Precis: The judgment of the Ankara IP court in a case involving a marketing authorisation application demonstrates that an exemption similar to the so-called Bolar exemption can apply to Gx pharmaceutical companies.
Background
The so-called Bolar exemption was introduced into Turkish law on 22 June 2004 with an amendment to Patent Decree Law No 551 and was maintained in the IP Code that entered into force on 10 January 2017.
Article 85/3(c) of the IP Code rules that…
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The issue of how the similarity assessment will be carried out in the signs containing house marks is discussed in the Trademark Examination Guideline of the Turkish Patent and Trademark Office, by providing several precedents on this topic.
House mark, also referred to as the main, parent or umbrella trademark, is, as the name suggests, an upper concept that serves as a roof to bring together the families of trademarks created by companies.
House marks are signs that have…
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Introduction
Article 31 of the Administrative Procedure Code No. 2577 (“APC”) sets out the cases to which Civil Procedure Code No. 6100 (“CPC”) shall apply where IYUK contains no provisions. As per the referred provision, CPC shall apply to expert examinations.
According to Article 266 of the CPC, courts decide to obtain expert opinion in cases where the resolution require special or technical information other than law, ex-officio or upon request of either party. However…
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Since the pandemic seems to lose its impact and life is going back to normal, it may be a good time to look into the lessons learned so far from Covid 19 pandemic and make necessary preparations against a possible new one.
The pandemic brought many discussions on IP rights from day one. As we all know, compulsory licensing was the first solution mechanism depended on by the governments as it was thought that the existing patent rights were the only obstacle to reaching a cure…
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With the bill known as ‘law against disinformation’, there are several provisions specifically related to the Law on the Regulation of Internet Broadcasts and Prevention of Crimes Committed through Such Broadcasts (“Law No. 5651”) and the Press Law. The amendment proposals related to the Law No. 5651 and the Press Law have been on the agenda for a while of the publication of the bill.
In addition to these issues discussed widely, with the bill, ‘over the top’ (OTT) services…
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In the cancellation action filed by the Turkish Pharmacist Union against some of the provisions of the Alternative Reimbursement Regulation (“Regulation”), the 10th Chamber of the Council of State decided to annul the attacked provisions of the Regulation on the ground that the Regulation was issued by the Social Security Institute (“SSI”) without obtaining prior opinion of the Ministry of Health. Upon the service of the court decision to SSI, due to the requirement to comply…
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On 15 June 2022, the Regulation on Pharmaceutical Warehouses and Products Available in Pharmaceutical Warehouses (Turkish language) (Regulation) was published in the Official Gazette numbered 31867. The Regulation abrogated the prior regulation dated 20 October 1999 and is now in line with Directive 2001/83/EC on medicinal products for human use.
Pharmaceutical warehouses are defined as establishments where one or all of the activities of procurement, storage, sale…
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On 30 May 2022, the Turkish Medicines and Medical Devices Agency (Agency) published an announcement (Turkish language) on its official website, stating that a draft Communiqué on the Instructions for Use in Electronic Form for Medical Devices (Draft) has been prepared and asked stakeholders to provide feedback on the Draft.
As part of Turkey's alignment process with EU law, the Draft has been prepared in accordance with Commission Implementing Regulation (EU) 2021/2226 laying…
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On 8 July 2022, the Regulation on Medical Device Clinical Trials (Turkish language) (Regulation) was published in the Official Gazette numbered 31890, repealing the former regulation dated 6 September 2014. The Regulation, which came into force on its day of publication, introduces amendments to ensure clinical trials comply with the Turkish Medical Device Regulation.
The Regulation sets rules in connection with the functionality date of the European Database on Medical…
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On 8 July 2022, the Decision Amending the Decision on Pricing of Medicinal Products for Human Use (Turkish language) was published on the Official Gazette numbered 31890. The Decision on Pricing of Medicinal Products for Human Use (Decision) is the legislation which set the rules on pricing of the human medicinal products.
The amendments to the Decision include:
An increase in pharmacist profit rates to be applied when determining the retail sale price of the products.
A new…
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On 6 July 2022, amendments (Turkish language) made by the Turkish Medicines and Medical Devices Agency to the Regulation on Clinical Trials of Medicines and Biological Products were published in the Official Gazette numbered 31888.
The amendments:
Introduce new provisions regarding the clinical trial application procedure, exceptional trials and the Agency's authority to obtain scientific opinion from a scientific consultancy committee while evaluating clinical trial…
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There previously used to be delays in the notifi cation of documents to applicants due to their failure to inform the offi ce ofaddress changes
A provision was added to the IP Code in order to fi nd a solution to the issue of serving documents to rights holders
All documents that could not be served due to an address change have now started to be served via publication through an Official Bulletin
In the past, there used to be delays in the notifi cation of documents to…
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