Update: See our article here regarding the final October 2020 Guidelines. On November 23, Innovative Medicines Canada and a number of pharmaceutical companies commenced an application for judicial review of the final...more
UPDATE: See June 23, 2020 article here describing the notable changes. See our article here regarding the final October 2020 Guidelines. On November 23, Innovative Medicines Canada and a number of research-based...more
Update: See December 30, 2020 and January 26, 2021 articles discussing the further amendments which defer the coming into force date of the Amended Regulations until July 1, 2021.
Further to our June 1, 2020 update,...more
6/12/2020
/ Amended Regulation ,
Canada ,
Drug Pricing ,
Health Canada ,
New Amendments ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Reporting Requirements
Update: See our June 10, 2020 article here describing the amendments extending the deadline, and our articles here and here regarding the amendments further deferring the coming into force date until July 1, 2021, and our...more
This article was last updated on June 26, 2020.
In view of COVID-19, we have compiled a list of important updates as it relates to the pandemic and its impact on Life Sciences.
We will continue to update this page as new...more
5/28/2020
/ Appeals ,
Canada ,
Canadian Intellectual Property Office (CIPO) ,
Coronavirus/COVID-19 ,
Court Closures ,
Court Schedules ,
Filing Deadlines ,
Food and Drug Act ,
Health Canada ,
Industrial Design ,
Life Sciences ,
Medical Supplies ,
Patent Act ,
Patents ,
Pharmaceutical Industry ,
Public Health Emergency ,
Time Extensions ,
Trademarks ,
Videoconference
In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below:
1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more
1/10/2020
/ Amended Regulation ,
Annual Reports ,
Biologics ,
Biosimilars ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Clinical Trials ,
Competition Authorities ,
Damages ,
Data Protection ,
Draft Guidance ,
EU ,
File Wrapper Estoppel ,
Food and Drug Act ,
Global Code of Ethics ,
Health Canada ,
Life Sciences ,
Medical Devices ,
National Pharmacare ,
New Rules ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pharmacies ,
PMNOC Regulations ,
Popular ,
Rebates ,
Section 8 ,
Statute of Monopolies ,
Supreme Court of Canada ,
United States-Mexico-Canada Agreement (USMCA)
On November 21, 2019, the Patented Medicines Prices Review Board (“PMPRB”) released draft new Guidelines for consultation, together with a backgrounder. The new Guidelines are intended to operationalize the amended Patented...more
11/25/2019
/ Amended Regulation ,
Canada ,
Draft Guidance ,
Drug Approvals ,
Drug Pricing ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Public Comment
September 21, 2019 marked the second anniversary of the certificate of supplementary protection (CSP) regime in Canada. CSPs provide an additional term of patent-like protection of up to two years. In our first anniversary...more
The amendments to the Patented Medicines Regulations (Regulations) published on August 21, 2019 have been the subject of two court challenges launched by groups of innovative pharmaceutical companies (22 companies in total)...more
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
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
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
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
On December 2, 2017 Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations (“the proposed Regulations”). The 75-day consultation period ends February 15, 2018. The proposed...more
12/5/2017
/ Canada ,
Consultation Periods ,
Drug Pricing ,
Health Canada ,
Life Sciences ,
Patent Act ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Pharmaceutical Industry ,
Proposed Regulation ,
Reporting Requirements ,
Third-Party
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
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
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
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
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
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