Federal Circuit: Sequenom’s Fetal DNA Claims Are Patent Eligible
Published: April 3, 2020
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.The Original Patents covered an extremely useful medical test for pregnant mothers and their unborn babies. Researchers determined that several types of DNA are floating around in the plasma of a pregnant mother. While more than 90% of the DNA is the mother’s DNA (“maternal DNA”), other DNA such as bacterial DNA, and most importantly here, fetal DNA is also present in the mother’s plasma. The fetal DNA is identifiable based on the fact that it contains DNA from both the mother and the father (“paternal DNA”). Therefore, using a sample of paternal DNA, the researchers were able to locate fetal DNA in a mother’s plasma by looking for segments of DNA that match the paternal DNA. By using fetal DNA from the mother’s plasma, the researchers determined they could eliminate the need for more invasive, and in some cases life threatening, test procedures. However, in 2015 the Federal Circuit determined the Original Patents covering this new testing approach were patent ineligible because the claimed subject matter was directed to a natural phenomenon.