Pharmaceutical prices in Turkey have always been a controversial issue. The prices of medicines for sale are set under the Decision on Pricing of Human Medicinal Products (“Decision”) and the Communiqué on the Pricing of Human Medicinal Products (“Communiqué”) of September 29, 2017, issued by the Ministry, which is vested with the competencies to regulate this area.
The Decision provides a reference pricing system, whereby the least expensive ex-factory price in one of the…
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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 February 19, 2013. The system is intended to begin operation on June 01, 2023. The courts in question constitute a big and important step towards ensuring the unity of the judiciary for European Union member states. With the completion of the approval processes for 17 European Union members, a few days before the start of the…
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The grounds for the invalidation of a patent within the scope of Industrial Property Law No. 6769 are listed per the numerus clausus principle. The concept of plausibility – which has been the subject of numerous evaluations, especially by the European Patent Office (“EPO”) and frequent debate in academic circles in recent years – has not yet found a place within the scope of any legal regulation in Turkey. Moreover, there is no consensus on a Turkish wording for an…
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In joint stock companies, which is one of the most preferred partnership types due to the limited liability of shareholders, due to various concerns such as family and personal concerns and the relevant shareholders’ unsatisfied expectations relating to the company’s performance, shareholders may sometimes wish to terminate the partnership with other shareholders. In such cases, it is critical which actions can be taken by the controlling shareholders against the minority who…
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The New Regulation on Licensing of Human Medicinal Products prepared by the TMMDA entered into force upon its publication in the Official Gazette numbered 31686, dated December 11, 2021. The Regulation on Licensing of Human Medicinal Products reflects up-to-date processes present in TMMDA practice that were absent in its previous iteration dated 2005, and provide compatibility with the EU directive numbered 2001/83/EC.
In order to ensure supply continuity an exception for…
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Although there is no explicit provision in Turkish Law for the acceptance of the ongoing opposition or appeal proceedings before the European Patent Office (“EPO”) as a “pending issue”, in practice due to the principle of procedural economy, pending issue decisions may be given by the Civil Courts of Intellectual and Industrial Property Rights on a case by case basis. As Turkey is party to the European Patent Convention, upon the issuance of a revocation decision regarding a…
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