Landscape of granted US patents in personalized diagnostics for oncology from 2014 to 2018.

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Abstract

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.