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 was the patentability of isolated genetic sequences, in this case encoding a previously identified, but unsequenced, protein.
Amgen inventors Marek Z. Kubin and Raymond G. Goodwin 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 clearly established patentability of genetic sequences based upon the nonobviousness of the exact chemical structure of the nucleotide sequence, irrespective of the routine means by which the invention may be deduced.
The Kubin case also weakens the art-level distinction of biotechnology inventions generally, which previously were considered merely “obvious to try” but with frequently unpredictable, and hence patentable, experimental outcomes. The commercial significance of this case is highlighted by the number of amicus briefs filed by entities such as Eli Lilly & Co., Amylin Pharmaceuticals, Johnson & Johnson, Novartis, GlaxoSmithKline, and the Biotechnology Industry Organization, in support of Amgen’s position of patentability. Given the momentum for passage of pending legislation for FDA approval of generic and follow-on biologics, the stakes have never been higher for changing the standard for obviousness of genetic sequence patent claims.