Canada: Top Headlines Of 2018

Last year ushered in a number of changes to the Canadian pharmaceutical and life sciences sector. 2018 also served as a year to explore the impacts of major intellectual property decisions and regulatory changes from 2017 including the impact of the Supreme Court's decision in NEXIUM striking down the Promise Doctrine and the implementation of CETA on single-track patent litigation under the newly amended Patented Medicines (Notice of Compliance) Regulations. Further, a number of IP and regulatory developments arose, such as: the potential for a national pharmacare program, advances to the self-care products framework for non-prescription drugs, natural health products and cosmetics, and amendments to the Patent Act and other intellectual property statutes as a result of Bill C-86.

We have compiled our list of Pharma in Brief's top headlines from 2018 below:

Legislative Developments

  • Bill C-86. The enactment of Bill C-86, the Budget Implementation Act, 2018, No. 2 in December 2018 brought with it significant changes to Canada's core IP statutes, including changes to the Patent Act that will affect patentees in the pharmaceutical and life sciences sector, such as: (i) the possible admissibility of the patent prosecution history (file wrapper) in litigation as evidence to rebut a patentee's representations on claims construction, (ii) revised and restated exceptions to infringement for experimental use and continued acts first undertaken prior to the claim date, (iii) provision for standard-essential patents, and (iv) regulations for demand letters and related offences.
  • New protections for biologics and other pharmaceuticals under the USMCA. The United States-Mexico-Canada Agreement (USMCA), which replaces the North American Free Agreement (NAFTA) will introduce new protections for biologics and other pharmaceuticals, including an extended data protection term of ten years for new biologics and a new patent-term restoration system for unreasonable delay in patent prosecution. This new system is not specific to pharmaceuticals and will be additional to any Certificate of Supplementary Protection (CSP) that may be available for pharmaceutical patents. Although signed in 2018, the USMCA awaits ratification by its member states in 2019 before it will come into force.
  • Health Sector Payment Transparency Act delayed or abandoned. The Ontario government passed the Health Sector Payment Transparency Act (HSPTA) as part of Bill 160 in December 2017 and published draft regulations for consultation in February 2018. The draft regulations defined terms, set thresholds, and established the manner and frequency of, and exceptions to, reporting requirements. However, in April 2018, the Ontario government delayed implementation until after the fall election. The regulations have not been revisited since the election and it is unclear whether they will be enacted or abandoned under the current Ontario government.

Regulatory Schemes and Guidance

  • Health Canada Expands the Submissions Under Review List to include ANDSs. As of October 1, 2018, Health Canada is publishing a list of abbreviated new drug submissions (ANDSs) under review on the Generic Submissions Under Review (GSUR) List. The list includes the medicinal ingredient(s), the therapeutic area and the number of submissions under review. Health Canada also expanded its Regulatory Decisions Summaries to include certain ANDSs, supplemental abbreviated new drug submissions (SANDSs) and supplemental new drug submissions (SNDSs).
  • The potential for a national pharmacare program. In February 2018, the Federal government tabled its 2018-2019 budget, which contemplated the creation of a national pharmacare program that would introduce a pricing and reimbursement model for certain prescription medications. Beyond the Standing Committee on Health's April 2018 recommendations on the best way to move forward with a universal single payer prescription drug coverage program, the Advisory Council on the Implementation of National Pharmacare is expected to provide a 2019 report commenting on the proposed implementation.
  • New CADTH guidelines for biosimilars. In February 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) released new procedural guidelines for both cancer and non-cancer-related biosimilar submissions. Key changes to the review and resubmission for biosimilars included shorter review times, fewer submission requirements, a new fee structure, and no provincial/territorial reimbursement recommendation.
  • Self-care products framework. Health Canada announced that it will advance the new self-care products framework, a new risk-based regulatory framework for non-prescription drugs, natural health products, and cosmetics, under existing legislation by updating the Natural Health Products Regulations and the Food and Drug Regulations on a rolling basis through 2020.

