Staking a claim on the building blocks of life: human genetic material within the United States patent system.

• Author: Osterlind, Alex

1. 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.

2. 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. To adequately convey the intricacies of the patentability of a gene, it is beneficial to outline some basics of DNA.

   1. DNA Background

      Traits within a group of organisms are passed from one generation to the next via deoxyribonucleic acid (DNA). (13) Known for its double helix shape, DNA is composed of two chains of nucleotides, with each individual nucleotide containing a sugar, phosphate, and a base consisting of one of adenine, guanine, thymine, or cytosine (referred to as A, G, T, or C, respectively). (14) Thus, the double helix of DNA can be conceptualized as being divisible into a number of shorter sequences of nucleotides. (15) If any shorter sequence of nucleotides codes for a protein, then that shorter sequence is known as a gene. (16) There are a number of stages in the process of making proteins from the shorter sequences within the double helix of DNA (i.e., genes), beginning with gene transcription. (17)

      In gene transcription, the double helix of the DNA is unwound, and one of the two chains of nucleotides makes messenger ribonucleic acid (mRNA). (18) A gene is copied onto this mRNA strand, allowing for the production of a protein after a gene translation process whereby a ribosome decodes the mRNA to create the particular protein. (19) However, while each gene has "exons" that code for proteins and regions that mark the beginning and the end of the gene, additional areas that do not code for proteins, called "introns," are also present in each gene. (20) Consequently, the introns must be spliced out of the gene when the mRNA is made, and only the exons and the regions marking the beginning and the end of the gene form the final mature mRNA. (21) This mature mRNA contains a number of sequences of three nucleotides, identified as codons, which individually code for a specific amino acid. (22) On a ribosome, adjacent amino acids are joined to form a protein. (23) The entire process from transcription to translation is known as gene expression, and the expression of the gene is realized in certain cells--e.g., heart cells, lung cells, and so forth. (24)

      The entire process of gene transcription and translation occurs within a chromosome and is therefore intrinsically unobservable by any individual attempting to extrapolate data. (25) However, it is possible to identify particular genes using technologies such as Expressed Sequence Tags (ESTs). (26) In a laboratory, an EST can be created by introducing special enzymes to the mRNA, causing synthesis from an mRNA strand to a complementary DNA (cDNA) strand. (27) The ESTs are subsequently created from fragments of the cDNA. (28) A cDNA strand will bind to a synthesized DNA complement and accordingly will facilitate in locating a specific gene on a chromosome. (29) Once a gene has been identified through the use of cDNA, it is possible to establish the function of that individual gene. (30) The implications of identifying the functions of individual genes are both extraordinary and extensive. Particularly, certain genes act as indicators of an individual's genetic susceptibility to a specific ailment. (31)

   2. Patent Law and Patentable Subject Matter

      In the United States, a patent bestows upon the patentee the exclusive right to prohibit others from making, using, or selling his invention for twenty years from the date the patent application is filed. (32) In this way, the rights of an inventor in his invention are reconciled with the benefit the public receives from the invention. Correspondingly, laws of nature, physical phenomena, and scientific formulas are inherently unpatentable because there would be no benefit to the public to reconcile with the patentee. (33)

      The federal government derives its power to grant patents from Article I, section 8, clause 8 of the Constitution, which provides, "Congress shall have Power ... [t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Rights to their respective Writings and Discoveries." (34) To facilitate this constitutional authority, the USPTO was established to administer and manage patents within the United States. (35) Coupled with this office, Congress enacted the Patent Act of 1952 (1952 Act), (36) which demarcated the requirements for acquiring a patent as novelty, utility, and nonobviousness. (37) Consequently, the Supreme Court has had a number of occasions in which to interpret Congress's meaning and intent behind the 1952 Act.

      In a precedential decision regarding the 1952 Act, the Supreme Court of the United States endeavored to define patentable subject matter with respect to processes in Gottschalk v. Benson? (38) In Gottschalk, the Court denied a patent for a process to "convert[] binary-coded decimal ... numerals into pure binary numerals," asserting that the "[t]ransformation and reduction of an article 'to a different state or thing' is the clue to the patentability of a process claim that does not include particular machines." (39) Moreover, the Court determined that such a patent would be tantamount to patenting an idea because "[t]he mathematical formula ... has no substantial practical application except in connection with a digital computer[;] ... the patent would wholly pre-empt the mathematical formula and in practical effect would be a patent on the algorithm itself." (40) Similar to Gottschalk, Parker v. Flook presented to the Supreme Court a potential patent for a method identical to previous systems already in use except for the mathematical algorithm used by the system to perform its end function. (41) Accordingly, the Court found the system unpatentable because the introduction of an alternative mathematical formula to a prior art system was, in effect, an attempt to patent a scientific formula that always has existed. (42) However, the Court prudently noted that "'[w]hile...