Canada: RxIP Update - 2016 Year In Review

Last Updated: January 11 2017
Article by Daphne Lainson

The following are highlights of developments in Canadian life sciences intellectual property and regulatory law in 2016, updating our 2016 mid-year highlights.

1. Substantive patent law developments

Utility and the promise doctrine remain unresolved in 2016: The Supreme Court of Canada (SCC) heard AstraZeneca's appeal on November 8 regarding the utility "promise" doctrine and AstraZeneca's patent relating to esomeprazole (NEXIUM). The decision was reserved. Also pending is a decision of the arbitration tribunal regarding the damages claim made by Eli Lilly under the North American Free Trade Agreement (NAFTA). The claim is based on the Canadian judiciary's application of the promise doctrine to patents pertaining to STRATTERA (atomoxetine) and ZYPREXA (olanzapine) as contravening Canada's obligations under NAFTA and the Patent Cooperation Treaty. The hearing concluded on June 8, 2016, and post-hearing submissions were filed on July 25.

Greater clarity is provided on obviousness and double patenting: The Federal Court of Appeal confirmed that the correct test for determining whether an invention is obvious under the "obvious to try" test is still whether it was "more or less self-evident" to try to obtain the invention, and not a lower standard, such as whether the solution provides a "fair expectation of success" or whether "the skilled person had good reason to pursue predictable solutions". The Federal Court of Appeal also clarified the test for double-patenting.

2. Section 8 and other claims following failed PMNOC Regulations proceedings

The Ontario Divisional Court denied Pfizer leave to appeal a decision permitting Apotex's unjust enrichment claim regarding sildenafil to proceed. The Federal Court of Appeal overturned Teva's $125 million award (venlaxafine, EFFEXOR XR) for improper reliance on hearsay evidence and remitted the matter to the trial judge for redetermination. However, the scheduled redetermination by the trial judge has been adjourned while a leave application to the SCC is pending, and if leave is granted, until the appeal is determined. Apotex was denied leave from the SCC regarding a decision striking an unjust enrichment claim against Eli Lilly relating to atomoxetine. However, Apotex's damage claim relating to Apo-Ramipril and based on alleged improper issuance of a patent/a failed prohibition proceeding pursuant to the Trademarks Act and Statutes of Monopolies has been permitted to proceed. The SCC also denied leave in a proposed class action regarding VIAGRA, which sought to allege that consumers had been overcharged as a result of Pfizer's unsuccessful prohibition proceeding.

3. Quantification of damages

The SCC declined to hear Apotex's proposed appeal regarding the relevance of a non-infringing alternative in assessing damages for patent infringement in a case involving lovastatin (MEVACOR). The Federal Court awarded Janssen close to $20 million from Teva for infringing its patent relating to levofloxacin (LEVAQUIN). Teva's appeal is pending.

4. Actions

Bayer prevails in drospirenone/ethinyl estradiol infringement action against Apotex and Cobalt and is entitled to elect between damages and an accounting of profits. On September 9, the Federal Court released a decision finding that Apotex and Cobalt each infringed Bayer's valid patent for an oral contraceptive composition combining drospirenone and ethinyl estradiol. The Court rejected all alleged grounds of invalidity: novelty, obviousness, overbreadth, insufficiency and utility, and granted Bayer a declaration of validity and infringement by Apotex and Cobalt, as well as an order enjoining Apotex and Cobalt from further infringement, and delivery up of any infringing goods. The Court requested written submissions on an election of damages or an accounting of profits. The judgment regarding the injunction and delivery up/destruction as it applied to Apotex has been stayed, and the Court has required that Apotex meet certain conditions including to expedite its appeal. Cobalt has also appealed. On October 27, the Federal Court found that Bayer should be entitled to elect between damages and an accounting of the defendants' profits despite Apotex's argument that it, not Bayer, should decide Bayer's remedy.


Patent term restoration, on the horizon: On October 31, the day following the signing of the Comprehensive Economic and Trade Agreement (CETA) between Canada and Europe, Bill C-30 was tabled in order to implement CETA. The Second Reading and Referral to Committee was completed on December 13. If passed into law, certificates of supplementary protection (CSPs) will become available, which may provide up to two years patent term restoration for marketing delays resulting from the regulatory approval process. Bill C-30 also provides regulation-making authority to end "dual litigation" under the PMNOC Regulations and the Patent Act. If CETA is not ratified, patent term restoration may still become available in Canada if the Trans-Pacific Partnership (TPP) is ratified. Public submissions on the TPP are being accepted until January 27, 2017, and the fate of the TPP remains uncertain.


Planning, reporting and consulting continue: At the end of 2015, the PMPRB released its 2015-2018 Strategic Plan. Reports were released in February analyzing generic drug pricing, in May on public drug plan expenditures, and October saw a Market Intelligence Report: Biologic response modifier agents, 2015, which was highlighted in the PMPRB November NEWSletter. The NEWSletter also reported on the consultations on modernizing pricing guidelines, which began in May to modernize and simplify the framework for determining when patented drug prices are excessive. Phase 1 of the consultation is complete, with the timing of phase 2 of the consultation process to be announced, which will allow stakeholders who provided comments on the PMPRB Discussion Paper an opportunity to make oral submissions. The PMPRB annual report was released, after being tabled in August. The 2015 Annual Report indicates that Canadian patented drug prices remain the third-highest among the seven comparator countries against which the PMPRB reviews prices, behind Germany and the United States. At the end of 2015, 93 investigations into possible excessive patented drug pricing were ongoing.

