In a unanimous decision in Association for Molecular Pathology, et. al. v. Myriad Genetics, Inc. et. al., the U.S. Supreme Court found “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” but cDNA (a synthetic or man-made DNA molecule) is patent eligible because it is not naturally occurring.
Section 101 of the Patent Act provides: “Whoever invents or discovers any new and useful composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” The Court has long held that laws of nature, natural phenomena, and abstract ideas are not patentable.
In Myriad, the Court wrestled with the delicate balance between creating incentives that lead to creation, invention, and discovery, on the one hand, and impeding the flow of information that might permit, or indeed spur, innovation, on the other hand. According to the Court, even if Myriad’s isolation of certain genes was “groundbreaking, innovative, or even [a] brilliant discovery,” Myriad did not create or alter any of the genetic information of the genes or the genetic structure of DNA. Consequently, “separating that gene from its surrounding genetic material is not an act of invention.” Indeed, the Court stated that “extensive effort alone is insufficient to satisfy the demands of § 101.”
In contrast, the Court stated that cDNA did not present the same obstacles to patentability as naturally occurring, isolated DNA segments because “a lab technician unquestionably creates something new when cDNA is made.” Thus, the Court drew a bright line between these two types of DNA constructs, which will guide practitioners going forward. In addition, the Court was careful to note that method claims, new applications of knowledge, and altering the order of naturally occurring DNA were not implicated by their decision in Myriad.
In light of the Court’s decision, patent applicants should consider reviewing and revising claims in pending patent applications where appropriate. In addition, litigants and patent owners should consider how, if at all, the Court’s decision impacts the validity of patent claims relating to DNA. Experienced Brinks attorneys are available to provide assistance.
Previous alerts regarding prior decisions in the Myriad case can be found at the following links:
- Supreme Court Appears Skeptical of the Patentability of Isolated DNA Molecules - April 2013
- Federal Circuit Upholds Claims to Isolated DNA Molecules (Again) - August 2012
- Federal Circuit Upholds Claims to Isolated DNA Molecules - August 2011