The impact of patenting on DNA diagnostic practice

Abstract

-Patents on genes often cover the gene sequence and the link between a disease and mutations in a gene, rather than a technology for the identification of mutations per se. Normally, patents are important for encouraging the development of new diagnostic tools and kits, but there is evidence that they can have severely deleterious effects on the delivery of genetic services. The difference largely depends on the licensing policy of the patent holder. This article describes different ways in which patents are used in this context and how the effects may be mitigated.

Commercial landscape of noninvasive prenatal testing in the United States

“…Concerns about diagnostic monopolies include that they will result in higher test costs, lower test availability and quality, fewer testing options for patients, and hampered test innovation and clinical research, thus reducing the quality of clinical care and decreasing patient access . Such concerns may be more pronounced in the United States, as all cffDNA‐based NIPT is available only from commercial laboratories rather than academic medical center or hospital‐based laboratories.…”

“…Concerns about diagnostic monopolies include that they will result in higher test costs, lower test availability and quality, fewer testing options for patients, and hampered test innovation and clinical research, 57,58 thus reducing the quality of clinical care and decreasing patient access. 59 Such concerns may be more pronounced in the United States, as all cffDNA-based NIPT is available only from commercial laboratories rather than academic medical center or hospital-based laboratories. Previous empirical research suggests that patenting and licensing practices, specifically exclusive licensing, have at least transiently reduced availability of genetic testing for several diseases such as long QT syndrome and hereditary breast and ovarian cancer.…”