In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update....more
3/27/2024
/ Biologics ,
Biosimilars ,
Compliance ,
Innovation ,
Life Sciences ,
Market Access Rule ,
Minister of Health ,
Patent Infringement ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Regulatory Agenda ,
Trademark Litigation
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)
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
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
6/30/2022
/ Biosimilars ,
Canada ,
Drug Approvals ,
Health Canada ,
Health Care Providers ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
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
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
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
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 October...more
8/27/2020
/ Biosimilars ,
CADTH ,
Canada ,
Drug Approvals ,
Drug Pricing ,
Health Canada ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Popular ,
Prescription Drugs ,
United States-Mexico-Canada Agreement (USMCA)
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
5/4/2020
/ Abuse of Process ,
Amgen ,
Apotex ,
Appeals ,
Canada ,
Motion to Dismiss ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Popular ,
Prior Use ,
Prior User Rights
On March 11, 2020, the Federal Court of Appeal dismissed Apotex’s appeal of the Federal Court’s decision ordering Apotex to pay over $61M from an accounting of profits from Apotex’s infringement of ADIR’s perindopril patent...more
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
3/3/2020
/ Anticipation ,
Appeals ,
Canada ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Prior Art ,
Remand ,
Treatment Method Patents
September 21, 2019 was the second anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations) heralding significant changes to the landscape for pharmaceutical...more
10/3/2019
/ Allergan Inc ,
Amended Regulation ,
Amgen ,
Apotex ,
Bristol-Myers Squibb ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Hatch-Waxman ,
Health Canada ,
Janssen Pharmaceuticals ,
Joinder ,
Leave to Appeal ,
Notice of Compliance ,
Patent Infringement ,
Patented Medicines ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Sandoz ,
Teva Pharmaceuticals ,
Trial Plan
IN THIS ISSUE:
- Federal Court dismisses Servier's application for order of prohibition regarding salt patent for perindopril arginine
- FCA upholds issuance of NON-W letter and cancellation of reconsideration process...more
6/14/2019
/ Adverse Events ,
Amended Regulation ,
Appeals ,
Canada ,
Dismissals ,
Emergency Rooms ,
Health Canada ,
New Guidance ,
Notice of Appeal ,
Notice of Compliance ,
Orders of Prohibition ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Supreme Court of Canada
IN THIS ISSUE:
-Abbott/Takeda permitted to plead that a third party’s patent would be infringed by alleged non-infringing alternative
- PMPRB News:
**PMPRB issues a Notice of Hearing for allegations of excessive...more
2/1/2019
/ Abbott Laboratories ,
Administrative Orders ,
Administrative Proceedings ,
Apotex ,
Appeals ,
Canada ,
Drug Approvals ,
Excessive Pricing ,
Generic Drugs ,
Health Canada ,
Judicial Review ,
Leave to Appeal ,
Medical Devices ,
Motions to Quash ,
Non-Infringing Alternatives (NIAs) ,
Novelty ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Pharmaceutical Patents ,
Pleadings ,
PMNOC Regulations ,
Promise Doctrine ,
Section 8 ,
Takeda Pharmaceuticals ,
Third-Party
On the eve of a section 8 trial, the Ontario Superior Court granted Abbott and Takeda leave to amend their pleadings to assert that Apotex’s purported non-infringing alternative (NIA) was unlawful as it would have infringed a...more
1/31/2019
/ Abbott Laboratories ,
Canada ,
Damages ,
Leave to Amend ,
Non-Infringing Alternatives (NIAs) ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Pleading Standards ,
PMNOC Regulations ,
Section 8 ,
Takeda Pharmaceuticals ,
Third-Party
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
1/8/2019
/ Apotex ,
Appeals ,
AstraZeneca ,
Biosimilars ,
CADTH ,
Calculation of Damages ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Damages ,
Eli Lilly ,
Health Canada ,
International Litigation ,
International Treaties ,
Janssen Pharmaceuticals ,
Judicial Review ,
Life Sciences ,
Lost Profits ,
Patent Act ,
Patent Infringement ,
Patent Litigation ,
Patent Validity ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prejudgment Interest ,
Proposed Amendments ,
Section 8 ,
Teva Pharmaceuticals ,
United States-Mexico-Canada Agreement (USMCA) ,
Vanessa's Law
As previously reported, the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”) came into force on September 21, 2017, heralding significant changes to the landscape for pharmaceutical companies in...more
10/1/2018
/ Amended Regulation ,
Canada ,
CETA ,
Discovery ,
Draft Guidance ,
Filing Deadlines ,
Health Canada ,
Jurisdiction ,
Leave to Appeal ,
Motion for Summary Judgment ,
Motion to Dismiss ,
Patent Infringement ,
Patent Validity ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Right To Appeal ,
Statute of Limitations
Teva succeeds in section 8 bortezomib action; infringement counterclaim dismissed -
On July 18, 2018, Justice Locke of the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines...more
9/4/2018
/ Apotex ,
Appeals ,
CADTH ,
Canada ,
Data Protection ,
Drug Pricing ,
Eli Lilly ,
Health Canada ,
Motion to Dismiss ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Premarket Approval Applications ,
Public Comment ,
Teva Pharmaceuticals
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