Gene patents: the controversy and the law in the wake of Myriad.

• Author: Liddle, Kenneth James

1. INTRODUCTION

   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.

2. 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. However, when the patent is on something that occurs within the human body, and that something could have life-saving potential, the monopoly granted by the patent abuts the public's interest in health, safety, and societal norms.

   There are numerous persuasive arguments on both sides of the debate. Those who argue against gene patents have argued that these patents are "unnecessary to promote innovation in genetic research, and violate medical and scientific ethics," (10) and that these patents are on "natural phenomena and laws of nature," (11) which "constitute part of the common heritage of humanity." (12) There is also substantial concern about the "chilling effect" gene patents may have on research. (13) A recent study of laboratory directors in the United States found that sixty-seven percent believed that gene patents decrease their ability to conduct research, and fifty-three percent decided not to develop a new clinical test due to an existing gene patent or license. (14)

   Another concern is that gene patents limit access and increase the cost to the patient. For example, in the United States, Myriad, Inc., offers a screening test for the BRCA gene that costs over $3000 per test. (15) However, this same test is offered free from patent protection in Canada at a cost of $1000 per test. (16) In 2008, Myriad spent $32 million providing these tests, with resulting revenues of over $222 million and a gross profit of $190 million. (17) A patient who receives a patented BRCA test is also limited in their ability to get a second opinion from another doctor. Because Myriad owns the patent for BRCA, they are the only company who can offer the test; the patient, or the patient's physician, would only have the option to re-administer the Myriad test. (18) For this reason, the American Medical Association has spoken out against the practice of gene patents, stating "[t]he use of patents ... or other means to limit the availability of medical procedures places significant limitation on the dissemination of medical knowledge, and is therefore unethical." (19)

   There are compelling arguments for gene patents as well. Some favor allowing patents on genes on the legal ground that these patents "fall within the categories of patent-eligible subject matter because they differ in kind from naturally-occurring DNA." (20) Others have argued that these patents "promote innovation by protecting investments in the innovation process." (21) Arguments can also be raised that it is Congress, not the judicial system, who should decide what is patentable, and that existing judicial remedies are sufficient to redress grievances in light of Congress's inaction on the subject. (22) Myriad has argued that the patents significantly contribute to the field of biotechnology. To patent a gene, the patent holder must describe in detail the patented invention so that others may improve on it. (23) In other words, the patent holder makes his science known to all in exchange for its patent. Myriad points out that since it patented BRCA, over 8600 research papers have been written about this gene, representing the work of over 18,000 scientists. (24) These patents, Myriad claims, are "essential for obtaining capital investment in the development and commercialization of technological breakthroughs." (25) The capital investments involved are substantial. A recent survey of 150 biotechnology companies found that seventy-seven percent of those surveyed expected to spend between five and fifteen years and over $100 million developing a single commercial product. (26) It is a persuasive argument, succinctly put, that "absent the promise of a period of market exclusivity provided by patents and the infusion of venture and risk capital derived there from, companies such as Myriad that capitalize on innovation simply would not be created and their products would not be brought to market or the clinic." (27)

   The controversy over gene patents is not limited to biotech companies and academia; the issue is also firmly in the public consciousness. In 2006, bestselling author Dr. Michael Crichton opened his novel Next with the phrase "Stop patenting genes"; he then penned an editorial in the New York Times warning readers that "[g]ene patents are now used to halt research, prevent medical testing and keep vital information from you and your doctor." (28) Groups such as the American Medical Association and the American Civil Liberties Union (ACLU) have expended considerable funds pushing the issue in the courts, Congress, and in the public debate. (29) In 2007, a patent reform bill was passed in the United States House of Representatives but failed to be considered in the Senate and as such never became law. (30) It seems apparent to parties on both sides of the debate that a compromise must be made, one that protects and rewards investment while at the same time maximizing the opportunity for affordable lifesaving care and treatment for patients. Where to draw that line, however, will remain the subject of much debate for the foreseeable future.

3. THE LAW OF GENE PATENTS FROM CHAKRABARTY UP TO MYRIAD

   The starting point for any discussion of the law of patentability is Article I, Section 8, Clause 8 of the United States Constitution, which provides that Congress shall have the power "[t]o promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." (31) Congress exercised this authority by passing 35 U.S.C. [section] 101, which provides that "[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title." (32) The scope of [section] 101 is to be construed broadly, as evidenced by the use of the word "any," (33) but this latitude is not without...