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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

2024 mid-year highlights in Canadian life sciences IP and regulatory law

In the first half of 2024, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more

2023 Highlights in Canadian Life Sciences IP and Regulatory Law

Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more

PMPRB news: Upcoming roundtable as first phase of new guidelines consultation, two new appointments

On October 25, 2023, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. The first phase will include a policy roundtable with stakeholders on...more

2023 Mid-Year Highlights in Canadian Life Sciences IP and Regulatory Law

In the first half of 2023, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...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

CADTH consultation on time-limited reimbursement initiative, and IMC report on what Canada can learn from Europe

The Canadian Agency for Drugs and Technologies in Health (CADTH) has released a consultation document for a Proposed Process for Time-limited Reimbursement Recommendations. The time-limited reimbursement recommendations would...more

Update on biosimilars in Canada – March 2023

In this article, 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 June 2022....more

Federal Court of Canada launches specialized Intellectual Property Chambers pilot project

With the creation of specialized Chambers in the Federal Court, parties can be confident that judges assigned to their intellectual property matters in Canada will have intellectual property expertise. ...more

New PMPRB Guidelines will not be implemented January 1, 2023

The Patented Medicine Prices Review Board (PMPRB) has advised that the new Guidelines will not be implemented on January 1, 2023, and that the Interim Guidance issued by the Board on August 18, 2022 will remain in place until...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

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

Court permits amendment of patent record to remove inventors and co-owner

In H. Lundbeck v Canada (Commissioner of Patents), 2021 FC 1394, the Court granted an application to amend a patent record to remove inventors and a co-owner. A Notice of Allegation (NOA) in respect of the patent was served...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

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