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    Lawyers Özge Atılgan Karakulak

    Özge Atılgan Karakulak

    Gün + Partners
    [email protected]

    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

    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.
    Özge Atılgan Karakulak

    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.
    Özge Atılgan Karakulak

    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.
    Özge Atılgan Karakulak

    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.
    Özge Atılgan Karakulak

    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.
    Özge Atılgan Karakulak

    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, …
    Özge Atılgan Karakulak

    The Euro Value Applied to Pharmaceutical Prices was increased by 36.77%

    On December 14, 2022, the Turkish presidential decree numbered 6546 was published in the Official Gazette, amending the Decision on Pricing of Medicinal Products for Human Use, which increases the value of 1 Euro in Turkish lira by 36.77% in December 2022. As a result, the price scales stipulated in the Decision were updated, and the threshold value for price-protected products has been determined as TRY 37.10 while it has been determined as TRY 19.39 for other products in line with the change in the exchange rate. This is the third time this year the exchange rate has been updated, and the amendment also indicates that there will be no revaluation in 2023.
    Özge Atılgan Karakulak

    Life Sciences 2023 in Turkey

    Turkey's healthcare system is primarily governed by the Fundamental Law on Healthcare Services No. 3359, which empowers the Ministry of Health (MoH) to issue regulations and establish a system with equal and equitable access. Hospitals and public health institutions are regulated and established by the MoH and its subsidiaries. The Social Security Institution provides insurance, while public, private, and training and research hospitals provide healthcare. Healthcare product licensing, pricing, and distribution are managed by the Turkish Medicines and Medical Devices Agency. E-Nabız, the MoH's encrypted personal health record system, was launched in 2015. Healthcare data is protected by Data Protection Law No. 6698 and Personal Health Data Regulation No. 30808.
    Özge Atılgan Karakulak