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
Before approving Janssen’s esketamine hydrochloride product (SPRAVATO) on May 20, 2020, the Minister of Health determined that it was not an “innovative drug” as defined by section C.08.004.1(1) of the Food and Drug...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 March 8, 2021, the Ontario Superior Court of Justice dismissed Apotex’s claims against Eli Lilly (Lilly) under the Statute of Monopolies, Trademarks Act, and common law conspiracy relating to Canadian Patent No. 2,041,113...more
9/8/2022
/ Apotex ,
Appeals ,
Canada ,
Civil Conspiracy ,
Dismissals ,
Eli Lilly ,
Patent Act ,
Patent Invalidity ,
Patent Litigation ,
Patent Registration ,
Patents ,
PMNOC Regulations ,
Statute of Monopolies ,
Trademarks Act
On April 1, 2022, the fee for filing a Certificate of Supplementary Protection (CSP) will increase from $9,756 to $9,952 in accordance with subsection 9(1) of the Certificate of Supplementary Protection Regulations (Canada...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 April 1, 2021, the fee for filing a Certificate of Supplementary Protection (CSP) will increase from $9,564 to $9,756 in accordance with subsection 9(1) of the Certificate of Supplementary Protection Regulations...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
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
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