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LCBO to Control Retail and Online Cannabis Sales in Ontario

Yasir Naqvi, Attorney General, Charles Sousa, Minister of Finance and Dr. Eric Hoskins, Minister of Health and Long-Term Care, announced Ontario’s planned approach to the federal legalization of cannabis as proposed by Bill C-45, the Cannabis Act, this morning. Bill C-45 left significant discretion to the provinces for determining the appropriate distribution, sale and retailing of cannabis.

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An Overview of Q2 2017 Healthcare Deal Activity in Canada

A look at the current healthcare landscape in Canada, including financing, mergers & acquisitions, notable transactions and big announcements.

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Ontario Conducts Public Consultation on Cannabis Legalization

On April 13, 2017, the Government of Canada released Bill C-45, the Cannabis Act, which, as discussed in a prior blog post, deferred significant discretion to the provinces with respect to the distribution, sale and retailing of cannabis.

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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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Cameron Mingay Discusses Potential Marijuana Supply Crunch with Bloomberg

With the legalization of recreational marijuana in Canada slated to occur within the next 12 months, a looming concern is whether Canada's supply will meet its demand. In a recent Bloomberg article, Cameron Mingay discusses practical realities associated with ramping up legal marijuana production in Canada.

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Alternative Financing Options in the Cannabis Industry

The recent developments in Canadian cannabis policy and legislation have sparked significant investment in licensed cannabis producers. Until recently, equity financing has been the primary form of financing, with Canadian cannabis companies raising approximately $1 billion over the past twelve months.

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Regulatory Change to Address Antimicrobial Resistance

On May 17th 2017, Health Canada announced changes to the Food and Drug Regulations regarding the use of antimicrobial drugs in animals. These changes, along with other ongoing initiatives, aim to address the increasing health concern posed by antimicrobial resistance. Microorganisms (such as bacteria, fungi, viruses and parasites) could develop resistance after exposure to antimicrobial drugs and render medicines ineffective against infections. This resistance increases the risk of infections in many important medical procedures such as organ transplantation, chemotherapy, diabetes management and major surgery.

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Disclosure Requirements for Non-Venture Issuers Regarding Women in Board and Executive Officer Positions – A Review

On June 7, 2017, the Canadian news cycle addressed cannabis industry insider criticism at the dearth of women on boards and in senior management positions at Canadian cannabis companies, with reports suggesting that 5% of board seats at publicly traded marijuana producers are occupied by women.

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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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Health Canada Improvements to the Licensing of Cannabis Production under the ACMPR

On May 26, 2017, Health Canada announced significant developments to the licensing process under the Access to Cannabis for Medical Purposes Regulations (ACMPR). As the medical cannabis industry continues to evolve, the Government of Canada has updated its licensing regime in order to streamline the process and enable increased production.

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Growing Pains: The emerging role of IP in selling Canadian cannabis

Licensed producers and others looking to enter Canada’s medical or recreational cannabis industry should be thinking about how they will distinguish their business, products and services from others, in what will undoubtedly become a crowded and competitive marketplace. Intellectual property protection available under Canadian and foreign laws should be an important part of that strategy.

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Health Canada Implements Mandatory Pesticide Testing of Cannabis

Health Canada has announced that it will require licensed cannabis producers to conduct mandatory testing of all cannabis products destined for sale for the presence of unauthorized pesticides.

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New Proposed Regulations Would Establish Mechanism to Import and Sell Unauthorized Drugs For an Urgent Public Need

Health Canada has recently proposed amendments to the Food and Drug Regulations to allow the importation and sale of drugs for an urgent public health need.  These proposed amendments would allow the importation of drug products that are not yet authorized for sale in Canada in the following circumstances:

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Draft Cannabis Act Released by Canadian Federal Government

Today the federal government released Bill C-45, the draft Cannabis Act. If enacted, this will make Canada the first G7 country to legalize recreational cannabis. Cannabis will remain illegal as the bill moves through the legislative process. If it is approved by Parliament, the bill could become law with a target date of no later than July 2018, according to the Government of Canada.

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March 2017 Deal Round-Up

The following is a selection of major deals in the life science space that closed or were announced as closed in March 2017.

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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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Mandatory Reporting of Drug Shortages and Discontinuances

As of March 14 2017, regulatory amendments implementing certain drug supply reporting requirements have come into force in Canada.  Although industry had established its own voluntary reporting system and website for this purpose in 2012, the newly implemented regulatory changes make such reporting mandatory and establish a new website.   

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Exporting Cannabis from Canada

A Licensed Producer (LP) can obtain a permit from the federal Minister of Health to export cannabis internationally from Canada to a single and specified importer. While export permits can currently only be used to export cannabis for medical purposes, some LPs are committing considerable resources on their international exportation efforts because of the current and potential future international opportunities within the global cannabis market. Additional regulatory information regarding cannabis exportation can be found in Subdivision G of the Access to Cannabis for Medical Purposes Regulations (ACMPR). 

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February 2017 Deal Round-Up

The following is a selection of major deals in the life science space that closed or were announced as closed in February 2017.

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