Turkey: Pre-Emptive Declaratory Judgments To Determine Whether Intellectual Property Infringement Exists In Turkey

Many years of intensive research and development activities are required to build solid and commercially profitable intellectual property assets. Companies invest substantial time and resources in technologies, design, research, and development to ultimately produce these intangible assets. Such assets are central to companies maintaining and enhancing their market position. Thus, companies adopt a range of measures to protect these intellectual property assets, including declaratory judgments described below.

Declaratory Judgment Actions to Determine Non-infringement

Obtaining a declaratory judgment in which a court determines that infringement has not occurred ("non-infringement determination") is a key pre-emptive defensive measure for protecting intellectual property. Sector-leading companies invest heavily in developing intellectual property rights. Therefore, it is common for these companies to also become embroiled in patent and trademark litigation wars to protect their investment.

Turkish law allows any interested party to ask the courts for a non-infringement determination against the registered owner of the relevant trademark, patent, or industrial design (the "Right Owner"). The legal framework in Turkey for such actions is outlined separately in the respective legislation relating to trademarks, industrial designs, and patents.

Prior to initiating proceedings, the requesting party will usually send a notice to the Right Owner through a notary public. The notice enables the Right Owner to comment on the requesting party's manufacturing activities, or manufacturing preparations.

The requesting party is entitled to initiate proceedings to obtain a non-infringement determination if either the Right Owner does not respond within one month of receiving the notice, or the requesting party is not satisfied with the Right Owner's response.

It is mandatory to seek the Right Owner's comments in the context of trademarks and industrial designs. Completing this step is a pre-requisite for initiating proceedings to obtain a non-infringement determination. For patents though, parties can directly initiate proceedings seeking non-infringement determinations without first seeking comments from the Right Holder. As a result, patent Right Owners can unexpectedly find themselves as defendants in such actions.

Proceedings seeking a non-infringement determination cannot be initiated against the Right Owner if infringement proceedings have already been initiated with regard to the intellectual property right in question. However, it is possible to initiate proceedings which at the outset jointly claim invalidity, as well as seek a non-infringement determination. When initiating proceedings, all parties noted in the Turkish Patent Institute's registry must be notified.

Non-infringement Determinations to Protect Pharmaceutical Patents

Proceedings seeking non-infringement determinations are particularly important for pharmaceutical patents, which require lengthy and expensive research and development investments. There are two main types of entity in the context of pharmaceutical research and development:

  • Innovator companies which produce original drugs by investing vast amounts of money, time, and resources into development, clinical trials, and manufacturing. Therefore, innovator companies play a significant and influential role in determining market dynamics for the pharmaceutical sector.
  • Generic companies which produce generic alternatives to original drugs. Generic drugs are the equivalent of original drugs in dosage form, safety, strength, quality, and performance. They are chemically identical to their reference counterparts (produced by innovator companies). A generic drug contains the same active substance(s) as the original drug. It should be identical in strength and dosage form to treat/heal the same disease(s), as well as being bioequivalent. However, its appearance and packaging can differ from the original drug.

Since innovator companies invest large amounts of time and money into their development activities, it is reasonable that mechanisms should exist which ensure they can reap the benefits of their efforts and be supported in further innovation activities. On the other hand, initiating proceedings for non-infringement determinations help generic companies to avoid being later required to defend themselves in infringement actions.

Innovator companies tend to prevent generic companies from entering the market with a generic copy of their original drug by patent thickets and follow-on patents. An innovator company may register patents in multiple categories, which are entirely identical to the original patent registration. In this way, the innovator company can refresh the basic patent protection by means of secondary or follow-on patents. These are primarily designed to keep competitors (including generic companies) out of the market.

No pharmaceutical product for human use in Turkey may be marketed unless it is authorized by the Ministry of Health. In granting a marketing authorization, the Ministry requires drug producers to submit the results of their pharmaceutical products' safety and efficacy tests, along with other documents regarding the product. During the data exclusivity period, generic drug producers cannot use or rely on the data gathered by innovator companies to obtain marketing authorization for a generic drug. However, if a patent exists, but no data exclusivity, third parties can apply for a marketing authorization without infringing on the patent (Article 75(f) of the Patent Decree Law). The applicant is not able to actually manufacture the generic drug though, due to the continuing patent protection. However, despite this manufacturing restriction, filing a marketing authorization while the patent is still active will save time.

If neither patent nor data exclusivity protection exist, generic companies are permitted to both manufacture and sell the generic drug in Turkey, provided the company holds marketing authorization.

Therefore, it is possible to create a generic drug without causing patent infringement if:

  • The basic data in the marketing authorization application is not protected by patent or data exclusivity mechanisms;
  • Both the patent and data exclusivity protection has expired.
  • The patent is invalid.

Consequently, generic companies acting defensively may choose to initiate proceedings seeking a non-infringement determination from the court which states that their generic product does not infringe patent rights. Such an action would be initiated after applying for marketing authorization to market and sell the product in Turkey. Under the Turkish Patent Law, generic companies can directly initiate such proceedings without first seeking comments from the related patent Right Holder. Therefore, in Turkey innovator companies can suddenly or unexpectedly be faced with a non-infringement determination action initiated by generic companies.

In case a non-infringement action is initiated against an innovator company since Turkish law requires the data which a marketing authorization application is based on to be kept confidential, irrespective of whether the application relates to an original or generic drug, an innovator company is not permitted to examine the generic applicant's data to determine whether the data infringes on the innovator company's rights. In these circumstances, an innovator company has two possible options:

  • Settlement Negotiations – Any time before or during court proceeding, the innovator company can contact the generic company seeking to find common ground for a possible settlement. During settlement negotiations, the parties may choose to arrange. On the arranged date, the parties would examine the data, in the presence of their lawyers, and an examination date and ask the Ministry of Health for permission to examine the application data without making copies. If the parties agree on the generic product's non-infringing status, a settlement protocol would be prepared and signed.
  • Court Proceedings - The innovator company may prefer to continue with the court proceedings. During proceedings, the court determines an examination date for the parties and/or an appointed expert body. The application data is examined and then an expert report is prepared. The innovator company would submit its opinion and objections regarding the generic drug. Based on these documents, the court makes its determination about whether the generic drug infringes or not.

Declaratory judgment actions are an important tool for innovator and generic companies for protecting their position in the market. Since both types of companies contribute to supporting public health and play an equally important role in the pharmaceutical sector, a careful balance must be maintained between the rights of both of them.

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
Yonca Çelebi
 
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
 
Related Articles
 
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