Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Kristin Wall ordered by Published Date Descending.
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Federal Court Of Appeal Agrees That The PMPRB Incorrectly Applied The Patent-Pertaining Analysis
The Federal Court of Appeal has provided new guidance on the proper approach to the "patent pertaining" analysis used by the Patented Medicine Prices Review Board, including on the identification of the medicine ...
11 Jul 2019
CUSMA Implementation Bill Introduced
CUSMA provides more protections for biologic and innovative pharmaceuticals under Canadian law.
10 Jun 2019
Top Headlines Of 2018
Last year ushered in a number of changes to the Canadian pharmaceutical and life sciences sector.
18 Jan 2019
Ontario Superior Court Rejects Apotex Attempts To Revive The Promise Doctrine By Dismissing Motion For Leave To Amend, Awards Substantial Indemnity Costs
The Ontario Superior Court of Justice (ONSC) recently denied Apotex's attempt to repackage the now defunct "promise of the patent" doctrine (the Promise Doctrine).
22 Nov 2018
New Protections For Biologics And Other Pharmaceuticals Under The United States-Mexico-Canada Agreement (USMCA)
As we reported, Canada has joined a new trilateral trade deal called the United States-Mexico-Canada Agreement (USMCA).
16 Oct 2018
Pan-Canadian Pharmaceutical Alliance (pCPA) Releases Draft Brand Process Guidelines
On June 13, 2018, the pan-Canadian Pharmaceutical Alliance (pCPA) released its draft Brand Process Guidelines (Guidelines) for stakeholder feedback.
21 Jun 2018
Pharma In Brief - CETA Tracker: Patent Term Restoration Is Coming Soon To Canada – What You Need To Know Now
With Canada moving closer towards implementing the Comprehensive Economic and Trade Agreement (CETA), major reforms to Canada's Patent Act are coming soon, including the availability of Certificates of Supplementary Protection (CSPs): ..
5 May 2017
Pharma In Brief - FCA Finds No Failure To Mitigate Apotex Damages Claim Against Health Canada For Delayed Apo-Trazodone NOC
The Federal Court of Appeal allowed Apotex's appeal, in part, from the Federal Court decision that found Apotex was entitled to damages for misfeasance of public office and negligence ...
24 Apr 2017
Pharma In Brief - Court Upholds Health Canada Decision Requiring Additional Information ‎On Certain Apotex Drugs Manufactured In India
The Federal Court dismissed Apotex's application for judicial review of the Minister of Health's (Minister's) decision to require additional information from Apotex as part of its Notice of Compliance (NOC) submissions for certain drugs manufactured in India by Apotex affiliates.
13 Apr 2017
CETA Tracker: Significant Amendments to the Patent Act Affecting Pharmaceuticals Nearly in Force
Major reforms to Canada's Patent Act are coming as the Canadian Parliament moves one step closer to ratifying the Comprehensive Economic and Trade Agreement (CETA).
31 Mar 2017
Pharma In Brief - Federal Court Upholds The Constitutionality Of The Patent Act's Price Control Provisions And The PMPRB's Powers To Amend Excessive Pricing Allegations
Alexion Pharmaceuticals Inc. brought two judicial reviews in relation to the Patented Medicine Prices Review Board's (the PMPRB or the Board) excessive price proceeding over its drug SOLIRIS® (eculizumab).
14 Jan 2017
Pharma In Brief - PMPRB Explores Application Of The "Patent Pertaining" Analysis To Formulations And Combination Drugs In Failure-To-File Application
These two combination patents, the panel held, were not intended or capable of being used to make an adapalene monotherapy on the basis that a simple reference to adapalene in the patents was insufficient to establish the necessary rational connection.
9 Jan 2017
Pharma In Brief - Top Headlines Of 2016
Pharma in Brief reported on many legal and regulatory developments of interest to the pharmaceutical industry in 2016. Looking back on 2016 as the new year begins, we have compiled our list of the past year's top headlines below. These include, in no particular order, key developments that affect the pharmaceutical industry and we will continue to monitor in 2017.
4 Jan 2017
Health Canada Issues Notice Of Impact Of FCA Case On PM(NOC) Guidance Document
Health Canada recently published a notice regarding the Guidance Document: Patented Medicines (Notice of Compliance) Regulations.
9 Nov 2016
Pharma In Brief - Apotex Claims $500 Million In Damages From Canadian Government Over Import Ban
The import ban was subsequently held to be unlawful by decision of the Federal Court and overturned.
1 Nov 2016
Pharma In Brief - "Dear Health Care Professional Letter" No Longer Required For Notice Of Compliance With Conditions (NOC/C)
Health Canada no longer requires manufacturers to prepare a "Dear Health Care Professional Letter" for drugs that have been issued a Notice of Compliance with conditions (NOC/c).
27 Oct 2016
Pharma In Brief - Amendments To The Ontario Drug Benefit Act And Drug Interchangeability And Dispensing Fee Act To Facilitate Access To Unlisted Drug Products And Streamline Generic Interchangeability
On October 1, 2016, amendments to regulations made under the Ontario Drug Benefit Act ("ODBA") and the Drug Interchangeability and Dispensing Fee Act ("DIDFA") came into force that aim to increase access to existing unlisted drug products and also accelerate the introduction of bioequivalent products into the market ...
22 Oct 2016
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