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
8/30/2024
/ Australia ,
Canada ,
Cross-Border ,
FDA Approval ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Litigation Strategies ,
Obviousness ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Webinars
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
8/30/2024
/ Australia ,
Canada ,
Cross-Border ,
FDA Approval ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Litigation Strategies ,
Obviousness ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Webinars
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
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
1/3/2024
/ Abuse of Process ,
Appeals ,
Biosimilars ,
CADTH ,
Canada ,
Compliance ,
Data Protection ,
Life Sciences ,
Medical Devices ,
Patent Act ,
Patent Infringement ,
Patent Term Adjustment ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Agenda ,
Regulatory Standards ,
Statute of Monopolies ,
United States-Mexico-Canada Agreement (USMCA)
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
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
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
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
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
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
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
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
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
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
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
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
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
10/27/2021
/ Biologics ,
Biosimilars ,
Canada ,
Drug Approvals ,
Drug Pricing ,
Health Canada ,
Intellectual Property Protection ,
Life Sciences ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
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
9/28/2021
/ Amended Regulation ,
Apotex ,
Appeals ,
Canada ,
Dismissals ,
Judgment on the Merits ,
Patent Infringement ,
Patent Litigation ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Sandoz ,
Teva Pharmaceuticals
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
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
7/1/2021
/ Appeals ,
Canada ,
Claim Construction ,
Dismissals ,
Interlocutory Orders ,
Motion for Summary Judgment ,
Motions to Quash ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents
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
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
5/3/2021
/ Biologics ,
Biosimilars ,
Canada ,
Health Canada ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
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 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
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