Canada: Supplemental Protection Certificates (SPCs): The Search For Clarity Goes On – When Is A Marketing Authorisation To Be Relied On?

In another attempt to clarify the basic criteria for SPC eligibility, Mr. Justice Arnold has referred AstraZeneca AB v Comptroller-General [2012] EWHC 2840 concerning the duration of an SPC when the marketing authorisation has been suspended, to the Court of Justice of the European Union.

The Facts

In March 2004, AstraZeneca, a British-Swedish multinational pharmaceutical company, obtained a marketing authorisation (MA) for their drug, Iressa, in Switzerland. Under the customs and patent union between Switzerland and Liechtenstein, the Swiss MA was automatically recognised in Liechtenstein and therefore the European Economic Area (EEA).

In 2003, AstraZeneca had submitted an application to the European Medicines Agency (EMA) for a European MA but the Committee for Proprietary Medicinal Products (CHMP) was not willing to grant one, citing insufficient data as having been provided. The data apparently failing to answer questions which had been raised by the CHMP. Having failed to provide sufficient data within the required time period, the MA was suspended in October 2005, terminating its effect in Liechtenstein.

The Swiss MA in operation from 2004-2005 was limited in duration and loosely applied the criteria the European Union (EU) authorities required under the relevant Directives. During this period, it was therefore legal to market Iressa in Liechtenstein, but nowhere else in the EEA or EU.

In 2008, AstraZeneca re-submitted its application to the EMA supported by further clinical trials and sufficient data addressing the CHMP's concerns with the original application. AstraZeneca was ultimately granted a European MA in 2009 and a new Swiss MA the following year, after which it was permissible for AstraZeneca to put Iressa back on the market in Switzerland and Liechtenstein. Between 2005–2009 it was illegal to market Iressa anywhere in the EU or EEA.  

The question therefore arose as to which MA applied as the first authorisation on the market for an SPC application.

Which was the first MA?

Under the SPC regime, the date of the first MA authorises the drug to be placed on the market in the EEA. An SPC cannot be granted for more than 5 years and the duration of the protection of the patent cannot exceed 10 years for the holder's first MA. 

The Comptroller of Patents in the UK regarded the 2004 Swiss MA as the first MA. The reason for this was because of the decision in Novartis AG and others v Comptroller-General of Patents, Designs and Trade Marks for the United Kingdom (Case C-207/03) where it was held that a Swiss MA could trigger the SPC provisions due to its effect in Liechtenstein and therefore the EEA.

However, AstraZeneca argued that the Swiss MA could not have triggered the SPC provision due to the Hassle AB v Ratiopharm GmbH (Case C-127/00) decision where it was held that the only MA which would trigger an SPC is one granted in accordance with the relevant EU Directives, which the Swiss MA was not. In addition, the principle which arose from Synthon BV v Merz Pharma GmbH & Co KgaA [2009] EWHC 656 (Pat) ("Synthon") was that when a product is placed on the market without first having received an EU-compliant MA, the product is outside the SPC system.  

Mr. Justice Arnold took into consideration three points when considering which was the first MA. First, the objective of the Regulation is to ensure sufficient protection to encourage pharmaceutical research which is important in the continuing improvement in public health. Second, the Regulation aims to prevent the development of different national laws leading to further discrepancies which are likely to create barriers to the free movement of medicinal products within the Community. Finally, the pharmaceutical sector is complex and it is important to take into consideration all the interests at stake, including those of public health.

He concluded that the Swiss MA was the first authorisation. Iressa was authorised to be placed on the market in Liechtenstein during the period from March 2004 to October 2005.

Is the drug now disqualified entirely from SPC protection?

In Synthon and Generics (UK) Ltd v Synaptech Inc C-427/09 ("Generics"), the Court held that where a product is placed on the Community market without first having undergone the testing and regulatory approval required under EU Directives, then not only will the SPC Regulation not apply, but any SPC that has already been granted will be invalid.  

The Comptroller argued that this implied the compound in Iressa could now never be granted a valid SPC having already been marketed in the EEA without first receiving an EU-compliant MA.

Mr. Justice Arnold agreed with the reasoning in Synthon and Generics which was more consistent with previous cases and viewed the product to be ineligible for any SPC protection. Although Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents (Case C-130/11) was considered, which suggests the contrary; it placed an unbalanced emphasis on the objectives of the SPC Regulation. 

Analysis

The decision means pharmaceutical companies should be alert that as soon as they are granted an MA in the EU or EEA the time to seek an SPC is running. It does not matter if the MA is suspended or disrupted in the future, the fact is that the medicinal product would have been authorised to be on the market from that initial date. 

Although, Mr. Justice Arnold has given his views on the matter, the case has been referred to the Court of Justice of the European Union (CJEU). This type of situation was not easily predicted and the referral arises due to alleged inconsistencies between a number of earlier rulings on SPCs.

So many SPC scenarios were not foreseen, it is difficult to know if we will ever have clarity. We await the CJEU's decision and hope clarity may yet be achieved. 

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
 
In association with
Related Topics
 
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