In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more
1/5/2022
/ Access to Information (ATI) ,
Apotex ,
Biosimilars ,
CADTH ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Class Action ,
Corporate Counsel ,
Damages ,
Data Protection ,
Excessive Pricing ,
Generic Drugs ,
Health Canada ,
Intellectual Property Protection ,
Life Sciences ,
Litigation Funding ,
Natural Products ,
Pan-Canadian Framework ,
Patent Infringement ,
Patent Litigation ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Statute of Monopolies
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
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
Apotex not permitted to plead promise-based invalidity grounds in Ontario section 8 lansoprazole action -
This motion arose in the context of a section 8 action in which Apotex claims damages for delay in the issuance of...more
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
An Update on Vanessa’s Law -
This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more
5/26/2018
/ Anti-Monopoly ,
Apotex ,
Appeals ,
Canada ,
Clinical Trials ,
Consumer Protection Laws ,
Damages ,
Drug Safety ,
Drug Testing ,
Eli Lilly ,
Food and Drug Act ,
Gilead Sciences ,
Health Canada ,
Jurisdiction ,
Leave to Appeal ,
Motion to Dismiss ,
New Regulations ,
Opioid ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pharmacies ,
PMNOC Regulations ,
Post-Market Approval ,
Prescription Drugs ,
Regulatory Reform ,
Section 8 ,
Supreme Court of Canada ,
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
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
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
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
Tribunal dismisses Eli Lilly’s NAFTA challenge on promise utility doctrine -
As previously reported, Eli Lilly submitted claims to international arbitration under the North American Free Trade Agreement (NAFTA) seeking...more
3/27/2017
/ Abbott Laboratories ,
Apotex ,
Appeals ,
Canada ,
CETA ,
Damages ,
Dismissals ,
Health Canada ,
NAFTA ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Summary Judgment ,
Takeda Pharmaceuticals ,
Teva Pharmaceuticals ,
Utility Patents
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
Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions -
As reported previously, on October 12, 2016, the Federal Court of Appeal...more
12/21/2016
/ Apotex ,
Biologics ,
Burden of Proof ,
CADTH ,
Canada ,
Diagnostic Tests ,
Evidence ,
Filing Deadlines ,
Health Canada ,
Health Information Technologies ,
Hospira ,
Janssen Pharmaceuticals ,
Leave to Appeal ,
Motion for Leave ,
Motion To Strike ,
New Guidance ,
Patent Infringement ,
Patents ,
Pfizer ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Public Comment ,
Supreme Court of Canada ,
Teva Pharmaceuticals ,
Trademark Infringement ,
Trademarks ,
Trans-Pacific Partnership ,
Unjust Enrichment
Federal Court of Appeal opines on the framework for analyzing obviousness-type double-patenting -
On November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA...more
11/30/2016
/ Accounting ,
Amgen ,
Apotex ,
Appeals ,
AstraZeneca ,
Biosimilars ,
Breach of Contract ,
Canada ,
CETA ,
Covenant of Good Faith and Fair Dealing ,
Damages ,
Double Patent ,
Drug Pricing ,
Eli Lilly ,
Free Trade Agreements ,
GlaxoSmithKline ,
Health Canada ,
Intellectual Property Protection ,
Mootness ,
Motion To Strike ,
New Legislation ,
Obviousness ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pleadings ,
Prescription Drugs ,
Reversal ,
Supreme Court of Canada ,
Utility Patents