Market Availability of Products
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… »
The Need for an Injunction in Cases Where the EPO Proceeding is a Pending Issue
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… »
Preliminary Injunction Decisions against Patent Trolls to Prevent the Enforcement of Patent Rights
Patent and utility model rights, vital to incentivizing R&D and innovation, provide their holders with a significant advantage over their competitors and grant an absolute right for a certain period. However, as in every system, there are players in the patent and utility model ecosystem who use these rights contrary to the purpose and spirit of the system. These players, who obtain patent/utility model registrations by taking advantage of the loopholes in the system… »
Named Patient Program
Named Patient Programs (“NPP”) is one of the exceptional pharmaceutical importation regimes for products that lack market authorisation or which are authorized but unavailable in the Turkish market for various reasons. In cases where a product does not have marketing authorization in Turkey or has a marketing authorization but cannot be found on the market, and patients need the product in question, it is possible to procure the pharmaceutical via this particular method upon… »
Current Practice of Bolar Exemption in Turkish Patent Law
Article 85(3)/(c) of the Industrial Property Law No. 6769 (“IPL”) regulates the Bolar Exemption, which stipulates the exclusion of experimental acts containing the invention subject to the patent from the scope of the patent right, including the licensing of pharmaceuticals and the necessary tests and experiments thereof. Undoubtedly, the purpose of the Bolar Exemption is to ensure that a generic medicinal product can be put on the market without losing time once the patent… »
Interactions with HCPs
Promotional activities of human medicinal products is regulated by the Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”) dated July 3, 2015. Under the Promotion Regulation, any advertisement of products to the general public, whether directly or indirectly, through any public media or communication channels, including the Internet, is prohibited. Pharmaceutical products may be promoted only to physicians, dentists and… »