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[Webinar] Cross-border IP strategies for IP owners and litigators - September 18th, 2:00 pm PDT

Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more

[Webinar] Cross-border IP strategies for IP owners and litigators - September 12th, 12:00 pm GMT

Explore skinny labelling & obviousness in Canada and Australia - If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more

Proposed legislation for patent term adjustment, and the interplay with CSPs

Bill C-47, “An Act to implement certain provisions of the budget tabled in Parliament on March 28, 2023,” aka “Budget Implementation Act, 2023, No. 1” is an omnibus bill that includes proposed amendments to the Patent Act to...more

PM(NOC) Regulations: Five-year anniversary of major amendments

September 21, 2022, marked the fifth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fifth year...more

Federal Court finds Minister of Health reasonable in concluding JAMP not a ‘second person’ for its SIMLANDI biosimilar

On August 17, 2022, the Federal Court, per Justice Fothergill, dismissed AbbVie’s applications for judicial review of the Minister of Health’s decisions that (1) JAMP was not a “second person” and therefore it was not...more

Competition Bureau closes two investigations into pharmaceutical patent litigation settlements

On May 20, 2022, the Competition Bureau announced that it closed two investigations into pharmaceutical patent litigation settlement agreements as evidence gathered during the two investigations suggested the agreements did...more

Update on biosimilars in Canada – June 2022

We provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, market access and competition) since our last update in October 2021....more

Federal Court holds summary trial appropriate, Apotex and Pharmascience will induce infringement of paliperidone palmitate patent

The Federal Court released a pair of decisions in patent litigation relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA): Janssen Inc v Pharmascience, 2022 FC 62 and Janssen Inc v Apotex, 2022 FC 107. Pharmascience...more

Update on biosimilars in Canada - October 2021

Since our last update in April 2021, there have been many developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access). Biosimilars approved in Canada - Health...more

PM(NOC) Regulations: Fourth year following major amendments

September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more

Strategies for in-house counsel to mitigate risk related to intellectual property

In today’s competitive innovation economy, companies across industries face a wide range of potential legal issues and risks related to intellectual property (IP). Whether it is infringement of a valuable patented technology,...more

Federal Court of Appeal finds summary trial appropriate, upholds dismissal of ViiV’s action for patent infringement re: Gilead’s...

Update: On September 15, 2021, ViiV applied to the Supreme Court of Canada for leave to appeal (Docket No. 39823). The Federal Court of Appeal dismissed an appeal by ViiV from a decision of the Federal Court granting...more

Federal Court dismisses Roche’s PMNOC Regulations actions against Sandoz re: pirfenidone

By judgment dated May 12, 2021, the Federal Court dismissed patent infringement actions related to Sandoz’s pirfenidone capsules and tablets for the treatment of idiopathic pulmonary fibrosis (IPF) (Roche’s ESBRIET):...more

Update on biosimilars in Canada - April 2021

The following provides an overview of the many developments regarding biosimilars in Canada (approvals, pending submissions, regulatory, litigation and market access) that have taken place since our last update in August...more

Federal Court reinstates decision that REMICADE new use patent is valid and infringed

Update: The litigation between Janssen and Hospira relating to the biosimilar INFLECTRA, including the appeal of the reconsideration decision, was discontinued in July 2021. As reported previously... the Federal Court had...more

Supreme Court of Canada leave applications – January 2021

Supreme Court denies leave in infliximab patent infringement action - On January 8, 2021, the Supreme Court of Canada denied leave to Janssen and Kennedy Trust (Docket No. 39099) with respect to the Federal Court of...more

Strict 45-day time limit for starting PMNOC action was suspended by COVID-19 Federal legislation

The Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) require that any section 6(1) action be brought within 45 days after the day on which the first person is served with a notice of allegation (NOA)....more

Federal Court of Appeal dismisses appeal of first trial decision under the amended PMNOC Regulations

UPDATE: On July 9, 2021, the Supreme Court of Canada denied Amgen’s leave to appeal (see article here). On November 3, 2020, the Federal Court of Appeal heard and dismissed the appeal of the first trial decision under the...more

Federal Court of Appeal sets aside Order for common trial across multiple actions under PMNOC Regulations

An interesting procedural question under the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) is the extent to which separate actions against multiple generic manufacturers can proceed...more

First decision under amended PMNOC Regulations: Federal Court finds Amgen’s filgrastim patent obvious

UPDATE: On November 3, 2020, the Federal Court of Appeal dismissed Amgen’s appeal. See our article here. On April 16, 2020, Justice Southcott of the Federal Court issued the first decision under the amended Patented...more

Federal Court of Appeal remands REMICADE new use patent decision on anticipation and obviousness

Update: On January 8, 2021, the Supreme Court of Canada dismissed Janssen’s application for leave to appeal (Docket No. 39099). On January 12, 2021, the Trial Judge issued the reconsideration decision, again finding the...more

Patent owner named as defendant may file reply in actions under the PMNOC Regulations

In an action commenced by Allergan against Apotex in respect of ulipristal (Allergan’s FIBRISTAL) under the Patent Medicines (Notice of Compliance) Regulations (PMNOC Regulations), an issue arose as to the appropriate...more

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