Prenatal Genetic Testing: Where Algorithms May Fail

November 13, 2017Articles
SciTech Lawyer

Dinsmore IP attorney Aubrey Haddach co-wrote an article about prenatal genetic testing for the ABA publication, The SciTech Lawyer. Haddach is co-chair of the ABA's Biotechnology Law Committee.

"On the forefront of the much anticipated arrival of genomic medicine, the field of noninvasive prenatal genetic testing (NIPT) has
lived up to its expectations as a game changer. NIPT is estimated to be worth $500 million in 2013, with potential to grow to 2.38 billion by 2022.1 NIPT not only has revolutionized access to prenatal testing for genetic disorders through a mere blood test, but it
also is unique enough to defy classification by both intellectual property law and the existing Food and Drug Administration (FDA) regulatory framework.
Much attention has been given to the Federal Circuit’s 2015 decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc.,2 invalidating the patent that protected Sequenom’s commercially offered Maternit21® test as non-patent-eligible subject matter under the Supreme
Court’s Mayo v. Prometheus decision.3 Less discussed is the technology itself, a screening test for a genetic condition, which relies significantly on “next-gen” DNA sequencing and proprietary algorithms to translate massive amounts of data into clinical results. The
NIPT technology is described below before turning to a discussion of the law."