As previously reported, the Federal Court of Appeal dismissed two decisions relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA), finding in a summary trial that each of Pharmascience and Apotex would induce...more
As previously reported, the Federal Court of Appeal dismissed Apotex’s appeal of a decision relating to macitentan (Janssen’s OPSUMIT), which found that Apotex would induce infringement of Janssen’s patent....more
On March 26, 2024, the Federal Court dismissed Medexus and Medac’s action for patent infringement of Canadian Patent No 2,659,662 (the 662 Patent), finding the asserted claims invalid for obviousness: Medexus Pharmaceuticals...more
As previously reported, the Federal Court released a pair of decisions relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA), finding in a summary trial that each of Pharmascience and Apotex would induce infringement...more
As previously reported, the Federal Court (FC) dismissed Janssen’s application for judicial review of the decision of the Office of Submissions and Intellectual Property (OSIP) refusing to list Canadian Patent No. 3,113,837...more
September 21, 2023, marked the sixth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the sixth year...more
On July 17, 2023, Justice Aylen of the Federal Court dismissed Janssen’s application for judicial review of the decision of the Office of Submissions and Intellectual Property (OSIP) refusing to list Canadian Patent 3,113,837...more
On May 12, 2023, Health Canada announced the fifth version of the Guidance Document: Certificates of Supplementary Protection....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
In a public decision dated July 6, 2022 in an action under the Patented Medicines (Notice of Compliance) Regulations, Justice Pallotta of the Federal Court found that Apotex would infringe Janssen’s patent relating to...more
As previously reported, the Federal Court of Appeal set aside the Federal Court’s decision dismissing Alexion’s application for judicial review and remitted the matter of whether Alexion’s SOLIRIS (eculizumab) was sold at an...more
On September 29, 2021, the Attorney General of Canada sought leave to appeal a decision of the Federal Court of Appeal (2021 FCA 157) setting aside the decision of the Federal Court dismissing Alexion’s application for...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 29, 2021, Canada applied to the Supreme Court of Canada for leave to appeal (Docket No. 39858).
In September 2017, the Patented Medicine Prices Review Board (PMPRB or Board) decided (see article here)...more
The Therapeutic Products Directorate (TPD), the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), and the Natural and Non-Prescription Health Products Directorate (NNHPD) have released their Drug Submission...more
7/30/2021
/ Annual Reports ,
Biologics ,
Canada ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Health Canada ,
Medical Devices ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Radiopharmaceuticals
Update: Health Canada’s “Forward Regulatory Plan: 2023-2025” no longer lists the 2019 proposed amendments to the Food and Drug Regulations, “Regulations amending the Food and Drug Regulations (Improving Access to Generic...more
4/27/2021
/ Abbreviated New Drug Submission (ANDS) ,
Canada ,
Comment Period ,
Food & Drug Regulations ,
Generic Drugs ,
Notice of Compliance ,
Patent Registration ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Proposed Amendments ,
Public Comment
As previously reported, in the final decision released under the pre-amended Patented Medicines (Notice of Compliance) Regulations (Regulations), the Federal Court granted a prohibition order relating to Canadian Patent No....more
4/6/2021
/ Apotex ,
Appeals ,
Canada ,
Janssen Pharmaceuticals ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patented Medicines ,
Pharmaceutical Patents ,
PMNOC Regulations
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
September 21, 2020 marked the third anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations), which heralded significant changes to the litigation landscape for...more
On July 24, 2020, Justice McHaffie of the Federal Court dismissed Natco’s application for judicial review, finding that Health Canada’s refusal to accept Natco’s Abbreviated New Drug Submission (ANDS) for its tenofovir...more
8/30/2020
/ Abbreviated New Drug Submission (ANDS) ,
Canada ,
Data Protection ,
Dismissals ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Canada ,
Judicial Review ,
Marketing Exclusivity Periods ,
Patent Infringement ,
Pharmaceutical Patents ,
Popular
On May 5, 2020, Manson J. of the Federal Court issued the second decision on the merits under the amended Patented Medicines (Notice of Compliance Regulations). The Court upheld the validity of Janssen’s patent for...more
6/4/2020
/ Appeals ,
Canada ,
Health Canada ,
Injunctions ,
Janssen Pharmaceuticals ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent Validity ,
Patents ,
Pharmaceutical Patents ,
Teva Pharmaceuticals
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
The Federal Court had previously allowed a concurrent trial on common invalidity issues in actions under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) against four generic manufacturers:...more
On October 10, 2019, Justice O’Reilly of the Federal Court issued two decisions relating to Pharmascience’s claim for section 8 damages under the pre-amended Patented Medicines (Notice of Compliance) Regulations for its...more
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