DNA Not Patentable Subject Matter – Synthetically Created DNA (cDNA) Is A Patentable Subject

The U.S. Supreme Court, in a critical ruling, held that the naturally occurring segments of deoxyribonucleic acid (DNA) in the human body (and presumably in other living organisms) is not patent eligible subject matter under 35 U. S. C. §101 by virtue of its isolation from the rest of the human genome. However, synthetically created DNA known as complementary DNA (cDNA), which contains the same protein-coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins is patent eligible subject matter. Assoc. for Molecular Pathology v. Myriad Genetics, Inc., Case No. 12-398 (S. Ct. June 13, 2013) (available here).  “[W]e hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.”

Myriad discovered the precise location and sequence of what are now known as the BRCAI and BRCA2 genes which can be used to predict a certain type of breast cancer in women.  Myriad identified the exact location of the BRCA1 and BRCA2 genes on chromosomes 17 and 13. Chromosome 17 has approximately 80 million nucleotides, and chromosome 13 has approximately 114 million.  Within those chromosomes, the BRCA1 and BRCA2 genes are each about 80,000 nucleotides long. If just exons are counted, the BRCA1 gene is only about 5,500 nucleotides long; for the BRCA2 gene, that number is about 10,200.

Myriad obtained a patent on the BRCAI and BRCA2 genes and built a lucrative and, to some, a controversial business testing for these genes.  Isolation is necessary to conduct such genetic testing, and Myriad was not the only entity to offer BRCA testing after it discovered the genes.

“We have ‘long held that this provision contains an important implicit exception [:] Laws of nature, natural phenomena, and abstract ideas are not patentable.’ Mayo, 566 U. S., at _ (slip op., at 1).   Rather, ‘they are the basic tools of scientific and technological work’ that lie beyond the domain of patent protection.” Id., at _ (slip op., at 2).

“As we have recognized before, patent protection strikes a delicate balance between creating ‘incentives that lead to creation, invention, and discovery’ and ‘imped[ing] the flow of information that might permit, indeed spur, invention.’” Id., at _ (slip op., at 23).  “Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. The question is whether this renders the genes patentable.”

“In this case, by contrast, Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

“Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes ‘new … composition[s] of matter,’ §101, that are patent eligible.”  Myriad explained that the location of the gene was unknown until Myriad found it among the approximately eight million nucleotide pairs contained in a subpart of chromosome 17.

“As already explained, creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring.”  Therefore, cDNA is patentable since it is created by man.

Related Posts