Standard essential patent (SEP) appears to be the new buzzword of patent law considering the upward trend in patent litigation arising from SEPs. Indeed, the continuous technological advancement supports the creation of SEPs so this trend is likely to continue in the near future.
Accordingly, SEPs is a concept arising from the interaction between patent rights, which provide exclusive use of an invention and ‘standards’ aimed at the widespread and mandatory use of this…
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Pharmaceutical prices in Turkey have always been one of the most controversial issues. The prices of medicines that are to be marketed are set in accordance with the Decision on Pricing of Human Medicinal Products (“Decision”) and the Communiqué on the Pricing of Human Medicinal Products (“Communiqué”) of 29 September 2017, issued by the Ministry of Health (“MoH”), which is vested with the competencies to regulate this area.
The Decision provides for a reference pricing…
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Introduction and Developments
With the Presidential Circular on Information and Communication Security Measures which came into force once published on July 6, 2019 (the "Circular"), it was aimed to mitigate and neutralize serious security risks encountered in the digitalization process and ensure the security of critical data for public institutions and organizations and enterprises providing critical infrastructure services.
The Information and Communication Security Guide…
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The New Regulation on Licensing of Human Medicinal Products (the “Regulation”) prepared by the TITCK entered into force upon its publication in the Official Gazette numbered 31686 and dated December 11 2021. It has been seen that the purpose aimed with the Regulation is reflecting up-to-date processes present in the TITCK practice but did not exist in the previous regulation dated 2005 and providing compatibility of the legislation with the EU directive numbered…
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It is not a secret that Turkey has an important geographical location for production and sales of counterfeit products as well as the ones in transit. Most of the smuggled products entering Turkey also turn out to be counterfeits. This requires brand owners to take an active role in Turkey to combat the counterfeits, cover all possible basis, and also seek alternative and creative approaches.
There are certain civil and criminal actions that can be taken while combatting…
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Named Patient Programs (“NPP”) is one of the exceptional importation regimes of pharmaceuticals without marketing authorization (“MA”) in Turkey, or with marketing authorization, but which are unavailable in the Turkish market for various reasons.
In cases where a pharmaceutical does not have an MA in Turkey, or has an MA, but cannot be found on the market, and patients are in need the pharmaceutical in question, it is possible to procure the pharmaceutical via this special…
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