Na Wang

Sep 6, 2024 | lexology.com | Na Wang

在过去数年中，我国医药行业发展迅速，已成为全球最大、最活跃的医药市场之一。为了进一步鼓励药品研发创新，近年来我国在医药行业启动了一系列药政和专利改革，包括药品专利权期限补偿的实施。本文对我国药品专利权期限补偿制度进行了全面的解析，并分析了该制度对创新药企业和仿制药企业的影响。 一、背 景 由于新药研发成本高、周期长、风险大，医药行业对专利保护的依赖性很强。如果没有专利保护，创新药企业很难收回研发成本并获得合理利润，从而影响其研发新药的积极性。然而，药品上市需要药品监管部门的严格审批，包括一系列研究，包括非临床安全性评价和临床试验等。这意味着即使专利申请获得批准，在获得上市批准之前，也要经过相当长的一段时间才能实施，导致专利保护期大大缩短。 专利保护期延长制度起源于美国1984年颁布的《药品价格竞争与专利期限补偿法案》，又称《Hatch-Waxman法案》[1]。随后，日本、韩国、欧盟、加拿大等多个国家或地区也相继建立了类似制度，以补偿创新药审批过程占用的时间导致的专利保护期损失。...

Sep 5, 2024 | mdpi.com | Le Feng |Lei Fan |Na Wang |Le Li

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Jul 22, 2024 | lexology.com | Na Wang

China has developed rapidly in the pharmaceutical industry in the past few years and has become one of the largest and most active pharmaceutical markets in the world. To further encourage innovation in drug development, China has initiated a series of regulatory and patent reforms in the pharmaceutical industry in recent years, including the implementation of patent term extension (PTE).

Jun 28, 2024 | mdpi.com | Ning Li |qian Xu |Na Wang |zhiyong Liu

All articles published by MDPI are made immediately available worldwide under an open access license. No special permission is required to reuse all or part of the article published by MDPI, including figures and tables. For articles published under an open access Creative Common CC BY license, any part of the article may be reused without permission provided that the original article is clearly cited. For more information, please refer to https://www.mdpi.com/openaccess.

Apr 12, 2024 | mdpi.com | Na Wang |Chun Zhang

All articles published by MDPI are made immediately available worldwide under an open access license. No specialpermission is required to reuse all or part of the article published by MDPI, including figures and tables. Forarticles published under an open access Creative Common CC BY license, any part of the article may be reused withoutpermission provided that the original article is clearly cited. For more information, please refer tohttps://www.mdpi.com/openaccess.