STACEY L. DOGAN, Northeastern University School of Law
Email: s.dogan@neu.edu
MARK A. LEMLEY, Stanford Law School
Email: mlemley@law.stanford.edu

Antitrust law promotes competition in the service of economic efficiency. Government regulation may or may not promote either competition or efficiency, depending on both the goals of the agency and the effects of industry "capture." Antitrust courts have long included regulated industries within their purview, working to ensure that regulated industries could not use the limits that regulation imposes on the normal competitive process to achieve anticompetitive ends. Doing so makes sense; an antitrust law that ignored anticompetitive behavior in any regulated industry would be a law full of holes.

The role of antitrust in policing regulated industries appears to be changing, however. A cluster of Supreme Court decisions in the past decade have fundamentally altered the relationship between antitrust and regulation, placing antitrust law in a subordinate relationship that, some have argued, requires it to defer not just to regulatory decisions but perhaps even to the silence of regulatory agencies in their areas of expertise.

Absolute antitrust deference to regulatory agencies makes little sense as a matter either of economics or experience. Economic theory teaches that antitrust courts are better equipped than regulators to assure efficient outcomes in many circumstances. Public choice theory - and long experience - suggests that agencies that start out trying to limit problematic behavior by industries often end up condoning that behavior and even insulating those industries from market forces. And as history has shown, relying on regulatory oversight alone without the backdrop of antitrust law would leave both temporal and substantive gaps in enforcement, which unscrupulous competitors could exploit to the clear detriment of consumers. The mere existence of a competition-conscious regulatory structure cannot guarantee against abuses of that structure, or against exclusionary behavior that falls just beyond its jurisdiction. Indeed - and perhaps ironically - the very regulatory structure that exists to promote competition can create gaming opportunities for competitors bent on achieving anti-competitive goals. Such "regulatory gaming" undermines both the regulatory system itself and the longstanding complementary relationship between regulatory and antitrust law.

We argue that the risk of regulatory gaming provides an important example of the need for ongoing antitrust oversight of regulated industries. We define regulatory gaming as private behavior that harnesses pro-competitive or neutral regulations and uses them for exclusionary purposes. We identify three possible instances of regulatory gaming: (1) product-hopping, in which the branded company makes repeated changes in drug formulation to prevent generic substitution, rather than to improve the efficacy of the drug product; (2) manipulation of government standard-setting organizations; and (3) claims of price squeezes by partially regulated industries.

Our goal in this paper is not to persuade the reader that these particular examples of regulatory gaming do or do not violate the antitrust laws. Rather, our point is that whether or not particular acts of regulatory gaming harm competition is and should be an antitrust question, not merely one that involves interpreting statutes or agency regulations. Some level of antitrust enforcement - with appropriate deference to firm decisions about product design and affirmative regulatory decisions that affect market conditions - provides a necessary check on behavior, such as product hopping, that has no purpose but to exclude competition.

JONATHAN BARNETT, USC Law School
Email: jbarnett@cgsh.com

Intellectual property rests on a simple incentive rationale: without imitation barriers, innovators rationally decline to invest. But this blanket proposition is incompatible with markets where innovation proceeds without substantial recourse to intellectual property and imitation is widespread. This discrepancy sometimes drives the alternative view that intellectual property or other access barriers often or even usually are not prerequisites for intellectual production. But "utopian" understandings oversimplify the complex incentive structures and circumscribed conditions under which some markets can induce innovation without intellectual property or practical equivalents. A simple rational choice framework anticipates that "sharing regimes" - that is, innovation environments bereft of exclusionary barriers but governed by reputational norms - can sustain a viable habitat for innovation but inherently deteriorate as endowment heterogeneity, group size, asset values and capital intensities increase. Empirics substantially track theory: industries that sustain innovation without robust intellectual-property protections tend to be confined to "low-stakes" settings or make indirect recourse to other exclusionary instruments. Critically, however, it is also the case that voluntarily-formed sharing arrangements pervade even economically-intensive markets. Properly understood, these sharing arrangements do not substitute for property but provide a vital complementary mechanism that alleviates the transaction-cost burden of an exclusionary regime. Examination of three "best cases" for the view that intellectual production can proceed without intellectual property - premodern craft guilds, academic research and open source software - supports this intermediate position: sharing practices proliferate to facilitate the low-cost circulation of knowledge assets but are consistently embedded within a legal or technological infrastructure that implements some barrier to imitation.

PETER LEE, University of California, Davis School of Law
Email: ptrlee@ucdavis.edu

Patents on biomedical research tools-technological inputs to experimentation-may inhibit scientific inquiry and the development of life-enhancing therapies. Various "public law" approaches to address this challenge, such as a common law experimental use exception to patent infringement, have achieved limited success. In the wake of these shortcomings, this Article argues that institutions that fund and support biomedical research are resorting to an underappreciated model of private ordering to resolve research holdup. Increasingly, federal and state agencies, universities, non-profits, and disease advocacy groups are conditioning vital research support on requirements that recipients of this support make resulting patented inventions widely available for noncommercial research purposes. In essence, these institutions are contractually constructing a biomedical research commons.

These efforts represent a significant shift towards "privatizing" patent regulation. Through a new model of "consideration-based patent regulation," public institutions are embedding policy objectives in contractual quid pro quos with individual recipients of research support. This model provides public institutions with considerable freedom to effectuate norms favoring wide dissemination of research technologies. This Article greets this development with cautious optimism, providing prescriptions for how public institutions may effectively manage the contractual construction of a biomedical research commons. It concludes by exploring the significant ramifications of this development for patent law, institutions, and theory.

ROBERT W. GOMULKIEWICZ, University of Washington School of Law
Email: bobgom@u.washington.edu

One prominent issue among free and open source software (FOSS) developers (but little noticed by legal scholars) has been "license proliferation." "Proliferation" refers to the scores of FOSS licenses that are now in use with more being created all the time. The Open Source Initiative ("OSI") has certified over seventy licenses as conforming to the Open Source Definition, a key measure of whether a license embodies FOSS principles. Many believe that license proliferation encumbers and retards the success of FOSS. The OSI has indentified the issue as one of its most strategic issues to address.

Why does proliferation occur? What are the pros and cons of multiple licenses? Does the growing number of FOSS licenses represent hopeless confusion (as many assume) or (instead) helpful diversity? What role has OSI played to date and what can it do in future to better ameliorate the negative effects of so many FOSS licenses? To provide context and color, these issues are examined using the story of the submission of the Simple Public License (SimPL) to the OSI for certification.

DANIEL J. GERVAIS, Vanderbilt University
Email: daniel.gervais@law.vanderbilt.edu

Intellectual property and human rights must learn to live together. Traditionally, there have been two dominant views of this "cohabitation," namely a conflict view, which emphasizes the negative impacts of intellectual property on rights such as freedom of expression or the right to health and security, and a compatibility model, which emphasizes that both sets of rights strive towards the same fundamental equilibrium. This Book Chapter takes the dualist view that both are right, though there is, and should be, much more truth to the second approach in the coming years.