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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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.…
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In disputes arising from the termination of the employment agreement by the employer, although the issue of whether the employment agreement is terminated with just cause or valid reason does not have an impact in terms of the evaluation of the reinstatement request, it is crucial in terms of requesting employment claims.
Yet, when the employment agreement is terminated with a valid reason or just cause, the reinstatement request shall be rejected in both cases, whereas the…
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