The Supreme Court released its decision in Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al. (Appeal No. 12-398) earlier today. The question presented was whether human genes are patent eligible. In a unanimous decision, the Supreme Court held that naturally occurring DNA sequences are products of nature and not patent eligible merely because they have been isolated. However, complementary DNA sequences (cDNA) are patent eligible because they are not naturally occurring.
In its decision, the Court acknowledged that patent protection attempts to balance the need to create incentives for research and innovation against the danger of impeding the flow of information that permits discovery. The Court indicated that products of nature are not patent eligibile because they are “basic tools of scientific and technological work” and “there would be considerable danger that the grant of patents would ‘tie up’ the use of such tools and ‘inhibit future innovation premised upon them.’” The Court acknowledged that the rule against patents on naturally occurring things has its own limits, because all inventions, at some level of abstraction, rely upon laws of nature and natural phenomenon and, if interpreted too broadly, could “eviscerate” patent law.
The Court concluded that although Myriad found the location of BRCA 1 and BRCA 2 genes, neither this discovery nor the separation of the genes from their surrounding genetic material rendered the genes new compositions of matter that are patent eligible. The Court also rejected the notion that isolating the sequence from the rest of the genome by severing chemical bonds creates a non-naturally occurring molecule, stating that the claims are not expressed in terms of their chemical composition but rather in terms of the order of bases — i.e., the genetic information.
In contrast, the Court determined that cDNA sequences are not products of nature because their creation removes the non-coding regions from the sequence, resulting in something new that is the product of human intervention. Per the Court: “cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived” and, as such, it “is not a ‘product of nature’ and is patent eligible . . . except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA,” in which case “a short strand of cDNA may be indistinguishable from natural DNA.”
At the end of its opinion, the Court made clear “what is not implicated by [its] decision.” The opinion does not consider the patent eligibility of Myriad’s method claims, patents on new applications of knowledge about the BRCA 1/BRCA 2 genes, or the patentability of DNA in which the order of nucleotides has been altered. Specifically, the Court wrote that an innovative method of manipulating genes while searching for BRCA 1/ BRCA 2 genes could potentially be the subject of a method patent, that many of Myriad’s unchallenged claims were directed to applications of the knowledge gleaned from its isolation of BRCA 1/2 genes, and that the Court has no opinion on the patent-eligibility implications of alterations to the genetic code.
In a short concurrence, Justice Scalia declined to join portions of the opinion “going into fine details of molecular biology,” stating “I am unable to affirm those details on my own knowledge or even my own belief.”