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近年来,全国各地出现了药品生产企业以其药品说明书著作权受到侵害为由提起的诉讼。药品说明书是否受著作权法保护的争议较大,已引起社会广泛的关注,这一问题直接关系到涉及医药领域药品说明书著作权侵权纠纷如何解决的问题。为了保证执法的统一,最高人民法院与国家食品药品监督管理总局(原国家食品药品监督管理局,以下简称国家药监局)政策法规司先后两次共同举办研讨会。此后,最高人民法院对药品说明书是否应受我国著作权法保护的问题进一步探索和研究,逐步达成共识。
In recent years, lawsuits filed by drug manufacturers around the country over the copyright infringement of their drug brochures have emerged. Whether drug manuals are subject to controversy over the protection of copyright law has caused widespread concern in society. This issue is directly related to how to solve disputes over copyright infringement involving pharmaceutical manuals. In order to ensure the unification of law enforcement, the Supreme Court and the State Food and Drug Administration (former State Food and Drug Administration, hereinafter referred to as SFDA) Department of Policy and Law jointly held two seminars. Since then, the Supreme People’s Court on drug documentation should be subject to the protection of copyright law to further explore and study, and gradually reach a consensus.