• Selected
• Entire List

Abstract:
A diverse group of politicians and public policy advocates have come together in the last year to advocate for the importation of inexpensive drugs from countries like Canada as a means of bringing down the high cost of medicine in the United States. Several state and municipal governments have joined the debate by proposing plans to provide foreign drugs to their citizens. While the safety of imported drugs has been the primary issue to date, a more significant set of obstacles for such schemes may be the patent rights covering some of the most critical treatments. Surprisingly, the subject has received very little attention, and the application of current law in this context - particularly when governments are involved - is astonishingly unclear.

This paper investigates the current legal framework and finds that the application of full constitutional property protections to the importation conflict would produce surprising and powerful results: (1) private organizations and municipalities share the same, crushing liability under the Patent Act; (2) despite Eleventh Amendment immunity in federal courts, state governments face nearly equivalent liability for takings claims based on the Fourteenth Amendment; (3) the federal government confronts liability under the Fifth Amendment that broadens its exposure under the recognized just compensation statute; and (4) attempts by Congress to modify the Patent Act to permit importation would likely constitute an unconstitutional taking. The paper concludes that such strong property protection is not necessarily anomalous and may reflect the continued propertization of intellectual property under U.S. law, exemplifying the legal equalization of intellectual property and tangible property.

drug, pharmaceutical, import, patent, intellectual property, parallel import, reimportation, fifth amendment, fourteenth amendment

Abstract:
Recent patent compulsory licenses issued by Thailand have focused attention on this property rights safety valve as a means for balancing access and innovation in essential medicines. While derided in some quarters, many view these measures as a legitimate exercise of the flexibilities that exist in international intellectual property agreements, recently enhanced as a result of the WTO's Doha round of trade negotiations. But the increasing willingness to utilize patent compulsory licenses faces a troubled future: the international framework is dangerously ambiguous and significantly misaligned. Chief among the concerns is the level of compensation owed to a patent owner for the loss of exclusivity. There is an utter lack of standards in international law, and countries generally resort to compensation conventions that are beset by myths regarding the available options, and shortsightedness as to the future impact. Largely ignored in the literature, this lack of a clear floor or ceiling to compulsory license compensation can make patent property rights less predictable, encourage gamesmanship by developing or developed countries wishing to cut expenditures and, most perversely, even stifle access. This article attempts to clarify the issue by focusing on the economic basis of compulsory licenses and identifying the underlying principles in existing compensation models. It suggests an innovative licensing framework that separates countries into three economic development tiers with different royalty mechanisms. Such a nuanced system, the article argues, will lead to more predictability and effective institutional mechanisms, ensuring continued innovation and greater access to essential medicines.

patent, intellectual property, compulsory license, global health, TRIPS

Abstract:
In 2003, two economists at Goldman Sachs produced a white paper predicting the economic growth of Brazil, Russia, India, and China, collectively termed the BRIC economies. This paper offered projections from the present date to 2050 relative to similar growth projections of the G6 countries. Applying capital accumulation and productivity growth to demographic trends, the authors discovered a surprising result. The BRIC economics may be larger in gross domestic product (GDP) terms than the entire current G6 within 40 years.

This article briefly examines the converging and diverging economic and legal trends of the BRICs from an intellectual property perspective. Part I of this article explores the BRICs macroeconomic converging and diverging forces such as growth opportunities and constraints, transformations and challenges, as well as outward and inward foreign direct investment. This section will take a particular focus on intellectual property laws and enforcement as emblematic of the challenges experienced by emerging BRICs. Part II amplifies the focus on intellectual property with an examination of one of the most controversial current intellectual property topics - that of pharmaceutical patent rights. This section will examine the compulsory licensing statutes and practices of each BRIC member and draw conclusions from these activities about the differing approaches of emerging nations to heretofore unfamiliar legal structures and obligations.

