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Insights

We share our knowledge and expertise to update our community and clients about legal developments in Turkey.

“Plausibility” in Turkish Patent Law and Its Impact on Invalidation Proceedings

The grounds for the invalidation of a patent within the scope of Industrial Property Law No. 6769 are listed per the numerus clausus principle. The concept of plausibility – which has been the subject of numerous evaluations, especially by the European Patent Office (“EPO”) and frequent debate in academic circles in recent years – has not yet found a place within the scope of any legal regulation in Turkey. Moreover, there is no consensus on a Turkish wording for an… »

Market Access- Alternative Reimbursement Models

The pharmaceutical industry has long required a unique model for price setting where its conditions could be negotiated with the SSI, exempt from regular price and reimbursement rules given to innovative products. With the enactment of the Social Security and General Health Insurance Law numbered 6552 in September 2014, alternative reimbursement models became an essential topic in the Turkish healthcare industry. The complementary provisions introduced with the Regulation on… »

Termination Disputes relating to Partnership in Non-Public Joint Stock Companies

In joint stock companies, which is one of the most preferred partnership types due to the limited liability of shareholders, due to various concerns such as family and personal concerns and the relevant shareholders’ unsatisfied expectations relating to the company’s performance, shareholders may sometimes wish to terminate the partnership with other shareholders. In such cases, it is critical which actions can be taken by the controlling shareholders against the minority who… »

Market Availability of Products

The New Regulation on Licensing of Human Medicinal Products prepared by the TMMDA entered into force upon its publication in the Official Gazette numbered 31686, dated December 11, 2021. The Regulation on Licensing of Human Medicinal Products reflects up-to-date processes present in TMMDA practice that were absent in its previous iteration dated 2005, and provide compatibility with the EU directive numbered 2001/83/EC. In order to ensure supply continuity an exception for… »

The Need for an Injunction in Cases Where the EPO Proceeding is 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 (“EPO”) as a “pending issue”, in practice due to the principle of procedural economy, pending issue decisions may be given by the Civil Courts of Intellectual and Industrial Property Rights on a case by case basis. As Turkey is party to the European Patent Convention, upon the issuance of a revocation decision regarding a… »

Preliminary Injunction Decisions against Patent Trolls to Prevent the Enforcement of Patent Rights

Patent and utility model rights, vital to incentivizing R&D and innovation, provide their holders with a significant advantage over their competitors and grant an absolute right for a certain period. However, as in every system, there are players in the patent and utility model ecosystem who use these rights contrary to the purpose and spirit of the system. These players, who obtain patent/utility model registrations by taking advantage of the loopholes in the system… »

Named Patient Program

Named Patient Programs (“NPP”) is one of the exceptional pharmaceutical importation regimes for products that lack market authorisation or which are authorized but unavailable in the Turkish market for various reasons. In cases where a product does not have marketing authorization in Turkey or has a marketing authorization but cannot be found on the market, and patients need the product in question, it is possible to procure the pharmaceutical via this particular method upon… »

Current Practice of Bolar Exemption in Turkish Patent Law

Article 85(3)/(c) of the Industrial Property Law No. 6769 (“IPL”) regulates the Bolar Exemption, which stipulates the exclusion of experimental acts containing the invention subject to the patent from the scope of the patent right, including the licensing of pharmaceuticals and the necessary tests and experiments thereof. Undoubtedly, the purpose of the Bolar Exemption is to ensure that a generic medicinal product can be put on the market without losing time once the patent… »

Interactions with HCPs

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Promotional activities of human medicinal products is regulated by the Regulation on the Promotional Activities of Pharmaceutical Products for Human Use (“Promotion Regulation”) dated July 3, 2015. Under the Promotion Regulation, any advertisement of products to the general public, whether directly or indirectly, through any public media or communication channels, including the Internet, is prohibited. Pharmaceutical products may be promoted only to physicians, dentists and… »

Developments in the field of Medical Devices

After the long-awaited Regulation on Medical Devices numbered 2017/745 (EU Regulation) prepared by the EU Commission entered into force, Turkey’s Medical Device Regulation, designed to be compatible with the EU’s Regulation, was published in the Official Gazette numbered 31499 on June 2, 2020. Several articles are expected to be brought into effect in accordance with the EU transition process to provide a similar transition process in Turkey. The Medical Device Regulation… »

REGIONAL COURT OF APPEALS: The Decision of the Turkish Medicines and Medical Devices Agency 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 Licensing of Human Medicinal Products (“Licensing Regulation”), which regulates “Abridged Application[s]”, 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. Referencing the authorization information of the original pre-licensed pharmaceutical is sufficient. However, because the subject product must be… »

SEP: Navigating the Technology-Driven World

Standard-Essential Patents (“SEP” or “SEPs”) 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. Considering the upward trend in patent litigation arising from SEPs, it would be fair to say that SEP has become patent law’s new buzzword. Licensing SEPs: FRAND Terms Standard Developing Organizations (“SDOs”) determine… »

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