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Second Round of Comments on Draft Regulation For Pharmaceutical Promotions

Updates -

In the second quarter of 2024, the Turkish Medicines and Medical Devices Agency (the “Agency”) published an announcement on its website, opening the Draft Regulation on the Promotional Activities of Human Medicinal Products and Food for Special Medical Purposes (the “Draft”) for external comments. Significant amendments proposed in the initial version can be reviewed by clicking here. Updates have been made to the Draft based on the opinions of sector stakeholders. The… »

Infinity Case Highlights Importance of Global Appreciation

The Court of Cassation has approved the First Instance Court’s decision in a case involving several INFINITY marks, shedding light on the principle of global appreciation of trademarks in the similarity examination. Background  On 8 January 2018 the applicant filed an application to register the trademark depicted below for “flying services by means of paragliding” in Class 41 before the Turkish Patent and Trademark Office (PTO):   After the application was published in… »

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… »

Applying Presumption of Patent Infringement Against Biosimilars

Before filing actions to assert patent rights against generics or biosimilars, the patent holder essentially operates in the dark. This is because, particularly in cases where the summary of product characteristics (“SmPC”) of the biosimilar/generic drug has not yet been published, or when it is not clear from the limited information in the SmPC whether the patent has been infringed. The relevant sections of the biosimilar/generic product’s dossier must be examined to assess… »

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… »

Legislative Developments for Artificial Intelligence in Turkiye

With the rapid expansion of the use of artificial intelligence (AI) and its integration into all areas of life, it has become essential to establish a legal framework that regulates the safe and ethical development, distribution and use of AI systems, considering the complexity and unique characteristics of this technology. In addition to promoting the safe, transparent, and human rights-respecting development of AI technologies, and aiming to protect the safety, rights, 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… »

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… »

The Turkish Court of Cassation Reminds of the Significance of “Vested Rights” in Two Recent Decisions: Frigo V Frico

Güldeniz Doğan Alkan and Dilan Sıla Kayalıca of Gün + Partners consider the Turkish Court of Cassation’s two recent decisions, underlining the significance of “vested rights” in the Turkish trademark law. The concept of “vested rights” is notable in the Turkish trademark law, as it serves as a strong defense against potential refusal of a later mark because of the likelihood of confusion it may create against an earlier one. In its two recent decisions related to the court… »

Guideline on Circumstances Requiring Reissue of a Marketing Authorization For a Licensed Pharmaceutical

Updates -

The transfer of pharmaceutical marketing authorizations (“MA”) entails intricate and interconnected procedures. Especially when it comes to imported pharmaceuticals, comprehensive contracts control the process when the foreign licensor company gives a license to a distributor in Türkiye and the products are offered for sale in the Turkish market. Before the MA transfer application is submitted to the Turkish Medicines and Medical Devices Agency (“Agency”), the license… »