Discovery of Evidence Is Not Subject to Bolar Exemption
Discovery of evidence and actions for determination of evidence are separately regulated under the Civil Procedural Law. Discovery of evidence is a preliminary step taken before any action on the merits, and it only serves to discover and record the evidence that may be relevant to an ongoing or future action on the merits. It must be emphasised that unlike the US and UK systems, there is no full and frank disclosure procedure under Turkish civil law. In other words, the… »
Impact of EPO Opposition on National Actions
Since Turkey’s inclusion as a member of the EPC, a hot topic has been the enforcement or invalidity of Turkish validation of European Patent(s) (“EP”) while proceedings before the European Patent Office (the “EPO”) are pending. Once an EP is validated in Turkey, it becomes a national patent three months after its first granted decision by the Examination Board of the EPO. For EPs, the Turkish Patent and Trademark Office (the “TPMO”) acts only as a procedural agency. Thus, the… »
2nd Damages Judgment in the Pharma Sector for Unjust PI
In 2018, the Istanbul IP Court decided on a generic pharmaceutical company’s damages claim based on an unjust PI, in what appears to be the first decision of its kind by the Turkish IP Courts within the pharmaceutical sector. The dispute between an originator firm and a generic firm derived from an infringement claim. The Court had issued a PI, which was lifted after 13 months based on the findings of an expert’s report, which found that no infringement had been made. The… »
New Guidelines on Named Patient Programme
In Turkey, the law explicitly states that pharmaceuticals which have their safety and efficacy proven through sufficient scientific and clinical studies within the direction of existing treatment guides, and are granted market authorisation by the Turkish Medicines and Medical Devices Agency (“Agency”) must be supplied only by pharmacies. However, the Agency is also competent to determine the exceptional importation regimes. Named Patient Program (“NPP”) is one of the… »
EC Certificates' Status During Transition Period for Brexit
Dicle Doğan and Fatma Sevde Tan, Gun + Partners On 1 February 2020, the Presidential Circular No 2020/1 was published on the Official Gazette No 31026 on the transition period for the UK's exit from the EU. The circular indicated that the UK will continue to be subject to EU law until 31 December 2020. Upon the publication of the Circular, the Turkish Medicines and Medical Devices Agency published an announcement (Turkish language) about the effects of this transition period… »
Consultation on New Draft Regulation on Promotion of Medical Devices
Dicle Doğan and Fatma Sevde Tan, Gun + Partners On 28 January 2020, the Turkish Medicines and Medical Devices Agency published a draft Regulation on the Sale, Advertisement and Promotion of Medical Devices (Turkish language) which will amend some of the existing provisions of the regulatory framework and introduce new rules. The most significant amendments are related to restrictions of medical device sales and advertising activities. The medical devices described in either… »