On July 29, 2011, the Court of Appeals for the Federal Circuit published its decision in Association for Molecular Pathology v. Myriad Genetics. The appeal was taken from a controversial Southern District of New York decision, which held that isolated DNA is not patent-eligible subject matter under 35 U.S.C. §101 due to being a product of nature. In addition, method claims directed to “comparing” or “analyzing” DNA sequences were found to lack subject matter eligibility, because they lacked any tie to a “machine-or-transformation.”

The appellant, Myriad Genetics, had requested that the Federal Circuit overturn the lower court decision on both procedural (lack of standing) and substantive (patent-eligibility) grounds.

In its opinion, the panel of three judges expresses agreement on the following:

  1. At least one plaintiff had standing to bring the case,
  2. cDNA (complementary DNA) is patent-eligible,
  3. Methods directed to “comparing” or “analyzing” DNA sequences are not patent-eligible, and
  4. Methods directed to “growing” transformed cells are patent-eligible.

The panel split 2-1 as to the patent-eligibility of isolated DNA (excluding cDNA) with Judges Lourie and Moore finding that isolated DNA claims are patent-eligible and Judge Bryson dissenting. While all three judges agreed that the standard for patent-eligibility under Section 101 is described by U.S. Supreme Court decision in Diamond v. Chakrabarty, 447 U.S. 303 (1980), each differed on how to apply that standard.

In Chakrabarty, the disputed patent claims were directed to a bacterium genetically modified to be capable of breaking down crude oil, an ability absent in naturally occurring bacteria. The U.S. Supreme Court found that the genetically modified bacteria was patent-eligible, because it was “a product of human ingenuity having a distinctive name, character [and] use” and having “markedly different characteristics from any found in nature and one having the potential for significant utility.”

In applying Chakrabarty, the lower court had found no “marked difference,” because the isolated DNA conveys the same information (sequence of nucleotides) and has the same function (coded for a protein related to breast cancer) as native DNA and that such informational and functional characteristics were products of nature rather than human ingenuity. In reversing, Lourie relies on isolated DNA having “a distinctive chemical identity from that possessed by native DNA,” while Moore writes separately to argue that the patent-eligibility of isolated DNA is based on being “not naturally produced without the intervention of man.”

Bryson dissents, saying that “Chakrabarty requires us to focus on two things: (1) the similarity in structure between what is claimed and what is found in nature and (2) the similarity in utility between what is claimed and what is found in nature.” He concludes that isolated DNA is therefore not patent-eligible, since “[t]he only material change made to those genes from their natural state is the change that is necessarily incidental to the extraction of the genes from the environment in which they are found in nature.”

Chemistry v. Biology, or Form v. Function

According to appellant Myriad Genetics, the lower court incorrectly applied Chakrabarty by “focusing not on the differences between isolated and native DNAs, but on one similarity: their information content.” Lourie agreed, declaring that the U.S. Supreme Court directs the focus of the inquiry not to similarity, but to whether or not there are “markedly different” or “distinctive characteristics” between the claimed subject matter and its counterpart found in nature.

BRCA1 and BRCA2 in their isolated state are not the same molecules as DNA as it exists in the body; human intervention in cleaving or synthesizing a portion of a native chromosomal DNA imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA.

Though Lourie acknowledges that isolated DNA are originally part of native DNA, he argues that the difference in chemical structure is sufficient to confer patent-eligibility, despite the similarities in sequence and function.

The claimed isolated DNA molecules are distinct from their natural existence as portions of larger entities, and their informational content is irrelevant to that fact. We recognize that biologists may think of molecules in terms of their uses, but genes are in fact materials having a chemical nature and, as such, are best described in patents by their structures rather than their functions.

Moore ultimately arrives at a similar conclusion, though she interprets Chakrabarty as applying a flexible test to determine whether the claimed subject matter has “markedly different characteristics with the potential for significant utility” resulting from human intervention as compared to nature. Like Lourie, she examines the chemical formula and structure of isolated DNA and compares to that of native DNA. She finds, for example, that isolated DNA sequence terminates in a phosphate group at one end and a hydroxyl group at the other end, while in native DNA, such a sequence is connected by phosphodiester bonds to other DNA in the chromosome. Further, she argues that “man has defined the parts that are to be retained and the parts that are to be discarded” and that there are “a variety of applications and uses in isolation that are new and distinct as compared to the sequence as it occurs in nature” (as primers and probes). As such, she concludes that such uses are an “enlargement of the range of . . . utility,” thereby rendering isolated DNA patent-eligible.

Bryson counters both Lourie’s and Moore’s approaches, arguing that “it would seem to make more sense to look to genetics, which provides the language of the claims, than to chemistry.” He argues that the majority’s focus on chemical structure fails to take into account the biological context of DNA, namely as genes coding for synthesis of proteins and trait inheritance. Moreover, “the claimed genes have been isolated according to nature’s predefined boundaries, i.e., at points that preserve the ability of the gene to express the protein for which it is coded.” As such, he concludes that it is not human ingenuity that determines the chemical structure of the isolated DNA, but nature.

[N]ature has defined the genes as independent entities by virtue of their capacity for protein synthesis and, ultimately, trait inheritance. Biochemists extract the target genes along lines defined by nature so as to preserve the structure and function that the gene possessed in its natural environment.

The dissent further notes that the isolated DNA claims in question (other than those directed to cDNA) are not directed to any particular chemical structure. Rather, the isolated DNA claims are directed to a particular genetic function: coding for the BRCA polypeptide. Bryson also notes that because proteins can be coded by multiple DNA sequences, the claims actually encompass numerous chemical structures that “share only one unifying characteristic: each codes for the same protein as the naturally occurring BRCA1 gene.”

In comparing the opinions penned by each of the three judges, it appears that each approach turns on a different interpretation of what it means to be “markedly different” under Chakrabarty. Lourie directs the inquiry to whether there are any differences in chemical structure, disregarding any similarities in biological function or informational roles as indicators of hereditary traits. Under the Lourie approach, a difference in chemical structure may be sufficient to make a claimed composition “markedly different” from a natural composition. Moore, on the other hand, favors an examination of whether human intervention resulted in any structural or functional differences. According to Moore, a difference in chemical structure and function, if resulting from human intervention, may therefore constitute a “marked difference” from a natural composition. In contrast, Bryson focuses on the similarities in structure and function between the claimed composition and its counterpart found in nature. In Bryson’s view, therefore, where the claimed composition and its natural counterpart shares the same sequence, codes for the same protein and indicates the same genetic trait, such similarities weigh against finding any “marked difference.”