Application of Bolar Exemption Under The Scope of Article 85/3 of The Industrial Property Law

In the field of pharmaceutical patent there must be a fair balance between scientific developments and the public interest to access (new) pharmaceuticals. In accordance to Industrial Property Law (IPL), the scope of patent prevention shall primarily be determined by the claims of the applicant. As high-budget research and development activities occur in pharmaceutical industry and by taking into account that the patent right includes the rights on generics, the claims on patent must be clearly defined. Activities listed under article 85/3 of IPL and exempted from patent prevention are consisted of acts undertaken privately for non-commercial purposes, acts undertaken for experimental purposes and preparation of medicine in accordance with medical prescription which have non-commercial nature and are undertaken for personal needs and purposes. Experimental acts listed under the said provision including those undertaken for obtaining pharmaceutical authorization and other related tests and trials are also classified as Bolar exemption and have critical importance in the area of pharmaceutical patent. As a result of this exemption generic pharmaceutical companies can execute the required trials and experiments for authorization, thus immediately after the expiration of patent term, they can participate in the market which may bring about a competitive medium. In addition the application of Bolar exemption to data exclusivity enables generic pharmaceutical companies to file abbreviated application for authorization by depending on the data of the original pharmaceuticals which will result in accomplishment of the difficult and long-term authorization process