Canada: Patent Law And Data Protection Under The Canada-European Union: Comprehensive Economic And Trade Agreement (CETA)

On September 26, 2014, the official text of the Canada-European Union: Comprehensive Economic and Trade Agreement (CETA) was published.1 CETA has yet to be ratified; however, the published text provides important guidance on upcoming changes to the law. CETA covers many fields; this bulletin highlights the CETA provisions relating to patent law and data protection.

Patent Term Restoration for Pharmaceuticals

Patent Term Restoration

Under CETA, Canada has agreed to provide a period of sui generis protection, commonly referred to as patent term restoration, for pharmaceutical products. A pharmaceutical product can include a single active ingredient or combination of active ingredients. Both chemical and biologic pharmaceutical products are eligible. The restoration will confer the same rights as the patent, but will apply only to the pharmaceutical product and its uses covered by the market authorization. For example, if there are claims in the patent to other pharmaceutical products or other uses not covered by the market authorization, the term of those claims will not be restored.

The Period of Patent Term Restoration

The period of the restoration will be equal to the period between the filing date of a patent and the date of the first market authorization, less five years, up to a set maximum period. For example, if a patent is filed in 2014 and the first market authorization is issued in 2020, the patent term restoration would be six years less five years, or one year. CETA provides a range for the maximum period of restoration between 2-5 years and also provides that a further restoration beyond 2-5 years is possible, to incentivize or reward research in certain target populations, such as children. Though CETA provides for a range for the maximum period of restoration, restoration, the Technical Summary of Final Negotiated Outcomes, Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Agreement-in-Principle (the Agreement-in-Principle),2 released in 2013, indicated that the maximum period will be only two years.

Because the period of the patent term restoration is based on the lapse in time between the patent filing date and the later market authorization date, by slowing down the market authorization process, an applicant could deliberately increase the lapse between the two dates. To prevent applicants from intentionally delaying market authorization to obtain a longer term of restoration, CETA allows the government to reduce the patent term restoration where there are "unjustified delays" in the market authorization process.

CETA does not describe or define circumstances that could be considered to constitute unjustified delays. Nor does it address whether the delay in obtaining a market authorization will be benchmarked against averages (e.g., average delay for other pharmaceutical products in obtaining market authorization) or if delays will be addressed on a case-by-case basis.  

Other Restoration Criteria

While CETA is vague regarding retroactivity, the Agreement-in-Principle outlines that pharmaceutical products already approved and on the Canadian market will not be eligible for retroactive patent term restorations.

CETA provides that patent term restorations will apply to patents claiming (i) the active ingredient or combination of active ingredients of the pharmaceutical product, (ii) the process to obtain the pharmaceutical product, or (iii) the application of the pharmaceutical product. Patent term restorations may not be available for patents claiming a formulation or dosage form, unless such claims are regarded as the "application" of the pharmaceutical product. There is no requirement to list a patent on Canada's patent register (Canada's version of the US Orange Book) in order to benefit from patent term restoration.

Only one patent term restoration will be available per pharmaceutical product: if a product is protected by more than one patent, only one patent may be selected for the restoration. If a product is protected by patents owned by more than one person, the owners must select a single patent for the restoration. Furthermore, a patent term restoration will only be available if the first application for market authorization is submitted "within a reasonable time limit," a timeframe which will be prescribed by law. A person will have at least 60 days from the date of first marketing authorization or the date of issue of the patent, whichever comes later, to apply for the restoration.

Takeaways

Brand name drug manufacturers will want: to (i) ensure, in drafting, filing and prosecuting patent applications, that at least one patent includes a claim which makes a patent eligible for restoration; (ii) consider which patent to target for the patent term restoration; (iii) once the patent targeted for the restoration is identified, seek to include within that patent multiple claims that would be eligible for restoration; (iv) ensure that the first application for market authorization of the pharmaceutical product is made within the time limit that will be prescribed by law; (v) avoid any "unjustified delay" when pursuing market authorization so as not to compromise the eligible period of a patent term restoration; and (vi) strategically assess timing of patent filing and regulatory submissions in view of the lack of retroactivity of CETA.

Appeals Under the Patented Medicines (Notice of Compliance) Regulations and Dual Litigation

CETA provides that Canada shall ensure that all litigants are afforded "equivalent and effective rights of appeal" for judicial decisions under the Patented Medicines (Notice of Compliance) Regulations. No information is provided on how this will be achieved.

The Agreement-in-Principle suggested that the new right of appeal under CETA "gives scope for Canada to end the practice of dual litigation."3 However, CETA does not comment on dual litigation. Once CETA is signed and ratified, these proposed amendments to Canada's law are likely to be contentious.

Data Protection

Pharma Products

CETA provides that data—the origination of which involves considerable effort—submitted for marketing approval of a pharmaceutical product that utilizes new chemical entities (including biologics), will receive protection for a total period of at least eight years. During that period, no generic drug manufacturer will receive marketing approval for a product relying on an innovator company's data. Canada's current data protection regime already provides for data protection of eight years.4

Plant Protection Products

CETA also requires Canada to provide a data protection period of at least 10 years for a test or study report to achieve, subject to certain conditions, a marketing authorization for a plant protection product. Protection may be extended beyond 10 years to encourage the authorization of low-risk plant protection products and minor uses. During this period, another person cannot rely on the protected data to obtain a marketing authorization for the product.

What Next?

There is still much to be done before Canadian legislation is amended to implement CETA. Canada's treaty-making process involves negotiation, signature, ratification and implementation; although CETA negotiations concluded on September 26, 2014, signature and ratification must still take place—and amendments to Canadian law will be required to make CETA enforceable. The government has estimated that CETA will be ratified in 2015 and that the impact of patent term restoration will not be felt until 2023.5

Footnotes

1 "Canada-European Union: Comprehensive Economic and Trade Agreement (CETA)," online: Government of Canada.

2 "Technical Summary of Final Negotiated Outcomes, Canada-European Union Comprehensive Economic and Trade Agreement, Agreement-in-Principle," [Agreement-in-Principle] online: Government of Canada.

3 Ibid.

4 See our bulletins on data protection:
http://www.torys.com/Publications/Documents/Publication%20PDFs/FDB2006-2.pdf
http://www.torys.com/Publications/Documents/Publication%20PDFs/FDR2009-1.pdf

5 Ibid.

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 Mondaq.com.

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

Authors
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
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
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

Mondaq.com (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 www.mondaq.com

To Use Mondaq.com 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.

Disclaimer

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.

General

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