Ariosa Diagnostics, Inc., et al. v. Illumina, Inc., et al.

Section 101 of Title 35 provides that a patent may be obtained for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” This Court has “long held,” however, that Section 101 “‘contains an important implicit exception: Laws of nature, natural phenomena, and abstract ideas are not patentable.’” Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589 (2013) (brackets omitted). The Myriad Court applied this rule in holding that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” and further explained that “separating [a] gene from its surrounding genetic material is not an act of invention.” Id. at 580, 591. The question presented is: Whether a patent that claims nothing more than a method for separating smaller DNA fragments from larger ones, and analyzing the separated DNA for diagnostic purposes, using well-known laboratory techniques is unpatentable under Section 101 and Myriad. (i)