European Union: A Therapy For European Patent Term Extensions: The Neurim Case And Supplementary Protection Certificates For "New Therapeutic Applications"

Last Updated: August 6 2012
Article by Christian Fulda, Martin Weber and Roland J. Graf
Most Read Contributor in United States, September 2019

On July 19, 2012, the Court of Justice of the European Union ("CJEU") issued its long-awaited decision in case C-130/11 Neurim Pharmaceuticals (1991) Ltd v. Comptroller-General of Patents.

In its ruling, the CJEU significantly liberalized the current practice for granting Supplementary Protection Certificates ("SPCs"), reducing the limitations imposed on the grant or duration of SPCs by earlier marketing authorizations ("MAs") for the same active pharmaceutical ingredient ("API").

Issue

The requirements for the grant of an SPC and for the computation of its duration are laid down in Articles 3 and 13 (1) of European Regulation 469/2009 (the "SPC Regulation"), respectively.

Article 3 (a) to (c) of the SPC Regulation specifies the conditions a product, defined as the API of a pharmaceutical preparation, has to fulfill in order to be entitled to the grant of an SPC. In particular, the API has to be protected by a basic patent in force; a valid MA has been granted, allowing the placing of the API (as a pharmaceutical product) on the market; and the product may not already be the subject of another SPC.

In addition, Article 3 (d) stipulates that the MA relied upon has to be "the first authorization to place the product on the market as a medicinal product."

Article 13 of the SPC Regulation concerns the calculation of the SPC term, specifying that this calculation shall include "the date of the first MA in the Community." Thereby, an earlier date for the MA will result in a shorter SPC duration.

Based on a consistent line of jurisprudence by the CJEU throughout the past years (Pharmacia, C-31/03 in connection with Hässle, C-127/00; MIT, C-431/04; Yissum, C-202/05), it was generally assumed that the earliest MA that issued for a respective API, even if concerning a different indication and/or a different species as covered by the basic patent for which an SPC was sought, was considered to be the "first" MA in view of Articles 3 and 13 of the SPC Regulation.

This had the consequence that such earlier MAs, when issued in the same country for which SPC protection was sought, were deemed to be prejudicial to the grant of an SPC relying on another, later MA (following from Article 3 (d) of the SPC Regulation).

Moreover, earlier MAs issued in any (other) member state of the European Union could at least potentially cut short the duration of SPCs based on a later MA for the same API (following from Article 13 (1) of the SPC Regulation), again irrespective of the therapeutic indication in question.

Procedural History

The reference for a preliminary ruling by the CJEU was made in the course of a dispute between Neurim Pharmaceuticals (1991) Ltd and the UK Intellectual Property Office ("UKIPO"), which had refused to grant an SPC based on an MA granted on June 28, 2007 for the medicinal product "Circadin," a formulation of melatonin for use as a medicinal product for human use for insomnia, and a corresponding European Patent.

The UKIPO's refusal was based on the fact that it had identified an earlier veterinary MA, dating from 2001, for melatonin (i.e., the same active ingredient as Circadin) for use in sheep as a medicine for regulating seasonal breeding activity. UKIPO held that, contrary to Article 3 (d) of the SPC Regulation, Neurim's MA for Circadin was not the first MA to place the product (i.e., the active ingredient melatonin) on the market. Under the SPC Regulation, both human and veterinary MAs are treated equally.

Neurim challenged this decision before the UK High Court of Justice and, since its action was dismissed, before the Court of Appeal (England & Wales) (Civil Division). The Court of Appeal referred to the CJEU for a preliminary ruling essentially on the question of which MA is to be regarded as being a "first" MA in the sense of Articles 3 and 13 of the SPC Regulation.

Ruling of the CJEU

With regard to Article 3 of the SPC Regulation, the Court has now clarified that the existence of an earlier MA as such does not preclude the grant of an SPC, as long as the later MA (and the SPC) concerns a different application of the same product for which a marketing authorization has been granted (C-130/11, item 1 of the Court's ruling).

