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Insights

We share our knowledge and expertise to update our community and clients about legal developments in Turkey.

The New Trademark Examination Guideline

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TÜRKATENT published The New Trademark Examination Guideline (“the Guideline”) on September 30, 2019. The Guideline defines the criteria regarding the examination of trademark applications on absolute grounds for refusal within the scope of the IP Code that came into force in 2017. The Guideline updates the previous guideline that had been in force since 2011, clarify the principles of absolute grounds for refusal that are explained in the IP Code, and provides consistency in… »

Turkish Court Deals With Indirect Infringement Case

Indirect infringement is not explicitly dealt with in the Turkish IP Law. However, the legislator confers, via Article 86 of the Industrial Property Code (IPC), a right to the patent holder to prevent third parties from supplying essential elements of the invention to unauthorised people, which will eventually lead to the working of the patented invention. In order for this provision to be implemented, third parties must be aware that these elements or instruments are… »

An Alternative to Data Transfers Abroad: Binding Corporate Rules

With the announcement dated April 10  2020, Turkish Data Protection Authority (“DPA”) determined Binding Corporate Rules as a mean to be used for the data transfer abroad based on Article 9/2 of Law on Personal Data Protection numbered 6698 (“Law”) and introduced a new tool for the highly controversial and ambiguous matter in Turkey. By indicating in the announcement that the undertakings taken as per Article 9/2 of the Law would be usually practical for the bilateral data… »

Turkish Court of Appeal Rules on Likelihood of Confusion

The Turkish Court of Appeal has overturned lower court decisions in a case concerning likelihood of confusion between trade marks sharing a common weak element. Güldeniz Doğan Alkan and Ayşenur Çıtak explain. Origins of the dispute Türkiye İş Bankası A.Ş., which is a popular bank and holder of the well-known trade mark Türkiye İş Bankası in Turkey, filed an application for the mark shown on the right in classes 9 and 36. An opposition was filed against the application… »

MedTech Europe Guidance Regarding Conduct During COVID-19 Crisis

In the current COVID-19 crisis medical device companies continue to prove support to healthcare professionals, healthcare organizations, healthcare systems and governments in order to fulfill the urgent needs. However, the local regulations and codes of conduct for the industry on relationship between the medical device companies and governmental organizations are still in force. Therefore, it is likely that some actions taken by the medical device companies in response to… »

European Parliament Approved the Proposal for Postponing the Implementation Date of Medical Device Regulation No (EU) 2017/745 (MDR)

The coronavirus (Covid-19) crisis has created extraordinary circumstances that require substantial additional resources and an increased availability of vitally important medical devices. However, none of this could reasonably have been anticipated at the time of adoption of the Medical Device Regulation numbered (EU) 2017 /745 (“MDR”) to be in the force on 26 May 2020. In this regard, on 3 April 2020, the European Commission has adopted a proposal to postpone by one year the… »

Questionable Approach of Turkish IP Courts in Assessing Bolar Exemption

Article 85(3) (c) of the Industrial Property Law excludes marketing authorisation applications from the scope of patent rights. However, the IP courts’ interpretation of this has been disproportionately weighted against patent holders. Generic pharmaceutical companies can obtain a marketing authorisation by carrying out a number of procedures before the Ministry of Health. As a result, entities that apply for a marketing authorisation seven to eight months before the… »

Key Developments and Predictions for Life Sciences in Turkey

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With Turkey having a population of 80 million that is covered by an extensive social healthcare system, the size and volume of the Turkish life sciences industry is significant. Despite many opportunities that accompany this potential for growth, it should also be noted that both the Turkish pharmaceutical and medical device industries remain heavily regulated in all aspects, ranging from market access, to pricing and reimbursement being covered by industry-specific… »

Pricing of Pharmaceuticals and the Fixed Exchange Rate

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Healthcare and pharmaceuticals make up a highly regulated industry sector in Turkey, and the pricing of medicines is no exception. The prices of medicines that are to be marketed in Turkey 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”) who is vested with the competencies to regulate the… »

Market Access-Reimbursement Agreements

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Until recently, there was no direct contractual relationship between the SSI and the pharmaceutical companies (“pharma companies”) regarding the pharmaceuticals purchased by the State. The pharma companies applied for the reimbursement of their products to the SSI and, once listed, companies sold their products to warehouses, which then distributed the products to the hospitals and pharmacies. In line with this sale and distribution chain, the SSI reimbursed the hospitals, or… »

Localisation of Previously Imported Products

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In Turkey, the innovator pharmaceutical market is dominated by originator companies of foreign origin, with local companies active in the generics market. The government’s unease with the emphasis on imported products in the Turkish market beckoned the state development plan to procure local production in the pharmaceutical market, a political act affecting the activities of many pharmaceutical companies of foreign origin. The aforementioned state development plan triggered… »

Named Patient Programs

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Named Patient Programs (“NPP”) is one of the exceptional importation regimes of pharmaceutical products without marketing authorisation (“MA”) in Turkey, or with marketing authorization, but which are unavailable in the Turkish market for various reasons. Only the Turkish Pharmacists’ Association (“TEB”) and the İbn-i Sina Health Social Security Center, established under the SSI, were authorized to import NPP products until December 2018. An amendment in the law was… »

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