European Union: One For All Or One For One: More Than One Supplementary Protection Certificate For One Basic Patent?

Last Updated: January 14 2014
Article by Christian Fulda, Roland J. Graf and Christiane S. Schweizer

On December 12, the Court of Justice of the European Union ("CJEU") issued its decisions in cases C-443/12, Actavis, and C-484/12, Georgetown (referred to as "Georgetown II").

In these decisions, the CJEU outlined the circumstances under which a patent proprietor may obtain more than one supplementary protection certificate ("SPC") based on the same basic patent. The decisions will necessitate changes in SPC-granting practice in the majority of Member States, liberalizing the practice in some while raising new requirements in others.


Regulation (EC) No. 469/2009 of the European Parliament and of the Council of May 6, 2009 (the "SPC Regulation") defines the conditions for the grant of an SPC in Article 3. These conditions are: (i) the product (meaning the active pharmaceutical ingredient, "API") or a combination of APIs has to be protected by a basic patent, (ii) a valid marketing authorization for the API exists, (iii) no other SPC exists for said API, and (iv) the marketing authorization referred to in (ii) is the first authorization to place the API on the market as a medicinal product. The wording of the SPC Regulation does not provide for a restriction on the number of SPCs obtainable per basic patent.

In C-181/95, Biogen, the Court held that, with regard to a case involving a single product, only one SPC per patent could be obtained. This judgment had been widely interpreted as leaving open the possibility of more than one SPC being obtainable on the basis of the same patent, as long as they related to different products.

However, in 2011, the CJEU decision C-322/10, Medeva, cast doubts when the Court held that "[W]here a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent (see Biogen, paragraph 28)" (C-322/10, Rdnr. 41). This would have amounted to a "one SPC per basic patent" rule.

Divergent national practices evolved in the course of the past two years. While Dutch authorities turned to a literal interpretation of both the Medeva and Biogen judgments, which could be summarized by "one SPC per patent," UK authorities chose to read Medeva in line with the previous interpretation of Biogen, which could be summarized by "one SPC per patent, per product."

In the Actavis and Georgetown cases described below, UK and Dutch courts referred questions to the CJEU seeking clarification on the correct application of Article 3 (c) of the SPC Regulation.

Procedural History

In the Actavis case, Sanofi had first obtained an SPC for Irbesartan, and subsequently for Irbesartan and Hydrochlorothiazide (the "Sanofi Combination SPC"), based on the same patent. Actavis challenged the validity of the Sanofi Combination SPC, arguing, inter alia, that the Sanofi Combination SPC had been granted based on the same basic patent as the Irbesartan SPC, and thus contravening Article 3 (c) of the SPC Regulation as interpreted in the Medeva decision.

In the Georgetown II case, Georgetown had applied for the grant of several SPCs concerning either proteins of single HPV types as active ingredients or combinations of proteins from different HPV types. All of these applications were based on one basic patent and one marketing authorization for a combination of the viruslike particles ("VLP") of the recombinant L1 protein of HPV 6, 11, 16, and 18. One of these SPC-applications, directed to HPV 16 only, (the "HPV 16 SPC-application") has been refused (appeal pending); two SPCs have been granted (directed to the combination of HPV 16 and 18 and, respectively, the combination of HPV 6, 12, 16, and 18—the "Georgetown Combination SPCs"); and five further SPC applications are pending. The Octrooicentrum Nederland has opposed the grant of the currently refused HPV16 SPC-application based on the fact that the Georgetown Combination SPCs had already been granted based on the same basic patent, contravening Article 3 (c) of the SPC Regulation as interpreted in the Medeva decision.

Rulings of the CJEU

In answer to requests for preliminary rulings of the respective national courts, the CJEU has confirmed that it is possible to obtain more than one SPC per patent, but only under certain conditions. According to the Actavis decision, where a first SPC protected an API, whether used alone or in combination, it is not possible to obtain a further SPC for such API in conjunction with another API—such as the Sanofi Combination SPC, where the other API is "not protected as such by the basic patent but simply referred to in the wording of the claims of the patent in general terms, such as [...] 'beta-blocking compound', 'calcium antagonist', 'diuretic', 'non-steroidal anti-inflammatory' or 'tranquilizer' [...]." By contrast, in the Georgetown II case, the Court noted in explicit distinction from the Actavis case that the combination of four active ingredients (including HPV-16) as well as HPV-16 as an active ingredient individually are protected by the Georgetown patent. Accordingly, the Court held that the second SPC was available based on the same patent.


Unfortunately, both decisions leave considerable room for interpretation. It is unclear when an API is "protected as such" by a basic patent. From the reasoning of both decisions, it appears that the Court applied the following logic: If a basic patent covers an API alone or in combination, an SPC based on a marketing authorization for such API also "exhausts" the use of such API in a fixed combination—unless the other API in turn is protected in isolation under the basic patent, for use as a sole ingredient or in a combination product. In that case, however, the SPC would actually be sought for that other ingredient, in combination with the first (for which an SPC had already been granted).

Practical Considerations

Owing to the open questions resulting from the Actavis and Georgetown II decisions, further referrals are to be expected. Still, Georgetown II-like cases should now be received in Member States that so far rejected a second SPC on the same basic patent per se. By contrast, applicants have to prepare to overcome objections in Sanofi-like cases.

With regard to drafting the claims of patents that potentially may serve as basic patents, once an API is being authorized, the litmus test may be whether an API referred to in the claims may also be claimed individually in an independent claim, i.e., as innovation, be it for sole use or in combination.

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.

Christian Fulda
Christiane S. Schweizer
In association with
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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.