Federal Circuit Limits Patentability Of Genetic Sequences

Originally published April 13, 2009

On April 3, 2009, the U.S. Court of Appeals for the Federal Circuit issued In re Kubin (Fed. Cir., No. 2008-1184), perhaps the most significant patent law decision affecting the genetic engineering industry in over a decade. At issue is the patentability of isolated genetic sequences, in this case encoding a previously identified, but unsequenced, protein.

Two Amgen scientists, Marek Z. Kubin and Raymond G. Goodwin, had invented a cDNA molecule encoding a natural killer cell activation inducing ligand (NAIL) protein involved in an immune response to tumors and viruses. The Federal Circuit held this invention to be obvious in view of knowledge of the protein's existence and commonly available cloning techniques for obtaining cDNA sequences. This decision criticized Federal Circuit precedent in cases, such as In re Deuel, 51 F.3d 1552 (Federal Circuit 1995), which had clearly established patentability of genetic sequences