September 21, 2024, marked the seventh anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the seventh year...more
On January 11, 2024, the Federal Court released its decision concluding that the Patented Medicine Prices Review Board (PMPRB or Board) was reasonable in its redetermination that the invention of Patent No. 2,478,237 (the 237...more
Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more
1/3/2024
/ Abuse of Process ,
Appeals ,
Biosimilars ,
CADTH ,
Canada ,
Compliance ,
Data Protection ,
Life Sciences ,
Medical Devices ,
Patent Act ,
Patent Infringement ,
Patent Term Adjustment ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Agenda ,
Regulatory Standards ,
Statute of Monopolies ,
United States-Mexico-Canada Agreement (USMCA)
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 December 5, 2022, the Federal Court of Appeal (FCA) dismissed Innovative Medicines Canada (IMC) and sixteen innovative pharmaceutical companies’ appeal regarding the validity of the amended basket of comparator countries...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 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
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
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 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
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
PMPRB amendments expected to come into force no earlier than Spring 2020 -
On April 1, 2019, Health Canada released Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief...more
5/3/2019
/ Appeals ,
Biosimilars ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Conflicts of Laws ,
Drug Safety ,
Food and Drug Act ,
Generic Drugs ,
Health Canada ,
Labeling ,
Online Sales Bans ,
Patent Invalidity ,
Patented Medicine Prices Review Board (PMPRB) ,
PMNOC Regulations ,
Prescription Drugs ,
Proposed Amendments ,
Public Comment
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
In 2018 we reported on a number of developments in life sciences IP and regulatory law. Our most-read articles were: #1 a June update on biosimilars (authored by Urszula Wojtyra); #2 a “live” summary chart of Vanessa’s Law...more
1/8/2019
/ Apotex ,
Appeals ,
AstraZeneca ,
Biosimilars ,
CADTH ,
Calculation of Damages ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Damages ,
Eli Lilly ,
Health Canada ,
International Litigation ,
International Treaties ,
Janssen Pharmaceuticals ,
Judicial Review ,
Life Sciences ,
Lost Profits ,
Patent Act ,
Patent Infringement ,
Patent Litigation ,
Patent Validity ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prejudgment Interest ,
Proposed Amendments ,
Section 8 ,
Teva Pharmaceuticals ,
United States-Mexico-Canada Agreement (USMCA) ,
Vanessa's Law
FCA overturns cefaclor damages decision on prejudgment interest issue, provides guidance on NIA defence -
On November 23, 2018, the Federal Court of Appeal (FCA) allowed in part Apotex’s appeal of a decision awarding Eli...more
12/22/2018
/ Amended Rules ,
Appeals ,
Biologics ,
Canada ,
Damages ,
Food and Drug Administration (FDA) ,
Free Trade Agreements ,
Generic Drugs ,
Health Canada ,
Intellectual Property Protection ,
International Litigation ,
Non-Infringing Alternatives (NIAs) ,
Notice Requirements ,
Patent Litigation ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prejudgment Interest ,
Prescription Drugs ,
United States-Mexico-Canada Agreement (USMCA)
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