In a unanimous decision delivered June 13, 2013, the Supreme Court held that merely isolating a naturally occurring DNA segment is not patent eligible, because it is a product of nature lacking creation or invention. Immediately following the release of the decision, the American Intellectual Property Law Association (AIPLA) expressed concern for the impact the ruling may have on investment and innovation in the biotechnology industry.
The case, Association for Molecular Pathology v. Myriad Genetics (12-398), concerned patents held by Myriad Genetics (Myriad) on human genes it isolated, mutations of which can substantially increase the risks of breast and ovarian cancer. The Federal Circuit in a split decision had found human genes to be patentable subject matter. Justice Thomas delivered the opinion of the Court, affirming in part and reversing in part the Federal Circuit’s decision, finding that a naturally occurring DNA segment is not patent eligible, but that cDNA is.
Myriad’s discovery of the precise location and sequence of the genes, while classified by the Court as a medical breakthrough, did not involve any creation or invention on the part of Myriad. Myriad found and separated the genes from their surrounding genetic material, but the location and order of the genes already existed in nature before Myriad discovered them, and discovery alone is insufficient for patent protection. cDNA sequences, while derived from naturally occurring DNA, are not a product of nature and thus are eligible for patent protection because they are a new creation.
AIPLA had argued in an amicus brief that the isolated DNA is patent eligible because without science, it cannot be found in nature. While true, the fact that the genes already existed in nature, not that they could be found, is what led to the Court’s decision. Among AIPLA’s concerns following the ruling is the Court’s lack of clarity in identifying how much natural material must be altered in order to be classified as man-made material eligible for patent protection.
It remains to be seen exactly what effect the ruling will have on the biotechnology industry. AIPLA warns that it could lead to reduced investment and research, while the Association for Molecular Pathology praised the decision as a victory for biomedical researchers, clinicians and patients alike.