Canada: Legalization 2.0: IP And Regulatory Considerations For Edibles, Extracts And Topicals

Although recreational cannabis was legalized in Canada in October 2018, legalization was restricted to specific products such as dried cannabis, oils and seeds. Recently, Health Canada published its amended Cannabis Regulations, which permit the legal production and sale of edibles, extracts and topicals. The amended regulations are scheduled came into force on October 17, 2019, and the earliest date the new products will be available to purchase is December 16, 2019.

The legalization of cannabis edibles, extracts and topicals will expand the cannabis market and create new opportunities for producers, innovators and investors. According to a recent report from Deloitte, the Canadian market for these new cannabis products is expected to be worth $2.7 billion annually, with edibles accounting for more than half ($1.6 billion).

As the regulatory landscape evolves, the cannabis industry continues to innovate. Opportunities exist for protecting intellectual property related to cannabis such as trademarks, industrial designs, plant breeders’ rights and patents. Companies must carefully review their business activities to ensure that they comply with the Cannabis Act and Regulations. Companies should also consider filing applications directed towards any innovative intellectual property that they develop to gain a competitive advantage in what is an increasingly competitive field.

The New Landscape

Edibles are products containing cannabis that are intended to be consumed in the same manner as food. These can include gummies, chocolates and baked goods such as brownies and cookies as well as drinks. As it stands, they are already a popular way of consuming cannabis south of the border.

Extracts are substances produced by subjecting any part of a cannabis plant to extraction processing, such as by using a solvent (e.g. butane or CO2) in order to concentrate phytocannabinoids such as tetrahydrocannabinol (“THC”) and/or cannabidiol (“CBD”). Extracts include products such as shatter, oil, rosin, wax and crumble and may be intended for inhalation (e.g. smoking or vaping) or oral ingestion (e.g. capsules or liquid extracts). Under the Cannabis Regulations, a cannabis extract may also be produced by synthesizing a phytocannabinoid that is otherwise produced by a cannabis plant.  Topicals are products intended for use externally on skin, hair and nails such as emulsions or ointments, creams, shampoos and conditioners.

The regulations limit the amount of THC for each cannabis product, and also the types and amount of other ingredients that can be included in a composition. For example, edibles are restricted to 10mg of THC per serving and package. It is prohibited to add vitamins, minerals or nicotine. The combination of cannabis with caffeine is permitted, but is limited to specified amounts. Similarly, the caffeine must come from naturally-occurring ingredients such as chocolate, tea or coffee and cannot be used as a food additive. The regulations will allow for a small concentration of ethyl alcohol in edible cannabis products (that does not exceed 0.5% w/w), given that ethyl alcohol is often present as a by-product in fermented ingredients or products (e.g. vinegars). Edibles must also have a durable life of 90 days or less and must be shelf-stable.

Cannabis topicals have a limit of 1000mg of THC per package and cannot contain alcohol or nicotine. Topicals cannot contain anything that may cause injury to the consumer when the product is used as intended. Organizations are encouraged to consult the Cosmetic Ingredient Hotlist, which is a list of substances that are prohibited in cosmetics.

Cannabis extracts cannot contain nicotine, caffeine, sugars, sweeteners or sweetening agents. Ethyl alcohol may be used in products that are intended to be ingested, but cannot be used in products that are inhaled.

The packaging for these cannabis products has to be plain and child resistant. The package and label cannot include elements that would associate the product with alcoholic beverages, tobacco products or vaping products. It is also prohibited to make health claims or cosmetic claims. With respect to cannabis edibles, dietary claims are also prohibited.

Health Canada will assess, on a case by case basis, all proposed products for flavour, colour, shape, smell and branding to determine if they will be appealing or enticing to children.

Innovation and Patent Protection

The sizable market for edibles, extracts and topicals is driving research and development into technologies related to these cannabis products as well.  Innovative products and methods are being developed for growing and processing cannabis, extracting cannabinoids and terpenes, and formulating phytochemicals into products with desirable biological activities, improved stability, and/or organoleptic properties such as smell, taste or feel.  The proprietary technology underlying these innovations can be very valuable and may also qualify for patent protection.

In Canada, an invention must meet a number of statutory requirements in order to be patentable including that it be new, useful, non-obvious and directed to patentable subject matter (e.g. not a pure scientific principle, abstract theorem or work of art).  Patent protection allows the patent owner to stop others from making, using or selling the claimed invention for 20 years from the patent filing date. This effectively provides market exclusivity for products or methods covered by the claims.  Patent protection is also generally available in other jurisdictions such as the United States and Europe for innovative technologies related to cannabis.

With respect to edibles, patent protection may be available for a food product that contains cannabis if the product is novel, not an obvious variant of other known products, and it meets the remaining statutory requirements for patentability.

Recipes that merely combine known food ingredients and cannabis using common cooking techniques are likely to be considered obvious and therefore not patentable even if the product itself appears novel. However, innovative food products or associated methods may be patentable. A number of patents have been granted with claims directed to cannabis-containing food and beverage compositions or methods of making such compositions. For example, patents that relate to cannabis have been granted for alcoholic drinks (US Patent No. 10,085,965), milk (US Patent No. 10,028,987) and coffee (US Patent No. 10,103,225).

Patent protection may also be available for new and non-obvious extracts or topicals or for methods related to the production or use of these products. Novel and inventive dosage forms may also be patented, such as formulations designed for use sublingually or for liquid spray formulations. In addition, innovative packaging or delivery systems designed specifically for cannabis or related products may be patentable.

A patent agent or lawyer can review a particular innovation and help determine whether it may qualify for patent protection and how best to proceed. Until then, it is critical to keep the details of your invention confidential as any public disclosure (such as a presentation, printed publication or website) can jeopardize or even eliminate your chances of obtaining a patent.

Keep in mind that whether or not an invention qualifies as patentable is a separate and distinct legal question from whether or not it is legal to practice the invention. Put another way, it is possible to obtain patent protection in Canada for products that are not yet legal to sell under the current Cannabis Act and Regulations.  The exclusive rights granted by patent can last for up to 20 years from the filing date of a patent application.  As the regulatory landscape continues to evolve, there may be significant value in developing patented products and technologies with an eye to the future and possible further changes to the legal regime governing cannabis.

Proceed with Caution

As the rush to patent cannabis innovations continues, producers and sellers of cannabis-related products should be aware of any patent rights that could potentially interfere with or prevent the production or sale of those products.

Cannabis patent litigation is already underway in the United States for a patent related to a cannabinoid-based medical product formula (see United Cannabis Corp v. Pure Hemp Collective Inc). Consider having a patent agent or lawyer perform a “freedom-to-operate” (FTO) analysis to identify patent applications or granted patents that are relevant to your cannabis products or commercial activities. An FTO analysis can help minimize the risk of patent infringement and may also provide important information on the R&D activities of your competitors.

This article was first published in the Cannabis Prospect Magazine. Please go to

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions