Sequenom Prenatal Test Patent Ruled Invalid

San Diego – Sequenom is a bio-tech company based in San Diego. Recently, its patent for pre-natal testing was held invalid by a Federal Circuit Judge on the grounds that it is not patent eligible because it is naturally occurring.

The popular test is called MaterniT21 and works by testing the mother’s blood. The test specifically locates pieces of fetal DNA within the mother’s blood that could show signs of defects, Down Syndrome, or other complications.

This newer test is popular as it is one of the first non-invasive tests available. Because it is non-invasive it also poses a far less risky procedure to the fetus. While the court conceded that MaterniT21 was beneficial to women, the court did not agree with the patent issuing as the method began and ended with a “natural phenomenon.” In the opinion memo, Judge Reyna wrote that “even such valuable contributions can fall short of statutory patentable subject matter, as it does here.”

Specifically, since the method tests for the presence of DNA in blood, it is this natural phenomena that is not “inventive” or eligible for patent protection. Increasingly it seems that patents with naturally occurring processes are being rejected or overturned based on prior case decisions. A prior case in which a patent was overturned was cited as precedent for the court’s decision to invalidate the Sequenom patent. The prior case involved a test that could link certain genes to breast-cancer risk.

While the decision means that Sequenom does not have the exclusive right to this type of test, Sequenom can still maintain a dominant position in the market by producing the best test with the most consistent results. More competition among the providers may also prove to be beneficial to women who have more choices apart from invasive testing such as an Amniocentesis. Amniocentesis is a medical procedure in which a small amount of amniotic fluid is removed from the sac surrounding the fetus. While an Amniocentesis is accurate there is also a 1 in 300 chance of it causing a miscarriage so it is much more risky.

A representative for Sequenom stated that the decision by the court should have little business impact partly because it already has patents in place in other parts of the world including Europe and Canada that are very similar in structure to the recent invalidated patent.