Intellectual Property Challenges for the Development of Genomic Diagnostics

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DESCRIPTION (provided by applicant): The purpose of this study is to contribute empirical data and critical analysis relevant to patenting and licensing of DNA sequence patents, focusing on genomic diagnostics. Recent survey data suggest that patents have generally not impeded research, but note that problems may arise in the area of diagnostics. Technologies for sequencing, genotyping, and gene expression profiling have created new classes of genomic diagnostics that can simultaneously test thousands of genes for mutations and variations, or for expression level differences. Gene-signature and pharmacogenetic diagnostics promise to guide clinical decisions in management of common chronic diseases like cancer, heart disease and diabetes. Some of these tests have recently entered the market and many more are in clinical trials. Developing such tests poses significant challenges, including mapping a complex intellectual property landscape and navigating potential thickets of existing DNA-sequence patents. In preliminary studies, we identified patents claiming DNA sequences that might be infringed by multi-gene diagnostics and, if strictly enforced, could block the use of these sequences in multi-gene tests. Finding and licensing such patents from many owners could prove difficult and expensive, involving multiple license negotiations and stacked royalty payments. While these problems are not inevitable, our recent studies show they could develop depending on what is patented, what is specifically claimed, how strictly and under what conditions claims are enforced. While companies are surely examining these issues, there is remarkably little publicly available research on the topic. To address this dearth of data, we will create and analyze IP landscapes for several multi-gene and expression profile diagnostics, selected to represent the kinds of tests being studied in ongoing clinical research. Our analysis will start by finding patents and critically interpreting their claims. We will then engage stakeholders to determine positive and negative effects of IP in developing and commercializing novel diagnostics. Stakeholders include, (1) clinical and basic researchers, (2) firms developing diagnostics, (3) scientists developing platform technologies, (4) licensing officials and legal experts, and (5) consumer groups. We will also analyze institutional norms and practices related to patenting and licensing of genomic inventions, with special attention to universities. Academic research institutions own a large fraction of DNA-sequence based patents and are likely to be important players, as patent owners, contributors of research, and end users of genomic tests. Our recent studies of multi-gene tests for hearing loss, cardiac channel defects, and ataxia syndromes illustrate that academic licensing practices will play a crucial role in diagnostics development. Together these data will contribute to understanding (1) whether patent thickets exist and how they might develop, (2) how existing guidelines for patenting and licensing are being used, and (3) how to refine the norms and practices of patenting and licensing DNA sequence patents. PUBLIC HEALTH RELEVANCE - This study aims to contribute empirical data and critical analyses relevant to patenting and licensing of DNA sequence patents, focusing on genomic diagnostics. We will analyze patent landscapes for select multi-gene and expression-profile diagnostics to assess if patent thickets exist and how they impact test development.