In Association for Molecular Pathology v. Myriad ("Myriad"), 569 U.S. ____ (2013), the Supreme Court issued its long-awaited decision regarding the patentability of genes.
The Court addressed two discrete issues: 1) the patentability of "naturally occurring" segments of DNA which has been isolated from the rest of the genome, and 2) the patentability of synthetically created DNA known as cDNA.
The court held that "naturally occurring" segments of DNA are a product of nature and are not patent eligible merely because they have been isolated. The court held that discovering the location of a gene, by itself, does not render a gene a new composition of matter that is patent eligible. The court further explained that claims to DNA molecules cannot be saved by the fact that isolating DNA from the human genome severs chemical bonds, thereby creating a nonnaturally occurring molecule, noting that the claims did not rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Rather, the claims to DNA at issue were held to fall "squarely" within the "law of nature" exception to patentability.
With regard to cDNA, the Court took a different stance. As stated by the Court, "cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments." cDNA, in contrast to DNA, is created from mRNA and "results in an exons-only molecule that is not naturally occurring." That is, cDNA does not naturally exist in nature because of the lack of introns caused by application of reverse transcriptase, an action that does not (or is highly unlikely to) occur in nature. The Court stated that "the lab technician unquestionably creates something new when cDNA is made." As a result, "cDNA is not a 'product of nature' and is patent eligible," in contrast to isolated DNA.
What you need to know
Composition claims directed solely to DNA sequences found in nature are no longer patent eligible. Modified DNA sequences—for example, sequences that have specific non-natural mutations introduced—would be eligible for patent protection.
Composition claims to cDNA molecules are patent eligible to the extent the cDNA is derived from DNA containing introns. cDNA derived from intronless DNA sequences would not be patent eligible.
The decision expressly states that patents on new applications of knowledge about a gene were not considered by the Court, nor were methods of manipulating genes.
What you need to do
In view of Myriad, inventors and applicants should recognize that claims solely covering DNA sequences that occur in nature are no longer patent eligible. Rather, inventors and applicants will need to look to man-made mutations in naturally occurring DNA sequences for patent protection, or present combination claims that include DNA as one component of the combination as the foundation for patent filings. Finally, method claims involving DNA still remain patent eligible in certain situations. The restrictions set forth in the Federal Circuit Myriad case and the recent Supreme Court decision in Mayo, each of which concern patentability of biomarker method patents, must be carefully considered to ensure that claims are crafted to withstand scrutiny.
In a related issue, claims which include "purified" or "separated" (non-DNA) materials are sometimes used in the pharmaceutical arts to attempt to define patentable subject matter. It is not clear what impact this decision has on the patentability of such claims, but it certainly didn't help.