Current Practice of Bolar Exemption in Turkish Patent Law
Article 85(3)/(c) of the Industrial Property Law No. 6769 (“IPL”) regulates the Bolar Exemption, which stipulates the exclusion of experimental acts containing the invention subject to the patent from the scope of the patent right, including the licensing of pharmaceuticals and the necessary tests and experiments thereof. Undoubtedly, the purpose of the Bolar Exemption is to ensure that a generic medicinal product can be put on the market without losing time once the patent…»
Interactions with HCPs
Promotional activities of human medicinal products is regulated by the Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”) dated July 3, 2015. Under the Promotion Regulation, any advertisement of products to the general public, whether directly or indirectly, through any public media or communication channels, including the Internet, is prohibited. Pharmaceutical products may be promoted only to physicians, dentists and…»
Developments in the field of Medical Devices
After the long-awaited Regulation on Medical Devices numbered 2017/745 (EU Regulation) prepared by the EU Commission entered into force, Turkey’s Medical Device Regulation, designed to be compatible with the EU’s Regulation, was published in the Official Gazette numbered 31499 on June 2, 2020. Several articles are expected to be brought into effect in accordance with the EU transition process to provide a similar transition process in Turkey. The Medical Device Regulation…»
REGIONAL COURT OF APPEALS: The Decision of the Turkish Medicines and Medical Devices Agency of Refusal of the Applications of the Original Medicine Owners to Obtain Information on Reference Product is Unlawful
As per Article 9 of the Regulation on Licensing of Human Medicinal Products (“Licensing Regulation”), which regulates “Abridged Application[s]”, if a pharmaceutical has been authorized before, it is not necessary to repeat the tests and research, and the data of these tests doesn’t have to be submitted for authorizing again. Referencing the authorization information of the original pre-licensed pharmaceutical is sufficient. However, because the subject product must be…»
SEP: Navigating the Technology-Driven World
Standard-Essential Patents (“SEP” or “SEPs”) are the concept arising from the interaction between patent rights, which provide exclusive use of an invention and “standards” aimed at the widespread and mandatory use of this innovation in the relevant market. Considering the upward trend in patent litigation arising from SEPs, it would be fair to say that SEP has become patent law’s new buzzword. Licensing SEPs: FRAND Terms Standard Developing Organizations (“SDOs”) determine…»
Food Supplements, Food for Special Medical Purposes and Other Products
The Regulation on the Importation, Production, Processing and Supply of Food Supplements was published by the Ministry of Food and Forestry on May 2, 2013, in the Official Gazette and came into force on August 2, 2013. The Regulation is not only the first regulation specific to food supplements but also includes provisions for the control and approval mechanism for food supplements that is to be established. However due to the many legislative changes it can be expected that…»
Development of Telemedicine Activities in Turkey
Telemedicine is not explicitly regulated under Turkish law. The existing legal framework, including the Medical Deontology By-law and Ethical Principles for Physicians, prohibits remote examination, diagnosis, and treatment of patients. During the COVID-19 pandemic, the legal gap in telemedicine became more serious as private hospitals especially started to provide online healthcare services to patients who could not visit healthcare centres due to the COVID-19 risk. The fact…»
Supply of Pharmaceutical Products from Abroad and Patent Rights
The supply of pharmaceutical products to Turkey via the named patient programme (the “NPP”) is one of the exceptional importation regimes for pharmaceutical products. Where a pharmaceutical product is not granted marketing authorisation in Turkey, or it is granted marketing authorisation but not found in the market where there is a patient need, it can be supplied via this particular route by physician request. If the product is approved for the NPP, it is added to the…»
Eco-Friendly Advertisements!
When you watch the commercials, do you often feel like advertising companies are working hard to convince you that their products or services are “eco”, “environmentally friendly”, “nature friendly”, “green” and “recyclable”? Does environmentally-friendly feature of a product have any impact on your preference to purchase or use it? In fact, are we yet at the end of an era of advertising products that are not “green” enough but promoted to be “green”? The “green advertising”…»
Turkey's Ongoing Decline In Corruption Perception Index
Transparency International’s annual report 2022 Corruption Perceptions Index (“CPI 2022”), aiming to measure the perceived level of public sector corruption based on various sources with the contributions of businesspeople, NGOs and country experts, was released on January 31, 2023. The index ranks 180 countries/territories by their perceived level of public sector corruption on a scale from 0 (highly corrupt) to 100 (very clean). CPI is regarded as one of the most credible…»
Litigation and Enforcement 2023 in Turkey
What are the main dispute resolution methods used to resolve large commercial disputes? The main and most commonly used method for resolving large commercial disputes in Turkey is litigation. Civil litigation is based on the principle that the parties to the dispute prepare their case. The judge is bound to hear claims, defences and evidence brought by the parties. However, the judge is entitled to make a legal assessment ex officio. The management of proceedings is at the…»
Arbitration Procedures and Practice 2023 in Turkey
How is commercial arbitration used and what are the recent trends? Use of Commercial Arbitration and Recent Trends In Turkey, arbitration traditionally evolved as a dispute resolution mechanism, which was used more frequently in large commercial disputes where a foreign party is involved and mostly when a legal counsel is involved in the preparation of the principal contract between the parties. For all other matters, particularly concerning disputes of smaller value…»