Last week, the United States Court of Appeals for the Federal Circuit (“the Court”) issued its decision in Assn. Mole. Path. et al. v. USPTO et al., more commonly referred to as the “ACLU/Myriad” gene patenting case. Members of the biotech and pharmaceutical industries have been anxiously awaiting this decision because of its potential impact on existing and future gene patents. The Court affirmed the District Court’s decision that Myriad's method claims directed to “comparing” or “analyzing” DNA sequences are not eligible for patent protection, but held that Myriad’s composition claims to “isolated DNA” molecules and method claims to screening potential cancer therapeutics are both patent-eligible under 35 U.S.C. §101. It is highly likely that the ACLU/plaintiffs will request a rehearing en banc at the Federal Circuit and/or petition for certiorari to the Supreme Court.
The plaintiffs challenged the patentability of certain composition and method claims relating to human genetics in seven patents assigned to Myriad arguing that 15 claims were drawn to subject matter that is patent-ineligible under 35 U.S.C. §101. The challenged claims cover two isolated human genes, BRCA1 and BRCA2, and alterations in these genes that are associated with a predisposition to certain breast and ovarian cancers. In 2010, the U.S. District Court for the Southern District of New York issued a summary judgment decision invalidating the challenged claims. Myriad appealed the decision. The decision from the three-judge panel was somewhat divided and included a majority opinion by Judge Lourie, a concurrence-in-part by Judge Moore, and a dissent-in-part by Judge Bryson.
“Isolated DNA” Molecules Are Patent Eligible.
The Court ruled that isolated DNA molecules are patent-eligible subject matter under 35 U.S.C. §101. The Court cited the Supreme Court’s decisions in Diamond v. Chakrabarty, 447 U.S. 303 (1980) and Funk Brothers 333 U. S. 127 (1948) as providing a framework for applying §101:
The distinction therefore, between a product of nature and a human-made invention … turns on a change in the claimed composition’s identity compared with what exists in nature. Specifically, the Supreme Court has drawn a line between compositions that, even if combined or altered in a manner not found in nature, have similar characteristics as in nature, and compositions that human intervention has given “markedly different,” or “distinctive,” characteristics.
Applying this test to the isolated DNAs in this case, we conclude that the challenged claims are drawn to patentable subject matter because the claims cover molecules that are markedly different — have a distinctive chemical identity and nature — from molecules that exist in nature.
The Court also distinguished isolated DNA from purified DNA, stating:
In this case, the claimed isolated DNA molecules do not exist as in nature within a physical mixture to be purified. They have to be chemically cleaved from their chemical combination with other genetic materials. In other words, in nature, isolated DNAs are covalently bonded to such other materials. Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity. In fact, some forms of isolated DNA require no purification at all, because DNAs can be chemically synthesized directly as isolated molecules.
Judge Moore concurred that isolated DNA molecules are patent-eligible but explained additional/alternate views for reaching this decision. Judge Bryson dissented from this part of the decision as applied to isolated genomic DNA sequences, but would have upheld the patent-eligibility of cDNA claims. cDNA is a single-stranded DNA derived from RNA. It can be used to sequence and analyze genes.
“Screening” Method Claims Are Patent Eligible.
The Court also ruled that Myriad's method claim directed to screening potential cancer therapeutics was patent-eligible. The Court found that this claim satisfied the machine-or-transformation test of Bilski v. Kappos, 130 S. Ct. 3218, and that it "is not so ‘manifestly abstract’ as to claim only a scientific principle.” The claim satisfies §101 because it “includes transformative steps, an ‘important clue’ that it is drawn to a patent-eligible process.” The Court noted that the claimed step of “growing” transformed cells in the presence or absence of a potential cancer therapeutic is “an inherently transformative step involving the manipulation of the cells and their growth medium.” The Court also stated that the claimed step of “determining” the cells’ growth rates necessarily involves physical manipulation of the cells.
The Court’s decision on this issue was unanimous.
“Comparing” or “Analyzing Method Claims Are Patent Ineligible.
The Court affirmed the District Court’s finding that certain claims directed to “comparing” or “analyzing” DNA sequences are not eligible for patent protection because “they claim only abstract metal processes.” The claims at issue recite, for example, (1) “a method for detecting a germline alteration” in a gene comprising “analyzing a sequence” of a gene; and (2) “a method for screening a tumor sample” for a mutation in a BRCA1 gene comprising comparing sequences from the tumor sample and a non-tumor sample.
The Court rejected Myriad’s arguments that the claims inherently embodied transformative steps that satisfied §101 such as “(1) extracting DNA from a human sample;” and “(2) sequencing the BRCA DNA molecule” because, according to Myriad, such steps “necessarily precede the step of comparing nucleotide sequences.” The Court distinguished its recent decision in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (Fed. Cir. 2010) by noting that while the Prometheus claims recited a “determining” step that embodied a transformation, the Myriad claims at issue did not. In Prometheus, the claimed methods included the steps of (a) “administering” a thiopurine drug to a subject; and/or (b) “determining” the drug’s metabolites levels in the subject, wherein the measured metabolite levels are compared with predetermined levels to optimize drug dosage. The Court noted that “Myriad’s claims, in contrast, do not include the step of ‘determining’ the sequence of BRCA genes by, e.g., isolating the genes from a blood sample and sequencing them, or any other necessarily transformative step.”
The Court’s decision on this issue was unanimous.
This decision is of great interest to patent holders in the biotech and personalized medicine fields. However, as noted above, it is likely that the plaintiffs will request a rehearing en banc at the Federal Circuit and/or petition for certiorari at the Supreme Court. As a result, this decision is unlikely to be the final word in this important controversy.