The Court in this context specified that "if a patent protects a therapeutic application of a known active ingredient which has already been marketed as a medicinal product, for veterinary or human use, for other therapeutic indications, whether or not protected by an earlier patent, the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient, as protected by the new patent, may enable its proprietor to obtain an SPC, the scope of which, in any event, could cover, not the active ingredient, but only the new use of that product." (emphasis added; C-130/11, paragraph 25)

It is of note at this stage that the Court already speaks of a (new) "therapeutic application" and former "therapeutic indications." It is left unclear whether the Court intentionally made this distinction in order to include other cases of new "therapeutic applications" rather than to limit those cases where grant of an SPC is allowed to new (different) medical indications only.

It is of further note that the Court, by referring to the SPC's scope ("in any event, could cover, not the active ingredient, but only the new use of that product"), appears to limit application of its ruling to basic patents not covering the API as such or its use in a pharmaceutical product as covered by the earlier MA.

With regard to Article 13 of the SPC Regulation—which addresses calculation of the SPC term depending on the time period that lapsed between the basic patent's filing date and the first MA granted in the EU—the Court ruled that the criteria according to the SPC Regulation for the assessment of a "first" MA should be the same for Articles 3 and Article 13(1) of the SPC Regulation (C-130/11, paragraph 30 and item 2 of the Court's ruling) and that, accordingly, an MA is considered to be the first MA as long as it concerns a product coming within the limits of protection conferred by the basic patent relied upon for the SPC application.

Practical Considerations

With regard to the future application of Article 3 of the SPC Regulation, earlier MAs for the same API might no longer be prejudicial to the grant of an SPC relying on a later MA, as long as the later MA concerns another medical indication or a new "therapeutic application," respectively. Given that in the case in question, the new "therapeutic application" was not only a new route of application in the narrow, pharmaceutical sense, but a new application in a different species and different indication, it is fair to conclude that new "therapeutic applications" at least encompasses new indications. It is open, however, whether other line extensions (new formulations, new routes of administration, dosage regimes, unit dosage forms, etc.) would be equally deemed new "therapeutic applications," i.e., in cases where the API has already been used in the same indication.

In addition, the impact of the MIT case (C-431/04) remains unclear, as it was not discussed in either the opinion of the Advocate General leading up to the Neurim decision or in the decision of the Court itself. In MIT, an SPC for a new formulation was denied. However, that case turned on the definition in Article 1 of the SPC Regulation of "combination of active ingredients" and the question of whether the combination of an API and excipient as a (pharmaceutically relevant) carrier was a combination of "active ingredients" under the SPC Regulation. The relationship of the basic patent (or its scope) to the earlier product was not discussed. Also, in that case, the basic patent would not have covered the use of the API in the earlier approved product, given that the basic patent was restricted to the new formulation.

Another open question is whether the nexus made by the Court between the patent and use of the patent in the authorized pharmaceutical ("the new therapeutic application of the same active ingredient, as protected by the new patent") is merely descriptive of the case at hand or a requirement. The wording of Article 3 requires only a patent covering the API and an authorized product using the API, but not an authorized product incorporating the specific use of the API as claimed in the basic patent. For example, a patent may claim use of X in the indication Y, and an SPC could be claimed based on the authorization of X in the indication Z (for what it is worth). If the nexus between patent and label of the authorized pharmaceutical is a requirement, this may result in validity issues for existing SPCs that refer only to the use of the API.

As far as Article 13 of the SPC Regulation is concerned, the wording of the Neurim ruling suggests that MAs concerning the same active ingredient, which have been issued in another member state of the European Union, should not be taken into consideration for the calculation of the term of an SPC relying on a later MA, as long as the later MA relates to a different therapeutic application. Also in this case, the interpretation of the new "therapeutic application" and the corresponding limitations with regard to the basic patent, as discussed in the preceding paragraphs, will have to be employed.

The rather broad and general wording of the decision is not atypical for judgments of the Court. However, while a range of questions on the precise scope of the decision remains, it is clear that the less literal interpretation of Article 3 of the SPC Regulation offers new opportunities to patent proprietors for obtaining SPC protection in cases where an API has already been authorized (and thus commercialized).

Following its recent judgments in the Medeva (C-322/10) and Georgetown (C-422/10) cases, the European Court of Justice has handed down another decision relating to the interpretation of the SPC Regulations that will have considerable impact on the filing and prosecution of patent term extensions. This will open new strategies not only for the pharmaceutical and biotechnology innovator industry seeking to extend the lifetime of their products but also for generic companies trying to enter the market with generic formulations or biosimilars.

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
 
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.

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