Limitations on Patent Rights: Private and Experimental Use, and the Bolar Exemption

Authors : Aybike Karahan, Özge Nur Çalık Sönmez

Pages : 478-505

Doi:10.59399/cuhad.1824762

View : 47 | Download : 55

Publication Date : 2025-12-30

Article Type : Research Paper

Abstract :Patent rights grant the holder exclusive authority over the use, production, commercial circulation, and enjoyment of both the material and moral benefits arising from an invention for a period of 20 years starting from the application date. This monopolistic entitlement is subject to certain limitations under national and international legislation to ensure public interest and maintain a balance between the inventor’s rights and societal welfare. Article 85 of the Industrial Property Code serves this purpose by excluding acts such as private use, experimental use, and trials related to drug licensing—including necessary testing—from the scope of patent protection. Private and experimental acts are defined as exceptions that encompass non-commercial activities serving personal purposes and contributing to the advancement of the state of the art. Experimental use related to drug licensing is commonly referred to in practice and doctrine as the \\\"Bolar exemption.\\\" The primary aim of the Bolar exemption is to facilitate the swift market entry of generic drugs, thereby improving access to medication and establishing a balance between public health and the interests of pharmaceutical manufacturers. This study aims to elaborate on how the limitations imposed on patent rights are applied at both national and international levels and to discuss the criteria that may justify restrictions on the patented invention within the scope of these exceptions. To ensure a fair balance between the inventor’s interests and public welfare, objective criteria must be established. Indeed, the formation of a uniform application is only possible when certain fundamental criteria are available to guide decision-making in each specific case.
Keywords : Deneme amaçlı fiiller, özel amaçlı fiiller, Ticaretle Bağlantılı Fikri Mülkiyet Anlaşması (TRIPS), Bolar İstisnası, Patent Hakkının Kapsamı

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