微生物菌株的特征对专有权范围的影响

F. S. Ivanov, K. V. Nasonova
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引用次数: 0

摘要

导言。随着基于重组产品和生物技术的药物制剂的大量上市,需要确定一项战略,以保护在生产过程中实施的主体(包括微生物生产者菌株)的专有权。确定在药物制剂(包括生物技术产品)的研究、开发和上市过程中,将微生物菌株作为知识产权主体的可能性和保护范围。研究材料包括根据选定主题的关键词进行专题查询的同行评审期刊上的现有出版物、官方网站、规范性法案、俄罗斯联邦和外国的专利申请程序。本文简要回顾了关于将菌株登记为知识产权主体的规范性法案。界定了微生物菌株在俄罗斯和外国境内申请专利和确定侵犯专利权的特征。结论。界定了将菌株作为知识产权主体进行保护所引发的问题,以及将菌株注册为专有权主体的可能性。
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Affect of Features of a Microorganism Strain on a Scope of Exclusive Rights
Introduction. A launch of larger number of pharmaceutical preparations based on recombinant products and biotechnologies leads to determine a strategy for protection of exclusive rights for subjects implemented into manufacturing process, including strains of microorganism-producers.Aim. To define a possibility and a protection scope of microorganism strain as intellectual property subjects at a step of research, development and launch of pharmaceutical preparations, including biotechnological products.Materials and methods. The materials of the study were available publications in peer-reviewed journals on thematic queries based on keywords of the selected topic, official websites, regulatory legal acts, regulating the procedure for patenting subjects in the Russian Federation and foreign countries.Results and discussion. A brief review of regulatory acts on registration of a strain as an intellectual property subject is presented. It was defined features of a microorganism strain for patenting and for establishing an infringement of patent rights in the territory of Russian and foreign countries. A possible scope of patent rights for strains is indicated.Conclusion. The problems raised upon protecting strains as intellectual property subjects as well as possibilities of strain registration as exclusive right subjects are defined.
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