Impact of gene patents and licensing practices on access to genetic testing for inherited susceptibility to cancer: Comparing breast and ovarian cancers with colon cancers

Abstract

Genetic testing for inherited susceptibility to breast and ovarian cancer can be compared to similar testing for colorectal cancer as a “natural experiment.” Inherited susceptibility accounts for a similar fraction of both cancers and genetic testing results guide decisions about options for prophylactic surgery in both sets of conditions. One major difference is that in the United States, Myriad Genetics is the sole provider of genetic testing, because it has sole control of relevant patents for BRCA1 and BRCA2 genes whereas genetic testing for familial colorectal cancer is available from multiple laboratories. Colorectal cancer-associated genes are also patented, but they have been nonexclusively licensed. Prices for BRCA1 and 2 testing do not reflect an obvious price premium attributable to exclusive patent rights compared to colorectal cancer testing, and indeed Myriad’s per unit costs are somewhat lower for BRCA1/2 testing than testing for colorectal cancer susceptibility. Myriad has not enforced patents against basic research, and negotiated a Memorandum of Understanding with the National Cancer Institute in 1999 for institutional BRCA testing in clinical research. The main impact of patenting and licensing in BRCA compared to colorectal cancer is the business model of genetic testing, with a sole provider for BRCA and multiple laboratories for colorectal cancer genetic testing. Myriad’s sole provider model has not worked in jurisdictions outside the United States, largely because of differences in breadth of patent protection, responses of government health services, and difficulty in patent enforcement.

Evaluating the Public Impact of Open Innovation

“…One methodology is case studies. The advisory committee I mentioned before commissioned a study to compare the development of genetic diagnostic tests for diseases where the relevant genes are patented to the development of tests where the genes are not patented (Cook-Deegan et al 2010). These studies suggest that patenting is not needed to motivate the development or perfection of diagnostic tests.…”

Molecular genetic testing and the future of clinical genomics

“…Clinical diagnostic laboratory directors select tests for development that will fit into existing throughput platforms, maximize efficiency and costs, and be subject to minimal competition. Laboratories that hold gene patents or that have exclusive licences for genetic testing benefit from such intellectual property by restricting test development and offerings by competing laboratories 133,134 . Newer technologies carry the additional costs of validation of novel platforms for clinical use, whereas WES and WGS in particular carry substantial costs in long-term data storage and informatics for interpretation of genomic variation.…”

Translating Personalized Medicine Using New Genetic Technologies in Clinical Practice: The Ethical Issues

“…In fact, some evidence points to the main effect of patents being on decreased volume rather than on costs due to the monopoly [69]. However, one often-overlooked issue that has been highlighted by the US court case challenging patents held by Myriad Genetics Inc. on BRCA1 and BRCA2 genes (hereafter referred to as the Myriad case [70]) is that the monopoly over clinical services afforded by the patent allows the patent holder to control not only how much patients pay for a genetic diagnostic test, but whether patients’ use of the test will be covered by insurance.…”