Law of Nature or Patent Eligible Invention—The U.S. Supreme Court clarifies whether isolated DNA strands and synthetically created cDNA are patent eligible.
On June 13, 2013, the Supreme Court ruled in the Myriad gene patents case (Association For Molecular Pathology v. Myriad Genetics, Inc.) that patent claims directed to isolated DNA that are identical to the naturally occurring sequence are not patent eligible. In a unanimous opinion, the Court held that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated". The court explained that groundbreaking, innovative, or even brilliant discoveries do not, by themselves, satisfy the requirements for patent eligibility, even when extensive effort was involved in making the discovery. "To be sure, [Myriad] found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention."
From the Court’s decision, it appears that for a new biological composition of matter to be patent eligible, it must not be identical to the biological composition as it occurs naturally. Claims to a cDNA sequence that is distinguishable from the naturally occurring DNA sequence (i.e., by having exons removed therefrom) were found to be patent eligible. The Court stated that this decision does not "consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of §101 to such endeavors."
This decision appears to affect all isolated products of nature, including genes, gene fragments, and other naturally occurring nucleotide sequences, as well as naturally occurring amino acid sequences, including peptides, ligands, and proteins, among others.
Thus, the Supreme Court's decision will have an impact on the patent portfolios of many companies in this field. Inventors and patent owners should contact a registered patent attorney to discuss and evaluate an appropriate strategy to properly protect their intellectual property.
Illustration courtesy of Wikimedia Commons; Author Jerome Walker.