American Journal of Law & Medicine

Conferring a federal property right in genetic material: stepping into the future with the Genetic Privacy Act.

"A wise man can hear profit in the wind." - Pel, quoting the Ferengi Rules of Acquisition(1)

I. INTRODUCTION

The expansive biotechnology(2) field includes many facets of medical research, from drug discovery and design,(3) to gene therapy(4) and the diagnosis of genetic diseases,(5) to the use of deoxyribonucleic acid (DNA) evidence to identify individuals(6) and genetic characteristics.(7) The biotechnology industry requires a readily available supply of biological raw materials, much of current research is founded on cells, tissues, organs, fetal tissues and placentas, and other samples derived from human donors.(8) However, this growing need for raw materials presents many economic, social, and ethical issues to society, researchers, and the existing legal regime.(9) Furthermore, because courts and legislatures fail to provide a clear national rule regarding biological materials, the resulting legal uncertainties chill research and investment.(10) Although very few cases address property rights in a person's organs, tissues, and genetic material, the issues of autonomy and privacy involved evoke analogies to deep-seated issues such as slavery,(11) the freezing of embryos,(12) and abortion.

There exist three distinctly interested and potentially conflicting parties involved when discussing research and the biotechnology industry: the raw-materials donors, the researchers and research institutions, and the public, who is the long-term beneficiary of medical research. The primary interest of biological-sample donors concerns the curing or resolution of their condition or disease. Donors are often unconcerned with the fruits of the medical research involved, unless such research impacts their condition directly. However, the researchers and research institutions involved are more often focused on the advancement of science and medicine through experimentation. These parties may seek financial, reputational, or other rewards in their research, and often require a ready supply of biological samples and patients with which to experiment. Finally, the public remains the final beneficiary of the knowledge and information gleaned through research, resulting in better health care for all. Thus, as an interested party, the public desires for the general health and welfare of the population to continually rise, but also recognizes the value of personal incentives.

While the rule adopted in the leading case of Moore v. Regents of the University of California(13) grants free reign to the biotechnology industry to utilize genetic raw materials, the court's decision fails to adequately protect a patient-donor's individual liberties and further fails to provide patients with any incentive to allow research utilizing their tissues. The 1990 Moore decision held that the removal of a person's cells and bodily tissues extinguishes a patient's property interest in his cells and genetic material.(14) In acknowledging the complexity of the issue, the California Supreme Court left the final disposition of such involved policy matters to the legislature.(15) Other courts addressing the issue of property rights in cell lines and genetic materials diverge, and even challenge the California Supreme Court's decision, thus creating a legal uncertainty as to the ownership and final disposition of disputed genetic materials.(16)

One potential form of legislative protection, the Genetic Privacy Act (GPA),(17) confers on the source of the DNA a protectable property interest in the DNA itself.(18) The GPA, in granting a proprietary interest in one's own genetic material, protects individual rights and simultaneously promotes continued research and development by establishing a clear rule on which investors and the biotechnology industry may rely.(19) Part II of this Note discusses existing case law by examining four recent cases concerning cell lines and genetic materials. Part III introduces and describes a variety of proposed changes to clarify rights in genetic materials, ranging from legislative initiatives to industry-wide voluntary royalty systems. Part IV describes three recent state bills in the Oregon, New York, and Pennsylvania legislatures, which address the issue of protection of genetic information. Part V reviews two federal legislative responses, the Genetic Privacy and Nondiscrimination Act (GPNA) and the GPA. Part VI concludes that while state legislative action and the GPNA represent positive steps, the passage of the GPA at a national level will provide optimum protection for individuals while concurrently furthering social goals by resolving the current legal uncertainty.

