On June 25, 2024, Health Canada published a notice of intent and Building resilience: Health Canada’s plan to address health product shortages, 2024 to 2028, relating to Health Canada’s plan over the next 4 years to address...more
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
Federal Court of Appeal (FCA) dismisses appeal on finding of inducement: Apotex Inc v Janssen Inc, 2023 FCA 220 -
Apotex appealed the trial decision, finding that Apo-Macitentan would infringe Canadian Patent No. 2,659,770...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 June 5, 2023, the Minister of Health released a statement on drug and other health product shortages, providing an update on actions being taken aimed at minimizing shortages and their impacts.
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On May 12, 2023, Health Canada announced the fifth version of the Guidance Document: Certificates of Supplementary Protection.
The changes are described as being made to reflect current administrative practices, and to...more
On May 12, 2023, Health Canada announced the fifth version of the Guidance Document: Certificates of Supplementary Protection....more
As previously reported, the Federal Court (FC) found that Teva would directly infringe but not induce infringement of certain claims of Canadian Patent No. 2,655,335 (335 patent) regarding its paliperidone palmitate product...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 September 2017, the Patented Medicine Prices Review Board (PMPRB) decided that Alexion’s SOLIRIS (eculizumab) was sold at an excessive price. In doing so, the Board departed from the Guidelines, in finding the appropriate...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
The Canadian Agency for Drugs and Technologies in Health (CADTH) held consultations which ended April 14, 2022 on two new proposals: (1) a proposed process for non-sponsored reimbursement reviews and (2) a streamlined process...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
On January 5, 2022, amendments came into force amending the Food and Drug Regulations to allow practitioners to request access to restricted drugs through the Special Access Program (SAP), which was previously prohibited....more
On January 7, 2022, Health Canada issued a notice of consultation for proposed amendments to the Medical Devices Regulations.
The notice of consultation (i) advises of the notice of intent published on December 11, 2021...more
Mid-year update: Health products approved in 2021 – In October 2021, Health Canada published a “Mid-year update: Health products approved in 2021”, which provides an update on the drugs, medical devices, over-the-counter...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