intellectual property, complusory licensing, foreign direct investment

Abstract:
The innovation impact of intellectual property compulsory licenses - government-imposed access without the authorization of the property owner - has generated great interest in the academic literature. Moreover, recent measures by the governments of Thailand and Brazil have generated increased international awareness of the issue. Equally significant, but receiving less attention is the impact of compulsory licenses on flows of foreign direct investment (FDI) to the granting nation. It is quite likely that FDI mechanisms provide an important attenuating factor that influences a country's compulsory license strategy. This paper investigates the compulsory license-FDI relationship, using essential medicines as a context. It explores the potential for collective action and bargaining on the part of licensing nations to minimize FDI losses while preserving access. Middle-developed countries (MDC) such as Egypt and Brazil are highlighted to demonstrate the extent to which nations with differing abilities to resist political pressure can influence FDI losses. The paper concludes by demonstrating optimal negotiating strategies using a unique game theory framework that models real-world licensing decisions

patent, intellectual property, compulsory license, global health, TRIPS, game theory

Abstract:
The optimal structure of the patent system in the United States as well as globally has been the subject of intense debate in recent years. The fear that patent rights are overly strong or too often cover non-inventive ideas has prompted many to question whether society is really coming out ahead. The call for dramatic reform seems to become stronger each year. Surprisingly, despite a great deal of analysis in the economic and legal literature, the quantitative impact of patents remains unclear. The failure to fully understand patent incentives is a barrier to optimal structure and use of the system; it may lead to less efficient development and dissemination of important, even life-saving, inventions.

This article suggests that our traditional policy of patent system design and reform is misguided. Attempts to comprehensively and rationally construct invention incentives through legal rules are exceedingly likely to fail due to the diverse goals and inherent complexity of the system. In view of the inability to effectively address all of the relevant policy levers in patent law, the article suggests instead utilizing a modulated, incrementalist method of strategic decision-making. General principles of a successful incrementalist approach to patent reform are discussed herein and compared to current reform initiatives.

Patent, intellectual property, innovation, incrementalism

Abstract:
Recent allegations that essential safety and efficacy information is often suppressed by medical product manufacturers or poorly evaluated by regulators have led to calls for greater information transparency. The public is justifiably concerned that its ability to conduct an informed risk-benefit assessment of drugs and medical devices is compromised. Several changes have already been made to federal regulatory law and medical research policy to mandate greater disclosure, and more are being considered. However, it is possible that these measures may backfire by enhancing significant tort-based economic disincentives for generating new information. In other words, greater disclosure could paradoxically lead to less information. The resulting shortfall could be extremely dangerous and have a detrimental effect on health care for years to come. This paper addresses the crisis on the horizon and proposes a unique solution that connects tort law disincentives to information production incentives. It explains why an economically rational company would be expected to respond to transparency with less information, and proposes a tort liability limitation as a solution that will encourage a cost-internalizing company to increase information production. The paper also considers the impact of the FDA's recent position on preemption along with other regulatory enhancements, and concludes that these are effective, but second-best solutions.

FDA, products liability, tort law, regulatory law, pharmaceuticals, medical devices

Abstract:
The U.S. government's threat to side-step Bayer, A.G.'s Cipro(R) patent in order to deal with the anthrax crisis in the fall of 2001 uncovered several important issues related to government appropriations of private patent rights. These issues, which include discerning the proper basis of the government's power and the appropriate measure of compensation as well as the need for legislative change, have heretofore received only indirect scholarly treatment. The analysis of these issues is important because of their probable impact on U.S. foreign policy regarding the protection and enforcement of intellectual property interests and the U.S. government's domestic preparedness to respond to future terrorist attacks.