II. THE CURRENT STATE OF THE CASE LAW

Few jurisdictions have encountered the issues inherent in the ownership of genetic materials(20) and cell lines.(21) Thus, there is little relevant case law available to examine the issues of conversion of genetic materials and the rights to one's own DNA and genetic information.(22) This situation results partly from the recent and rapid development of the field and the corresponding lag-time, as the law catches up to scientific advances, exploration, and inquiry.(23) Recently, the courts have begun to examine the issues involved in this burgeoning field, issues which have "clearly . . . affected society on many levels - medical, social, economic, legal, and ethical."(24) However, as discussed below, these cases fail to set forth a clear rule.

Moreover, because of the historic geographic concentration of the biotechnology industry on the west coast and the precedential effect of Moore v. Regents of the University of California(25) by the California Supreme Court, few contrary opinions are likely to appear. Furthermore, Moore generates much controversy, and commentators' legal analysis of the case law conflicts.(26) As will be explored later in this Note, the California Supreme Court in Moore refrained from recognizing a cause of action for conversion of extracorporeal body parts.(27)

A. Moore v. Regents of the University of California

The first and most famous case examining property rights in excised bodily tissues is Moore v. Regents of the University of California.(28) In 1976, John Moore sought treatment at the University of California at Los Angeles Medical Center (UCLA) for hairy-cell leukemia.(29) The attending physician, Dr. David Golde, recommended that they remove Moore's enlarged spleen so as to slow down the disease.(30) Before the operation, Golde was "aware that `certain blood products and blood components were of great value in a number of commercial and scientific efforts' and that access to a patient whose blood contained these substances would provide `competitive, commercial, and scientific advantages.'"(31)

Although Moore consented to a splenectomy, he was unaware that prior to the operation, Dr. Golde arranged to retain parts of the spleen for research purposes.(32) Golde told Moore that his treatment required a specific follow-up regimen, which Moore followed for seven years.(33) During this time, Dr. Golde removed Moore's tissues, sperm, bone marrow, blood, and other samples with which Dr. Golde and his associate, Dr. Shirley Quan, continued their research.(34)

Moore signed a "very elaborate and very complicated" consent form presuming to divest him of all rights to the cell line and the products derived therefrom.(35) From Moore's spleen and his other biological samples, Golde and Quan established the "MO" cell line, which potentially produces a host of biomedical, hormonal, and immune-system proteins in great quantities.(36) In 1984, Golde and Quan received a patent for the cell line and assigned the rights to the Regents of the University of California.(37) Quan, Golde, and the University of California subsequently entered into commercial contracts and licensing agreements for which biotechnology companies paid them stocks, fringe benefits, and more than $400,000(38) for access to a potential market estimated at over $3.01 billion.(39)

When Dr. Golde asked Moore to sign another elaborate consent form, Moore became very suspicious and explicitly withheld consent.(40) In 1984, Moore sued Dr. Golde, Dr. Quan, the Regents of the University of California, and UCLA in California state court, claiming thirteen causes of action, including conversion of bodily property, lack of informed consent, breach of fiduciary duty, fraud, unjust enrichment, and negligent misrepresentation.(41) In expressly considering only the first allegation, the trial court sustained a demurrer with respect to the conversion claim, and dismissed all other claims, as based on the conversion claim.(42)

The appeals court reversed and found Moore's allegations of conversion adequate to overrule the demurrers; it further found that Moore's interest in his bodily tissues amounted to a personal property right.(43) The court also concluded that one possesses a right of dominion over one's body and the interests therein. The court overturned the defendants' demurrer and remanded the case to decide the other causes of action.(45)

Both defendants, UCLA and Golde, appealed to the California Supreme Court, which held that Moore had stated a valid cause of action for breach of the doctors' disclosure obligations,(46) but agreed with the trial court that Moore's conversion claim failed.(47) The court held that the defendants failed to convert Moore's cells because he abandoned them when the doctors removed them from his body.(48)

The court based its decision on prior case law, public health codes, and the public interest in preventing a chilling effect on the biotechnology industry.(49) The court believed that to hold otherwise would restrict access to needed raw materials, both legally and as a practical matter.(50)

While other cases discuss property rights in cell lines, Moore stands as the only case addressing property rights as between a raw-materials donor and the researchers who establish the cell line. All other court cases pertain to property rights as between researchers.(51) However, the analysis of property rights in cell lines remains important because the issues and discussion closely relate to the social and personal concerns of raw-materials donors.

