Show all postsFiltered by tag: Trends and Commentary

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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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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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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Canada’s Cannabis Opportunity in the Era of Trump

Although the United States government’s attitudes toward cannabis have eased in recent years, the election of President Donald Trump has generated renewed uncertainty surrounding the future of the U.S. cannabis market. Canada, conversely, will very likely soon be one of the first industrialized countries with fully legalized recreational and medical cannabis, and investment in the Canadian cannabis market has been unprecedented. Unburdened by the U.S.’s significant political and legal uncertainty, Canada has an opportunity to expedite its already rapid industry development to position itself as a global leader in the market for legal recreational and medical cannabis products.  

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January 2017 Deal Round-Up

The following is a summary of major deals in the life science space that closed or were announced as closed in January 2017. Vancouver-based Quark Venture Inc., through its Global Health Sciences Venture Fund, continued to be an active investor, with investments made both in Canada and the United States in the month of January 2017.

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Have Your Say on Federal Food Regulatory Change: Consultation Open On Draft Safe Food For Canadians Regulations

In January 2017, draft regulations under the Safe Food For Canadians Act (which was passed in November 2012) were published.  The draft Regulations can be found here.

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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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Key Takeaways from the 2017 Cantech Investment Conference

On January 18, 2017, investors, analysts, and entrepreneurs converged on the Metro Toronto Convention Centre for the 2017 Cantech Investment Conference. Exhibitors at the conference spanned a number of industries from cybersecurity to specialty finance to cannabis.

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The Academies Release Major Report on Cannabis and Cannabis-derived Products

The National Academies of Sciences, Engineering, and Medicine has released a major US government-funded report entitled "The Health Effects of Cannabis and Cannabinoids: The Current States of Evidence and Recommendations for Research" (the "Report") outlining benefits and harms associated with cannabis on a range of public health and safety issues. Cannabis scientific and medical research has historically been impeded because of its illegality, stigma, and related challenges, so the report represents a major positive step towards providing guidance and evidence-based research for physicians, researchers, and patients alike.

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Cameron Mingay Discusses Divesting for Growth

In the pharmaceutical and biotechnology industry, strategic acquisitions and consolidation are often pointed to as the prevailing trends. However, divestment of non-core business units has become an important tool to drive strategic growth across all industries, including in the life sciences sector.

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Deciphering the Term Sheet: Valuation

This article is the first in a series of articles that will delve into the most important terms in investment Term Sheets for early-stage companies.

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Tips for First-Time Investment Fundraisers

The first time a venture seeks external fundraising, often from an angel investor or venture capital firm, is a major milestone. The following suggests some tactical tools for reaching out to, and getting the attention and interest of, these investors:

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New US$500 Million Global Life Sciences Venture Fund Launched

Quark Venture Inc., a Canadian based venture firm, and GF Securities Company Limited, a China based investment bank, have recently launched a US$500 million life sciences venture capital fund. The fund will be based out of Vancouver, and is expected to focus on building a diversified portfolio of innovative biotechnology, pharmaceutical, and life sciences companies. It is now the largest life science fund in Canada and has already committed US$100 million into various life sciences companies.

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Developing Toronto's Life Science and Healthcare Innovation Economy

The core theme of the 2016 World Economic Forum in Davos, Switzerland was the arrival of the Fourth Industrial Revolution, with its velocity, scope and disruptive impact on almost every industry of every country.1  Much of the change is attributable to the creation and duplication of the digital universe of data, believed to be expanding by 40% per year.2  One of the sectors which is expected to be radically altered, and benefit significantly, is life sciences, and particularly, healthcare.

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The Capital Landscape for Early-Stage Life Science Ventures

As an early-stage start-up, regardless of industry, understanding the players in the investment landscape is important. Over the past several years, the types of investors interested in early-stage life science ventures has diversified, with investors that would normally invest at later stages now often looking to fund companies at earlier stages of commercialization.1  The following is a cross-section of the key players.

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The Growth of the Cannabis Industry

Over the past decade, cannabis distribution in North America has evolved from a criminal offense to – well, still a criminal offense – but also a billion dollar legal industry. The lines are often blurred as the cannabis industry undergoes a major regulatory and legal overhaul. As an emerging industry, we have seen, and will continue to see, an increasing number of opportunities for the development and growth of cannabis companies in both Canada and the United States. The development of cannabis in the areas of life sciences and medicine has been accompanied by an expansion of the recreational market.

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