On November 30, 2012, the U.S. Supreme Court decided to consider the question of whether human genes are patentable subject matter. The American Civil Liberties Union ("ACLU"), representing petitioner Association for Molecular Pathology, challenged Myriad Genetics' patents claiming "isolated" DNA molecules. The ACLU's position is that such patents improperly claim laws of nature and, thus, are not patentable. The Federal Circuit Court of Appeals disagreed, however, determining that Myriad's claims to isolated DNA molecules are patent-eligible. Now, the Supreme Court may have the final word.
At issue is the patentability of human genes, i.e., DNA. Natural DNA exists in the human body as one of forty-six large, contiguous DNA molecules. In contrast, isolated DNA is a free-standing portion of a larger, natural DNA molecule. Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule. The Federal Circuit reasoned that isolated DNA has a "markedly different chemical structure compared to native DNA." This is because isolated DNA results from human intervention to cleave or synthesize a discrete portion of a native chromosomal DNA, which imparts a distinctive chemical identity on that isolated DNA. Thus, the Federal Circuit decided that the "claimed isolated DNA molecules are distinct from their natural existence as portions of their larger entities" and are patent-eligible subject matter.
In its Supreme Court petition, the ACLU argued that patents on isolated DNA improperly claim products and laws of nature because isolated DNA is defined according to a naturally-occurring functional characteristic, namely coding for a naturally-occurring polypeptide. The ACLU alleges that isolated DNA does not have markedly different characteristics from DNA found in nature because both are DNA, their structures are not markedly different, the protein coded by each is the same, and their use in storing and transmitting information about a person's heredity is identical. Based on this, the ACLU believes that isolated DNA is not patentable subject matter.