RIAS), the Committee has stated these … Continue reading

PMPRB Update: New periods for compliance with the new Guidelines

By Christopher A. Guerreiro, Brian R. Daley and Kristin Wall on April 20, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The PMPRB has confirmed that patentees of “Grandfathered” and “Gap” medicines will have two reporting periods to comply with new price ceilings to be set under its new Guidelines, replacing previous guidance that only one reporting period would be permitted. Updates to the Guidelines As we reported, the Guidelines were released by the PMPRB on … Continue reading

Food and Drug Regulations amended: COVID-19 drugs and vaccines transitioned out of interim order framework

By John Greiss, Sarah Pennington and Kristin Wall on April 13, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Food and Drug Regulations (FDR) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance (NOC) under the FDR. Certain provisions of the amendments came into force on March 18, 2021, while others will come into force on … Continue reading

Two new interim orders update previous orders on medical devices and foreign products during pandemic

By John Greiss and Kristin Wall on April 1, 2021 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Minister of Health has issued two new interim orders (IOs) regarding authorizations for COVID-19-related products. The first new order extends interim authorizations for COVID-19 medical devices until transition regulations can be passed. The second new order extends and updates the Minister’s authority to permit the import and sale of foreign drugs, medical devices, and … Continue reading

Federal Court of Appeal provides guidance on the “inventive concept”

By Paul Jorgensen, Christopher A. Guerreiro and Mark Davis on March 23, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court of Appeal (FCA) has held that the “inventive concept” can go beyond the essential elements of the claim and may include advantageous properties stated in the patent’s description. The FCA confirmed that the inventive concept is the end-point in the obviousness analysis: for a claimed invention to be obvious, the gap between … Continue reading

Ontario Superior Court summarily dismisses Apotex’s novel monetary claims under Statutes of Monopolies, Trademarks Act, and at common law

By Morgan Westgate, David Yi and Allyson Whyte Nowak on March 18, 2021 Posted in Damages, Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On March 8, 2021, the Ontario Superior Court granted summary judgment dismissing novel claims by Apotex under the UK and Ontario Statutes of Monopolies, the Trademarks Act, and at common law. It is the first decision on the merits of Apotex’s novel claims and arises in the context of litigation relating to Eli Lilly’s patented … Continue reading

Health Canada consults on proposed guidelines for the use of electronic media in prescription drug labelling

By Sarah Pennington, John Greiss and Randy Sutton on March 18, 2021 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. The intent of the draft guidance document is to describe Health Canada’s expectations for manufacturers who distribute prescription drug information through an electronic means, such as a website or mobile … Continue reading

Federal Court of Appeal upholds one of the last prohibition orders under the old PM(NOC) Regulations

By Sarah Pennington, David Yi and Kristin Wall on March 9, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

The Federal Court of Appeal has affirmed one of the last judgments granting a prohibition order under subsection 6(1) of the pre-September 2017 Patented Medicines (Notice of Compliance) Regulations (the PM(NOC) Regulations). The Court of Appeal upheld the prohibition order despite a decision in a subsequent action under the amended PM(NOC) Regulations finding that the … Continue reading