Claims that a key US patent no. 6,258,540 held by Sequenom, the molecular diagnostic testing company that began the now the increasingly contested non-invasive prenatal testing (NIPT) commercial market, have been largely upheld.
The patent, which underpins Sequenom’s MaterniT21 Plus test, wasinvalidated last year by the District Court for the Northern District of California as a ruling against Sequenom, who had been seeking a summary judgement against rival company Ariosa for patent infringement. This decision, currently on appeal with the Court of Appeals for the Federal Circuit, stated that the patent was ineligible on the basis that it pertains to a naturally occurring phenomenon (the presence of cell-free fetal DNA in the maternal bloodstream) despite the fact that it claims a method of testing for paternally inherited nucleic acids of fetal origin and various applications. Read more.