Patents, paradigm shifts, and progress in biomedical science.

Author:Lee, Peter

CONTENTS INTRODUCTION I. THE THEORY OF PARADIGM SHIFTS II. INNOVATION-ENHANCING AND INNOVATION-INHIBITING EFFECTS OF PATENTS IN NORMAL SCIENCE A. Traditional Just Traditional for Patent Law B. Rebuttals to Traditional Patent Theory: Scientific Communism and the Tragedy of the Anticommons 1. Norms of Communal Sharing and Implications for Patent Law 2. The Tragedy of the Anticommons C. The Mixed Relationship of Patents to Normal Scientific Progress III. THE CHANGING LANDSCAPE OF BIOMEDICAL SCIENCE AND IMPLICATIONS FOR NORMAL SCIENTIFIC PROGRESS A. Trends Encouraging Greater Patenting of Research Tools B. The Narrowing of the Experimental Use Exception C. Implications of Commercialization for Patent Law and Scientific Progress IV. PATENTS, PARADIGM SHIFTS, AND SCIENTIFIC PROGRESS A. Alternative Hypothesis Generation and the Path to Paradigm Shifts B. Research Tools, Upstream Monopolies, and the Inversion of Traditional Patent Logic CONCLUSION INTRODUCTION

Conventional wisdom holds that patents contribute to progress. (1) This sentiment underlies the Copyright and Patent Clause of the U.S. Constitution, which states, "The Congress shall have Power ... To 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...." (2) This traditional rationale posits that grants of monopoly power provide an effective incentive for parties to invest in costly research and development to bring new inventions to market. (3) Organizations such as Pharmaceutical Research and Manufacturers of America, for example, argue that patent protection is necessary to recoup the hundreds of millions of dollars in initial investments necessary to develop new drugs. (4) Without such protection, copiers could simply free ride on the ingenuity and investment of creative enterprises, thus depleting the latter of any incentive to innovate. Society ultimately benefits, the conventional wisdom goes, by encouraging innovation and advancing the state of science and technology available to the public at large.

A growing counterintuitive insight, however, holds that patents actually deter innovation. At a fundamental level, patents conflict with traditional scientific norms of open sharing. Furthermore, proclaimers of the "tragedy of the anticommons" contend that overpropertization of resources results in their underuse. (5) In biotechnology, the increased patenting of "research tools"--materials, protocols, and equipment that comprise critical inputs of scientific experiments--has heightened anxieties that patents inhibit research and development. (6) Revisiting the example of pharmaceuticals, patents on upstream "building block" materials or on foundational experimental protocols may hinder downstream investigations and efforts to translate basic science into useful drugs. In this manner, patents can stifle innovation and hamper progress.

While both traditional and anticommons theories focus on patents' relationship to progress in technology, (7) this Note takes a different approach. Moving beyond the level of applied science, this Note examines patents' contribution to the advancement of scientific theory, the scientific community's conceptual understanding of the basic structure and properties of natural phenomena. Current scholarship has largely ignored patents' role in the evolution of scientific theory and lacks a robust analytic framework for conceptualizing this relationship. This Note looks to the "scientific humanities" to fill this void and bring to light the significant and unexpected influence of patents on scientific and inventive activity. This Note thus adds a new perspective to the intellectual property debate by drawing on the history, philosophy, and sociology of science to argue that patents may play a surprising role in the evolution of the scientific community's basic understanding of natural phenomena.

Throughout this analysis, the theory of scientific paradigms as expounded by philosopher of science Thomas Kuhn and the distinction between what he calls "normal science" and "paradigm shifts" will be central. (8) Research and application within a dominant theoretical framework--what Kuhn calls a scientific paradigm--comprises "normal science." (9) The creation of a novel theoretical framework that better explains a particular set of natural phenomena comprises a paradigm shift, the most fundamental kind of scientific change. For example, progress in normal science might involve innovatively applying current theories of neural physiology to stimulate cell growth in the human brain through the use of embryonic stem cells. In contrast, paradigmatic change would involve creating an entirely new theoretical model of how the brain works. Ultimately, a paradigm shift such as this could suggest novel ways to induce spontaneous regeneration of neurons that do not require embryonic stem cells.

