At issue are four composition of matter claims directed to primers, which are synthetic DNA molecules, and two method claims involve comparisons between “wild-type BRCA sequences” and the patient’s BRCA sequences. 

The court affirmed the lower court’s determination that the composition of matter claims are not patent-eligible under § 101.  These primers contain the identical sequence of the BRCA sequence directly opposite to the strand to which they are to bind, and are therefore structurally identical to the ends of DNA strands found in nature.  It makes no difference that they synthetically replicated, and it is irrelevant that the single-stranded form of the DNA cannot be found in the human body, separating genetic material from its surrounding material is not an act of invention. 

The court also affirmed the lower court’s determination that the method claims are not patent-eligible under § 101.  The unlimited step of merely comparing the “wild-type BRCA sequences” to the patient’s BRCA sequences is an abstract idea; it is not limited to the detection of cancer and therefore could cover detection of yet-undiscovered genetic alterations.  Thus, allowing a patent on this comparison step could impede research relating to the BRCA genes and patent law should not be used to monopolize these building block steps of research.  Further, the additional steps of the method claims are not sufficient to transform the abstract idea into a patent-eligible method because they are well-known conventional activity at that time.  

University of Utah Research Foundation v. Ambry Genetics Corp., Case No. 2014-1361, -1366 (December 17, 2014); Opinion by: Dyk, joined by Prost and Clevenger; Appealed From: District of Utah, Shelby, J.  To read the full opinion, click here.

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