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… »
DERBY Case: Court of Appeal Overturns Lowercourt Decisions in Controversial Ruling
In opposition proceedings, the Court of Appeal has found that there was copyright infringement since the opponent’s logo had been copied in the mark applied for The well-known status of the earlier mark also served as a basis for the decision Arguably, the court correctly found that the applicant’s trademark should not be registered, but erred in its reasoning Background The owner of the DERBY trademark, registered and well known for razor blades, opposed an application for… »
Turkish Appeal Court Rules in Cow Trade Mark Case
In a case concerning trade mark and copyright law, the Turkish Court of Appeal has ruled that the use of a figure intensively cannot prevent the use of similar figures, as long as they are not identical. Background A recent decision of the Court of Appeal concerned an application to register a trade mark (shown right) in classes 29 and 43. The word elements in this application can be considered of low distinctiveness: ET means “meat” in Turkish, and so is descriptive for… »
Unfair Approach of Turkish IP Courts while Assessing “Bolar Exemption”
The article 85(3) (c) of the Industrial Property Law, which excludes the marketing authorization application from the scope of the patent right, is interpreted by the IP courts against the patent holder in a disproportionate way. The exemption here is the procedures that generic companies required to perform before the Ministry of Health in order to obtain a marketing authorization. Thus, for example, it enables the generic pharmaceutical company that applied for marketing… »