Pharma & Biopharma

Intellectual Property

Strong protection of intellectual property as the stimulus for long-term research and sustainable investment.

我们为什么重视知识产权?

专利到期是对制药行业的威胁,也是通用公司的机会。平均而言,药物的收入在其专利到期后3年减少了90%。有几种线路扩展的方法,例如药物的组合,新施用,剂量,新的异构体以及新的固体形式或配方。

Strong intellectual property protection in the form of drug substance patents provide incentives for companies to make the long, costly investments that eventually lead to medical advances and fund future research.

Extra layers of protection can be added to a drug substance patent by applying a solid form patenting approach - either by inclusion of additional claims related to solid forms or filing additional solid form patents related to an initial drug substance patent. Here the term solid form refers to both crystalline (polymorphs, hydrates, solvates, salts, cocrystals,) and amorphous materials (amorphous drug substance, amorphous solid dispersions and co-amorphous). As solid form patents are typically filed after the initial drug substance patent, they additionally have the potential for a later expiration date.

The potential success of such a strategy is based on non-obviousness and novelty. For any compound it is impossible to predict, and thus not obvious, how many different solid forms exist or their properties. Furthermore, essentially every new solid form is novel by definition. As a consequence, virtually every new solid form is potentially a patentable entity.

布鲁克(Bruker)为固体形式表征提供了全面的分析系统,因此为了定义强有力的专利主张以及随后对专利的保护。通常认为X射线衍射(XRD)数据对于表征所要求的形式,通常以及互补红外(IR),拉曼和/或固态核磁共振(NMR)数据至关重要。

布鲁克解决方案

XRD独特地直接以固体形式探测分子排列。因此,XRD是晶体结构分析和可能发生的任何形式的相关属性表征的首选工具。XRD粉末图案和衍生的峰列表是指纹,可以验证给定晶体形式的多态性身份,无论是作为单相还是其他固体材料的混合物,并在混合物中量化其丰度。必威手机客户端XRD指纹还允许确定给定样品的多态性纯度,并量化不同多晶型物的丰度。因此,XRD指纹通常被认为是表征固体材料的黄金标准,通常用于定义专利主张以及专利保护。必威手机客户端

Solid-state NMR is a complementary technique that comes into play to resolve any potential doubts in solid form characterisation. It measures relaxation times to uniquely tell apart solid forms. Solid-state NMR is especially relevant when higher resolution is required or the analysis and quantification of amorphous form. Being a powerful information-rich technique, gives valuable structural information to increase the level confidence of your solid form characterisation for both drug substance and drug product.

布鲁克high-end instrumentation sheds light on solid form, providing answers from multiple angles, through multiple techniques. Complete characterization and accurate quantification ensure quality, while securing your market rights. Millions are spent by drug originators and generics firms on intellectualproperty lawsuits dealing with solid form. When this happens, you want the best data in your hands!

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LabScape Maintenance Agreements, On-Site On-Demand and Enhance Your Lab are designed to offer a new approach to maintenance and service for the modern laboratory