Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al, 569 U.S (2013)

The Supreme Court of the United States held on 13 June 2013 that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but synthetic DNA (cDNA) is patent eligible because it is not naturally occurring. The decision of this landmark case departed from many years of decisions to the contrary from the U.S Patent and Trademark Office (USPTO) which have accepted approximately over 3000 patents on isolated DNA sequences in the United States before this case started.

The plaintiffs, Association for Molecular Pathology, challenged specific patent claims made by Myriad Genetics (Myriad) in relation to its isolated BRCA1 and BRCA2 genes, its diagnostic methods, and its methods of identifying drug candidates, and argued the invalidity of these claims on the basis that they are not patentable subject matter under §101 of Title 35 of the United States Code.

The central issue before the court was whether the Myriad's isolation of DNA claims a "new and useful composition of matter" (as required under §101) or whether it instead claims "naturally occurring phenomena", an important implicit exception to §101 (Mayo v Prometheus, 566 U.S). Noting that the location and order of the BRCA1 and BRCA2 genes existed in nature before Myriad found them, Justice Thomas held that "Myriad did not create anything … it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention". Relying on the decision in Funk Brothers Seed Co. v Kalo Inoculant Co., 333 U.S. 127, Justice Thomas noted that whilst Myrad Genetics did indeed find an important and useful gene, "groundbreaking, innovative or even brilliant discovery does not by itself satisfy the §101 enquiry".

There are two additional points worth highlighting from this decision. Firstly, with regard to cDNA, Justice Thomas held that while "cDNA retains the naturally occurring exons of DNA … it is distinct from the DNA from which it was derived", and as a result, it is not a "product of nature" and is patent eligible under §101. Secondly, Myriad did not bring a "method claim" before the Court. Justice Thomas noted that "had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent". However, the processes used by Myriad to isolate DNA "were well understood, widely used, and fairly uniform in so far as any scientist engaged in the search for a gene would likely have utilized a similar approach."

Interestingly, some feel the Supreme Court's opinion in this decision does not settle all questions about the issue of the patentability of DNA. It appears that the emerging practice in this field is to patent a method or process of working with a gene, rather than trying to isolate and patent the gene itself. It is also important to compare this decision with Australian Federal Court's decision in Cancer Voices Australia v Myriad Genetics [2013] which upheld the validity of Myriad's BRCA1 gene patent. In this decision, the Federal Court concluded that "isolated nucleic acid is the product of human intervention" and is therefore a "manner of manufacture" (a requirement of patentability under section 18(1) of the Patents Act 1990 (Cth). The decision is currently the subject of an appeal to the Full Federal Court.