Patents in Genomics and Human Genetics

Abstract

Genomics and human genetics are scientifically fundamental and commercially valuable. These fields grew to prominence in an era of growth in government and nonprofit research funding, and of even greater growth of privately funded research and development in biotechnology and pharmaceuticals. Patents on DNA technologies are a central feature of this story, illustrating how patent law adapts---and sometimes fails to adapt---to emerging genomic technologies. In instrumentation and for therapeutic proteins, patents have largely played their traditional role of inducing investment in engineering and product development, including expensive postdiscovery clinical research to prove safety and efficacy. Patents on methods and DNA sequences relevant to clinical genetic testing show less evidence of benefits and more evidence of problems and impediments, largely attributable to university exclusive licensing practices. Whole-genome sequencing will confront uncertainty about infringing granted patents but jurisprudence trends away from upholding the broadest and potentially most troublesome patent claims.

Trends in genetic patent applications: the commercialization of academic intellectual property

“…22, 39, 40 Oldman 40 searched for trends in patent claims in genomics, proteomics, and biotechnology by using keywords in the Espacenet titles such as genes, proteins, DNA, amino acids, nuclide nucleic acids, and RNA in the time period 1990–2003. Unfortunately, as this study used a different method the results are difficult to compare.…”

“…A famous case is the commercial company Myriad, which has the rights to commercialize specific hereditary breast cancer genes. 22 For several years now, people have objected to these patents due to the potential impact on diagnostic testing. 23, 24 However, in June 2013, the Supreme Court decided in the Myriad case that human genes, defined as genomic DNA, are not patentable 25, 26, 27…”

Key Principles and Clinical Applications of “Next-Generation” DNA Sequencing

“…Issues surrounding the appropriate disclosure and use of NGS data, necessary adaptations of patent law to facilitate the clinical use of NGS technologies, and establishment of insurance reimbursement protocols for NGS testing must also be addressed in the coming years to enable society to embrace the transition to a post-genomic era of medicine (87)(88)(89).…”

“Trust is not something you can reclaim easily”: patenting in the field of direct-to-consumer genetic testing

“…As noted by Cook-Deegan and Heaney, a "single blocking patent on a normal gene or any common disease-associated variant can be sufficient, if exclusively licensed to just one provider, to limit testing by other laboratories for that clinical condition." 34 The validity of such claims however is in doubt following the US Supreme Court's decision in Mayo v. Prometheus 35 from March 2012, i.e., after 23andMe's patent application was accepted but before it was granted. In that case, the Supreme Court found that methods that are based on "laws of nature" are not patentable.…”