Case Law Developments

  • Developments on PM(NOC) cases and CSPs following CETA. In September 2017, following the enactment of the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), key reforms to the Patent Act were introduced, including patent term restoration (CSPs) for patented pharmaceuticals under the Certificate of Supplementary Protection Regulations and a new single-track pharmaceutical patent litigation system under the Patented Medicines (Notice of Compliance) Regulations. With respect to CSPs, 16 CSP applications have been granted, 4 applications have been refused, and 7 applications are still pending, according to Health Canada's online Register. The first application challenging the Minister's decision to refuse a CSP was commenced in the Federal Court (Federal Court file No. T-1603-18) in August 2018. With respect to proceedings under the newly amended Patented Medicines (Notice of Compliance) Regulations, approximately 20 actions were started in 2018. Early interlocutory decisions included: (i) the Federal Court's decision to dismiss Amgen's motion against Genentech, Inc. and Hoffman-La Roche Limited for early dismissal of two patents under section 6.08 of the Patented Medicines (Notice of Compliance) Regulations, and (ii) the requirement for a concurrent trial on issues of validity in cases brought by a first person against two generics related to patents covering Biogen's FAMPYRA .
  • Post-NEXIUM decisions. The impact of the Supreme Court's landmark ruling in AstraZeneca Canada Inc. v Apotex Inc., 2017 SCC 36 (NEXIUM), which rejected the "Promise Doctrine", played out in different contexts throughout the year. For one, the Ontario Court of Appeal and the Federal Court of Appeal reached conflicting conclusions as to whether the NEXIUM decision's change in law triggered the special circumstance exception to the doctrine of issue estoppel. Further, AstraZeneca successfully relied on the NEXIUM decision to avoid liability for section 8 damages. The Court also refused Apotex's motion to re-open validity to adjudicate the issue of overpromising in light of the Supreme Court decision. Finally, the Ontario Superior Court rejected Apotex's later attempt amend its pleadings in a section 8 damages action in order to revive the Promise Doctrine under the guise of invalidity allegations.
  • Infringement damages and accounting of profits decisions. The Federal Court of Appeal upheld the Federal Court's damages order that Teva pay Janssen over $18 million for infringing sales of levofloxacin (LEVAQUIN) in Canada. The Federal Court of Appeal also held that Janssen US had standing to claim damages under section 55(1) of the Patent Act (i.e., Janssen US was not required to demonstrate that it had held title in Canada to the LEVAQUIN tablets it had sold to Janssen Canada). In a decision relating to Bayer's patents for YAZ and YASMIN, the FCA reiterated that the patentee, and not the infringer (Apotex), is entitled to elect between damages and an accounting of profits after a finding of infringement. In a case between Eli Lilly and Apotex related to CEFACLOR, the Federal Court of Appeal confirmed that in assessing the availability of a non-infringing alternative (NIA) defence, the NIA must be legal and cannot infringe any patent, and its economic viability must be considered objectively. The Federal Court of Appeal upheld the Federal Court's damages award but remitted the issues of prejudgment interest to the Federal Court for redetermination. Finally, in a redetermination of profits decision related to COVERSYL (perindopril), the Federal Court dismissed Apotex's NIA defence finding that Apotex could not and would not have sold the NIA in the hypothetical world. The Court refused to reduce Servier and ADIR's profits.

As 2019 unfolds we will continue to monitor developments in these areas and look forward to sharing them with you in Pharma in Brief.

About Norton Rose Fulbright Canada LLP

Norton Rose Fulbright is a global law firm. We provide the world's preeminent corporations and financial institutions with a full business law service. We have 3800 lawyers and other legal staff based in more than 50 cities across Europe, the United States, Canada, Latin America, Asia, Australia, Africa, the Middle East and Central Asia.

Recognized for our industry focus, we are strong across all the key industry sectors: financial institutions; energy; infrastructure, mining and commodities; transport; technology and innovation; and life sciences and healthcare.

Wherever we are, we operate in accordance with our global business principles of quality, unity and integrity. We aim to provide the highest possible standard of legal service in each of our offices and to maintain that level of quality at every point of contact.

For more information about Norton Rose Fulbright, see

Law around the world

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