On May 28, 2024, the Turkish Medicines and Medical Devices Agency (“Agency”) published a Draft Regulation on the Promotional Activities of Human Medicinal Products and Food for Special Medical Purposes (“Draft”) on its official website and announced that opinions regarding the Draft can be delivered to the Agency. Significant amendment proposals that differ from the current regulation are as follows:
In General
In addition to physicians, dentists, and pharmacists, promotion…
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Pharmaceuticals that are not authorized in Türkiye or authorized but not available on the market shall be procured from abroad as per a special authorization and on a case by case basis (Named Patient Program-NPP). This supply can be conducted by public institutions approved by the Ministry ofHealth that are defined as Foreign Pharmaceutical Suppliers (Suppliers) and currently constitute theSocial Security Institution and the Turkish Pharmacists Association. The Suppliers can…
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The Turkish Constitutional Court (“Court”) annulled paragraph 12 of Article 77 of the Consumer Protection Law, which granted the Advertisement 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.
In its decision, the Court ruled that the scrutinized legal rules do not meet…
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The Advertisement Board ("Board") closely monitors the discount sales campaigns, which have become a tradition in e-commerce, held in November and known as "Legendary November Discounts", "Fabulous Friday Discounts", where discounts at various rates are announced for a large number of products. The Board imposes administrative sanctions on discount sales advertisements and practices that deceive and mislead consumers and create the perception that there is a higher price…
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Brand communication of alcoholic products to consumers is strictly prohibited in Türkiye and there is full prohibition of advertisement of alcohol, any manner in all forms of media. This ban includes broadcasts on TV and radio, advertisements in cinema, product placement, printed media, as well as advertisements on social media and digital platforms.
Alibi branding is an alternative mechanism for promotion of alcohol brands and in fact, this is a grey area. Although there is…
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Unfair commercial practices, also known as the "dark patterns", have entered the agenda of the Advertisement Board. Dark patterns may in fact be considered as unfair commercial practices regulated under the Regulation on Commercial Advertising and Unfair Commercial Practices ("Regulation"). Pursuant to the Regulation, a consumer-oriented commercial practice is deemed to be unfair if it does not comply with the requirements of professional care and if it significantly impairs…
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Artificial intelligence, which has become one of the most important components of modern technology, has rapidly transformed our interaction with technology, seamlessly integrating into various areas of our daily routines.
AI technologies, offering significant advancements and innovative solutions in fields such as medicine, finance, transportation, education and many others, have also brought with sensitivities towards critical issues such as ethics, security and privacy.…
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One must have deep knowledge and experience in many different disciplines to play a role in the solution of complex and multi-layered patent law disputes. One of the most important examples of this situation are compensation actions filed following the abolition of preliminary injunctions in patent disputes related to the pharmaceutical industry. As a matter of fact, the decisions of the courts of first instance and the Court of Appeal in these types of cases give direction…
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The Bolar Exemption falls under the provision of Article 85(3)/(c) of the Industrial Property Code No. 6769 (IP Code) and regulates the marketing authorisation of pharmaceuticals, the testing and experiments required for this purpose and the exemption of experimental acts involving the patent subject to the invention from the scope of rights protected by the patent. The aim of the Bolar Exemption is to ensure that Gx pharmaceutical products can be put on the market without…
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Standard-Essential Patents (SEPs) is a concept arising from the interaction between patent rights, which provide exclusive use of an invention and “standards” aimed at the widespread and mandatory use of this innovation in the relevant market. Considering the upward trend in patent litigation arising from SEPs, it would be fair to say that SEP has become patent law’s new buzzword.
Licensing SEPs: FRAND Terms
Standard Developing Organisations (“SDOs”) determine the technical…
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Filing patent invalidation actions for tactical purposes, such as jeopardizing patent infringement actions of patent owners and gaining time by complicating the infringement proceedings, has become a common strategy of infringers in recent years. With this strategy, the parties infringing the patent may cause the patent owner to suffer due to the inability to enforce their patent as they are entitled to during the limited protection period of 20 years, even if the invalidity…
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The concept of the Unified Patent Court (UPC) entered the lives of European Patent holders with the UPC Agreement, an international agreement dated 19 February 2013. The Unified Patent Court started operating as of 01 June, 2023. The Unified Patent Court constitutes a big and important step towards unity of the judiciary for European Union member states. The Statistics and Trends Centre of the European Patent Office (EPO) reported that 17,788 unitary effect requests were made…
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