PDF(Pubmed)
Abstract：
Despite an ever-increasing need for newer, safer, more effective, and more affordable therapies to treat a multitude of diseases and conditions, drug development takes too long, costs too much, and is too uncertain to be undertaken without the conferment of exclusionary rights or entry barriers to motivate and sustain investment in it. These entry barriers take the form of patents that protect intellectual property and marketing exclusivity provisions that are provided by statute. This review focuses on the basic ins and outs of regulatory and patent exclusivities for which new chemical entities (NCEs), referring to never-before approved drugs with an entirely new active ingredient, are eligible and uses RRx-001, a small molecule aerospace-derived NCE in development for the treatment of cancer, radiation toxicity, and diseases of the NLR family pyrin domain containing 3 (NLRP3) inflammasome, as a \"real world\" example. This is intended as a \'101-type\' of primer; its aim is to help developers of original pharmaceuticals navigate the maze of patents, other IP regulations, and statutory exclusivities in major markets so that they can make proper use of them.
摘要：
尽管对更新的需求不断增加，更安全,更有效,和更实惠的疗法来治疗多种疾病和病症，药物开发需要太长时间，成本太高,并且太不确定，无法在不授予排他性权利或进入壁垒以激励和维持对其的投资的情况下进行。这些进入壁垒采取保护知识产权的专利和法规规定的营销排他性条款的形式。这篇综述的重点是新化学实体(NCEs)的监管和专利排他性的基本来龙去脉。指的是以前从未批准过的具有全新活性成分的药物，符合资格，并使用RRx-001，一种小分子航空航天衍生的NCE开发用于治疗癌症，辐射毒性，和NLR家族pyrin结构域含3（NLRP3）炎性体的疾病，作为一个“现实世界”的例子。这旨在作为“101型”的底漆；其目的是帮助原始药物的开发人员浏览专利的迷宫，其他知识产权法规，以及主要市场的法定排他性，以便他们能够适当利用它们。
