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






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

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.


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.


Pricing of Pharmaceuticals and the Fixed Exchange Rate

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.


Market Access - Alternative Reimbursement Models

For an extended period, the pharmaceutical industry needed a unique model of reimbursement where its conditions could be set together through negotiation with the SSI, and the regular price and reimbursement rules did not apply to innovative products.


The Need for an Injunction in Cases Where the EPO Proceeding is held as a Pending Issue

Although there is no explicit provision in Turkish Law for the acceptance of the ongoing opposition or appeal proceedings before the European Patent Office as a “pending issue” due to the principle of procedural economy, in practice, pending issue decisions may be given by the Civil Courts of Intellectual and Industrial Property Rights according to the particular circumstances.


Named Patient Program

Named Patient Programs is one of the exceptional importation regimes of pharmaceuticals without marketing authorization in Turkey or with marketing authorization, but which are unavailable in the Turkish market for various reasons.


SEP: Navigating the Technology-Driven World

Standard-Essential Patents 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.


Regional Court of Appeals: The Decision of the TMMDA 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 Authorization, which regulates “Abridged Application”, 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, …

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