[Ip-health] Federal Circuit oral arguments on patent eligibility of DNA claims

Krista Cox krista.cox at keionline.org
Mon Apr 4 16:08:01 PDT 2011


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

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

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 also noted at one point that the Department of Justice's
position distinguishing "isolated DNA" from cDNA was "straddling the
middle." She 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 suggested 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
involve d more than mere isolated DNA.

Krista Cox
Staff Attorney
Knowledge Ecology International
(202) 332-2670

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