Gene Patents: The Controversy and the Law in the Wake of Myriad
Liddle, Kenneth James, Suffolk University Law Review
The topic of gene patents is as controversial as it is misunderstood, and the law surrounding these patents was not made any clearer following the United States District Court for the Southern District of New York's decision in the Myriad patent case. (2) The concept that someone might patent, and therefore own, the rights to the genes in your body has created controversy since the earliest patents on genes were issued in the early 1980s. Thirty years later, the concept remains controversial, as the courts and legislatures struggle to resolve the central issues. Can someone really own the genes in your body? And what exactly does that mean? The answers to these common questions lie at the intersection of law, science, business, and politics.
To understand the state of the law, I will begin with a discussion of the science surrounding gene patents, including the ethical, business, and policy concerns. I will then examine the history of patent law as it relates to these patents, followed by a close examination of the Myriad court decision and Myriad's appeal. I will conclude with a discussion of possible outcomes for the case and the future of gene patents.
II. GENE PATENTS: THE SCIENCE AND THE CONTROVERSY
While a thorough discussion of genetics is beyond the scope of this paper, a cursory review of the science is necessary to understand the law and the controversy. A gene is a basic unit of heredity information that occurs naturally in all living organisms. (3) It is both a molecule, in that it is an actual composition of matter, as well as a set of instructions for future cells. A gene is made up of several segments of deoxyribonucleic acid (DNA), which are comprised of several chemical units called nucleotides. one gene can have thousands of nucleotides strung together. The order of these nucleotides, and the DNA within each, form all the genes within an organism, and those genes together make up that individual organism's genome. The genome is what determines an individual's physical characteristics, such as sex, hair color, or height. (4)
Genes can also be extracted from the cells using a variety of methods. This extracted DNA, also known as isolated DNA, can be further altered or tested to make it more useful in research. This process of analysis, commonly referred to as gene sequencing, is analogous to examining a specimen under a microscope, in that you are able to view a naturally occurring molecule that you otherwise would not be able see with the naked eye. (5) By analyzing or performing diagnostic tests on the structure of isolated DNA, it is possible to locate variations or mutations which are associated with an increased risk of certain diseases such as cancer. (6)
There are between 20,000 and 25,000 genes in the human body; together these make up the human genome. (7) Currently over twenty percent of these genes are protected, at least in part, by a patent in the United States. (8) These patents cover both the gene as they occur naturally as well as the gene in its isolated or altered form. In addition to patents on the genes themselves there are also patents on the methods, processes, and tools that are used in the isolation and diagnosis of gene sequences.
The controversy surrounding the practice of patenting genes lies mainly in negative consequences, both real and perceived, that such patents have on research and development and on consumers, particularly those without health insurance. At its core, a patent is the right to have a monopoly on an invention. (9) One who makes use of another's patent without permission infringes on that patent and may be liable for damages to the patent holder. This is a fairly uncontroversial proposition when the subject matter is an inventor's independent creation of a new machine that manufactures a certain item in less time and at a lower cost. A patent protects the inventor's ingenuity and allows the inventor to profit from his investment and his vision. …