The United States Supreme Court has held that naturally occurring DNA, isolated from the rest of the human genome is not patentable but synthetically created DNA or cDNA (complimentary DNA) can be patented.
Isolation of genes to create cDNA
The patentee discovered the precise location and sequence of BRCA1 and BRCA2 genes, and developed medical tests to detect mutation in these. These tests aid in assessing risk of breast and ovarian cancer. The patentee sought exclusive rights to isolate the gene and create cDNA which would have exons-only nucleotides containing the information necessary to create strings of amino acids used to build proteins in the body. The Federal Circuit Court had held both DNA and cDNA to be patent eligible.
Separation of gene not an act of invention
Examining patent eligibility under 35 U. S. C. §101, the Supreme Court held that the DNA claim fell within the implicit exception ‘laws of nature’. It observed that despite extensive research efforts – ‘iterative process’ of discovery, merely locating the gene did not give rise to new composition of matter. Also, severing of chemical bonds in the process of isolation of the DNA from the genome did not make it a non-naturally occurring molecule. Separating a gene from surrounding genetic material by itself was not an act of invention. The patent claims related to information contained in the genetic sequence, not the specific chemical composition of a particular molecule.
No method claim
As regards cDNA, the Court held that since the non-coding regions of the DNA were removed, a new molecule containing only exons which was not a naturally occurring molecule was created. Thus cDNA was distinct from DNA. The appellant had argued that the cDNA was not patent eligible since it still contained the nucleotide of DNA as dictated by nature. An important observation by the Court is that there were no method claims or claims regarding new applications of the knowledge gained by the respondent. [Association for Molecular Pathology v. Myriad Genetics Inc., US Supreme Court Order dated 13th June, 2013]