Staking a Claim on the Building Blocks of Life: Human Genetic Material within the United States Patent System

Article excerpt

I. INTRODUCTION

The discovery of human genetic material introduced an invaluable tool in the advancement of medicine. International efforts under the Human Genome Project have drawn to a close, identifying approximately 20,000-25,000 of the genes in the human body, thereby facilitating diagnoses of disease, predispositions to debilitations, pharmaceutical development, and numerous other fields. (1) Indeed, genetic research enables innumerable beneficial medical applications, and, predictably, such research in the united States has been commodified through patent law. In fact, it is estimated that twenty percent of the human genome is subject to patent protection, (2) prohibiting others from any unauthorized research of the patented genetic material or unauthorized utilization of it in clinical testing procedures. (3) Allowing patent protection for human genetic material has sparked a heated debate, with each side asserting diametrically opposite interpretations of how, or even if, gene patents are contemplated under the Intellectual Property Clause of the Constitution. (4) competing interests in the field are not easily reconciled. For example, incentivizing genetic research by offering patent protection encourages research and development in the field but simultaneously limits access for illuminating and potentiating additional research on patented genes.

Illustratively, patents held by Myriad Genetics, Inc. (Myriad) for the BRCA1 and BRCA2 genes provide indicators that evince an individual's predisposition to breast and/or ovarian cancer. (5) However, in the united States, only Myriad may perform testing procedures utilizing the BRCA genes due to patent protection. (6) Yet, in France, a physician not constrained by the United States patents discovered a deficiency in Myriad's testing procedures; (7) such a deficiency could not be discovered by non-Myriad researchers in the United States, who are restricted from unauthorized uses of patented subject matter. (8) However, the value of the BRCA genes as markers for certain cancers was discovered by researchers at Myriad (9)--an advance that was encouraged by the financial benefit of patent protection. The BRCA genes provided a rallying point for salient opponents of gene patents, such as the American Medical Association, the March of Dimes, and the American Society for Human Genetics, who condemn the BRCA gene patents. (10) Thus, while the American judiciary has to date taken a stance that approves the patentability of human genes, intense opposition remains.

This Article examines the place, if any, of genes within the United States patent system by first providing a broad background of the United States patent system, including the foundational cases that have shaped the system. Further, this Article briefly describes human genes to explain how genetic material is viewed within the United States patent system. Subsequently, "gene patents" within the United States are explained. Building upon this milieu, the merits of arguments in opposition to gene patents are examined by focusing on the arguments presented in an ongoing suit filed by the American Civil Liberties Union (on behalf of various parties) against Myriad Genetics, the holder of several gene patents, and the United States Patent and Trademark Office. (11) Finally, this Article concludes with a brief forecast of the fate of gene patents in the United States and how concerns about the deleterious effects of gene patents might be addressed.

II. LEGAL BACKGROUND

Charged with assessing the validity of patents, the United States Patent and Trademark Office (USPTO) will issue a patent to an applicant who "invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." (12) Given only a cursory glance, the requirements to obtain a patent appear precisely defined. However, dramatic intellectual and technological developments in fields such as biotechnology have created substantial difficulties in applying the requirements for a patent in the United States. …