Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
In the first half of 2025, the Rx IP Update team reported on a number of developments in Canadian life sciences IP and regulatory law. Below are our top stories....more
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
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
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
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
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
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
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
On October 1, the Trump administration announced that it had secured a new trade agreement with Canada and Mexico. The United States-Mexico-Canada Agreement (USMCA) would replace the North American Free Trade Agreement...more
Health Canada News - Health Canada issues updated guidance on PMNOC Regulations - Health Canada has issued updated guidance reflecting the September 21, 2017 amendments: Guidance Document: Patented Medicines (Notice of...more
While the patent eligibility of diagnostic method claims remains questionable in the United States, the Canadian Intellectual Property Office has issued updated guidance on the types of diagnostic method claims that can–and...more
Federal Court of Appeal opines on the framework for analyzing obviousness-type double-patenting - On November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA...more