Supreme Court Issues Ruling on the Patentability of the Human Genome
In its recent decision, Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. ___ (2013) the Supreme Court of the United States addressed the patentability of the human genome. In Myriad, the plaintiffs challenged the validity of two types of patents, one of which covered a specific sequence of human DNA and the other covered a type of synthetic DNA, known as cDNA. The Court found the former was not patentable but the latter was.
The Court began its decision by discussing the structure of DNA and the history of Myriad’s discovery. It then articulated the legal standard governing naturally occurring patents by citing Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980), for the principle that “[p]roducts of nature are not created, and manifestations ... of nature are free to all men and reserved exclusively to none.” (internal quotation marks omitted).
The disputed patents in the first issue involved the BCRA1 and BCRA2 gene sequences. Mutations in these genes are related to higher rates of ovarian and breast cancer. Myriad Genetics discovered the specific location of these two genes which allowed them to develop tests which checked for mutations. Following this discovery Myriad Genetics sought a number of patents, which, in essence, patented the sequence of the DNA code that tells a cell to produce the BRCA1 and BCRA2 amino acids. These patents gave Myriad the exclusive right to isolate an individual’s BRCA1 and BRCA 2 genes by breaking the bonds that connect the DNA to the rest of the individual genome. The Court found that it was “undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 or BRCA2 genes.” For this reason the Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated....”
Having invalidated the BRCA1 and BRCA2 patents, the Court addressed Myriad’s patent on cDNA. cDNA differs from normal DNA in one key aspect. Naturally occurring DNA contains nucleotides known as “exons” which code for the creation of amino acids and “introns” which do not code for amino acids. cDNA is a synthetic strand of DNA which only contains exon sequences. The Court determined this was patentable because the lab technician creates something new that would not occur naturally when creating cDNA and thus cDNA is not a product of nature. The Court was careful to point out that this decision did not rule on the patentability of DNA in which the naturally occurring sequence of nucleotides has been altered.
If you have any comments or questions regarding this article, please feel free to contact Kirk Lyons at klyons@lyons-flood.com or George Proios at gnproios@lyons-flood.com.
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