After Prometheus, are Human Genes Patentable?

Abstract

On November 30, 2012, the U.S. Supreme Court granted certiorari in Association for Molecular Pathology v. Myriad Genetics, Inc. on the question, “Are human genes patentable?” For over 150 years Supreme Court decisions have excluded from the federal patent power laws of nature and physical phenomena. The words "invention," "new" and "useful" in §101 are consistent with these exclusions from the federal patent power, so they are not the result of a judicially active court limiting the will of Congress.

The conclusions of Judges Lourie and Moore in Myriad Genetics that the isolated DNA segments of claim 1 constitute patentable subject matter disregard the Supreme Court's decisions in Chakrabarty and Funk Brothers on products derived from nature. “Isolation” is not an inventive step changing an unpatentable physical phenomenon into patentable subject matter. Claim 1 is effectively an unpatentable claim on a human gene.

Turning to claim 2, even if the isolated cDNA segments do not - under Chakrabarty and Funk Brother - constitute a patentable product, under Prometheus the isolated cDNA segments claim an unpatentable law of nature - the genetic code. Since no inventive step has been added to the genetic code in claim 2, the cDNA of claim 2 constitutes unpatentable subject matter under Prometheus.

The Federal Circuit’s disregard in Myriad Genetics of the laws of nature threatens to eviscerate the public domain of basic scientific knowledge. The inventive step requirement of Prometheus promises to protect that public domain.

Keywords: gene, patent, DNA , Myriad

JEL Classification: K19, K20, K30, K41