Lawyers Özge Atılgan Karakulak

Özge Atılgan Karakulak

Özge Atılgan Karakulak

Gün + Partners

Özge Atılgan Karakulak has been with Gün + Partners since 2005 and has been a partner since 2013. She is chair of the firm’s life sciences industry and competition practices and co-chair of patent and utility models practice.

With the combination of Özge’s advisory and litigation expertise and in-depth knowledge of the life sciences sector, she advises clients across all phases of the business cycle of life science products, such as registration/authorization procedures, promotion practices, pricing and reimbursement regulations, distribution relationships and co-marketing deals, as well as on issues of merger control, vertical restraints and abusive conduct.

Özge has acted on behalf of originators in numerous complex patent infringement and validity actions in the pharmaceutical industry and she was involved in the first-ever pharmaceutical data exclusivity and unfair competition actions in Turkey.

In addition to her corporate work, Özge advises multinational industry associations in Turkey on numerous regulatory policy papers and drafting regulations for the Turkish government authorities.


Practice Areas & Work Department

Life Sciences

Intellectual Property

Patent and Utility Models

Competition


Languages

English

Turkish


Memberships

International Bar Association (IBA), Co-Chair of the Intellectual Property and Entertainment Law Committee

Seton Hall University School of Law Healthcare Compliance Certification Program, Advisory Board Member

Association Internationale pour la Protection de la Propriété Intellectuelle (AIPPI)

Licensing Executives Society (LES)

Galatasaray University Alumni Association

IP in Business Transactions 2024 in Turkey - Part 2

Security can be taken over all main IPRs, namely trade marks, patents, designs, and copyright. In practice, security is commonly taken over trade marks or patents. It is important to conduct detailed due diligence to determine the owner of the IPRs and whether any security has been taken over them.

19.09.2024

IP in Business Transactions 2024 in Turkey - Part 1

Basis for patent assignment. Under the Intellectual Property Law No. 6769 (IP Law), a patent can be assigned in whole. A patent cannot be assigned in part.

16.09.2024

Named Patient Program

Named Patient Programs is one of the exceptional pharmaceutical importation regimes for products that are not authorized or authorized but unavailable in the Turkish market for various reasons.

19.08.2024

Market Access – Alternative Reimbursement Models

In the presence of alternative reimbursement models such as payback, value-based, indication-based reimbursement, performance-based, etc., developed for drug reimbursement systems throughout the world, ...

15.08.2024

Pricing of Pharmaceuticals and the Fixed Exchange Rate

Due to the rapid increase in the current exchange rates, pharmaceutical prices have been one of the most controversial issues in Türkiye in 2023.

14.08.2024

Healthcare Regulation 2024 in Turkey - Part 2

The Ministry of Health (MoH) is the main body in charge of health services in Türkiye. It regulates all healthcare institutions in the country, which includes patient care facilities such as hospitals, clinics and diagnostic centres and the practice of medical and other health professions. The Turkish Medicines and Medical Devices Agency (Agency) is a regulatory agency of the government that acts as the highest sanitary authority in terms of medical safety on medicines, health products, cosmetics and personal care products.

05.10.2023

Healthcare Regulation 2024 in Turkey - Part 1

Turkey's healthcare system, governed by the Fundamental Law on Healthcare Services No. 3359, falls under the Ministry of Health's purview. Social Security Institution (SSI) health insurance covers the active population, retirees, and dependents, while co-payments apply to certain services. The Health Services Pricing Commission regulates pricing, and the Regulation on Drug Reimbursement governs reimbursement. Licenses for private hospitals require Ministry of Health approval. Foreign companies cannot provide healthcare services. Competition law applies to private hospitals and clinics, subject to Turkish Competition Authority oversight.

02.10.2023

Pricing of Pharmaceuticals and the Fixed Exchange Rate - 2023

Pharmaceutical prices in Turkey have always been one of the most controversial issues. The prices of medicines that are to be marketed are set under the Decision on Pricing of Human Medicinal Products and the Communiqué on the Pricing of Human Medicinal Products of September 29, 2017, issued by the Ministry, which is vested with the competencies to regulate this area.

20.03.2023
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