By Michele Goodwin

Over sixty years ago, Judge Charles Clark wrote that the function of courts "cannot be limited to a mere blind adherence to precedent." He cautioned fellow jurists against engaging in lofty formalism. Clark warned that judges must avoid clinging to precedent simply for the sake of it and "artfully" dodging new doctrine. Clark recognized the value of judges fully exercising their mental powers and "discovering and applying" new trends in law as the technology and policies of the time demanded. Clark's pragmatic advice to his colleagues on the bench remains timeless.

Beyond a doubt, the burden of crafting judicial responses to nascent technology is a formidable process. The struggle today is not the relationship between legal standards for the "old" law of horse and buggy and the "new" automobile. Rather, the challenge for the contemporary bench is determining the proper application of law and legal concepts to sexy new technologies and biotechnologies such as the ownership of genetic materials, the regulation of genetically modified foods and organisms, and the appropriate criminal and tort law standards to mishaps, fraud, and breaches of fiduciary duties.

Since the Supreme Court's landmark decision in Diamond v. Chakrabarty (1980), which made patenting living organisms legal in the United States, applications for biologically derived patents have taken off at break-neck speed. With equal velocity and controversy have been claims of fraud, deception, invalidity, and unfair dealing in the relationships between patients, medical researchers, and multi-national pharmaceutical companies. In cases ranging from Moore v. Regents, which involved the non-consensual taking and manipulation of a patient's genetic materials by his physician (1990), to more recent cases involving the marketing of infected human tissues, judges stand in the gap of bumpy, unpaved terrain-often without legislative guidance. For some scholars, they are the principle arbiters between David and Goliath in this new terrain. Yet, how judges view their roles may be very different than how the public conceptualizes their authority and obligations.

In Moore v. Regents, for example, the California Supreme Court found that there is no such thing as one's ownership in his body. Moore lost on all but one count in a case involving over a dozen causes of action. Moore's critical argument was that his doctor (also a medical researcher) acquired his spleen, semen, blood, and other biologics under false pretenses-essentially theft-and later capitalized and derived a patent on that which was conscripted from Moore's body. The court was not persuaded by Moore's claim although there was no dispute about his doctor's unethical conduct in acquiring Moore's cell-line and other biologics. For many years, this case has riveted law students attempting to reconcile intellectual property law, property law, and the court's decision: how Moore's doctors could own a patent (and profit) on a cell line derived from Moore's body and yet exclude Moore.

But a change may be underfoot.

Most recently, a lower court delivered a stunning blow to biopharmaceutical corporations in Association for Molecular Pathology v. U.S. Patent and Trademark Office (better known as the "Myriad Case") by ruling several very high-profile patents invalid. Myriad Genetics and the University of Utah Research Foundation own the patents on BRCA1 and BRCA2 genes, which are definitively linked to hereditary breast and ovarian cancers. The patents grant Myriad the exclusive right to perform diagnostic tests on the genes and herein are the most significant problems voiced by critics. The tests cost over three thousand dollars per administration and have contributed in large part to hundreds of millions in revenue earned by the company in the last two years.

But some wonder, how can a gene that is found in the human body of some women afflicted with breast cancer be owned by a corporation? The concerns over Myriad's patent involve the practical, theoretical, and conspiratorial. As with traditional property ownership rights, owners possess the power to exclude, ward off, and destroy property, and the authority to prosecute those that impose upon or trespass against your property.

Understandably, this unique intellectual property status involving the BRCA mutant genes causes alarm. Among the plaintiffs' claims is that in order for a woman to discover whether the patented mutant genes exist in her body, she has to pay Myriad for the test to discover what is in her body. Particularly sensitive in that case is that the genes under dispute are associated with ovarian cancer (BRCA 2) and breast cancer (BRCA 1), a disease that remains incurable and afflicts 1 in 8 women in the United States.

As a socio-economic matter, poor women without insurance could conceivably be "priced out" from learning whether they might be at risk for breast cancer. For African American women (who are less likely to develop breast cancer, but five times more likely than their white counterparts to die from it), the outcome of this litigation and future appeals might be particularly relevant. Myriad offers no real answer to the underlying social-justice critique voiced by critiques concerned about the corporatization of medical knowledge that could save lives.

However, Judge Sweets' District Court ruling in the Myriad case was interpreted by some to be a guidepost for effective judicial decision-making in the biotech age. In the past, courts not only struggled with evaluating the differences between horse/buggy and car/train in tort law, but also in contract, and even property law; but they took the leap, realizing that the bench could not fall prey to ambivalence or myopic thinking. Notably, judges defined what those assignations would mean for people harmed by the technology. Judges were not blind to the economic dynamics of technology (i.e. incentivizing industry and research) nor the political landmines associated with expanding civil remedies for individuals harmed by the developing technologies.

Increasingly, contemporary conflicts in biotechnology mimic their predecessors and will require an engaged, courageous, equipped judiciary. Metaphorically, contemporary biotechnologies and commercial usage of genetic knowledge converge like old locomotives on roads without guardrails and train crossings without lights, whistles, and signals. The socio-legal questions and problems emanating new technologies demand focused attention from the judiciary.             


Michele Goodwin, JD, is Everett Fraser Professor of Law at the University of Minnesota.

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