With respect to the Myriad method claims for “comparing” or “analyzing” gene sequences, the lower court had held that such claims were not patent-eligible, because they encompassed abstract mental processes independent of any machine or transformation, as required by the prevailing standard articulated by the Federal Circuit in In re Bilski. 545 F. 3d 943 (Fed. Cir. 2008). That strict requirement regarding “machine-or-transformation” has since been deemed too restrictive by the U.S. Supreme Court in Bilski v. Kappos. 130 S. Ct. 3218 (2010). The presence of a “machine-or-transformation,” however, is still recognized as an important clue regarding patent-eligibility of method claims.

One of Myriad’s method claims for “comparing” or “analyzing” is provided below:

 A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from a group consisting of the alterations set forth in Tables 12A, 14, 18, or 19 in a human which comprises

  • analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or
  • analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ IDS NO:1.

As can be seen, the steps involve only “analyzing” sequences of DNA. On appeal to the Federal Circuit, Myriad argued that the lower court incorrectly applied the machine-or-transformation test in light of Prometheus Laboratories, Inc. v. Mayo Collaborative Services, No. 2008-1403 (Fed. Cir. 2010). In Prometheus, the disputed method claims were directed to “determining” a level of a drug in the patient’s blood. The Prometheus court held, however, that the determination necessarily involves a transformation, noting that there was no way to inspect and determine the level of drug in the patient’s blood other than through a transformative method such as chromatography. It should be noted that the U.S. Supreme Court has granted certiorari in Prometheus, so the standard for what constitutes a “transformation” may change in the coming months.

The Federal Circuit panel distinguished Myriad’s method claims from Prometheus, however, based on the finding that the claimed “comparing” or “analyzing” of sequences can be performed mentally. While Myriad attempts to argue that the claimed “sequence” must be embodied in the actual DNA molecule, the panel found numerous instances in the patent specifications where the term “sequence” refers to an informational list of the DNA nucleotides. Further, references to the “human sample” were found to be merely indicative of source. As such, the claimed “sequence” encompassed mere information and “comparing” or “analyzing” such information encompassed abstract mental processes. The Federal Circuit therefore found that such method claims are not patent-eligible.

In contrast, other method claims, which included a step for growing transformed cells and determining changes in growth rates, were found not to be abstract. Although the appellee argued that such steps were mere data-gathering, the Federal Circuit panel found that growing transformed cells was “an inherently transformative step involving the manipulation of the cells and their growth medium.” Further, the step of “determining” the cells’ growth rates “necessarily involved physical manipulation of the cells.” As such, the Federal Circuit found that such method claims involving steps for “growing” cells and “determining” their growth rates to be patent-eligible.

The Federal Circuit decision may be appealed to the U.S. Supreme Court. In the meantime, ensuring the patent-eligibility of method claims may continue to involve incorporation of a “machine-or-transformation.” While no longer a necessary pre-condition, satisfying the “machine-or-transformation” test has weighed in favor of finding patent-eligibility. In the meantime, proceedings related to Prometheus may provide important clues as to how the method claims in Myriad may stand up if the U.S. Supreme Court were to grant certiorari.