Method Claims Applying Conventional Techniques to a Natural Phenomenon Held to be Patent Ineligible Subject Matter
By Ali Shalchi
The U.S. District Court for the Northern District of California found Sequenom’s patent claims on a prenatal diagnostic method to be invalid and not infringed by Arisoa Diagnostic’s Harmony Test product, because the asserted claims were directed at patent ineligible subject matter. Ariosa Diagnostics, Inc. v. Sequenom, Inc., No. 3:11-cv-06391-SI (N.D. Cal. Oct. 30, 2013). The court, applying relevant Supreme Court cases, including Prometheus and Myriad Genetics, found that the patent claims were based on a routine and conventional use of natural phenomenon and were therefore patent ineligible. See Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012) and Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).
Sequenom is the exclusive licensee of the patent at issue, U.S. Patent No. 6,258,540 (“‘540 patent”), which it licensed from Isis Innovation Limited. The ‘540 patent is directed at non-invasive prenatal detection methods that are performed on a maternal serum or plasma sample to detect a paternally-inherited nucleic acid of fetal origin. The prenatal diagnosis may include sex determination, blood typing and other genotyping, as well as detection of pre-eclampsia in the mother. The ‘540 patent is based on the discovery in 1996-1997 that cell-free fetal DNA (“cffDNA”) is detectable in maternal serum or plasma samples, such that the process of isolating fetal cells was no longer needed.
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