New Law on E-Commerce Obliges Platforms to Remove Infringing Content
A new law (No 7416) regarding e-commerce ― announced in the Official Gazette dated 7 July 2022, and coming into effect 1January 2023 ― will oblige sites to take down a product if they receive a legitimate complaint arguing that there is a violation ofintellectual and industrial property rights on their platform. The basic regulation concerning the responsibilities of e-commerce sites regarding the content that they host was included inLaw 5651 on the Regulation of Internet… »
A Milestone Decision on the Patentability of Second Medical Use Claims
As per the EPC definition, a substance or composition that is already known to have been used in a “first medical use” may still be patentable for any second or further use, provided that said use is novel and inventive. Even though the first medical use was the subject of patent protection within the EPC 1973, this convention did not regulate that the substance could be subject to a patent in different medical uses (second/further medical use). While there was no regulation… »
Product Liability and Safety 2022 in Turkey
Sources of Law What are the main areas of law and regulation relating to product liability? The Product Safety and Technical Regulations Law 7223 (Law 7223) is the main law regarding product safety. Replacing Law 4703 on the Preparation and the Application of the Technical Regulations Related to Products, Law 7223 places some new obligations on actors who supply products to the market. It also ensures that the national legislation is in line with the European Union's 2019… »
Drug Reimbursement Practices
We come across constantly on the street, on the Internet, in the cafés when we go to buy coffee with donation campaigns carried out to cover the costs of patient treatments. Although it is essential for the state to cover the health costs in accordance with the constitutional principle of the social state, we encounter with more news of uncovered treatment costs. For example, Spinal Muscular Atrophy, the disease known colloquially as SMA, results from the inability of… »
Bolar-Like Hurdle for Generics
Precis: The judgment of the Ankara IP court in a case involving a marketing authorisation application demonstrates that an exemption similar to the so-called Bolar exemption can apply to Gx pharmaceutical companies. Background The so-called Bolar exemption was introduced into Turkish law on 22 June 2004 with an amendment to Patent Decree Law No 551 and was maintained in the IP Code that entered into force on 10 January 2017. Article 85/3(c) of the IP Code rules that… »
Similarity Assessment of House Marks
The issue of how the similarity assessment will be carried out in the signs containing house marks is discussed in the Trademark Examination Guideline of the Turkish Patent and Trademark Office, by providing several precedents on this topic. House mark, also referred to as the main, parent or umbrella trademark, is, as the name suggests, an upper concept that serves as a roof to bring together the families of trademarks created by companies. House marks are signs that have… »
Consequences of Decisions in Cases Requiring Technical Expertise Without Expert Examination in Administrative Trials
Introduction Article 31 of the Administrative Procedure Code No. 2577 (“APC”) sets out the cases to which Civil Procedure Code No. 6100 (“CPC”) shall apply where IYUK contains no provisions. As per the referred provision, CPC shall apply to expert examinations. According to Article 266 of the CPC, courts decide to obtain expert opinion in cases where the resolution require special or technical information other than law, ex-officio or upon request of either party. However… »
Neither a Compulsory License nor an IP Waiver is the Solution to Finding or Accessing the Vaccine
Since the pandemic seems to lose its impact and life is going back to normal, it may be a good time to look into the lessons learned so far from Covid 19 pandemic and make necessary preparations against a possible new one. The pandemic brought many discussions on IP rights from day one. As we all know, compulsory licensing was the first solution mechanism depended on by the governments as it was thought that the existing patent rights were the only obstacle to reaching a cure… »
New Regulations Expected For OTT Service Providers
With the bill known as ‘law against disinformation’, there are several provisions specifically related to the Law on the Regulation of Internet Broadcasts and Prevention of Crimes Committed through Such Broadcasts (“Law No. 5651”) and the Press Law. The amendment proposals related to the Law No. 5651 and the Press Law have been on the agenda for a while of the publication of the bill. In addition to these issues discussed widely, with the bill, ‘over the top’ (OTT) services… »
SSI Publishes Amendment to the Alternative Reimbursement Regulation Upon Annulment of the State Council
In the cancellation action filed by the Turkish Pharmacist Union against some of the provisions of the Alternative Reimbursement Regulation (“Regulation”), the 10th Chamber of the Council of State decided to annul the attacked provisions of the Regulation on the ground that the Regulation was issued by the Social Security Institute (“SSI”) without obtaining prior opinion of the Ministry of Health. Upon the service of the court decision to SSI, due to the requirement to comply… »
Regulation on Pharmaceutical Warehouses and Products Available in Pharmaceutical Warehouses Published
On 15 June 2022, the Regulation on Pharmaceutical Warehouses and Products Available in Pharmaceutical Warehouses (Turkish language) (Regulation) was published in the Official Gazette numbered 31867. The Regulation abrogated the prior regulation dated 20 October 1999 and is now in line with Directive 2001/83/EC on medicinal products for human use. Pharmaceutical warehouses are defined as establishments where one or all of the activities of procurement, storage, sale… »
Medical Devices: Draft Communiqué on Instructions For Use in Electronic Form Published
On 30 May 2022, the Turkish Medicines and Medical Devices Agency (Agency) published an announcement (Turkish language) on its official website, stating that a draft Communiqué on the Instructions for Use in Electronic Form for Medical Devices (Draft) has been prepared and asked stakeholders to provide feedback on the Draft. As part of Turkey's alignment process with EU law, the Draft has been prepared in accordance with Commission Implementing Regulation (EU) 2021/2226 laying… »