Patents and Utility Models
Bar Admission: Istanbul Bar Association
Özge Atilgan Karakulak is a partner since 2013 and chair of the firm’s life sciences industry and competition practices and she is co-chair of intellectual property practice. She has been working for Gün + Partners since 2005.
With the combination of Özge’s advisory and litigation expertise and in-depth knowledge of the life sciences industry, 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. She was involved in the first ever pharmaceutical data exclusivity actions in Turkey.
In addition to corporate clients, Özge serves as a counsel to the Association of Research-Based Pharmaceutical Companies (AIFD) and the Association of Research-Based Medical Technologies Manufacturers (ARTED) in Turkey and advises on many regulatory policy papers and drafting regulations proposed to the Turkish governmental authorities.
Languages: English, Turkish
Recent changes to the Regulation on the Sale, Advertisement and Promotion of Medical Devices introduced a sponsorship exemption for training activities held in medical device simulation centres and cadaver centres for surgical training, which are no longer categorised as scientific or educational meetings. However, no clear definition of what constitutes a 'medical device simulation centre' or 'cadaver centre for surgical training' has been provided.
Recent amendments to the Guidelines on the Supply from Abroad and the Use of Pharmaceuticals have changed the practice of the Named Patient Programme (NPP) in Turkey. Supplying non-approved or unavailable pharmaceutical products from abroad is an exceptional route under the NPP. However, increased regulatory and price pressures have resulted in more products becoming unavailable on the Turkish market.
The new Regulation on the Promotional Activities of Pharmaceutical Products for Human Use was recently published. The regulation contains new provisions relating to the disclosure obligations of marketing authorisation holders and other frequently debated matters, including co-promotion, the promotion of pharmaceuticals imported on a patient basis and financial support for conferences.
The Pharmaceutical and Medical Device Institution recently published new Guidelines on the Supply from Abroad and the Use of Pharmaceuticals. The purpose of the guidelines is to determine the procedures regarding the supply of pharmaceuticals from abroad that have no marketing authorisation in Turkey or that have marketing authorisation but are not available on the Turkish market for various reasons.
A new autonomous administrative body to control the Turkish healthcare industry was recently established. It will support research and development activities in the healthcare sector. It is likely therefore that researchers and innovators will find a more encouraging scientific and economic environment in Turkey in the near future.
The long-awaited Regulation on the Sale, Advertisement and Promotion of Medical Devices, which bans the advertisement to the public of some categories of medical device, is now in force. The regulation introduces provisions relating to the sale, advertisement and promotion of medical devices, promotional activities for medical devices and the real or legal persons engaged in these activities.
New guidelines were published in mid-2013 that introduce new training and certification requirements for medical sales representatives, with representatives now expected to take an examination. Those who do not pass the examination will no longer be able to practice. Employers may therefore be obliged to make some of their employees redundant in order to comply with the law.
The legal provisions regulating the working principles of healthcare professionals employed by state institutions in Turkey have frequently been debated, particularly in recent years. Although a previous decree-law on the topic was overruled by the Constitutional Court, the government has once again set out to implement a regime of restrictions on the working principles of state-employed healthcare professionals.
A new regulation regarding products that are offered for sale with health claims recently entered into force. The duties of the Pharmaceutical and Medical Device Institution have been extended in order to fulfil the regulation's objectives. The new regulation will bring a more detailed level of awareness in relation to the correct use of health claims, as well as suitable protection for consumers.
As the 16th largest pharma industry in the world and the seventh largest in Europe, the healthcare sector in Turkey is experiencing continuous development and growth. As part of its ongoing plans, the Ministry of Health previewed before the industry a new initiative known as 'free health zones', the main purpose of which is to support the growth of the health sector by facilitating foreign investment in Turkey.
The Competition Authority recently concluded its investigation into the pharmaceutical sector. The report notes two main concerns in relation to regulation in the pharmaceutical sector - protecting public health and ensuring the sustainability of pharmaceutical expenditure. The authority focused on the latter, with its investigation concentrating on the development of price competition at the supplier level.
The law on patents in Turkey is still relatively new and the history of patent disputes short. Problems in relation to the protection and enforcement of patent rights, especially for pharmaceutical products, include insufficient expertise in the expert panels to which patent cases are referred, and issues of access to a counterparty's evidence in ongoing actions under freedom of information requests.
Specific rules have governed the promotion of medicinal products in Turkey since the early 1990s. However, the regulation currently in place does not cover medical devices and no specific rules exist for such devices from the perspective of either interaction with healthcare professionals or advertising to the public. The Ministry of Health is in the process of drafting a new regulation, but this has yet to be published.