An unborn baby’s DNA (“fetal DNA”) can be used to determine the sex of the baby as well as to test for conditions such as Down’s syndrome. In the past, procedures to get samples of fetal DNA for testing involved sticking a large needle through the abdominal wall and into the uterus of the mother to obtain amniotic fluid, but such procedures are invasive and can be life threatening in some cases. Sequenom Inc. devised and patented less invasive options and licensed them to Illumina, Inc. Ariosa Diagnostics, Inc. and others, however, challenged the patent eligibility of those options when accused of patent infringement.
Specifically, the various lawsuits have repeatedly brought into question whether the patent claims for these new prenatal tests and related methods are patent eligible under 35 U.S.C. §101 or if they are merely directed to ineligible natural phenomena. In fact, in 2015, the Federal Circuit found Sequenom and Illumina’s patents (the “Original Patents”) were invalid as unpatentable because they were directed to a natural phenomenon. This ruling raised many concerns in the industry as to which, if any, inventions of this type could be protected.
Continue Reading Federal Circuit: Sequenom’s Fetal DNA Claims Are Patent Eligible