A Q&A guide to the commercialisation of healthcare in Turkey.
This Q&A provides an overview of the regulatory framework for the commercialisation of medical products in Turkey. It covers the key requirements for manufacturing, marketing and advertising medicines, medical devices, biological products and natural health products.
1.What is the definition of medicine (or equivalent) in your jurisdiction?
Under the Law on Pharmaceuticals and Medical Preparations...»
On 12 February 2021, the Turkish Medicines and Medical Devices Agency published new guidelines (Turkish language) for the implementation of regulation on sales, advertising and promotion of medical devices. The new guidelines introduce detailed provisions on implementing some of the significant amendments that were made to the Regulation on Sales, Advertising and Promotion of Medical Devices on 2 September 2020.
Under the guidelines, in addition to advertising and promotional...»
Filing trademarks on a broad coverage of goods and services lists without intention to use is a common practice in Turkey. Owners of such trademarks might have acted in bad faith at the time of filing, or could abuse their rights arising from such trademarks while enforcing them.
To illustrate, owners of trademarks having overly broad specifications may request third parties to pay a high amount of money to grant them letters of consent, to withdraw their opposition, or to en...»
Amendments Related to Signature Specimen
The Amending Law Related to the Technology Development Zones and Certain Other Laws (the "Law No. 7263") was published in the Official Gazette on February 3, 2021 and entered into force on the same date. Article 22 of the Law No. 7263 amended Article 40 of the Turkish Commercial Code with respect to issue of signature specimen.
In this regard, the amendment provides that signature samples of real person merchants and authorized signato...»
Since Turkey’s inclusion as a member of the EPC, a hot topic has been the enforcement or invalidity of Turkish validation of European Patent(s) (“EP”) while proceedings before the European Patent Office (the “EPO”) are pending.
Once an EP is validated in Turkey, it becomes a national patent. For EPs, the Turkish Patent and Trademark Office (the “TPMO”) seems to have transferred its powers and duties to the European Patent Office; therefore, it functions as an institution that...»
Discovery of evidence requests are specially regulated under Civil Procedural Law No. 6100. Discovery of evidence serves the purpose of determining a fact that has not yet been examined in an ongoing action or a fact that will be put forward in a future action.
It must be emphasised that unlike the US and UK systems, there is no full and frank disclosure procedure under Turkish civil law. In other words, the parties may decide, at their discretion, which documents they will o...»
In 2020, an arbitration judgment was held in accordance with the ISTAC serial arbitration procedure regarding the compensation request for employee invention and, as far as it is known, this is the first and pilot file in which the Regulation on Employee Inventions, Inventions in Higher Education Institutions and Public Funded Projects, will determine the price tariff for employees’ inventions and the arbitration procedure to be followed in case of dispute.
Within the scope o...»
One of the most striking developments of 2020 is a preliminary injunction decision given as a result of the implementation of the provision, “Prevention of the Indirect Use of Invention,” regulated in Article 86 of the IPL.
Although the expression “Indirect Use of Invention” is often confused with the concept of “Indirect Infringement of Patents,” in fact, indirect patent infringement is not clearly regulated in our law. Turkish IP Code numbered 6769 (“IP Code”) lists the act...»
The supply of pharmaceutical products to Turkey via the named patient programme (the “NPP”) is one of the exceptional importation regimes for pharmaceutical products. Where a pharmaceutical product is not granted marketing authorisation in Turkey, or it is granted marketing authorisation but not found in the market, but patients need it, it can be supplied via this special route by physician request. The entities that are authorised to import pharmaceuticals within the scope ...»
The new IP Law (the “Law”) numbered 6769 abolished the provisions on “The use requirement of patents,” and “The evidence of use” of the Decree Law Pertaining to the Protection of Patent Rights. The Law now focuses on the requirements of use for patents within the provision of a Compulsory License.
Accordingly, a patent owner must make use of the patented invention within three years following publication of its granted decision in the Official Bulletin (‘the Bulletin’), or wi...»
The Turkish Court of Appeal (CoA) has upheld lower court decisions which ruled in favour of cancelling the Turkish Patent and Trademark Office’s (‘Office’) Re-Examination and Evaluation Board’s (‘Higher Board’) decision for invalidation of the ‘Mazstar’ trade mark on the basis of likelihood of confusion with the plaintiff’s trade marks bearing the common element ‘Star’.
Article 6/1 of the Industrial Property Code (IPC) rules that ‘Upon opposition, the proposed t...»
1. How is commercial arbitration used and what are the recent trends?
Use of commercial arbitration and recent trends
In Turkey, arbitration traditionally evolved as a dispute resolution mechanism, which was used more frequently in large commercial disputes where a foreign party is involved and mostly when a legal counsel is involved in the preparation of the principal contract between the parties. For all other matters, particularly concerning disputes of smaller value, Turk...»