Combining the concept of paradigm shifts with an anticommons approach to property theory, this Note argues that strong patent protection of research tools--critical inputs of scientific experiments--can play a vital first step in inducing paradigm shifts. This Note will review how patents conflict with scientific norms of communal sharing and how patenting upstream research tools can discourage experimentation and testing. (10) By raising the cost of "doing science" within an established paradigm, however, patents encourage scientists to create alternate theories of how natural phenomena operate, theories whose investigation does not depend on using patented research tools. Patents thus accelerate the process by which researchers generate and test insurgent scientific theories. While most of these theories will prove incorrect or no better than the current paradigm in terms of empirical validity and predictive capacity, some will more successfully explain how a natural process, such as neurogenesis, functions. By accelerating the creation of alternate theories, patents increase the likelihood that scientists will challenge existing paradigms and replace them with new ones.

While this paradigm-shift-inducing dynamic may apply to a wide range of scientific disciplines, this Note will focus on biomedical research. The growing commercialization and commodification of biomedical science have allowed patents to exert substantial influence over basic research activities. Scientific, economic, statutory, and legal developments increasingly allow and encourage universities to patent products of federally funded research. In parallel, the common law doctrine of the experimental use exception--which traditionally allowed free use of patented material for noncommercial purposes--has been significantly narrowed in the context of university research. In this manner, "[b]iotechnology research presents an unusual, if not unprecedented, juxtaposition of the [proprietary] incentives of the patent law system" and the traditional scientific norm of communal sharing. (11)

Although scientists cannot patent abstract theories such as E = [mc.sup.2], they can patent the associated technological aids that researchers need to investigate them. (12) Patents on research tools earlier and earlier in the development chain thus raise the possibility of creating individual ownership rights in theories. All theories suggest means of testing and validating themselves. The current "central dogma" of DNA translation and transcription has defined and rendered meaningful an entire material culture of technologies ranging from restriction enzymes to electrophoresis machines. These physical artifacts both reflect prevailing assumptions of DNA structure and function and allow scientists to extend, test, and apply those assumptions. Patents on biotechnology research tools can therefore effectively create exclusive rights to explore certain foundational theories. For example, patents on human embryonic stem cells restrict the universe of researchers who can investigate the hypothesis that these cells can differentiate into any type of human tissue. As research tools become more specialized and propertized, more and more fields of inquiry will ultimately fall under the domain of patents. While this raises concerns over the inhibitory effect of patents on scientific progress, it also opens the door for patents to help induce paradigm shifts.

Analyzing patent law through the lens of paradigm shifts reveals an important but underappreciated benefit of strong patent protection. Patents, by encouraging scientists to experiment outside the realm of mainstream research tools, encourage them to generate and test new theories. Some of these theories will more completely and cleanly explain the operation of natural processes, thus deepening our fundamental understanding of nature. Considering the role of patents in the evolution of scientific theory thus deepens any debate on the function and value of patents. Arguments that too much patent protection deters innovation may only be considering one level of innovation--that of technological advancement. In this new light, however, any detrimental effect that patents may have on discouraging downstream research and development must be weighed against their value in encouraging the paradigm shifts that advance fundamental scientific theory. Patents emerge as a fulcrum defining the balance between two kinds of valuable scientific activity: hypothesis validation and exploration (comprising the main business of normal science) and hypothesis generation (leading to paradigm shifts). Without recognizing this function, policy choices defining patent regimes are uninformed and incomplete.

Consistent with its interdisciplinary orientation, this Note draws on several parallel sources to build its central arguments. Part I introduces the concept of paradigm shifts, the dominant framework for this Note's examination of patents and progress. Part...

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