نوع مقاله : مقاله پژوهشی
نویسنده
استادیار حقوق خصوصی، گروه حقوق، دانشکده علوم انسانی، دانشگاه جهرم، جهرم، ایران.
چکیده
کلیدواژهها
موضوعات
عنوان مقاله [English]
نویسنده [English]
Within the framework of moderating the exclusive rights arising from intellectual property regimes, a spectrum of legal mechanisms—including the doctrine of exhaustion, fair use exceptions, and compulsory licensing systems—have been established. Yet among these legal provisions, the so-called Bolar exception, despite its strategic role in balancing the interests of rights holders and public welfare, has received comparatively limited attention from legislators and legal scholars as a significant innovation in intellectual property law. Under this provision, third parties are permitted to utilize patented drugs prior to the expiration of patent terms—without infringing rights or obtaining the patent holder’s consent—for the purpose of generating data necessary to secure regulatory market approval. This study thus seeks to address a pivotal question: What normative function does this legal construct serve within intellectual property regimes, and how does it influence pharmaceutical innovations? Employing a comparative-analytical methodology supplemented by doctrinal legal research, this paper systematically examines: (1) the conceptual foundations of the Bolar exemption; (2) its jurisprudential justification within IP frameworks; and (3) its policy implications for pharmaceutical access.
کلیدواژهها [English]
