Turkey: Assessing The Difficulties Of Enforcing Patent Rights Over NPP Products

Last Updated: 27 May 2019
Article by Ozge Atilgan Karakulak and Selin Sinem Erciyas

The supply of pharmaceutical products to Turkey via the named patient programme (NPP) is one of the exceptional importation regimes for pharmaceutical products. Where a pharmaceutical product is not granted marketing authorisation in Turkey but patients are in need of it, it can be supplied via this special route. The entities that are authorised to import pharmaceuticals from abroad within the scope of the NPP are the Turkish Pharmacists’ Association (TEB) and the Ibn-i Sina Health Social Security Center Warehouse established under the Social Security Institution (SSI Warehouses).

If the product is approved for the NPP, then it is added to the Foreign Drug List of the Ministry of Health (MOH) and the TEB and SSI import the products on a named patient basis.

In most cases, there is a Turkish entity which plays a role in the supply of the pharmaceutical product via the NPP route. The role of these companies is either to find and offer for sale the pharmaceutical products to the TEB or SSI Warehouse or to bid for such supply.

Infringement

Quite frequently, the supply method causes some problems for the protection and enforcement of patent rights in circumstances of potential patent infringement in Turkey. The patent owner, who also supplies the patented product via the NPP in Turkey, becomes aware of the competitor product by its inclusion on the foreign drug list. In some cases, the patent in question is a compound patent and therefore the infringement by the newly-added NPP product is inevitable. On the other hand, it may also be the case that the patent holder knew about the newly-added product from other markets and already tested it and approved the patent infringement.

In these scenarios, the patent owner is almost certain about the patent infringement and ready to take legal action in order to prevent the infringement. However, the only known party to the patent owner, taking the steps causing infringement, is either the TEB or SSI Warehouses, as the importer of the infringing products. Indeed, there is case law from the Courts of Appeal ruling that in cases of supply of an infringing product via the NPP, the TEB should be the addressee of the patent infringement action as the importer of the infringing products.

However, the TEB or the SSI Warehouses are the business partners of the patent owner for supply of its patented product via the NPP in Turkey. Consequently, the patent owner prefers taking action against the company that offers the infringing product for sale to the TEB or SSI Warehouses, if such company can be located at all. Even though this information is available to the TEB and SSI warehouses they strongly resist giving information about the identity of the company offering the infringing products for sale to the TEB or SSI warehouses. In some cases finding the identity of the Turkish company taking part in the NPP supply of an infringing product may also not be sufficient to prevent the infringement. In a precedential case, the IP Court rejected a precautionary injunction demand, stating that the real person who offered the supply of the infringing product to SSI was an employee of a foreign company located abroad and ruling that the PI demand should be directed to the foreign company located abroad. It is also debatable whether the foreign company’s act of supplying products to a real person resident in Turkey or a Turkish company abroad would constitute patent infringement according to Turkish IP Law.

Compulsory licences

Another problem that patent owners face regarding NPP products is the threat of a compulsory licence due to insufficient use of the patented product. It is clear that administrative bodies would like to supply patients with the cheapest product. With this primary aim, they ignore the patent infringement committed against the original NPP product. Therefore if the patent owner pushes hard to prevent supply of a cheaper infringing product via the NPP, the administrative authorities may decide to consider if there is room for a compulsory licence due to insufficient use of the patent disclosing the NPP product in Turkey or for public interest reasons.

In terms of a compulsory licence due to insufficient use of a patent, the third party demanding a compulsory licence should apply to the patent holder first to ask for a contractual licence and if this demand is rejected or not responded to within a reasonable time limit then an application before the Turkish IP Court should be filed. Consequently, the IP Court should evaluate and decide if the conditions for a compulsory licence due to insufficient use of a patent are fulfilled.

The provision on compulsory licences due to public interest also stipulates non-use or insufficient use of the patent, which causes serious damage to the technological or economic development of Turkey. However, in this case it is not necessary to apply to the patent owner for a contractual licence first or to apply to the IP Court. Compulsory licences due to public interest reasons may be granted by the decision of the president. Consequently it is a much more straightforward way of grant of a compulsory licence over a patent, especially for a patent protecting an NPP product which is a burden for the public budget.

There is no precedent case yet in which the administrative body has granted a compulsory licence for a patent protecting an NPP product, on the ground that the patent is being used insufficiently and the insufficient use of the patent causes serious damage to technological or economic development in Turkey. However, in a very recent case, the Ministry of Health used this option as a tool to negotiate the price of the patented NPP product and managed to convince the patent owner to supply the government with the patented NPP product in return for a drastically discounted price.

Our feeling is that the MOH as well as other governmental bodies may frequently use the compulsory licence due to public interest provision as a tool in price negotiations, especially for NPP products.

There are legal steps that may be taken against arbitrary interpretation of the provision on compulsory licences due to public interest reasons. However, the foreign companies supplying NPP products to Turkey will most probably refrain from taking legal action against the government until it becomes a must for them.

First published by Managing IP – Turkey IP Focus 2019, 04.04.2019

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
 
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
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