Reviewing Appraisal Rights in Turkey
Turkish Commercial Code No. 6102 (TCC), which entered into force on July 1, 2012, brought many novelties to form a modern vision of commercial law, whereas the former rules were inadequate to meet the needs of the practice. The focus was mainly on transparency, auditability, and equivalence among shareholders, and the relevant legislation has adopted new principles with respect to corporate governance and shareholders’ rights. As part of these novelties, the TCC provides… »
Distribution and Marketing of Drugs 2019 in Turkey
Distribution Pre-conditions for distribution 1. What are the legal pre-conditions for a drug to be distributed within the jurisdiction? Authorisation Under the Regulation on Licensing of Medicinal Products for Human Use (Official Gazette No. 25705 of 19 January 2005), no medicinal product for human use can be marketed unless it is licensed in Turkey. The licence is issued by the Medicines and Medical Devices Agency (Agency) of the Ministry of Health For placing the product on… »
Declaration of Non-Infringement Can Be Rejected in Absence of Marketing Authorisation
The Courts of Appeal have now ruled that the plaintiff of a determination of non-infringement of patent action (a Gx or generic pharmaceutical company) had no legal benefit in filing such an action before a marketing authorisation (MA) was granted for its generic application, which was pending before the Ministry of Health. Until this decision the IP courts used to accept and examine determination of non-infringement actions from Gx companies even if they had pending MA… »
Determination of Non-Infringement Action Is To Be Rejected If Marketing Authorisation Is Not Granted Yet
As per Article 154 of the Turkish IP Law any person who has a legal interest can file an action to have the Court determine that his acts do not constitute an infringement of the intellectual property rights of a rights owner. For a quite long time patent owners were squeezed between conflicting approaches in the implementation of, on the one hand, the legal interest condition in determination of non-infringement actions (DNI), and, on the other hand, the Bolar exemption in… »
Online Marka Tecavüzü Davalarında Yetki – Avrupa Birliği Adalet Divanından Ön Karar: AMS Neve v. Heritage Audio SL
Turkey’s Pharmaceutical Industry and Key Developments
“In Turkey, the active population, retirees and their dependants are covered by health insurance provided by the Social Security Institution (‘SSI’). Employers must pay monthly contributions for their employees, who automatically become covered. Those who are self-employed may also benefit from this insurance coverage by voluntarily paying monthly contributions. Health insurance provided by the SSI covers practically every physical examination, test and treatment (both… »
FICPI Turkey – Roundtable Meeting on EP Opposition Procedures
FICPI – TURKEY arranged its sixth roundtable meeting on opposition proceedings of European Patents before the European Patent Office (“EPO”), the protection of the amended version of already validated patents in Turkey following the opposition procedure and how the opposition procedures of the Turkish Patent and Trademark Office (“Office”) should be as per the new law. Mr. Barış Atalay, who is a European and Turkish Patent Attorney and member of FICPI – TURKEY, moderated the… »
Obligation of Notification of Personal Data Violations to Turkish DPA
Law on Protection of Personal Data numbered 6698 provides under the article titled “Data Security Liabilities” that, data controllers must take all necessary technical and administrative measures to ensure the appropriate level of security to: Prevent unlawful processing of personal data, Prevent unlawful access to personal data, Maintain safeguarding of personal data. Within the scope of the same article, if the data processed is obtained/ accessed by third parties through… »
New Guidelines on Protection of Personal Data in Pharmacovigilance Activities
The Agency published Guidelines on Protection of Personal Data in Pharmacovigilance Activities (“Guidelines”) on 1 August 2019. The Guidelines state that no explicit consent is required for the processing of patient data reported by the adverse effect notification, regardless of whether the person making the adverse effect notification is a patient, healthcare professional or relative. Additionally, pursuant to the Guidelines, the persons under the confidentiality obligation… »
New Milestone in Turkish arbitration: Istanbul Arbitration Association’s Code of Ethics for Arbitrators
The Istanbul Arbitration Association (ISTA) is the only non-governmental organisation (NGO) in Turkey focused on transforming the country, and especially Istanbul, into a reputable, reliable and effective arbitration centre, fully recognised in the national and international arenas. It works to promote the advantages of using Istanbul as a seat of arbitration, to foster arbitration in Turkey, and to ensure that arbitration practices in Turkey are conducted in a fair… »
Can One Arbitrate With a Turkish Party Based on a Contract in a Language Other Than Turkish?
Although parties to international transactions frequently agree to arbitrate, they sometimes reconsider that commitment when a dispute arises, and look to challenge the validity of the arbitration agreement. Thanks to the separability presumption, the courts and the tribunals insulate the arbitration agreements from attacks on the underlying contract and uphold arbitration. However, the separability presumption sometimes backfires; particularly if one is attempting to… »
Court of Cassation Issues Long-Awaited Decision on Non-Use Revocation Actions
A four-day legal gap was created following the annulment of Article 14 of Decree-Law No 556, which regulated the use requirement The Court of Cassation has recently considered this legal gap for the first time It is now clear that one may file a non-use revocation action without having to wait for the expiry of the five-year period following the publication of the IP Code Background In 2016 the Turkish Constitutional Court annulled Article 14 of Decree-Law No 556, which… »