From Chakrabarty to chimeras: the growing need for evolutionary biology in patent law.

Author:Iwasaka, Ryan M.T.

    In 1988, the U.S. Patent and Trademark Office (PTO) granted the first patent on a "nonnaturally occurring non-human multicellular living organism":(1) a mouse genetically engineered to be particularly susceptible to cancer.(2) Although Congress had earlier provided limited protection for certain cultivated plants,(3) bioengineered animals--ranging from single-celled bacteria to mammals and amphibians--were barred from patent protection on ethical and moral grounds. In 1980, the U.S. Supreme Court drew upon a growing trend in the law to allow patents for "anything under the sun that is made by man,"(4) thereby opening the universe of patentable subject matter to living organisms. The Court, however, failed to define the boundaries of this new area of patent doctrine, choosing instead to induce the fledgling biotechnology industry to draw policymakers into the issue. But Congress and the PTO tacitly refused to address the growing concerns and let the question of animal patentability go unresolved. As a result, over 6000 biotechnology patent applications were filed, which were then held in limbo until the PTO's 1988 action.(5)

    The PTO's decision to grant the mouse patent was its second attempt to force Congress or the courts to end the tumultuous and confusing decade-long struggle over animal patentability. In response to the PTO's new policy, a flood of legal and political challenges flowed from numerous special interest groups that feared the detrimental moral and economic effects such patents could have on nature and society.(6) In 1991, the PTO obtained partial closure on the issue when the U.S. Court of Appeals for the Federal Circuit consolidated and disposed of the legal challenges, dismissing the claims for lack of standing.(7) Although the Federal Circuit failed to address any questions of morality or law effectively, its conclusion cleared the way for the PTO's declaration that bioengineered animals and plants were appropriate subject matter for patent protection, provided that they met the traditional standards set forth in 35 U.S.C. [sections] 101.(8) Both the Federal Circuit and the PTO relied heavily on the Supreme Court's earlier opinion and did little to clarify the guidelines or definitions for patentability. They merely established a case-by-case review process that gave the PTO arbitrary discretion over the factors it would consider in determining acceptable subject matter. This system, akin to the ill-constructed "I know it when I see it" analysis that Justice Potter Stewart employed for pornography,(9) remains the regime under which patent review for bioengineered organisms operates today.(10)

    Despite the lack of systemic clarity, the basic question of animal and plant patentability appeared to be settled. Yet as of July 1999, the PTO faced a backlog of new applications and old appeals, due in part to the lack of established guidelines).(11) Among the thousands of pending biotechnology patent applications, the PTO had received over 1900 patent applications specifically for genetically altered animals and had approved fewer than ten percent)(12) And among those applications, the PTO received one highly controversial application: a request for a patent on the process by which scientists can create "chimeras," hybrid organisms that are part animal and part human.(13) The PTO recently denied this request, citing the government's rigid moral ban against patents on human beings.(14) But this test case reopened old wounds, exposing the lack of defined standards and the PTO's inability to address such questions within a clear and reasoned framework.(15) The chimera case uncovered one important development in contemporary patent law: It revealed that the issue is no longer whether animals and plants can be patented, but which animals and plants should receive patent protection.

    In light of this controversy, the government's failure to resolve the questions surrounding live-organism patents appears to have had two new effects. First, it has left some room for debate over the fundamental propriety (not legality) of permitting plant and animal patents. Opponents of such patents argue that the absence of standards underscores the complexity and tenuous nature of patenting life; consequently, they argue, the PTO should suspend its practice, at least until Congress revises the law to regulate the powerful effects that modern technology can have on the development of new plants and animals.(16) Second, the lack of standards has led to confusion over which organisms qualify for patent protection. The lack of doctrinal clarity generally takes two forms: (1) patent applications refused by the PTO for unclear reasons; and (2) patents granted for organisms that would not meet even the basic legal standards of prior art and obviousness upon which the PTO and courts have always relied.(17) These factors have combined to create the backlog of applications and appeals pending in the patent system.

    This Note attempts to address the need for clear standards by proposing the introduction of rules and tests based on the principles of evolutionary biology. Evolutionary biology can generally be defined as the study of species' development through their interaction with the environment. It is based on Charles Darwin's theory of natural selection.(18) Darwin hypothesized that life developed through a process of competition between and within species. In any given natural environment,(19) species can thrive or perish, thereby allowing nature to select certain organisms for survival and others for extinction. A single trait or a collection of traits may lead to the selection of one species over another, and, within a particular species, the mutation of a single trait may result in the creation of a new species that would supplant the existing one through a process of interbreeding. Evolutionary biology then draws upon the fields of population ecology, genetics, and predictive modeling to form an integrated methodology for describing the evolutionary history and potential of a given organism.(20)

    Although the integration of evolutionary biology seems to be an obvious step in the development of the law of plant and animal patents, an extensive search of the legal and scientific literature reveals scant reference to anything that resembles Darwin's idea and the science it spawned.(21) This omission is stunning. Over the last half-century, genetic technology has redefined the scope of human power over nature and the basic building blocks of life. Biotechnology has harnessed this power to "create" organisms that this world has never seen before. The introduction of new organisms into our environment inevitably changes the biological landscape. Evolution is the organized and reasoned process of such changes. Thus, the inclusion of this scientific theory should provide, in its basic form, a framework upon which we may build a mode of analysis that will shift patent law away from the ad hoc and toward the logical. Evolutionary biology offers a tested foundation where there currently is none and is, therefore, superior to the current system.

    Through the application of evolutionary biology, the functional elements of natural selection and population ecology can be applied to the analysis of animal and plant patentability. Employing evolutionary biology, this Note proposes that patents be granted only on those nonnaturally occurring organisms that exist in some tangible form and that are theoretically favored due to the intervention of, and their utility to, humans.(22) It argues, in essence, that patentable organisms should be defined as nonnaturally occurring plants and animals whose prospects for continued existence are predicated not upon their selection by nature, but upon their selection by people.

    Part II of this Note recounts the development of the legal standards regarding animal and plant patents. Part III then introduces the proposal for applying evolutionary biology and discusses its utility in the patent-application process. In particular, Part III employs the theory in order to evaluate the role that human intervention plays in the development and survival of genetically altered organisms. Part III also discusses the methods by which evolutionary biology can be injected into the existing patent-review process and weighs the advantages and disadvantages that would result from the use of these scientific principles. Part IV concludes this study by reasserting the value of evolutionary biology in addressing many of the deficiencies in the current doctrine, including those raised in the chimera controversy.

    At the outset, an important caveat bears mentioning: This Note does not directly address the moral and ethical concerns that have dominated the debate over animal and plant patents. Rather, this Note offers a reform of the troubled patent-application process, notwithstanding the moral objections. The proposal assumes that the PTO will continue to issue patents on living organisms regardless of the outcome of the chimera case or the ongoing objections of the opposition. Property interests and the value to scientific inquiry appear to be such weighty incentives that the debate may never come to a complete resolution.(23)

    Instead of becoming mired in moral and ethical controversy, this Note addresses real and immediate deficiencies in the patent-application process. These problems are systemic, requiring detailed attention that opponents and proponents of live-organism patents seem unwilling to give them at this time. In the meantime, it is this Note's contention that the PTO is erroneously issuing patents on organisms that are, or would be, the products of nature. The proposal offered here is an attempt to rectify this situation. At the very least, this Note seeks to expose the need for more rigorous scientific assessment in the process by showing that the current case-by-case patent-application...

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