Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more
7/10/2019
/ Amended Regulation ,
Apotex ,
Appeals ,
Biosimilars ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Clinical Trials ,
Competition Authorities ,
CUSMA ,
Damages ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Canada ,
Health Insurance ,
Intellectual Property Protection ,
International Litigation ,
Life Sciences ,
Medical Devices ,
National Pharmacare ,
Patent Litigation ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drug Coverage ,
Prescription Drugs ,
Section 8 ,
Statute of Monopolies
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
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
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
September 21, 2018 marked the first anniversary of the certificate of supplementary protection (CSP) regime. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the...more
10/2/2018
/ Canada ,
Certificates of Supplementary Protection (CSPs) ,
CETA ,
Data Protection ,
Drug Approvals ,
Health Canada ,
Innovation ,
Medical Research ,
Notice of Compliance ,
Patent Expiration ,
Patents ,
Pharmaceutical Patents ,
Research and Development
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
IN THIS ISSUE:
- Shire’s VYVANSE patent valid, prohibition order issued
- First judicial consideration of Vanessa’s Law: Health Canada must disclose requested clinical trial data
- PMPRB News
- Patented Medicine...more
8/1/2018
/ CADTH ,
Canada ,
Canadian Patent Office ,
Clinical Trials ,
Constitutional Challenges ,
Disclosure Requirements ,
Discovery Disputes ,
Drug Approvals ,
Health Canada ,
Leave to Appeal ,
Motion to Compel ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Tobacco ,
Tobacco Regulations ,
Vanessa's Law
In this special mid-year edition, we take a look at the major highlights in Canadian life sciences and intellectual property law that we have reported on over the last six months, starting with one of the most closely-watched...more
7/11/2018
/ Appeals ,
Biosimilars ,
CADTH ,
Canada ,
Cannabis Act ,
Certificates of Supplementary Protection (CSPs) ,
Commercial Marketing ,
Damages ,
Health Canada ,
Intellectual Property Litigation ,
Life Sciences ,
Nexium ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmacies ,
PMNOC Regulations ,
Prescription Drug Coverage ,
Proposed Amendments ,
Section 8 ,
Teva Pharmaceuticals
Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing -
While common among member countries of the Organisation for Economic Co-operation and Development...more
5/4/2018
/ Apotex ,
Appeals ,
AstraZeneca ,
CADTH ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Clinical Evaluations ,
Confidential Information ,
Damages ,
Discovery ,
Drug Approvals ,
EU ,
Health Canada ,
Healthcare Reform ,
Leave to Appeal ,
Medical Devices ,
Medical Marijuana ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patent Term Extensions ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drug Coverage ,
Prescription Drugs ,
Public Consultations ,
Section 8 ,
Summary Judgment ,
Supreme Court of Canada
No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding -
What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC)...more
4/4/2018
/ Calculation of Damages ,
Canada ,
Corporate Misconduct ,
Costco ,
Dismissals ,
Eli Lilly ,
Janssen Pharmaceuticals ,
Medical Devices ,
Motion To Strike ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
Pharmacies ,
PMNOC Regulations ,
Prescription Drugs ,
Rebates ,
Section 8 ,
Teva Pharmaceuticals
Federal Court of Appeal dismisses Teva’s levofloxacin damages appeal -
On February 8, 2018, the Federal Court of Appeal issued public reasons for its decision dismissing Teva’s appeal relating to the damages and costs...more
3/1/2018
/ Appeals ,
Biosimilars ,
CADTH ,
Canada ,
CPTPP ,
Damages ,
Drug Pricing ,
Generic Drugs ,
Graphical User Interface ,
Health Canada ,
Medical Devices ,
Patent Infringement ,
Patent Term Extensions ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Promise Doctrine ,
Supreme Court of Canada ,
Teva Pharmaceuticals ,
Trans-Pacific Partnership
The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues.
