United States: One For All Or One For One More Than One Supplementary Protection Certificate For One Basic Patent?

Last Updated: December 31 2013
Article by Christian Fulda, Roland J. Graf and Christiane S. Schweizer
Most Read Contributor in United States, September 2019

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 Mondaq.com.

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

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.


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