The U.S. District Court for the Northern District of California sided with Ariosa and invalidated multiple claims in Sequenom’s patent for the detection of fetal cell-free (cffDNA) in the blood-stream of pregnant women.
Ariosa Diagnostics had asked the court to declare that its Harmony(tm) non-invasive prenatal test was not infringing on patent no. sequenom-ariosa-decision
While the patent as issued may have been “too broad” and multiple constituents believed it may have created an inappropriate monopoly in the cell-free fetal testing space….
In terms of a patent, from a more general perspective it seems like much of the logic invalidating the patent may be problematic. A combination of steps to form a new process, and achieve a new purpose, should be patentable even if the constituent steps where already well known. While the mere “discovery” of a phenomenon should not be patentable, (Myriad and composition of matter), techniques, methods, and development of a diagnostic based on the phenomenon (in this case reading signals from cffDNA in maternal blood) would seem to meet the patent bar.
Sequenom argued that their test is indeed new and different, and demonstrates significant increases in efficiency compared to other methods. Verinata and Natera had also been seeking rulings from the court that their diagnostic tests do not infringe on Sequenom’s patent.
Sequenom haas stated that they will appeal the decision. It will be interesting how this plays out.