As we...more
1/11/2018
/ Apotex ,
Appeals ,
AstraZeneca ,
Biosimilars ,
Bristol-Myers Squibb ,
Calculation of Damages ,
Canada ,
CETA ,
Confidential Business Information (CBI) ,
Constitutional Challenges ,
Damages ,
Data Protection ,
Drug Pricing ,
Duty to Mitigate ,
Exports ,
Food & Drug Regulations ,
Generic Drugs ,
Hatch-Waxman ,
Health Canada ,
India ,
Jurisdiction ,
Life Sciences ,
Patent Infringement ,
Patent Terms ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pfizer ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Promise Doctrine ,
Proposed Amendments ,
Supreme Court of Canada ,
Teva Pharmaceuticals
Canada’s new linkage litigation scheme: A comparison to Hatch-Waxman -
The September 21, 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations (see our article here) introduced a new scheme for...more
12/2/2017
/ Annual Reports ,
Appeals ,
Canada ,
Drug Approvals ,
Drug Pricing ,
Hatch-Waxman ,
Health Canada ,
Intellectual Property Protection ,
Linkage Litigation Schemes ,
Litigation Funding ,
Motions to Quash ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations
Pfizer obtains orders of prohibition on polymorphic form patent -
On September 22, the Federal Court, in a pair of decisions, granted Orders of prohibition under the Patented Medicines (Notice of Compliance) Regulations...more
10/30/2017
/ Apotex ,
Appeals ,
AstraZeneca ,
Canada ,
CETA ,
Competition Authorities ,
Health Canada ,
Health Care Providers ,
Judicial Review ,
Mandatory Disclosure Rules ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Supreme Court of Canada ,
Technical Errors
Federal Court of Appeal Applies Supreme Court’s Utility Test to SPRYCEL Patent -
In its first decision to consider the Supreme Court of Canada’s landmark decision in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36...more
On September 7, 2017, the Government of Canada published final pharmaceutical regulations flowing from CETA. According to an Order in Council, the new regulations will be in force on September 21, 2017....more
Gilead prevails in SOVALDI appeal -
The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). In the trial decision, as previously reported, the...more
8/24/2017
/ Apotex ,
AstraZeneca ,
CADTH ,
Canada ,
Gilead Sciences ,
Health IT ,
Noninfringement ,
Patent Act ,
Patent Infringement ,
Patent Invalidity ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Patents ,
Pleadings ,
PMNOC Regulations ,
Prescription Drugs ,
Proposed Amendments ,
Public Consultations ,
Teva Pharmaceuticals
Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful -
As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more
7/24/2017
/ Apotex ,
AstraZeneca ,
CADTH ,
Canada ,
CETA ,
Dismissals ,
Drug Approvals ,
EU ,
Food & Drug Regulations ,
Generic Drugs ,
Health Canada ,
Imports ,
Janssen Pharmaceuticals ,
Leave to Appeal ,
Opioid ,
Patent Infringement ,
Patent Validity ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Product Labels ,
Proposed Regulation ,
Public Consultations ,
Public Health ,
Reversal ,
Supreme Court of Canada ,
Warning Labels
Supreme Court of Canada News -
SCC denies Apotex leave to appeal omeprazole infringement decision. On June 1, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal (docket no. 37478) the Federal Court...more
6/29/2017
/ Apotex ,
Appeals ,
Canada ,
Competition Authorities ,
GlaxoSmithKline ,
Health Canada ,
International Litigation ,
Leave to Appeal ,
Medical Marijuana ,
Mergers ,
Motion To Strike ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Personal Jurisdiction ,
Pharmacies ,
PMNOC Regulations ,
Prescription Drugs ,
Product Labels ,
Section 8 ,
Supreme Court of Canada ,
Teva Pharmaceuticals
Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission -
On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more
6/1/2017
/ Administrative Proceedings ,
Apotex ,
Appeals ,
Canada ,
CETA ,
Damages ,
Data Protection ,
Dismissals ,
Double Patent ,
Drug Approvals ,
Electronic Filing ,
Eli Lilly ,
Generic Drugs ,
Health Canada ,
Health Information Technologies ,
Judicial Review ,
Licenses ,
Life Sciences ,
Mandamus Petitions ,
Medical Devices ,
Obviousness ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Supreme Court of Canada ,
Teva Pharmaceuticals ,
Trials
Bill C-30 was passed by the Senate yesterday, May 11, 2017 without amendment. Bill C-30 is the bill that will implement the Canada-European Union Comprehensive Economic and Trade Agreement (CETA). As reported here, this...more
Teva awarded section 8 damages regarding pregabalin and olanzapine -
On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more
4/29/2017
/ Amgen ,
Bristol-Myers Squibb ,
Calculation of Damages ,
Canada ,
Damages ,
Declaratory Rulings ,
Drug Approvals ,
Eli Lilly ,
Patent Invalidity ,
Patented Medicines ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Section 8 ,
Teva Pharmaceuticals
Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent infringement -
On February 2, 2017, the Federal Court of Appeal released a...more
2/23/2017
/ Apotex ,
Appeals ,
Apportionment ,
AstraZeneca ,
Calculation of Damages ,
Canada ,
CETA ,
Constitutional Challenges ,
Disgorgement ,
Drug Pricing ,
EU ,
Judicial Review ,
Mylan Pharmaceuticals ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Trade Agreements
Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld -
As previously reported, the Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the...more
2/4/2017
/ Apotex ,
Appeals ,
Canada ,
Canadian Institute for Health Information (CIHI) ,
Canadian Intellectual Property Office (CIPO) ,
CETA ,
Competition Authorities ,
Damages ,
Double Patent ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Hearsay ,
Jurisdiction ,
Medical Devices ,
Mergers ,
Motions to Quash ,
Noninfringement ,
Notice of Compliance ,
Obviousness ,
Patent Applications ,
Patent Invalidity ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Supreme Court of Canada