December 3, 2012

ACLU's Myriad Genetics Appeal to Be Heard by Supreme Court: Human Gene Patentability at Issue

DNA2.jpgOn 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.

In opposition, Myriad argued that the Federal Circuit correctly decided that the claimed isolated molecules are human-made compositions of matter. Myriad explained that, when determining patent-eligibility, the proper distinction to make is between products of nature and human-made inventions. Isolated DNA is a product of human ingenuity, not of nature, because human intervention has given the claimed molecules markedly different or distinctive characteristics, resulting in a molecule with a structure that had never existed before. Myriad's position is that numerous inventive choices yielded human-made molecules with structures and utilities different from any material existing in nature, and thus are patent-eligible subject matter.

The ACLU alleges that "the question of whether human genes and the information they convey are patentable subject matter is of paramount importance to the future of patent law, the advancement of medical science, and the health of patients." Whether this case lives up to the ACLU's proposition remains to be seen, but it is likely that the case will garner significant interest from groups that could be impacted by the Court's decision.

In deciding whether human genes are patentable, the Supreme Court will have the opportunity to further define the question of patent-eligible subject matter. The Supreme Court has been active in this area, and has recently considered patentability twice: in its 2010 In re Bilski decision (concerning methods of hedging risk in energy markets) and its 2012 Mayo v. Prometheus decision (concerning processes for optimizing drug dosages for treatment of a disease). Unlike those cases, which considered the patentability of processes and methods, this appeal concerns the patentability of compositions of matter. Thus, even though the question presented concerns the patentability of human DNA, this case may act as a vehicle for the Supreme Court to issue a broader holding that implicates the patentability of compositions generally. For this reason, the Supreme Court's decision in this case may have a far-reaching impact for many industries that patent compositions of matter.