Patents, Paradigm Shifts, and Progress in Biomedical Science
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Note Patents, Paradigm Shifts, and Progress in Biomedical Science Peter Lee CONTENTS IN TRO D U CTION .......................................................................................... 66 1 I. THE THEORY OF PARADIGM SHIFTS ................................................... 665 II. INNOVATION-ENHANCING AND INNOVATION-INHIBITING EFFECTS OF PATENTS IN NORMAL SCIENCE ...................................................... 669 A. TraditionalJustifications for PatentLaw .................................... 669 B. Rebuttals to TraditionalPatent Theory: Scientific Communism and the Tragedy of the Anticommons ...... 671 1. Norms of Communal Sharing and Implicationsfor P atent L aw ............................................................................. 671 2. The Tragedy of the Anticommons .......................................... 673 C. The Mixed Relationship of Patents to Normal Scientific P rogress ....................................................................................... 675 III. THE CHANGING LANDSCAPE OF BIOMEDICAL SCIENCE AND IMPLICATIONS FOR NORMAL SCIENTIFIC PROGRESS .......................... 679 A. Trends EncouragingGreater Patentingof Research Tools ......... 679 B. The Narrowing of the Experimental Use Exception .................... 681 C. Implications of Commercializationfor Patent Law and Scientific Progress....................................................................... 684 659 Imaged with the Permission of Yale Law Journal 660 The Yale Law Journal [Vol. 114:659 IV. PATENTS, PARADIGM SHIFTS, AND SCIENTIFIC PROGRESS ................ 686 A. Alternative Hypothesis Generation and the Path to P aradigm Shifts ............................................................................ 686 B. Research Tools, Upstream Monopolies, and the Inversion of TraditionalPatent Logic .......................................................... 690 C ON CLU SION ............................................................................................. 694 Imaged with the Permission of Yale Law Journal 20041 Patents, Paradigm Shifts, and Progress INTRODUCTION Conventional wisdom holds that patents contribute to progress.' 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 .... 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 1. While commentators generally relate patents to scientific and technical advancement, courts have also situated patents within a broader program of social and economic progress. Regarding patent laws, the Supreme Court has noted, "The authority of Congress is exercised in the hope that '[t]he productive effort thereby fostered will have a positive effect on society through the introduction of new products and processes of manufacture into the economy, and the emanations by way of increased employment and better lives for our citizens."' Diamond v. Chakrabarty, 447 U.S. 303, 307 (1980) (quoting Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 480 (1974)) (alteration in original). 2. U.S. CONST. art. I, § 8, cl.8. 3. See Bruce Abramson, Promoting Innovation in the Software Industry: A First Principles Approach to Intellectual Property Reform, 8 B.U. J. SCI. & TECH. L. 75, 76 (2002) (arguing that the U.S. intellectual property system expressly advocates "harnessing the profit motive to promote artistic and scientific progress"). 4. One oft-cited but controversial 2001 study from Tufts University estimates that the average cost to develop a new drug is $802 million. Joseph A. DiMasi et al., The Price ofInnovation: New Estimates of Drug Development Costs, 22 J.HEALTH ECON. 151, 166 (2003); see also Ceci Connolly, Price Tag for a New Drug: $802 Million, WASH. POST, Dec. 1, 2001, at A1O. Opportunity costs, however, represent almost half of this figure. Public Citizen, using data from Pharmaceutical Research and Manufacturers of America, estimates the after-tax R&D costs for developing a new drug in the 1990s to be $56.5 to $71.0 million. PUBLIC CITIZEN, RX R&D MYTHS: THE CASE AGAINST THE DRUG INDUSTRY'S R&D "SCARE CARD" 6 tbl.2 (2001), available at http://www.citizen.org/documents/acfdc.pdf. Imaged with the Permission of Yale Law Journal The Yale Law Journal [Vol. 114:659 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 5. Michael A. Heller, The Tragedy of the Anticommons: Property in the Transition from Marx to Markets, 111 HARV. L. REV. 621 (1998). 6. The National Institutes of Health (NIH) defines "research tools" as "tools that scientists use in the laboratory, including cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools (such as PCR), methods, laboratory equipment and machines." Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, 64 Fed. Reg. 72,090, 72,092 n. 1 (Dec. 23, 1999). 7. See, e.g., Arti Kaur Rai, Regulating Scientific Research: Intellectual Property Rights and the Norms of Science, 94 Nw. U. L. REV. 77, 79 (1999). While Rai evaluates the influences of law and norms on basic science research, she situates her analysis in an instrumental view that emphasizes patents' relationship to technological progress. She does not consider patents' effects on the evolution of scientific theory, instead framing her inquiry in terms of "the central instrumental goals of intellectual property--success in stimulating the creation, disclosure, and development of inventive or creative works." Id. 8. While Rebecca Eisenberg has also discussed Kuhn's framework in the context of patents' influence on basic science, see Rebecca S. Eisenberg, Patents and the Progress of Science: Exclusive Rights and Experimental Use, 56 U. CHI. L. REV. 1017, 1051-52 (1989), this Note is unique in applying the concept of paradigm shifts to explain how patents may advance scientific theory. Imaged with the Permission of Yale Law Journal 2004) Patents, Paradigm Shifts, and Progress 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