Insights
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… »
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… »
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… »
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… »
Validity of Release in Settlements Made Before Mediators
Release agreements that concern employee receivables from employers are subject to certain formal requirements under article 420 of the Code of Obligation No. 6098 (TCO). In this regard, the following conditions must be met: release agreements that concern employee receivables from employers must be executed in writing; at the date of release, at least one month must pass from the date of the termination of employment; the type and amount of the receivable subject to release… »
Artificial Intelligence and Blockchain Technologies and Their Impacts on Brand Protection
In recent years, developments in digitalization have started to make crucial impacts on many fields, including intellectual property, from creation to monetization and enforcement levels. Brand owners and brand protection professionals are heeding updates in artificial intelligence (AI) and blockchain-based technologies such as smart contracts, metaverses and non-fungible tokens (NFTs), with total market trading volume of approximately $12.13 billion only for the first… »
Patent and Trademark Office Implements Service by Publication Procedure
There previously used to be delays in the notifi cation of documents to applicants due to their failure to inform the offi ce ofaddress changes A provision was added to the IP Code in order to fi nd a solution to the issue of serving documents to rights holders All documents that could not be served due to an address change have now started to be served via publication through an Official Bulletin In the past, there used to be delays in the notifi cation of documents to… »
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… »
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… »
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… »
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… »
COVID-19: Guideline on Risk Management Plans for Vaccines Published
On 24 March 2022, the Turkish Medicines and Medical Devices Agency (Agency) published on its official website the Guideline on Essential Requirements for Risk Management Plans of COVID-19 Vaccines (Turkish language). The guideline is prepared as an attachment to Module IV of the Guideline on Good Pharmacovigilance Practices. The guideline aims to provide detailed explanations on the procedures and requirements that marketing authorisation holders should complete for… »