B. Miles, Inc. v. Scripps Clinic and Research Foundation

In 1980, Scripps-Miles, a corporation jointly owned by the parties, retained Dr. Zimmerman as a consultant.(52) Dr. Zimmerman provided the corporation with an antigen later used to create a monoclonal cell line whose antibodies possessed an affinity for Factor VIII:C.(53) When the corporation dissolved in 1982, Miles acquired the monoclonal antibody laboratory.(54) However, defendants Zimmerman and Scripps continued to use the cell line for research and eventually obtained a patent for a process utilizing the antibodies to produce purified Factor VIII:C.(55)

Miles sued Scripps and Zimmerman alleging conversion and breach of fiduciary duty.(56) Although the trial court granted defendants' motion to dismiss because the statute of limitations barred the suit,(57) the Ninth Circuit reversed and remanded to the trial court.(58) On remand, the district court found that although California law appears to recognize a right to commercialize a cell line, because of the California Supreme Court's Moore opinion, conversion fails to protect this intangible right.(59)

The court distinguished this case from Moore by noting that "[Miles] does have a property interest in the right to commercialization of the cell line."(60) In Moore, the plaintiff's raw materials led to a cell line, whereas in Miles, "the cell line is the starting point."(61) However, the court refused to extend California conversion law to cover Miles's intangible right, and stated that such a decision is "more appropriately the subject of legislative deliberation and resolution."(62) In denying a cause for conversion, the Miles court noted that conversion exists as a strict liability tort and cited contract law and patent law protections as adequate to protect personal interests.(63) With respect to the alleged breach of fiduciary duty, the court held that "no possible action for breach of duty lies here,"(64) because the breach of duty action depends on the conversion action. The court used similar reasoning to dismiss the actions for concealment and fraud.(65) The court dismissed the case in its entirety, with prejudice.(66)

C. The Hagiwara Incident

The Hagiwara case also involves a dispute between researchers' rights versus raw-materials donors' rights, conversion of genetic material, and the conversion of a cell line.(67) Although no clear judicial decision arose because the parties settled out of court, the incident provides the closest situation to that experienced in Moore.(68) In 1982, Dr. Hagiwara brought his mother's tumor cells from Japan to the United States in an attempt to develop a cure for her.(69) Hagiwara and other researchers at the University of California at San Diego Medical Center (UCSD), believing that these cells possessed unusual cancer-fighting potential, began experimentation and eventually produced a cell line from them.(70)

Without notifying the laboratory head, Hagiwara brought some of the cells from the cell line back to Japan to attempt to treat his mother.(71) At this time, Hagiwara applied for a Japanese patent for the cell line, and began commercialization of the cell line's products.(72) On notification of Hagiwara's actions abroad, UCSD claimed ownership of the cell line as assignees of its employees' discoveries and because the research occurred in UCSD facilities during Hagiwara's employment there.(73) Hagiwara claimed ownership because he provided the cells, conducted the research, and possessed familial ties to the cell source.(74) The parties settled before completion of a full trial.(75) UCSD became the owner of intellectual property rights of the cell line in the United States and Dr. Hagiwara received an exclusive license for Asian markets.(76)

Thus, although the property issues and ethical concerns in the Hagiwara incident are closely analogous to those in Moore, no judicial resolution exists for comparison.

D. United States v. Arora

In 1989, Dr. Arora, a researcher at the National Institutes of Health (NIH) in Bethesda, Maryland, hired Dr. Sei as a post-doctoral student.(77) Arora served as Sei's mentor and together, they collaborated on both research and publications. …

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