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

ABSTRACT

Introduction: 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.

KEYWORDS:

• Patents
• cancer
• diagnostics
• commercialization
• precision medicine

Article highlights

• This review develops a focused landscape of US granted patents claiming biomarker measurements in cancer patient samples and uses the findings as a guide to build case studies on aspects of diagnostic commercialization.

• Claims on biomarker measurement in patient-derived samples have increased substantially, and the rise of claims linking biomarker measurement to methods of treatment and specific therapies reflects the shift toward personalized medicine in cancer.

• Unique combinations of biomarker types, detection modalities, and indications provide opportunity to build innovative patent portfolios.

• Combining an assignee portfolio analysis with non-patent sources of information can be used to recapitulate the evolution of a successful commercialization strategy for personalized diagnostic platforms.

• New entrants developing personalized diagnostics can use patent data as a starting point to understand the dynamics and strategies used to participate in the broader commercialization ecosystem.

This box summarizes key points contained in the article.

Declaration of interest

The author was supported by Global Prior Art, Inc. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was funded by Global Prior Art, Inc. as part of normal operations.