Show all postsFiltered by: A. Chandimal Nicholas

Have Your Say on Possible Changes to the Food and Drug Regulations: Generic Drug Equivalence and Related Terminology

Health Canada is soliciting input on possible changes to the Food and Drug Regulations regarding establishing pharmaceutical equivalence between a proposed generic drug product and the Canadian Reference Product ("CRP"). These proposed changes are intended to better harmonize the framework with the practices of other major regulatory bodies. Consultations, which are the first in a series of consultations, will be open until October 13, 2017

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Major changes to Canada's intellectual property and patent landscape with the implementation of CETA

September 21, 2017 marks the provisional entering into force of the Comprehensive Economic and Trade Agreement ("CETA") between Canada and the European Union, and concurrently the coming into force of Bill C-30, the Canada-European Union Comprehensive Economic and Trade Agreement Implementation Act  (the "CETA Implementation Act"), an act which implements Canada's obligations under CETA.

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SCC Rejects Promise Doctrine in Seminal Pharmaceutical Patent Case

The Supreme Court of Canada’s (the “Court” or the “SCC”) recent judgment in AstraZeneca Canada Inc. v Apotex Inc., (2017 SCC 36, “AstraZeneca v Apotex”) released on June 30, 2017, constitutes an important paradigm shift in Canadian patent law. As described in greater detail below, the SCC has rejected the “promise of the patent” doctrine (the “Promise Doctrine”), a doctrine which has been a unique and fundamental principle in Canadian patent law, used to determine if the subject matter claimed in a patent is useful, as required by section 2 of the Patent Act.

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Major Changes Proposed to Canada's Patented Medicines Regulations

On May 16, 2017, the Federal Minister of Health, the Hon. Jane Philpott announced a number of proposed regulatory changes to the Patented Medicines Regulations (the "Regulations"). The proposed regulations are being implemented with the primary intent of "protecting Canadians from excessive drug prices"1. The proposed modernization framework constitutes the most significant suite of regulatory changes in twenty years. As noted in our blog post dated July 1, 2016, these proposed changes are part of ongoing reform to Canada's regulatory framework relating to patented drug prices. 

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Eli Lilly and Company v Government of Canada: Solidifying the Sovereignty of Canadian Courts

Recently, a Chapter 11 NAFTA tribunal (the “Tribunal”) decided not to interfere with the Canadian Courts’ treatment of utility in the context of patent law. The Tribunal noted that Canadian patent law had not experienced a dramatic shift through the Canadian Courts’ treatment of utility, and that the application of utility in Canada was neither arbitrary nor discriminatory. 

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Judge Phelan’s Comments for the Pharmaceutical Industry: Apotex Inc. v Canada (Minister of Health)

In Apotex Inc. v Canada (Minister of Health) (“Apotex”), the Federal Court (the “Court”) provided some guidance with respect to the procedure pharmaceutical companies should undertake to obtain a Notice of Compliance (“NOC”). Overall, the Court’s findings suggest that pharmaceutical companies should put their best foot forward in their application or on appeal in front of expert panels considering or reconsidering their applications because overturning an expert panel’s decision is often difficult with Courts showing deference to expert panels.

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To Engage or Not to Engage: Guidance on Motions to Strike a Within Application

The Federal Court has reaffirmed and clarified how a pharmaceutical brand company should respond to a generic company’s motion to strike an application for abuse of process under s. 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations.

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Health Canada Releases New Biosimilar Biologic Drugs Guidance Document

Health Canada has recently released the revised Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs (the “Guidance Document”), replacing the March 2010 Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics. The Guidance Document is meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations, but does not have the force of law. The Guidance Document is one of the primary resources provided by Health Canada regarding approval of biosimilars.

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Amendment to PMPRB Compendium of Policies, Guidelines and Procedures Takes Effect

On September 1, 2016, the Patented Medicine Prices Review Board (the “PMPRB” or the “Board”), Canada’s independent quasi-judicial patented drug price watchdog, implemented an amendment (the “Amendment”) to section C.11 “Review of Prices of New Patented Drug Products at Introduction” of the Compendium of Policies, Guidelines and Procedures (the “Guidelines”)1. The Amendment brings an incremental but important change to the Guidelines, of which patentees in the pharmaceutical, biotechnology, and healthcare industries should be aware.

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An Opportunity to Reshape Patented Medicines Regulation in Canada

The Patented Medicine Prices Review Board (the “PMPRB” or the “Board”) is currently canvassing stakeholder input on its Discussion Paper1 released on June 24, 2016, as part of an initiative to reform and modernize its regulatory framework.  

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