Policing future nontherapeutic applications of genetic enhancement through international agreement.

• Author: Peterson, Daniel R.

1. INTRODUCTION II. WHAT THE HECK IS GENE ENHANCEMENT? AND WHAT'S ALL THE FUSS ABOUT? A. Can You Get a Patent on That? B. Gene Therapy: The Beginnings C. The Lesson of Jesse Gelsinger D. Gene Therapy vs. Gene Enhancement E. W.W.P.D. (What Would Prometheus Do?) III. ON REACHING INTERNATIONAL ACCORD A. Overview B. How WIPO Started it All C. What is the WTO? D. International Treaties and Genetic Enhancement IV. PROPOSING A SOLUTION A. Overview V. CONCLUSION I. INTRODUCTION

   It is fair to say that, since the International Human Genome Sequencing Consortium's announcement of the completion of the Human Genome Project on April 14, 2003, legal scholars, scientists, and the general public alike have been skeptical of what exactly the announcement entailed. (1) Despite often being touted in unduly laudatory language, (2) it is yet unclear what benefits the world will reap from this massive and expensive (3) scientific undertaking and who will control the legal, social, and ethical implications of such potentially powerful knowledge.

   Against the backdrop of this knowledge, corporations around the world have begun to patent gene sequences with the hope of finding and developing the first blockbuster gene therapy, (4) sometimes with little regard to the actual utility of such DNA sequences. (5) Nearly all patent schemes have three requirements for patentability: novelty, nonobviousness, and utility. (6) Many scholars have questioned the wisdom of patenting such gene sequences when a direct application of the sequence has not been described. (7) The dilemma of gene patenting will be discussed further in Part II. (8)

   One especially controversial form of gene therapy is known as gene enhancement. Gene enhancement describes the field of scientific research wherein patients' genomes will be modified for "nontherapeutic" or "non-medical" reasons. (9) Potential benefits of such technology include "everything from physical qualities such as height, weight, appearance, strength, and agility to behavioral qualities including intelligence, creativity, mood, personality, and passion." (10) Although the actual implementations of such gene enhancement techniques may not be realized until the distant future, scholars are already attempting to tackle the ethical dilemma that gene enhancement presents today. (11)

   Because of the significant impact that such technology could potentially have on the world from both an economic and a human rights perspective, international bodies such as the World Intellectual Property Organization (WIPO), the World Trade Organization (WTO), and the United Nations Convention on Biological Diversity (CBD) meet frequently to develop policy and have enacted various international agreements (12) with the hope of harmonizing worldwide treatment of gene modification technologies. (13) Due in large part to the differing perspectives of developed nations as compared to developing nations, there has been a deadlock in determining how the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (14) should be amended to account for the emergence of technologies based on patented DNA sequences and gene therapy methods. (15) Gene enhancement presents a novel challenge for the international intellectual property community because of the ethical considerations involved in fundamentally altering the human condition for reasons that are purely cosmetic rather than health related. Due to its potential perpetual nature, (16) pursuing genetic enhancement risks "building in" any such genetic superiority to future generations: a scenario with potentially dangerous consequences. (17)

   Part II of this paper discusses the history of gene therapy and gene enhancement, focusing on the successes and failures to date, public misconceptions about genetic enhancement, and the philosophical basis for opposition to this type of research. Part III reviews the current state of international agreements, proposed amendments, and the roadblocks faced in reaching an accord. Part IV proposes a solution that will help the international community distinguish between therapeutic and nontherapeutic gene modification patents, setting up a system that will discourage the latter but encourage the former, while still respecting the rights of peoples in developing countries whose genetic makeup was instrumental in the developing of such technologies. Part V concludes with a plea to the international community to move forward from gridlock to a workable plan that is not simply the result of the group of developed nations leveraging TRIPS' enforcement capabilities to strong arm their way into an overly favorable agreement on an issue that is so fundamental to the human condition.

