On June 13, 2013, the U.S. Supreme Court in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., __ U.S. __ (2013) (opinion here), held that genes and DNA fragments merely isolated from nature without alteration are not patent-eligible. Justice Thomas, who delivered the opinion of the Court, stated that claims to isolated DNA (in this case, isolated BRCA1 and BRCA2 genes that are used to determine an increased risk of certain cancers) are excluded for falling within the law of nature exception to patent-eligibility. The Court conceded that Myriad found the location of the BRCA1 and BRCA2 genes, but that this discovery, by itself, does not render the BRCA genes new compositions of matter that are patent-eligible. The Court explained that with respect to isolated DNA molecules:
In this case, … Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the Section 101 inquiry. (citing Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)).
In contrast to isolated DNA, altered or modified DNA, the Court explained, remain patent-eligible as well as applications of any information gleaned from the isolation of the gene or a new method used to isolate the DNA. The Court in footnote 8 also noted that the possibility that an unusual and rare phenomenon that might randomly create a molecule similar to one created synthetically, such as a synthetic cDNA molecule made through human ingenuity, would not render the synthetic molecule unpatentable.
Thus, the Supreme Court has removed from patent-eligibility a class of discoveries that has been the backbone of the biotechnology industry for the last few decades. Isolated DNA molecules, such as isolated genes that describe the gene as it exists in nature, microRNA and interfering RNA, if claimed as isolated molecules, now fail the Supreme Court’s patent-eligibility test. To meet the new standard, the patent claim must contain an element that explicitly shows human intervention, such as a modification to the DNA sequence or the addition of an element useful in the application of the technology. Unlike the Supreme Court’s Prometheus decision which incorporated patent concepts of novelty and non-obviousness into the patent-eligibility standard, this Myriad decision did not intermix the separate criteria for patentability. Therefore it is likely that if the isolated DNA molecule is novel and non-obvious, the addition of the element showing human intervention into the claim would qualify the claim for patent-eligibility under the new standard.
On the same day that the Supreme Court issued its decision, the USPTO issued guidelines (attached) for its examiners instructing them that isolated DNA molecules that are unaltered should be rejected for failing to satisfy 35 U.S.C. Section 101. Synthetic or altered DNA molecules remain patent-eligible.