Patenting DNA: Balancing the Need to Incentivize Innovation in Biotechnology with the Need to Make High-Quality Genetic Testing Accessible to Patients

The issue of gene patentability implicates everyone from doctors, to patients, to biotechnology researchers, to holders of patents claiming genes of all kinds. Proponents of gene patents argue that patents are necessary for incentivizing innovation, commercializing valuable inventions, and promoting the disclosure of information for the benefit of the public, and that these objectives are particularly important in the biotechnology industry. Opponents of gene patents fear that the exclusive rights conferred by a patent restrict public access to medical treatments and diagnostic methods, which raises serious questions about the appropriate scope of such patents. These opposing positions spur the gene patent debate. To resolve this debate, the need to incentivize innovation must be balanced with the need to make medical testing and treatment readily available and affordable to the public. This Comment argues that isolated genes are proper subjects for patent claims and should not be categorically excluded from patenteligible subject matter. Additionally, however, this Comment recognizes that gene patents raise legitimate concern about patient access to highquality genetic tests; therefore, Congress should enact certain research exemptions that would immunize researchers from infringement liability for performing noncommercial activities involving a patented gene. Part II.A discusses the purpose of the United States Patent Act and summarizes the subjects considered eligible for patent protection under current law. Part II.B briefly describes the science underlying gene patents and discusses gene patents in the context of an ongoing case, Association for Molecular Pathology v. United States Patent &