Judicial challenges to PMPRB jurisdiction unsuccessful, so far: in June, the Federal Court struck Alexion's constitutional challenge of PMPRB provisions in the Patent Act. The Court noted that should leave to appeal be granted in the Sandoz matter, the issue of the constitutionality of the price control regime and the jurisdiction of the PMPRB would be open to consideration by the SCC. However, Sandoz and ratiopharm discontinued their application for leave to appeal on September 8. An appeal by Alexion of its challenge remains pending.

7. Health Canada/CADTH

New transparency initiatives include an expanded Health Canada listing of Regulatory Decision Summaries and Submissions Under Review. Further, flowing from Vanessa's Law, Health Canada released a Draft Guide on Disclosure of Confidential Business Information, an interim approach to drug safety updates, and an Issue Identification Paper for comment regarding mandatory reporting of serious adverse drug reactions by healthcare institutions.

8. Biologics update

Health Canada provides further guidance on biosimilars: New Guidance for biosimilars was adopted on November 14, replacing the Guidance from March 5, 2010. A revised Fact Sheet: Biosimilars was also published.

BIOSIMILAR approvals and litigation continue in 2016: BRENZYS, a product of Samsung Bioepis, was approved on August 31, making it the sixth biosimilar after OMNITROPE (Sandoz, 2009), REMSIMA/INFLECTRA (Celltrion, Hospira, 2014), BASAGLAR (Eli Lilly, 2015), and GRASTOFIL (Apotex, 2015). A PMNOC proceeding concerning Sandoz's etanercept biosimilar is pending; a patent impeachment/infringement trial is on-going for REMSIMA/INFLECTRA and a patent infringement/impeachment action for GRASTOFIL is pending. Amgen's leave to appeal to the SCC the FCA decision dismissing the GRASTOFIL PMNOC proceeding for mootness was denied. For INFLECTRA, the Federal Court upheld a decision summarily dismissing the PMNOC proceeding relating to the IBD indications based on a patent found to "speak specifically and directly to and only to the RA Indications" of infliximab. Janssen is seeking leave to appeal to the SCC the FCA decision finding that a cross-referenced drug submission did not trigger section 5 of the PMNOC Regulations absent early working, resulting in a NOC to Hospira for infliximab.

Other biologics news for 2016 included a settlement of The Children's Hospital of Eastern Ontario (CHEO) action with Transgenomic, allowing "CHEO and all other Canadian public sector hospitals and laboratories the right to test Canadians for Long QT syndrome on a not-for-profit basis ... without legal roadblocks from [the] gene patents." In addition, CIPO has signalled a change in practice for humanized antibodies with a decision clarifying support requirements.

9. Patent litigation practice

A "quia timet" patent infringement claim was allowed to proceed, with the Federal Court dismissing Teva's motion to strike a patent infringement claim by Gilead made further to Teva's impeachment action regarding patents relating to tenofovir disoproxil fumarate products (TRUVADA and VIREAD). Valeant's prohibition application under the PMNOC Regulations in respect of metformin (Valeant's GLUMETZA) was struck as an abuse of process upon a section 6(5)(b) motion brought by Apotex. New case management guidelines for PMNOC applications were released in May. The "blinding" of experts in PMNOC applications (e.g. as to the generic's product) continues to have mixed results: one judge found it not determinative; another weighed it as a relevant factor in preferring one expert's testimony over another, while another found the 'blinding' of experts was not a reason to prefer one expert's opinion over another's opinion. In another decision, the Court found that the blinding issue is a question of relevance, reliability and weight rather than a doctrinal matter, and therefore approached the evidence on a case-by-case basis.

10. Competition law

In March, the Competition Bureau released updated Intellectual Property Enforcement Guidelines which describe the Bureau's approach to conducting investigations of potentially anti-competitive activities relating to intellectual property, including settlements in PMNOC proceedings and "product switching". In October 2016, the Competition Bureau released a report questioning restrictions on health care advertising.

11. PMNOC Regulations and data protection statistics

Based on the 8 Federal Court PMNOC Regulations decisions reported by year-end, the patentee was successful on the merits on 3 patents in 3 cases and the generic manufacturer was successful on 6 patents in 6 cases. The FCA affirmed all 5 PMNOC Regulations appeals (patentee on 3 patents; generic manufacturer on 2 patents). See summary table here. See also the Therapeutic Products Directorate report providing a statistical overview of Health Canada's administration of the PMNOC Regulations and data protection; and the Therapeutic Products Directorate and the Biologics and Genetic Therapies Directorate's Drug Submission Performance Annual Reports.

The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

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.

Daphne Lainson
Similar Articles
Relevancy Powered by MondaqAI
Bereskin & Parr LLP
Smart & Biggar/Fetherstonhaugh
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Bereskin & Parr LLP
Smart & Biggar/Fetherstonhaugh
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must 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