Revisiting the USPTO's Examination Guidelines for Gene Patents: Congressional Inaction, USPTO Restraint, and Judicial Remedy

Abstract

Since 1992 the USPTO has been issuing gene patents based on the premise that a gene sequence consists of patentable subject matter and meets the requirements set forth in 35 USC § 101 et seq. Various scholars and international societies have recently questioned the USPTO's stance, raising both normative concerns as well substantive problems associated with the number and scope of gene patents on the availability and access of diagnostic tests as well as their effect on scientific innovation and method validation. This paper examines recent Congressional testimony, USPTO's deference to Congress' inaction, and the possibility of judicial remedy through currently pending litigation of Association for Molecular Pathology et. al. v. United States Patent and Trademark Office, et. al. The author argues that the pending litigation may, and should, break the current stalemate and prompt re-examination of the current US patenting guidelines to arrive at a solution that integrates important policy considerations related to innovation, access, and validation.