On Monday, April 4, 2011, a panel of three Federal Circuit judges heard oral arguments about the patentability of the BRCA 1/2 gene claims in American Molecular Pathology, et. al, v. U.S. Patent and Trademark Office, et. al.. The panel included Judge Lourie, Judge Bryson and Judge Moore. Gregory Castanias from Jones Day argued for Myriad’s position, defending the DNA claims while Chris Hansen of the ACLU argued against the patentability of the claims. The U.S. Solicitor General, Neal Katyal also appeared to argue the Department of Justice’s position that the isolated DNA is not patent eligible.
The hearing, which lasted over an hour, addressed standing and jurisdictional issues with the focus on the University of Pennsylvania researchers who received a cease and desist letter from Myriad Genetics in 1998 after examining the BRCA 1/2 genes who are the most likely of the named plaintiffs seeking declaratory judgment to have standing. Substantively, the judges raised numerous questions regarding the meaning of “products of nature,” whether isolated DNA constitutes a product of nature or a human-made invention, the process involved in isolating the DNA, and whether the courts or Congress is best situated to resolve the issue in dispute.
One analogy used by Counsel for Myriad Genetics compared isolated DNA found in the body to a baseball bat found in a tree. He argued that while “Only God can make a tree,” the baseball bat is a human made invention simply using the material found in the tree. He further suggested that the BRCA claims represent matter that is not naturally found in an isolated form and than isolation requires the skill of man. Judge Lourie noted during Myriad’s oral argument that the purified DNA claims by Myriad genetics might differ when inside the human body because they are covalently bonded to other molecules.
The Solicitor General took an opposing position, however. He noted that he did not believe anyone would argue that Lithium, the third element on the periodic table of elements, is patent eligible. Like Myriad’s argument, Lithium is not found on its own in nature; it is naturally found in salts or combined with other elements. Its purification, the Solicitor General argued, does not render Lithium patent eligible. He made a similar argument as to whether a single electron could be patented when isolated given the fact that it does not appear on its own in nature, but rather, is found in the composition of an atom. Counsel for the ACLU also argued against the baseball bat example, instead using the analogy that kidney taken out of the human body would not be eligible for patent protection.
In response to the question of whether Congress may be better suited to determine the scope of 35 U.S.C. 101’s language prohibiting patenting on products of nature, the Solicitor General remarked that the question was a pure question of law and therefore best heard before the courts.
During rebuttal, Counsel for Myriad continued to argue that the isolated DNA claims are different than what is naturally found in the body. When questioned by the judges about the Lithium hypothetical, Counsel for Myriad ultimately acknowledged that he believes that Lithium would be patent eligible under his reasoning for the BRCA 1/2 claims.
Judge Moore noted at one point that the Department of Justice’s position distinguishing “isolated DNA” from cDNA was “straddling the middle.” She also suggested that some concerns existed about the impact the case will have due to the fact that the USPTO has been granting DNA patents for 35 years. The Solicitor General argueed that the outcome of the case, if following the DOJ’s position, would be fairly limited and apply only to isolated DNA while most of the previous DNA patents granted by the USPTO involved more than mere isolated DNA.