For superstitious people, the date June 13, 2013, would portend unfavorable events. For chemists and biotechnologists, the date brought a Supreme Court decision that ruled isolated genes to be ineligible for patent protection in the United States, an event with grave consequences for patent law and the biotechnology industry.
The decision, in a unanimous opinion authored by Justice Thomas, reverses years of precedent and U.S. Patent & Trademark Office practice and gives no weight to the chemical structure difference between native chromosomal DNA that contains many genes and an isolated, chemically separate fragment that codes for a single polypeptide.
The case before the Supreme Court is Association for Molecular Pathology et al v Myriad Genetics et al., 569 U.S. ____ (2013). Myriad was granted patents claiming, inter alia, “an isolated DNA coding for a BRCA1 polypeptide,” which has “the amino acid sequence set forth in SEQ ID NO:2” (SEQ ID NO:2 sets forth an amino acid chain 1,863 amino acids long). Another patent claims a similar isolated DNA coding for the BRCA2 polypeptide whose amino acid sequence is recited in the patent.
It is useful to recount the decision of the Court of Appeals for the Federal Circuit case on which certiorari was granted, 689 F. 3d, 1303 (Fed. Cir. 2012). The majority opinion was authored by Judge Alan Lourie, the only chemist of the many judges and justices who ruled on this case, from the beginning to the end.
In the detailed, cogently reasoned 17-page portion of his opinion dealing with the patent eligibility of isolated DNA, he explained that the DNA molecules in chromosome 17 and 113 are about 80 million and 114 million base pairs in length, respectively; they are bound to other molecules in chromatin and packaged in the chromosome; the claimed isolated DNAs are about 80,000 base pairs in length and each codes for a single polypeptide.
The isolated DNAs are not merely purified components of a mixture existing in nature but have to be chemically cleaved from a large molecule and isolated as separate, structurally distinct chemical entities. They are molecules that are produced by making and breaking chemical bonds in the parent chromosomal DNA, and in subsequent smaller chromosomal segments, to produce new molecules that have a different chemical structure from the chromosomal DNA as it exists in nature.
Thus, the claimed isolated DNAs are nonnatural molecules and are therefore eligible for patent protection under 35 U.S.C. 101 (the section of the U.S. patent statute that sets forth what subject matter is patentable) if they satisfy the other statutory criteria for patentability. They are not products of nature, one of the types of subject matter that are not eligible for patent protection.
Judge Lourie viewed the informational content of the new molecules as irrelevant to the threshold issue of patent eligibility but, rather, relevant to the utility of the molecules that may be considered in claims to methods of use and not claims to the molecules themselves.
Judge Moore concurred in the result, but did not agree with Judge Lourie’s chemical rationale. Instead, her concurrence was based on policy grounds, giving deference to Patent Office policy and the effect on the biotechnology industry of a holding of patent ineligibility for isolated genes.
Judge Bryson wrote a dissent that was mirrored in the eventual Supreme Court opinion. In his view, “[T]here is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken.” He characterized the structural differences as “merely ancillary to the breaking of chemical bonds, a process that is itself not inventive.”
He focused on the fact that the isolated genes have the same genetic code for the BRCA polypeptides as the genes which are part of chromosomes 17 and 13, and function in the same way. In his view, this informational symmetry “dwarfs the significance of the structural differences” and does not remove the isolated DNA from the category of products of nature, thus precluding patent eligibility.
In other words, he characterized the isolated genes and the chromosomal DNA from which they are isolated in terms of their informational content rather than their chemical structures. The dissent included criticisms of the Myriad claims regarding claim breadth, issues that properly are considered under Section 112 of the patent statute.
The Supreme Court took Judge Bryson’s dissent and made it the basis of its decision, holding the isolated genes unpatentable under Section 101 of the patent statute. The opinion characterized the claimed invention as being the discovery of the information in the DNA, rather than the chemical isolation of the molecule that uses the “information” in the biochemical process of protein synthesis. The opinion states that “separating [a] gene from its surrounding genetic material is not an act of invention.”
In a key passage that goes to the heart of the Court’s opinion, the Court states, “Myriad’s claims [are not] saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule (emphasis added). Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA.”
Rather, the Court concludes that Myriad’s invention is the discovery of the genetic information in the code embodied in the gene and present in both the natural and isolated DNA, therefore the identity of information renders the nonnatural molecule to be categorized as a product of nature and patent ineligible.
Myriad’s invention is not just the discovery of the location and sequence of the BRCA1 and BRCA2 genes that code for specific polypeptides, but their chemical isolation. To state that a claim for a DNA molecule is not a claim for a chemical composition is nonsense. It is a claim for a chain of nucleotide base pairs, a molecule whose utility resides in the genetic code embodied in the molecule. The molecule is admitted to be “nonnaturally occurring” and yet is called a product of nature!
To a chemist, this is incomprehensible, as Judge Lourie recognized and the other judges and justices could not.