a Biotechnology & Pharmaceuticals Group , Global Prior Art, Inc , Boston , MA , USA.
Expert Opin Ther Pat. 2019 Mar;29(3):191-198. doi: 10.1080/13543776.2019.1575809. Epub 2019 Feb 6.
Personalized diagnostic testing (PDx) is a key component of the precision medicine toolkit and has shown the most development in cancer applications. Recent changes in the regulatory and legal landscapes regarding PDx development and commercialization have brought uncertainties to both intellectual property strategies and business model development. While the regulatory and legal uncertainties have been well-documented, there has been little reported analysis of the recent patent landscape and movement of IP into the PDx market. Areas covered: This article provides a snapshot landscape analysis of cancer-associated PDx US granted patents from 2014 to 2018, with a focus on claim types, biomarkers, and associated detection strategies, and assignee-specific IP portfolio analyses. Expert opinion: Patent-driven research is commonplace in the legal world for performing patentability, clearance, and validity analyses. The results from this review show that patent-driven analysis is also insightful for understanding strategies to build IP portfolios around biomarker and detection platforms, identifying partners and competitors, and driving PDx technologies into the market. This information is an important source of business intelligence and can provide companies or investors with valuable information for making strategic decisions in developing and commercializing PDx technologies.
个体化诊断检测（PDx）是精准医学工具包的重要组成部分，在癌症应用中发展最为迅速。最近，PDx 开发和商业化的监管和法律环境发生了变化，给知识产权策略和商业模式发展带来了不确定性。虽然监管和法律方面的不确定性已经得到了很好的记录，但最近关于专利格局和知识产权向 PDx 市场转移的分析报告却很少。涵盖领域：本文对 2014 年至 2018 年美国癌症相关 PDx 授予专利进行了快照式景观分析，重点关注权利要求类型、生物标志物和相关检测策略，以及特定受让人的知识产权组合分析。专家意见：专利驱动的研究在法律界很常见，用于进行专利性、可授权性和有效性分析。审查结果表明，专利驱动的分析对于围绕生物标志物和检测平台构建知识产权组合、识别合作伙伴和竞争对手以及推动 PDx 技术进入市场的策略也具有深刻的见解。这些信息是商业智能的重要来源，可为公司或投资者提供有价值的信息，帮助他们在开发和商业化 PDx 技术方面做出战略决策。
