News & Analysis as of

Canada Biosimilars Patents

Goodwin

Biocon Settles with Bayer and Regeneron, Securing Canada Market Entry Date for Aflibercept Biosimilar

Goodwin on

On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept)....more

Smart & Biggar

2023 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

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

Smart & Biggar

PMPRB publishes annual Meds Pipeline Monitor report

Smart & Biggar on

The Patented Medicine Prices Review Board (PMPRB) recently published its Meds Pipeline Monitor 2022 report, which highlights medicines in the pipeline that may impact future clinical practice and drug spending in Canada if...more

Smart & Biggar

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

Smart & Biggar on

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

Smart & Biggar

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

Smart & Biggar on

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

Smart & Biggar

Update on biosimilars in Canada – March 2023

Smart & Biggar on

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

Goodwin

An Interview with Rachel Goode, Ph.D, about Biological Patent Thickets

Goodwin on

Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to...more

Smart & Biggar

2022 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022): Contents: 1. Patent decisions on the merits 2. PMNOC Regulations: Fifth-year anniversary of major amendments,...more

Smart & Biggar

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

Smart & Biggar on

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

Smart & Biggar

2022 mid-year highlights in Canadian life sciences IP and regulatory law

Smart & Biggar on

In the first half of 2022, 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 July and...more

Smart & Biggar

2021 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more

Smart & Biggar

Update on biosimilars in Canada - October 2021

Smart & Biggar on

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

Smart & Biggar

Supreme Court of Canada denies Amgen leave to appeal decision invalidating its filgrastim patent

Smart & Biggar on

As previously reported, Amgen sought leave to appeal a decision of the Federal Court of Appeal (2020 FCA 188) affirming Justice Southcott’s decision that the relevant claims of its filgrastim (NEUPOGEN) patent were invalid...more

Smart & Biggar

2021 Mid-Year Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

In the first half of 2021, 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

Smart & Biggar

Update on biosimilars in Canada - April 2021

Smart & Biggar on

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

Smart & Biggar

2020 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: Table of Contents 1. COVID-19: CIPO, Federal Courts, Health Canada 2. PMPRB:...more

Smart & Biggar

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

Smart & Biggar on

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

Smart & Biggar

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more

Smart & Biggar

Biosimilars: Comparison chart between Canada, US and Europe

Smart & Biggar on

As more biosimilars continue to be approved across the world, it is helpful to compare the applicable regimes across major jurisdictions. We have collaborated with Brian Coggio of Fish & Richardson, and Mary Foord-Weston and...more

Smart & Biggar

Rx IP Update - July 2019

Smart & Biggar on

Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN - On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB...more

Smart & Biggar

2019 Mid-Year Highlights in Canadian Life Sciences IP

Smart & Biggar on

Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more

Smart & Biggar

2018 Highlights in Canadian Life Sciences IP

Smart & Biggar on

In 2018 we reported on a number of developments in life sciences IP and regulatory law. Our most-read articles were: #1 a June update on biosimilars (authored by Urszula Wojtyra); #2 a “live” summary chart of Vanessa’s Law...more

Smart & Biggar

Rx IP Update - November 2018

Smart & Biggar on

In This Issue: Ontario Court of Appeal allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed due to “promise doctrine” - In an action by Apotex for compensation from...more

Smart & Biggar

Federal Court dismisses first motion for early dismissal under amended PMNOC Regulations

Smart & Biggar on

In public reasons released on July 30, 2018, the Federal Court dismissed the first motion for summary dismissal brought under section 6.08 of the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC...more

Smart & Biggar

Rx IP Update - 2018 Mid-Year Highlights in Canadian Life Sciences IP

Smart & Biggar on

In this special mid-year edition, we take a look at the major highlights in Canadian life sciences and intellectual property law that we have reported on over the last six months, starting with one of the most closely-watched...more

34 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide