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首页> 外文期刊>Pharmaceutical patent analyst >SPC update: Advocate General opines on the meaning of 'protected by'
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SPC update: Advocate General opines on the meaning of 'protected by'

机译：SPC更新：倡导普通的作品对“受保护”的含义

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Supplementary Protection Certificates: an introduction Before a pharmaceutical product can be commercialized, marketing authorization must first be obtained. For innovative pharmaceuticals products, the authorization process will typically involve carrying out clinical trials so that regulatory authorities can satisfy themselves that the product has acceptable levels of safety and efficacy. While these trials can take many years to complete, they are plainly necessary to protect patients. It will also normally be the case that innovative pharmaceutical products are the subject of patent protection and for such patent(s) to be in force during the authorization process. This interplay between regulatory requirements and intellectual property rights gives rise to a tension — the innovator's valuable patent monopoly is in force and diminishing in length day-by-day but yet the innovator is prevented from commercializing its product until it has successfully completed the lengthy and mandatory authorization process. Supplementary Protection Certificates (SPCs) are European sui generis rights that aim to compensate the innovator in such circumstances. SPCs extend the period of protection by up to five years following expiry of the underlying patent so as to balance (at least in part) any erosion of the patent term by the regulatory process.
机译：补充保护证书：在制药产品可以商业化之前的介绍，必须首先获得营销授权。对于创新的药品产品，授权过程通常涉及进行临床试验，以便监管机构可以满足产品具有可接受的安全性和疗效水平。虽然这些试验可能需要多年才能完成，但它们明显保护患者。通常情况下，创新的药品是专利保护的主题以及在授权过程中要生效的专利。监管要求与知识产权之间的相互作用引起了紧张局势 - 创新者的宝贵专利垄断在一天中的长度，但在成功完成冗长之前，无法防止创新者将其产品商业化。强制授权流程。补充保护证书（SPC）是欧洲隋一般权利，旨在在这种情况下弥补创新者。在底层专利到期后，SPCS将保护期限延长多达五年，以便通过监管程序进行平衡（至少部分地）专利期限的任何侵蚀。

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