Insights
The Supervisory Power of The Re-Examination and Evaluation Board
It is observed that the supervisory power of the Re-examination and Evaluation Board (“Higher Board”), which is in charge of examining and finalizing appeals against the decisions taken by the Turkish Patent and Trademark Office (the “Office”) regarding the registration of IP rights, is in the form of a review of expediency. This issue is regulated in paragraph 4 of Article 6 of the Regulation on the Turkish Patent and Trademark Office Board of the Re-examination and… »
From Plant to Pill: Introducing Cannabis to the Pharma Industry
The Regulation on the Cultivation and Control of Cannabis for the Production of Active Pharmaceutical Ingredients ("Regulation") prepared by the Ministry of Agriculture and Forestry (“Ministry”) was published and came into force upon being published in the Official Gazette numbered 32661 dated 13 September, 2024. The Regulation includes provisions on the control, harvesting, evaluation, processing, disposal, display, export and/or purchase/sale of cannabis cultivation for the… »
IP Rights 2024 in Türkiye: Overview
Patents Requirements to Obtain a Patent 1. Provide a brief definition of a patent, the key legal requirements to obtain it and the law that applies. Conditions for a Patent A patent is an industrial property right that gives the patent owner the right to prevent third parties from certain activities such as producing, using, selling, or importing the product or process that is the subject of the invention for a 20-year period. The applicant must prove the following to obtain… »
A Trade mark or a Song? Turkish Court of Cassation Casts Some Light on this Distinction
Article 4 of the Law No. 6769 on Industrial Property indicates that sounds can be registered as trade marks if they are capable of being distinguishable for the goods or services of one undertaking from that of another: “Trademarks may consist of any signs like […], sounds and the shape of goods or their packaging, provided that such signs are capable of distinguishing the goods or services of one undertaking from those of other undertakings and being represented on the… »
Food Supplements
With the regulations published in the Official Gazette numbered 32169 and dated April 20, 2023, comprehensive amendments were made to the legislation on the use of health claims for food and food supplements and the use of nutrition claims. Thus, the Turkish Food Codex Regulation on Nutrition Claims under the authority of the Ministry of Agriculture and Forestry and the Regulation on Health Claims for Food and Food Supplements under the authority of the Agency, has entered… »
Application Fee for Scientific Meetings of Pharmaceuticals and Medical Devices Has Been Introduced
The Agency first announced on its official website on 4 January 2024, that the Guidelines on Scientific Meetings and Educational Activities to be Conducted within the Scope of the Regulation on the Sales, Advertisement and Promotion of Medical Devices (“Guidelines”) was amended, and that the most significant change introduced by the amendment to the Guideline is the collection of fees by the Agency for scientific meetings and applications for educational activities. According… »
Interactions with HCPs, Transfer of Values and Payments
The Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”), dated July 3, 2015, regulates the promotional activities of medicinal products for human use. Under the Promotion Regulation, any advertisement of products to the general public, whether directly or indirectly, through any public media or communication channels, including the Internet, is prohibited. Pharmaceutical products may be promoted only to physicians… »
Pricing of Pharmaceuticals and the Fixed Exchange Rate
Due to the rapid increase in the current exchange rates, pharmaceutical prices have been one of the most controversial issues in Türkiye in 2023. The price of medicines for sale are set under the Decision on Pricing of Human Medicinal Products (“Decision”) and the Communiqué on the Pricing of Human Medicinal Products (“Communiqué”) of September 29, 2017, issued by the Ministry, which is vested with the competencies to regulate this area. The Decision provides a reference… »
IP in Business Transactions 2024 in Turkey
IP Assignment Assignment Basis and Formalities 1. On what basis can the main IPRs be assigned? What formalities apply? Patents Basis for patent assignment. Under the Intellectual Property Law No. 6769 (IP Law), a patent can be assigned in whole. A patent cannot be assigned in part. Formalities for patent assignment. Under the IP Law, a patent assignment must be in writing and signed by both parties and notarised before a notary public. Registration of a patent assignment with… »
Update on the Medical Devices Regulations in Turkey
All kinds of manufacturing, marketing, and after-sales activities of medical devices are highly regulated in Turkey. The main framework for ensuring safety and compliance with the technical specifications is governed by the Law on Product Safety and Technical Specifications No. 7,223, which is an umbrella legislation covering all products intended to be placed on the market, supplied, or placed on the Turkish market. Further to above, general rules and principles of medical… »