Bolar Exemption
The practice known as Bolar Exemption is regulated under Article 85(3)(c) of the Industrial Property Law in Türkiye. According to this provision, experimental acts involving a patented invention, such as those carried out for the purpose of obtaining marketing authorization for pharmaceuticals, including the necessary tests and trials, are excluded from the scope of the rights conferred by the patent.
The Bolar Exemption allows generic drug manufacturers to conduct the required tests and studies for marketing authorization while the original product’s patent is still in force. This enables them to complete the necessary preparations in advance, so that the generic product may be introduced to the market promptly upon the expiration of the patent protection period.
In this context, the monitoring of the scope, validity, and duration of pharmaceutical patent protection is of critical importance for companies seeking to benefit from the Bolar Exemption.
The Bolar Exemption stands out not only as a mechanism permitting experimental acts within the scope of patent protection but also a facilitator of procedures related to data exclusivity.
SIMAJ, is able to provide consultancy services to its clients in connection with the legal and administrative processes that may arise in this area.
End-To-End Services
Our patent and trademark attorneys, each highly qualified in their respective fields, will guide you through every stage of the process, from application to registration, ensuring you take the most appropriate steps.
As a Turkish and European Patent Attorney and mechanical engineer, I am founding partner of SIMAJ, I have the privilege of advising clients on a board of spectrum of patent related matters, including prosecuting patent applications, conducting freedom-to-operate and patentability analysis, and providing strategic portfolio development advice, for over 30 years. My focus on developing new methods of providing our services to clients means I like to think outside the box: I like to think about how we can build better relationships with our clients and help them in ways traditional lawyers don’t.
As the General Manager and Patent Department Manager at SIMAJ, I bring both administrative oversight and deep technical insight to our Patent and Design departments. My role involves not only managing and coordinating the strategic direction of these departments but also ensuring the consistent delivery of high-quality legal and technical services across all aspects of IP protection, drawing on over 25 years of experience. My experience as the Head of Patent Department at the Turkish Patent and Trademark Office has given me a strong understanding of institutional procedures and regulatory frameworks, which I now integrate into our client-focused practice. Moreover, I am able to reflect this experience into my work in freedom to operate analyses, patent prosecution, drafting and filing, licensing, claim charts and analysis, novelty, infringement and invalidation searches. This comprehensive approach enables us to provide our clients with holistic and forward-looking intellectual property solutions aligned with their business objectives.
As a Turkish Trademark Attorney and Partner at SIMAJ since 1997, my practice spans the full spectrum of intellectual property protection, including trademark prosecution and enforcement, design registration, and contract advisory work related to the commercialization of IP rights. I regularly assist clients with developing and managing their global trademark and design portfolios, advising on filing strategies, as well as drafting and negotiating licensing, co-existence, and assignment agreements.
As a Turkish Trademark Attorney and Partner at SIMAJ, I advise clients across the full spectrum of IP rights since 1997, with a particular focus on trademark protection, enforcement, and portfolio strategy. My practice extends to domain name dispute resolution and negotiating and drafting complex licensing agreements. This comprehensive approach allows us to offer clients holistic and forward-thinking IP solutions that align with their commercial goals.
Mert is experienced in assisting multi-national clients in IP portfolio management. He is experienced in both patent and trademark rights.
Büsra is a chemical engineer working as a part of the patent team in SIMAJ. She is responsible for patent prosecution, drafting, and novelty research as well as patent infringement.
Kutluhan is a chemical engineer who is a part of our patent team in SIMAJ. He particularly focuses on drafting, process management, and novelty research.
Kardelen is a physics engineer and is part of our patent team. She particularly focuses on drafting, process management, and novelty research.
