As we previously reported, JAMP sought leave to commence an application against Janssen under the abuse of dominance provisions of the Competition Act (the Act), relating to ustekinumab (Janssen’s STELARA and FINLIUS). This...more
After filing a new drug submission for its ustekinumab biosimilar PYZCHIVA (Janssen’s STELARA), Samsung commenced the underlying action against Janssen for impeachment of Canadian Patent No. 3,113,837. Janssen sought to add a...more
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
On February 7, 2024, the Federal Court dismissed Takeda’s action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to dexlansoprazole (Takeda’s DEXILANT). Justice Furlanetto...more
On May 26, 2023, the Minister of Health determined that Biosimilar Collaborations Ireland Limited was entitled to the benefit of section 5 of the Patented Medicines (Notice of Compliance) Regulations (Regulations), including...more
On March 30, 2023, the Ontario Superior Court of Justice dismissed Apotex’s claim under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating to Apo-Atomoxetine (Lilly’s...more
As we previously reported, the Ontario Court of Appeal affirmed the lower court’s decision dismissing Apotex’s claims against Eli Lilly under the Ontario and English Statutes of Monopolies, Trademarks Act, and common law...more
As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (422 patent)—which relates to treatment of prostate cancer in humans by co-administration of abiraterone acetate (Janssen’s ZYTIGA) and...more
As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (422 patent) – which relates to treatment of prostate cancer in humans by co-administration of abiraterone acetate (Janssen’s ZYTIGA) and...more
As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (“422 patent”) – which relates to treatment of prostate cancer in humans by co-administration of abiraterone acetate (marketed by Janssen...more
On August 9, 2019, the Minister of Health denied Merck’s application for a Certificate of Supplementary Protection (CSP) for Canadian Patent No 2,670,892 relating to the drug suvorexant (Merck’s BELSOMRA). On September 29,...more
On April 26, 2021, the Federal Court granted Teva’s motion for a stay of the re-examination proceeding commenced by Pharmascience in respect of Canadian Patent No. 2,760,802 (802 patent) relating to glatiramer acetate (Teva’s...more
6/18/2021
/ Canada ,
Motion To Stay ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Re-Examination ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Teva Pharmaceuticals
Update: Apotex has appealed.
On March 8, 2021, the Ontario Superior Court of Justice granted Eli Lilly’s (Lilly) motion for summary judgment and dismissed Apotex’s claims under the Statutes of Monopolies, Trademarks Act, and...more
4/1/2021
/ Canada ,
Dismissals ,
Intellectual Property Protection ,
Patent Act ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Statute of Monopolies ,
Summary Judgment ,
Trademarks Act
On December 24, 2020, the Federal Court issued a decision in a patent infringement action pursuant to s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations relating to silodosin (Allergan’s RAPAFLO): Allergan...more
On December 21, 2020, the Certificate of Supplementary Protection Regulations were amended to add the United Kingdom as a “prescribed country” for the purpose of determining the timeliness of the Certificate of Supplementary...more
As previously reported, the Federal Court of Appeal (FCA) dismissed Millennium Pharmaceuticals and Janssen’s appeal from a decision granting Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of...more
2/13/2020
/ Appeals ,
Canada ,
Damages ,
Dismissals ,
Janssen Pharmaceuticals ,
Leave to Appeal ,
Notice of Compliance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Section 8 ,
Supreme Court of Canada ,
Teva Pharmaceuticals
As previously reported, the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of Compliance) Regulations relating to Teva’s bortezomib product (Janssen markets bortezomib as...more
12/4/2019
/ Appeals ,
Canada ,
Dismissals ,
Janssen Pharmaceuticals ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Popular ,
Reaffirmation ,
Reversible Error ,
Section 8 ,
Teva Pharmaceuticals
Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN -
On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB...more
8/1/2019
/ Adverse Action Report ,
Annual Reports ,
Appeals ,
Biosimilars ,
CADTH ,
Canada ,
Dismissals ,
Draft Guidance ,
Drug Pricing ,
Guidance Update ,
Health Canada ,
Hospitals ,
Interlocutory Appeals ,
Judicial Review ,
Patent Act ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Public Consultations ,
Teva Pharmaceuticals
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
Federal Court finds invalidity allegations relating to patent for metformin formulations not justified -
On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more
4/6/2019
/ Administrative Procedure ,
Apotex ,
Appeals ,
CADTH ,
Canada ,
Clinical Evaluations ,
Competition Authorities ,
Delisting ,
Enforcement Guidance ,
Federal Budget ,
Final Guidance ,
Final Rules ,
Health Canada ,
India ,
Intellectual Property Litigation ,
Judicial Review ,
Leave to Appeal ,
Medical Devices ,
Minister of Health ,
National Pharmacare ,
Patent Invalidity ,
Patent Litigation ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Premarket Approval Applications ,
Prescription Drugs ,
Proposed Regulation ,
Public Access Laws ,
Reversal ,
Scientific Evidence ,
Supreme Court of Canada
Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal -
As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more
3/5/2019
/ Apotex ,
Appeals ,
Biologics ,
Canada ,
Costco ,
Damages ,
Dismissals ,
FDA Approval ,
Filing Deadlines ,
Fines ,
Generic Drugs ,
Health Canada ,
Health Insurance ,
Janssen Pharmaceuticals ,
Leave to Appeal ,
Marketing ,
Medical Devices ,
Minor Children ,
Mylan Pharmaceuticals ,
New Guidance ,
Novartis ,
Orders of Prohibition ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Pharmacies ,
PMNOC Regulations ,
Post-Market Approval ,
Prescription Drug Coverage ,
Prescription Drugs ,
Rebates ,
Risk Assessment ,
Supreme Court of Canada ,
Teva Pharmaceuticals
As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their generic o-desmethyl-venlafaxine (ODV) succinate products (Pfizer’s PRISTIQ) until expiry of...more
3/2/2019
/ Anticipation ,
Apotex ,
Appeals ,
Canada ,
Dismissals ,
Evidence ,
Hearsay ,
Obviousness ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Reaffirmation ,
Teva Pharmaceuticals ,
Trial Court Orders ,
Writ of Prohibition
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
In This Issue:
Ontario Court of Appeal allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed due to “promise doctrine” -
In an action by Apotex for compensation from...more
12/6/2018
/ Apotex ,
Appeals ,
Biosimilars ,
CADTH ,
Canada ,
Eli Lilly ,
Lack of Novelty ,
Leave to Appeal ,
Life Sciences ,
Motion To Strike ,
Patent Invalidity ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Promise Doctrine ,
Proposed Amendments ,
Remedies ,
Sandoz ,
Supreme Court of Canada ,
Teva Pharmaceuticals