There exist two fundamental legislations about data exclusivity in Turkey. These are; “Decree Law No. 551 on the Protection of Patent Rights” and “Human Medicinal Products Licensing Regulation”.

Third paragraph of 83rd article of Decree-Law No. 551 on the Protection of Patent Rights currently in force (as of June 27, 1995) is as follows: "Where an application for patent has been filed for pharmaceutical or veterinary products/drugs and for chemicals destined to agriculture, the authorities issuing authorizations/licenses for the manufacture and sale of such products and requesting for this purpose information and test results, that were not disclosed to the public and the realization and accumulation of which requires considerable expenses and efforts, shall keep such information and test results secret/confidential. The authority asking for such information and test results shall take the necessary measures to prevent unjustified/illegitimate use thereof."

The regulation about data exclusivity in Turkey – Human Medicinal Products Licensing Regulation – was published on 25705 numbered Official Newspaper on 19th January, 2005 (last amendment made on 22.04.2009). 9th Article of this regulation is about abridged applications and it determines the duration of data exclusivity and the relationship between the data exclusivity duration and the patent duration, if any. The said Article provides a six-year period of data exclusivity only for pharmaceuticals for use in humans to prevent the marketing of generic drugs/products. This period starts from the date on which the authorization is first granted in any member states of EU Customs Union and cannot exceed the patent term of 20 years.

As for  requirements for applying for data exclusivity in Turkey, indeed, patent protection is not necessary for data exclusivity in Turkey. Meanwhile, in case of presence of any patent protection, data exclusivity cannot exceed the patent term of 20 years. On the contrary, if the registered patent expires prior to the expiration of the six-year period then the data exclusivity period will automatically end with the expiration of the registered patent protection. In other words, having a registered patent protection does not have a lengthening effect but can have a shortening effect in respect of the data exclusivity period if the patent protection expires prior to the 6 years-term of data exclusivity. In other words, the term of data exclusivity, whether it is a full 6 years term or less depends on the expiry date of the basic patent (which is usually the product patent) of the drug product, if any.  

The  basic patent is generally accepted as the patent for the active product ingredient (API) itself. However, there are uncertainties in the practice of the Ministry with regard to the determination of the type of the patent covering the drug product which will obtain data exclusivity i.e., the patent for the API itself, indication, formulation etc.

With regard to application procedure for data exclusivity, please note that the applicant is requested to declare the data exclusivity (if any) while filing a request of authorization with the Ministry of Health. There is no specific form issued by the health authority to fill in (therefore there is also no specific “box” to tick on the application form) or a specific recommended wording, for the application procedure for data exclusivity. The data exclusivity claim can be added into the document filed for requesting authorization before the Ministry of Health, as an additional explanation/request.

It is recommendable to clearly declare the expiry date of the data exclusivity term and to support such information with the European public assessment reports of the European Medicines Agency showing the initial authorisation date of the product in the European Union or with any other alternative and acceptable document.

Additionally, we recommend to include the information regarding the patent protection, since the Turkish health authorities are inclined to link the data exclusivity with the patent protection in Turkey. Therefore it is advisable to declare the patent protection information while filing a request of authorization with the Ministry of Health even if they are not the basic patents in respect of the general view of the Turkish health authorities (on grounds that they are not covering the active ingredient itself).

There is no deadline for filing the declaration of data exclusivity since it is automatically started without the requirement of any application procedure. However, it is strongly recommended that data exclusivity should be declared while filing the request of authorization with the Ministry of Health, i.e. as a part of the authorization request.

-As for the patent term extension such as SPC in Turkey, the reply is negative as Turkey has not introduced and enacted any instrument/act with a view to extend patent protection such as SPC. Accordingly the protection as of the Decree-Law No. 551 on Turkish patents for the full term of 20 years cannot be extended, as of the current state of the legislation.

It is to be noted that Turkey has refused the application of SPC during the negotiations handled previously with USA and the European Union (EU) because this subject has not been included to an international agreement and because Turkey is not a full member of the EU.