The Court of Appeals for the Federal Circuit recently issued an opinion in University of Utah Research Foundation v. Ambry Genetics Corp. ruling that composition claims directed to a pair of primers used to sequence the BRCA1 and BRCA2 genes and method claims directed to determining a patient's risk of cancer are patent ineligible under 35 USC § 101. The court likened the primers to the isolated DNA sequences at issue in Myriad, finding that the primers claimed here "necessarily contain" a DNA sequence that is "structurally identical to the ends of the DNA strands found in nature." In its discussion, the court seems to have ignored the claim itself, which was directed not to one primer, but to a composition containing a pair of primers. Regarding the method claims, the court side-stepped the law of nature exception and instead applied the 'abstract idea' test in Alice to hold that the claims described the abstract idea of "comparing" genes using "routine and conventional steps."
This decision is yet another strike against patent protection for medical diagnostic technologies, making obtaining patent protection in this industry even more challenging. Stay tuned however. The appellants in Ambry have requested an extension of time until February 17, 2015 to file a petition for panel rehearing or rehearing en banc. Also, we expect the Federal Circuit to issue its opinion in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 19 F.Supp.3d 938 (N.D. Cal. 2013) (patent claiming a non-invasive method of detecting birth defects) in the next quarter, and it could use that decision as an opportunity to clarify what is patent eligible in the medical diagnostic technology area.