美国药物专利保护策略的研究

发布时间：2018-08-20 19:01

【摘要】：新药的开发需要大量的投资,持续有效的专利保护是制药行业保障药品销量的一个重要因素。本文将介绍美国药物相关专利保护政策,企业通过制定有效的专利保护策略和产品发展战略,充分运用药品专利保护,保障新药的销售和利润,延长销售平稳阶段的时间,从而将该药物的收益最大化。本文浅析我国制药企业专利保护的反思与启示。进取型策略是指,制药企业在原研产品专利保护期内,不断开发研究新的化学药物成分,不断申请新的辅助专利,并充分利用现有专利保护体制,最大限度延长专利保护期,巩固市场领导地位,抗击并阻止仿制药的上市。专利保护期的后期阶段,仿制药纷纷提交简约新药申请ANDA;此时防守型策略需要原研企业采取行动计划,防备仿制药上市及其收益,这些策略有助于延续原研产品的收入。包括专利侵权诉讼、授权仿制药、OTC转换、橙皮书除名。收入最大化策略,是指药品已过专利保护期,通过再次开发,结合专利申请策略,有效延长产品生命周期,与仿制药直接竞争的策略。本文主要讨论三种专利保护策略:进取型策略、防守型策略、收入最大化策略,很多产品应用策略获得商业成功。然而药物研发实践不断发展,企业必须不断调整其专利保护策略,必须关注并考虑这些影响未来保护策略的因素。
[Abstract]:The development of new drugs requires a large amount of investment, and effective patent protection is an important factor to ensure drug sales in pharmaceutical industry. This article will introduce the United States drug related patent protection policy. By formulating effective patent protection strategies and product development strategies, enterprises will make full use of drug patent protection, ensure the sale and profit of new drugs, and prolong the time of smooth sales. In order to maximize the benefits of the drug. This paper analyzes the reflection and enlightenment of patent protection in Chinese pharmaceutical enterprises. Aggressive strategy means that during the patent protection period of original products, pharmaceutical enterprises continuously develop and study new chemical components, continuously apply for new auxiliary patents, make full use of the existing patent protection system, and extend the patent protection period to the maximum extent. Consolidate market leadership to combat and prevent the marketing of generic drugs. At the late stage of patent protection, generic drugs apply for ANDA.At this time, the defensive strategy requires the original research enterprise to take action plan to guard against the listing of generic drugs and their income, which helps to continue the revenue of the original product. Including patent infringement litigation, authorized generic drug OTC conversion, orange book delisting. Revenue maximization strategy refers to the strategy of extending product life cycle effectively and competing directly with generic drugs through re-development and patent application strategy. This paper mainly discusses three kinds of patent protection strategies: aggressive strategy, defensive strategy, revenue maximization strategy, and many product application strategies to obtain commercial success. However, with the continuous development of drug research and development practice, enterprises must constantly adjust their patent protection strategies, and must pay attention to and consider these factors that affect the future protection strategies.
【学位授予单位】：上海交通大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R95

【参考文献】