Artificial Intelligence and Pharmaceutical Industry: The Transformation in the Technology and Patent System Shaping the Future
Artificial intelligence influences every aspect of our lives and creates revolutionary effects in the pharmaceutical industry as well as in many other sectors. From DeepMind's AlphaGo success to Tempus' personalized approaches to cancer treatment, AI-enabled innovations offer not only scientific achievements, but also wide-ranging advantages such as operational efficiency, cost reduction and risk reduction. However, this technological leap also raises critical questions about… »
Amendments to the Consumer Protection Law and E-Commerce Law
The Law No. 7529 on Amendments to the Consumer Protection Law and Certain Other Laws was published in the Official Gazette dated 30 October 2024 and numbered 32707. The law introduced amendments particularly to the direct sales provisions and administrative fines ruled by the Consumer Protection Law, as well as to the E-Commerce Law. Some amendments took immediate effect upon its publication date, while others will come into force later. Key Amendments to the Consumer… »
Crypto Asset Regulations Came Into Force
The need for legal regulation regarding crypto assets has been discussed for a considerable time. With the amendments made by Law no. 7518 (the “Law”) introduced to the Law on Capital Markets no. 6362, published in the Official Gazette numbered 32590 dated July 2, 2024, a comprehensive legal basis for crypto assets has been established within the Turkish legal framework for the first time. The Law has authorized the Capital Markets Board (the “Board”) for drafting secondary… »
Calendarization Process for the Market Authorization of Medicines
Introduction The Guidelines for the Calendarization Process of Medicinal Products for Human Use (the “Guidelines”) aims to regulate the process for the market authorization applications on medicinal products for human use filed with the Turkish Medicines and Medical Devices Agency (the “Agency”). The Agency has determined the procedures and principles for calendarization processes of the applications found eligible in the pre-assessments. The Guidelines has been initially… »
Is It Really Number One Of Türkiye?
Article 8 of the Regulation on Commercial Advertisement and Unfair Commercial Practices ("Regulation") permits comparative advertisements under specific conditions. Subparagraph (a) requires that such advertisements should "not be misleading or deceptive," while subparagraph (f) mandates that "claims based on objective, measurable, and numerical data must be substantiated by scientific tests, reports, or documents." Additionally, Article 9, titled "Burden of Proof," specifies… »
Turkish Court of Cassation’s Highlighting Decisions on Conceptual Similarity Evaluation
In the 1st paragraph of Article 6 of the Industrial Property Law no. 6769, which regulates the relative refusal grounds in trademark registration, the existence of a likelihood of confusion requires the condition of “identicalness or similarity” of the trademarks along with the similarity of the goods and/or services. During the evaluation of the similarity between the trademarks, the focus is commonly gathered on visual, aural and semantic similarity. The existence of any… »
The Most Remarkable Competition Law Issue of Recent Years: Competition Violations in Labor Markets
With the on-site inspections and investigations conducted by the Competition Board (“Board”) in recent years, against innovation-oriented technology companies, pharmaceutical companies, and companies operating in the information technology sector due to competition violations in labor markets, a need has arisen to provide clarity regarding the application of the Law on the Protection of Competition (“Law”) to labor markets and how anti-competitive agreements that restrict… »
Second Round of Comments on Draft Regulation For Pharmaceutical Promotions
In the second quarter of 2024, the Turkish Medicines and Medical Devices Agency (the “Agency”) published an announcement on its website, opening the Draft Regulation on the Promotional Activities of Human Medicinal Products and Food for Special Medical Purposes (the “Draft”) for external comments. Significant amendments proposed in the initial version can be reviewed by clicking here. Updates have been made to the Draft based on the opinions of sector stakeholders. The… »
Infinity Case Highlights Importance of Global Appreciation
The Court of Cassation has approved the First Instance Court’s decision in a case involving several INFINITY marks, shedding light on the principle of global appreciation of trademarks in the similarity examination. Background On 8 January 2018 the applicant filed an application to register the trademark depicted below for “flying services by means of paragliding” in Class 41 before the Turkish Patent and Trademark Office (PTO): After the application was published in… »
Enforcement of Foreign Judgments 2025 in Turkey
Legislation Treaties Is your country party to any bilateral or multilateral treaties for the reciprocal recognition and enforcement of foreign judgments? What is the country’s approach to entering into these treaties, and what, if any, amendments or reservations has your country made to such treaties? Except for multilateral treaties on family law, Türkiye is not a signatory to multilateral treaties for the reciprocal recognition and enforcement of foreign judgments. However… »
A Trade mark or a Song? Turkish Court of Cassation Casts Some Light on this Distinction
Article 4 of the Law No. 6769 on Industrial Property indicates that sounds can be registered as trade marks if they are capable of being distinguishable for the goods or services of one undertaking from that of another: “Trademarks may consist of any signs like […], sounds and the shape of goods or their packaging, provided that such signs are capable of distinguishing the goods or services of one undertaking from those of other undertakings and being represented on the… »
Applying Presumption of Patent Infingement Against Biosimilars
Before filing lawsuits to assert patent rights against generics or biosimilars, the patent holder essentially operates in the dark. This is because, particularly in cases where the summary of product characteristics (“SmPC”) of the biosimilar/generic drug has not yet been published, or when it is not clear from the limited information in the SmPC whether the patent has been infringed, the relevant sections of the biosimilar/generic product's dossier must be examined to assess… »