The U.S. Court of Appeals for the Federal Circuit recently decided Utah Research v. Ambry Genetics Corporation, Nos. 2014-1361 and 2014-1366, on appeal from the U.S. District Court for the District of Utah.
The case involved several of the same patents that had been addressed by the Supreme Court in its June 13, 2013, opinion in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013). In Myriad, the Supreme Court held that claims directed to isolated DNA were drawn to patent-ineligible subject matter because the isolated DNA strands, which are naturally occurring and separated from the rest of the human genome, were natural phenomena. Shortly after the Myriad decision, a number of generic competitors, including Ambry, entered the market for medical kits designed to test for susceptibility to particular kinds of cancer. On July 9, 2013, Myriad sued Ambry in the United States District Court for the District of Utah and, on that same day, requested a preliminary injunction. The District Court denied the request for a preliminary injunction, and Myriad filed an appeal to the Federal Circuit.
The appeal involved four claims directed to compositions of matter and two claims directed to methods of screening for alterations in BRCA1 genes. None of the claims at issue had been directly considered by the Supreme Court in Myriad or during any previous appeal to the Federal Circuit.
The four composition of matter claims on appeal were directed to primers, which are short, synthetic, single-stranded DNA molecules that bind specifically to intended target nucleotide sequences. The Federal Circuit found that because the primers necessarily contain the identical sequence of the BRCA sequence directly opposite to the strand to which they are designed to bind, they are structurally identical to the ends of DNA strands found in nature. Accordingly, the court held that the primers were not distinguishable from the isolated DNA found patent-ineligible in Myriad.
Contrary to Myriad’s argument, the court held that it made no difference that the identified gene sequences were synthetically replicated, because the naturally occurring genetic sequences within the primers were identical to those found in nature and did not perform a significantly new function. Citing the Supreme Court's decision in Myriad, the court held that neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.
The two method claims on appeal involved comparisons between the wild-type BRCA sequences with the patient’s BRCA sequences. The Federal Circuit found that these claims were patent-ineligible because they recite abstract ideas, citing the Supreme Court's decision in Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014).
The court found that the requirements of the method claims at issue, which call for comparing wild-type genetic sequences with the subject’s genetic sequence, generally corresponded to the first step of Alice, and the further requirement, which describes the technique used in making the comparison, generally corresponded to the second step of Alice. With respect to the first requirement, or the "comparison" step, the Federal Circuit made reference to its previous 2012 Myriad decision. In that decision, the court held that certain method claims were patent ineligible because they claimed an abstract mental process of "comparing" and "analyzing" two gene sequences, and required merely comparing the patient’s gene with the wild-type and identifying any differences that arise.
With respect to the further requirement of the technique used to make the comparison, the Federal Circuit explained that under Alice, one must consider whether the additional claim limitations, either in isolation or combination with the other non-patent-ineligible elements, are sufficient to “‘transform the nature of the claim’ into a patent-eligible application.” The court found that the comparison techniques detailed in the method claims were the well-understood, routine, and conventional techniques that a scientist would have thought of when instructed to compare two gene sequences. Accordingly, they could not transform the abstract ideas recited in the "comparison" step into patent eligible subject matter under § 101.
The Federal Circuit expressed no view on the patent eligibility of another method claim not at issue that identified ten predisposing mutations of the BRCA-1 gene sequence discovered by the patentees.