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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

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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… »

Implementation of Discovery of Evidence in Patent Law

One of the most important temporary protection measures regulated by Turkish law is the determination of evidence. The implementation of determination of evidence, which is regulated in Articles 400 et seq. of the Code of Civil Procedure No. 6100 and is subject to simple legal procedure, may be requested for the purpose of making a discovery, obtaining an expert examination or taking witness statements in order to determine facts that have yet to be examined in a pending… »

Advertisement Board is Again Able to Block Access

Turkish Constitutional Court (“Court”) annulled the paragraph 12 of Article 77 of the Consumer Protection Law, which granted the Advertisement Board (“Board”) the power to partially or entirely block access to websites containing unlawful advertising content. The relevant rule was considered to be unconstitutional pursuant to the Court’s decision dated 13 September 2023 and numbered 2022/70 E. - 2023/152 K. which was published on the Official Gazette dated 27 October 2023 and… »

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… »

Developments in the Field of Medical Devices

The Regulation on the Sale, Advertisement, and Promotion of Medical Devices (“Medical Device Promotion Regulation”), the legislation containing detailed provisions on the sales, advertising, and promotion activities of companies, was significantly amended on May 26, 2023, and introduced number of new procedures to the medical device sector. These procedures, which are not essentially considered as promotional activities, are governed by the Medical Device Promotion Regulation… »

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… »

Named Patient Program

Named Patient Programs (“NPP”) is one of the exceptional pharmaceutical importation regimes for products that are not authorized or authorized but unavailable in the Turkish market for various reasons. In cases where a product does not have marketing authorization in Türkiye or has marketing authorization but cannot be found on the market, and patients need the product in question, it is possible to procure the pharmaceutical via this method upon the request of a physician.… »

Market Availability of Products and Parallel Trade

The export of products manufactured and imported for the Turkish market, may restrict patients' access to treatment after their launch. In addition, pharmaceutical prices in Türkiye are much cheaper compared to many other countries, and this has an impact on prices in other markets. The Circular No. 2014/11 on the Availability of Medicines in the Market issued by the Agency stated that necessary measures will be taken to prevent problems in pharmaceutical supply that may… »

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