Mehta Hina, Tidwell Lille, Liotta Lance A
George Mason University, Manassas, VA, 20110, USA.
Tidwell Medical Technologies, LLC, Cary, NC, 27518, USA.
Methods Mol Biol. 2017;1606:379-397. doi: 10.1007/978-1-4939-6990-6_25.
Patents are designed to protect and encourage creativity and innovation. Patenting a biomedical discovery can be a requirement before a pharmaceutical company or biotech entity will invest in the lengthy and capital-intensive drug development and clinical trials necessary to achieve patient benefit. Although scientists and clinicians are well versed in research publication requirements, patent descriptions and claims are formatted in a manner quite different from a research paper. Patents require (a) a series of logical statements clearly delineating the boundaries of the novel aspects of the invention and (b) sufficient disclosure of the invention so that it can be reproduced by others. Patents are granted only for inventions that meet three conditions: novelty, non-obviousness, and usefulness. Recent changes to US patent law limit the scope of patentable material. Products of nature such as nucleic acids and proteins, or steps used to observe natural events, are no longer patent eligible. This chapter provides basic guidelines and definitions for inventions, inventorship, and patent filing which are summarized using a question and answer format.
专利旨在保护和鼓励创造力与创新。在制药公司或生物技术实体对实现患者受益所需的漫长且资本密集型的药物研发和临床试验进行投资之前，为生物医学发现申请专利可能是一项要求。尽管科学家和临床医生精通研究论文的发表要求，但专利描述和权利要求的格式与研究论文截然不同。专利要求：（a）一系列逻辑陈述，清晰界定发明新颖方面的界限；（b）对发明进行充分披露，以便他人能够重现。只有符合新颖性、非显而易见性和实用性这三个条件的发明才能获得专利。美国专利法最近的变化限制了可专利材料的范围。诸如核酸和蛋白质等自然产物，或用于观察自然事件的步骤，不再具备专利资格。本章以问答形式总结了有关发明、发明权和专利申请的基本指导方针和定义。
