By: Douglas L. Rogers
On April 15, 2013, the U.S. Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Inc. on the question, “Are human genes patentable?” This article argues that human genes are not patentable and that isolating a gene from its surroundings in a human body—or creating synthetically what exists in nature as DNA—does not cause the DNA to become patentable subject matter. The isolated DNA segments of claim 1 have the identical nucleotide sequence and the same function as native DNA, and the isolated DNA of claim 1 do not reflect the marked changes required under Chakrabarty, or the inventive step required under Prometheus, to change an unpatentable product of nature into patentable subject matter. Claim 2 describes those nucleotides in the DNA sequence that code for the polypeptide identified in the Myriad Genetics patent specification and simply reflects the genetic code, an unpatentable law of nature. Since no inventive step has been added to the law of nature, claim 2 constitutes unpatentable subject matter under Prometheus. The Federal Circuit’s contrary decision in Myriad Genetics disregards 150 years of Supreme Court cases that physical phenomena found in nature and laws of nature are not patentable subject matter and threatens to enclose building blocks of nature under federal patent law. The Supreme Court should reverse the Federal Circuit’s decision in Myriad Genetics on claims 1 and 2.
Cite: 11 Duke L. & Tech. Rev. 434