2. WHAT THE HECK IS GENE ENHANCEMENT? AND WHAT'S ALL THE FUSS ABOUT?

   This Part will discuss the development of gene therapy techniques, leading into the controversy over gene enhancement. It will focus on the differences between gene therapy and gene enhancement and attempt to shed light on public misconceptions about the current viability of genetic enhancement. This Part will also examine the underlying philosophical basis for opposition to this type of research.

   1. Can You Get a Patent on That?

      The first gene patent filed in the United States was on a cDNA gene sequence and was granted in 1982. (18) "However, many researchers assert that the first therapeutically important DNA patent was issued in 1985 [and concerned a DNA molecule] useful in producing proteins." (19) Each year since, courts and patent offices have refined the requirements necessary to patent DNA sequences in an attempt to ensure legitimate access and prevent the use of such sequences from being unduly restricted by one or more patents that lack any practical application. (20) These regulations have left many researchers in the unfortunate predicament of deciding between keeping their research findings to themselves or disclosing them and starting a one year timeframe in which they must derive a commercially useful application for their DNA sequence or risk never having patent protection on their findings. (21) Not surprisingly, this has led many researchers to favor nondisclosure, an outcome contrary to the aims of any patenting system. (22) Those scientists that have patented genes, especially those relating to human diseases, have faced resentment from some members of the community over the perceived lack of access to treatment that their intellectual property rights have created. (23)

      Arguments in favor of allowing gene patenting include the encouragement of innovation, (24) the elimination of duplicative research efforts, (25) the reduction of secrecy, (26) and ensured access to new inventions after a limited timeframe passes. (27)

      The arguments against gene patenting are somewhat less economic and somewhat more ethical in nature. Allowing gene patenting could potentially reward the easiest step taker in the scientific process, rather than the researcher who determines the actual function or application of the gene. (28) Patent stacking (29) could "discourage product development because of high royalty costs." (30) And, theoretically, at least, gene patenting would allow "one organism to own all or part of another organism." (31) The ethical dilemma presented by this subject will be examined in greater detail in Part IV.

   2. Gene Therapy: The Beginnings

      Eventually, the idea to replace "bad genes" in humans with "good genes" was brought to fruition by Dr. W. French Anderson in September 1990. (32) In that case, four-year-old Ashanthi DeSilva was treated with genetically modified copies of her own white blood cells to combat a rare, single gene, hereditary disease called Severe Combined Immunodeficiency (SCID) that essentially paralyzes the patient's immune system. (33) Although the procedure was successful in helping Ashanthi return to a more normal lifestyle, (34) this first practical application of gene therapy was both a blessing and a curse to the field of gene therapy research. The successful treatment of SCID led to more than 400 clinical trials to test the efficacy of gene therapy on a number of diseases. (35) The initial foray into the field of gene therapy, however, may have been a classic case of look before you leap, meeting with little success and at least one tragic consequence.

   3. The Lesson of Jesse Gelsinger

      In September of 1999, a patient named Jesse Gelsinger, who had agreed to undergo an experimental gene therapy clinical trial, was being treated for a rare metabolic disease at the University of Pennsylvania's Institute of Human Gene Therapy in Philadelphia. (36) Unfortunately for Jesse, the researchers "were not following all of the federal rules requiring them to report unexpected adverse events associated with the gene therapy trials; worse, some scientists were asking that problems not be made public." (37) The now well-documented result of the trial was Jesse's untimely death. Around the same time, there were also news reports of other unreported human and animal deaths attributed to gene therapy experiments gone awry. (38)

      When the news of Jesse's death hit the general public, enthusiasm for gene therapy cooled and experiments slowed almost to a halt. (39) The Gelsinger case taught us how little we truly knew about the complex interaction between our genes and our environment. Gene therapies were still in their embryonic stages and, thus, were unpredictable and, for the most part, unsuccessful. (40)

      Gene therapy trials eventually picked back up by 2002 and have met with mild success in delivering therapeutic genes and treating an array of illnesses, including cancer. (41) It is important to note, however, that all these experiments had a therapeutic or disease treating effect in the patients or animals that were a part of the trials. (42) Though Jesse's was the first heavily publicized death relating to gene therapy treatments, it will not likely be...