Here is the actual text of Judge Sweet’s opinion that DLH brought to our attention below:
Association for Molecular Pathology v. U.S. Patent and Trademark Office, __ F.Supp.2d __ (S.D.N.Y. 2010):
The question thus presented by Plaintiffs’ challenge to the composition claims is whether the isolated DNA claimed by Myriad possesses “markedly different characteristics” from a product of nature. In support of its position, Myriad cites several differences between the isolated DNA claimed in the patents and the native DNA found within human cells. None, however, establish the subject matter patentability of isolated BRCA1/2 DNA.
The central premise of Myriad’s argument that the claimed DNA is “markedly different” from DNA found in nature is the assertion that “[i]solated DNA molecules should be treated no differently than other chemical compounds for patent eligibility,” Myriad Br. at 26, and that the alleged “difference in the structural and functional properties of isolated DNA” render the claimed DNA patentable subject matter, Myriad Br. at 31.
Myriad’s focus on the chemical nature of DNA, however, fails to acknowledge the unique characteristics of DNA that differentiate it from other chemical compounds. As Myriad’s expert Dr. Joseph Straus observed: “Genes are of double nature: On the one hand, they are chemical substances or molecules. On the other hand, they are physical carriers of information, i.e., where the actual biological function of this information is coding for proteins. Thus, inherently genes are multifunctional.” Straus Decl. 1 20; see also The Cell at 98, 104 (“Today the idea that DNA carries genetic information in its long chain of nucleotides is so fundamental to biological thought that it is sometimes difficult to realize the enormous intellectual gap that it filled. . . . DNA is relatively inert chemically.”); Kevin Davies & Michael White, Breakthrough: The Race to Find the Breast Cancer Gene 166 (1996) (noting that Myriad Genetics’ April 1994 press release described itself as a “genetic information business”). This informational quality is unique among the chemical compounds found in our bodies, and it would be erroneous to view DNA as “no different” than other chemicals previously the subject of patents.
Myriad’s argument that all chemical compounds, such as the adrenaline at issue in Parke-Davis, necessarily conveys some information ignores the biological realities of DNA in comparison to other chemical compounds in the body. The information encoded in DNA is not information about its own molecular structure incidental to its biological function, as is the case with adrenaline or other chemicals found in the body. Rather, the information encoded by DNA reflects its primary biological function: directing the synthesis of other molecules in the body – namely, proteins, “biological molecules of enormous importance” which “catalyze biochemical reactions” and constitute the “major structural materials of the animal body.” O’Farrell, 854 F.2d at 895-96. DNA, and in particular the ordering of its nucleotides, therefore serves as the physical embodiment of laws of nature – those that define the construction of the human body. Any “information” that may be embodied by adrenaline and similar molecules serves no comparable function, and none of the declarations submitted by Myriad support such a conclusion. Consequently, the use of simple analogies comparing DNA with chemical compounds previously the subject of patents cannot replace consideration of the distinctive characteristics of DNA.
In light of DNA’s unique qualities as a physical embodiment of information, none of the structural and functional differences cited by Myriad between native BRCA1/2 DNA and the isolated BRCA1/2 DNA claimed in the patents-in-suit render the claimed DNA “markedly different.” This conclusion is driven by the overriding importance of DNA’s nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its isolated form. The preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature.
Id., at __ F.Supp.2d __, slip op. pgs. 121 – 125, internal citations omitted