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
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
Update: The Federal Court updated the Guidelines on May 18, 2021, which can be found here.
The Federal Court has released a new consolidated practice direction, Case and Trial Management Guidelines for Complex...more
11/30/2020
/ Amended Regulation ,
Canada ,
Case Management ,
Complex Litigation ,
Discovery ,
Document Productions ,
Evidence ,
Expert Witness ,
Health Canada ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Trials
UPDATE: On July 9, 2021, the Supreme Court of Canada denied Amgen’s leave to appeal (see article here).
On November 3, 2020, the Federal Court of Appeal heard and dismissed the appeal of the first trial decision under the...more
11/25/2020
/ Amended Regulation ,
Amgen ,
Appeals ,
Biosimilars ,
Canada ,
Dismissals ,
Health Canada ,
Obviousness ,
Patent Litigation ,
Patents ,
Pfizer ,
Pharmaceutical Patents ,
PMNOC Regulations
On October 29, 2020, Justice Manson of the Federal Court ordered the Minister of Health to issue a notice of compliance (NOC) to Fresenius Kabi for IDACIO (adalimumab), a biosimilar of AbbVie’s HUMIRA: Fresenius Kabi v...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
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)
On May 7, 2020, the Patented Medicines Prices Review Board (PMPRB or Board) ordered Galderma to file prescribed sales and financial information for DIFFERIN (0.1% adapalene) until the expiry of the 237 patent (2,478,237),...more
An interesting procedural question under the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) is the extent to which separate actions against multiple generic manufacturers can proceed...more
6/2/2020
/ Appeals ,
Canada ,
Generic Drugs ,
Health Canada ,
Intellectual Property Protection ,
Patent Litigation ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Rule 105
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
In an action commenced by Allergan against Apotex in respect of ulipristal (Allergan’s FIBRISTAL) under the Patent Medicines (Notice of Compliance) Regulations (PMNOC Regulations), an issue arose as to the appropriate...more
2/10/2020
/ Affirmative Defenses ,
Allergan Inc ,
Apotex ,
Canada ,
International Litigation ,
Notice of Compliance ,
Patent Litigation ,
Patented Medicines ,
Pharmaceutical Patents ,
Pleadings ,
PMNOC Regulations
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 June 2018....more
11/1/2019
/ Biosimilars ,
CADTH ,
Canada ,
Competition Authorities ,
Drug Approvals ,
Generic Drugs ,
Health Canada ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Pharmaceutical Industry ,
Pharmaceutical 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
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
By: Urszula Wojtyra On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB or Board) and returned to the Board the matter of whether the invention of the 237...more
7/11/2019
/ Agency Deference ,
Appeals ,
Canada ,
Claim Construction ,
Judicial Review ,
Patent Expiration ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
Reasonableness Factors ,
Remand ,
Standard of Review
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:
-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