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class="content-area"> <main id="main" class="site-main" role="main"> <article id="post-43" class="post-43 post type-post status-publish format-standard hentry category-zschanquan tag-zhishichanquan"> <header class="entry-header"> <h1 class="entry-title">如何绕开仿制药开发中的「专利陷阱」？</h1> <div class="single_info"> <span class="xiaoshi"> <a href="http://news.jingshiqifu.com.cn/43.html" rel="nofollow" target="_blank">北京产权律师事务所</a> </span> <span class="date">2018-08-01 22:56 </span> <span class="views"> 阅读 1 次 </span> <span class="edit"></span> </div> </header><!-- .entry-header --> <div class="entry-content"> <div class="single-content"> <p>相信很多的朋友们已经看过我们的<strong>《我不是药神》</strong>了这部电影揭示了印度仿制药价格只有我国所售原创药价格几十分之一的真相，专利保护与生命健康之争的话题也刷爆了微博和微信朋友圈。有些人认为似乎只要专利到期，就可以放心大胆仿制，事实却远远没有那么简单。那大家就跟京师企服小编来了解一下如何绕开仿制药开发中的「专利陷阱」吧。</p><p>在仿制药立项阶段，企业都会盯梢某药品原始专利的法令情况，但这远远不够。因为新药专利请求一般不只包含某结构通式的根本化合物专利、化合物制备办法专利；代表性化合物专利及该化合物衍生物专利、化合物中间体专利；药物组合物专利、药物制剂专利、药物用处专利等组成的是一个专利维护网络，从根本化合物专利到制剂专利的请求时间跨度可达十几年甚至二十几年，维护期天然更长。</p><p>以医治高血脂的普伐他汀为例，专利权人日本三共公司请求了54项专利组成专利维护网络，内容包含普伐他汀制备、别离精制、普伐他汀盐、制剂配方、多种医治用处等。</p><p>因而，仿制企业在盯梢核心专利一起，要对仿制过程中触及的工艺、配方、辅料等有关悉数专利盯梢剖析，不只有助于提高仿制药品疗效，还能防止侵略外围专利。</p><p>原创药在专利布局时，往往会就同一项发明在利益相关的许多国家和区域提出请求，取得专利维护。相同内容在不同国家、区域取得的专利构成本家专利。</p><p>因为专利的地域性特点，某一国家专利到期，并不意味在全世界专利就必定悉数到期，在产品出售过程中还需要剖析该专利在特定区域或国家专利法令状态，防止呈现侵略专利权行为。</p><p>我国的发明专利维护期为请求日算起20年，某一项药物专利在我国到期能够仿制，但在产品出口到其他国家则有可能构成侵权。如美国法令规则专利自请求日起算20年停止，可是为保证原研药厂的权力，若原研药厂就该专利药正请求新的专利时，其专利权将可延伸。原维护期先为17年，届满后能够屡次请求延伸。2003年FDA的Medicare新规，原创制药公司能够取得一次30个月商场独占权延伸期。如欧盟国家专利维护期为20年，一起规则，自1993年1月2日后的药品专利在取得有关卫生部门的出产许可后，假如维护期剩下期限缺乏15年，能够延伸5年。日本为请求日起20年，可有5年延伸期。韩国从请求日起至20年之日停止，在必定条件下能够延伸维护，最多延伸5年。所以在我国仿制的失效专利药物进入这些国家，应当根据该国法令规则查询是否专利到期。</p><p>在专利布局方面，仿制药企业应对原研化合物的外围专利进行规避规划后，一般最好对晶型专利、药物制剂专利、制备办法专利等外围技能进行布局。</p><p>一起，仿制药企业一方面要监控竞争对手，发现侵权目标，及时提起侵权诉讼冲击对手，第二方面是实时盯梢原研公司及其他药企新揭露的专利请求和新授权的专利，对存在侵权危险的专利提前准备无效。好了今天京师企服小编的介绍就到这里了，以上文章仅供参考希望可以帮到大家。</p> 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