This important topic is addressed in detail in the paper. The author finds that, under the current statutory scheme, unauthorized government appropriations of private patent rights should be treated as eminent domain takings, compensable at the level required by the Fifth Amendment to the U.S. Constitution. Moreover, the author determines that Fifth Amendment compensation for patent takings is properly calculated by the same rules employed to assess non-punitive, actual damages in private infringement actions. Such rules best adhere to the eminent domain underpinnings of the government's right to appropriate patents. Additionally, private infringement damages rules preserve the innovation incentives that the Patent Act is intended to foster. The author implores courts addressing claims against the government for patent appropriation to immediately dispose of rules creating a preference for more limited damages in the form of a reasonable royalty and adopt the private infringement model of assessing a compensation remedy. In briefly discussing proposed legislation meant to alter this system and further limit the compensation due an aggrieved patent owner, the author concludes that such legislation is unnecessary at this time and potentially harmful in the long term.

Abstract:
Nascent development in alternative energy technologies can be greatly affected by intellectual property environments. Tight control over foundational patent rights by a few companies can hold up commercialization. Conversely, widely dispersed ownership can create thickets that discourage innovation investment ex ante. Given the high technology nature of the most promising alternative energy proposals, such IP impacts are of great concern. This article considers the issue in the specific context of the most widely used alternative fuel source, ethanol-based biofuels. It finds that the ownership environment is quite diverse and theoretically ripe for a so-called anticommons effect. However, using analogies to general agricultural biotechnology, the article demonstrates that the biofuel patent environment is likely to undergo a striking transformation through the effects of private ordering. It articulates a general model of ordering behavior and suggests the most important conditions that facilitate ordering in particular industries. The article concludes that market-based reordering of patent ownership, although not without negatives, may promote efficient commercialization and blunt the need for government intervention in certain alternative energies. It should be factored into any rational public energy policy.

patents, alternative energy, biofuel, anticommons, intellectual property, ethanol

Abstract:
Statutory and common law limitations on intellectual property rights are important aspects of the overall scheme that balances creation and innovation incentives and the rights of the public. Contractual waivers of these rights - particularly in the form of so-called shrink-wrap, click-wrap or browse-wrap licenses - may pose a problem to the extent that they allow an inappropriate extension of intellectual property rights. An issue that has been substantially buried in the many publications discussing this issue from the perspective of contract enforceability and liability is whether the application of efficient contract remedies may alleviate the tension in the regimes apparently in conflict. This paper gives in-depth consideration to that question by providing a comprehensive detailing of the relevant intellectual property rights limitations, addressing the application of contracts to constrain intellectual property limitations and considering potential contract remedies for a breach of the aforementioned contracts for their likely effect on property owners and society. It identifies the practical barriers to efficient and equitable solutions to contractual restraint and presents a striking, graphical demonstration of their impact. The paper concludes with recommendations to help promote efficient merging of federal intellectual property and state contract law.

Abstract:
The judiciary's influence on the economic and social environment in the United States in creating and revising legal rules has been the subject of considerable examination. One of the most important ways in which the courts have such an impact is when their modifications to existing legal rules are applied retroactively and affect actions and decisions made in reliance of the prior rules. Although the concern over the retroactive application of judicial determinations has waned in recent years, the issue is as important today as ever in the context of property rights, and in particular, intellectual property rights.

In this paper, Professor Daniel R. Cahoy takes an in-depth look at how judicial retroactivity can negatively affect efficiency in the economic environment of intellectual property rights. He explains that the special sensitivity to retroactivity exhibited by intellectual property interests make a compelling case for prospective decision making in certain circumstances. Professor Cahoy reviews the general law of retroactivity in the civil law context, and notes that intellectual property rights may provide the incentive to test the continued viability of prospective judicial decision making and preserve the useful remnants of the Chevron v. Huson doctrine. He concludes that courts should give increased consideration to prospective limitations and proposes a more workable and specific version of the Chevron test for intellectual property interests. To demonstrate the practical use of his Enhanced Chevron Test, Professor Cahoy applies his recommendations to three recent and important cases in the field of patent law, including the closely-watched case of Festo Corp. v. Shoketsu Kinzoki Kogyo Kabushiki Co.

intellectual property, patent, copyright, trademark