The Tsai Center supports the research of the faculty of the SMU Dedman School of Law at the intersection of law, science, and innovation. Examples of recent and historically significant scholarship by the faculty in this area includes the following:
The law of copyright—traditionally an arcane and obscure specialty—has evolved into an extraordinarily controversial legal arena. To a significant extent, though not exclusively, this has been caused by the emerging clashes between copyright on the one hand and digital technology and the internet on the other. Some see copyright as the aggressor in the copyright wars, guilty of threatening the digital revolution, the internet, information policy, privacy, freedom of speech and the public domain. Much of this assault on copyright is culturally driven by the Internet's champions. Inevitably, this cultural challenge is now duly reflected in legal argument as well. As copyright law has generated more and more controversy, several legal scholars have come forth to challenge the traditional reconciliation of copyright and freedom of speech. Among the aforementioned scholars, whom I will collectively refer to as the “free speech critics”, virtually all of them reject the traditional reconciliation of copyright and freedom of speech—though some do believe that the two fields can be harmonized on other grounds. While I regard this genre of scholarship as quite thought-provoking, to the extent that it rejects the traditional reconciliation of copyright and freedom of speech, I ultimately find it unpersuasive. Fortunately, I am not alone; so does the United States Supreme Court, as well as nearly every other federal court that has had occasion to consider the issue. In a nutshell, my thesis is that the Court's recent opinion in Eldred v. Ashcroft
should properly be read as the resounding rejection of practically all of the modern first amendment-based copyright challenges. The time has come for the free speech critics to return to the drawing board and, if anything, re-examine free speech doctrine rather than copyright. Moreover, and contrary to recent criticism, the Court's re-endorsement of the traditional reconciliation of copyright and free speech is correct, sensible, and persuasive.
Mobile health (“mHealth”) technologies that employ portable devices such as smartphones and tablets for medical purposes are rapidly transforming the medical profession. Yet adapting existing regulatory processes to ensure the safety and efficacy of this new set of products has proved challenging for the U.S. Food and Drug Administration (FDA). In this Article, we highlight issues encountered by the agency in applying its authority and its established approval and monitoring processes to this new genre of medical devices. After reviewing legislative proposals and recommendations by the FDA as to the appropriate scope of agency oversight of mHealth products, we present policy recommendations for updating the FDA’s authority. We conclude that preserving the FDA’s premarket and postmarket authority and providing the agency with additional funding and expertise provide a more promising solution than strictly limiting FDA’s authority, which could impede the agency’s ability to adapt to future innovation by tying it to existing products.
Natural gas produced through hydraulic fracturing remains a critical, and controversial, component of U.S. energy production. A key environmental issue associated with fracking is the management and disposal of the enormous quantities of wastewater generated in the process. Substantial federal authority exists to regulate fracking wastewater under the Resource Conservation and Recovery Act and the Clean Water Act. Regulation under RCRA, however, depends on classification of the wastewater as a RCRA “hazardous waste.” Although EPA has generally exempted oil and gas wastes, including fracking wastewater, from classification as a RCRA hazardous waste, it appears that fracking wastewater would not generally be classified as a hazardous waste even without the exclusion. Tailored regulation under RCRA could, however, be accomplished through EPA adopting a set of “contingent management” requirements, but this would first require EPA to list fracking wastewater as a RCRA hazardous waste. The discharge of fracking wastewater is also subject to regulation under the Clean Water Act. Fracking wastewater generated from the onshore production of shale gas (and presumably natural gas from tight sandstone) is generally subject to a national “technology-based” zero discharge limitation. Since 1982, however, EPA has claimed that no national effluent limitations apply to the discharge of wastewaters generated from production of coal bed methane. EPA’s position, originally adopted through private correspondence, is open to question, and its proposed decision to drop development of such limitations is based on unexplained economic judgments. Although EPA has consistently claimed that CBM discharges are subject to site-specific limits based on “best professional judgment,” EPA has provided little guidance on development of such limits. In addition, EPA has established no specific limitations on the discharge of fracking wastewater from Publicly Owned Treatment Works. EPA policies suggest it should adopt a federal “pretreatment standard” that prohibits the transfer of fracking wastewater to POTWs. EPA has the authority, but not the will, to establish a set of consistent national regulations that will assure the proper management of fracking wastewater. EPA must address these issues to assure that continued reliance on fracking in the U.S. is based on environmentally sound practices.
Any state that recognizes the validity of surrogacy contracts, whether by decision or by statute, without specifically addressing the issues discussed in this article, will create a confused and potentially dangerous regime of law. One need only review the Baby M
trial court opinion to appreciate the magnitude of the problems. Accordingly, while the problems identified here are less acute in New Jersey after their supreme court’s decision to invalidate the contract, they are unfortunately very much with us in most other jurisdictions.
High tech companies—especially in the emerging areas of the Internet of Things, wearable devices, and personalized medicine—have found it difficult to enforce their patents on interactive technologies. This is especially true when multiple parties combine to perform all of the steps of a claimed method. This problem is referred to as joint or divided infringement, and some commentators advocate that “interactive” patents susceptible to divided infringement should not be enforced. In contrast, this article argues that economic theory supports the enforcement of interactive patents. Previous papers have analyzed divided infringement problems from a doctrinal and policy perspective. This article is the first to analyze divided infringement from an economic perspective, using three prevalent economic theories of the patent system. Uniquely, all three prevalent economic theories of the patent system—1) reward theory, (2) prospect theory, and (3) rent dissipation theory—support the enforcement of interactive patents. Reward theory is consistent with enforcing the rights of interactive patents so long as the patent system balances the social cost with the social benefit of interactive technologies. Prospect theory recommends enforcing interactive patents where it would promote an inventor’s ability to commercialize her invention free from direct competition. Finally, rent dissipation theory suggests enforcing interactive patents if it will effectively reduce the dissipation of patent rents. Viewing interactive patent enforcement through the lens of these economic theories reveals how doctrinal tests for divided infringement may align with the economic goals of the patent system. Although it is likely that the doctrinal test for divided infringement will continue to evolve, start-ups and disruptive, hi-tech companies who own interactive patents should find some guidance in the notion that the economic underpinnings of the patent system support enforcement of their interactive inventions.
Rehabilitation’s making a comeback. Long thought to be an outdated approach to punishment, rehabilitation is reemerging in the wake of scientific advances. Not only have these advances in the fields of pharmacology, genetics, and neuroscience brought new rehabilitative possibilities, but the media’s communication of these advances to the general public have set the stage for rehabilitation’s reprise. The media constantly pummels the general public with reports of scientific breakthroughs like functional magnetic resonance imaging, prepping the public to be more accepting of deterministic viewpoints and to be more open to the possibility of transforming individuals. The rehabilitation that is emerging, however, differs in kind from the rehabilitation that reigned during the previous era. Instead of being aimed at transforming an individual’s character, this new rehabilitation focuses instead on changing the offender’s behavior. This intense focus on offender behavior may make rehabilitation in the form of transforming an offender’s biochemical composition more palatable to the average American, and indeed this new approach has the potential to be faster, more targeted, and more effective. Adoption of this new rehabilitation, though, discards the humanity of offenders, ignoring the dignity to which they are constitutionally entitled, and it also poses new concerns of coercion. In addition to recognizing rehabilitation’s return, it is important to understand this new version of rehabilitation and the implications it raises for the dignity of offenders.
While the existence of patent assertion entities is not new, in recent years they have proliferated, spawning debate concerning their impact on the patent system and, more broadly, on technological innovation. Despite the fear that they instill in their targets — or perhaps because of it — patent assertion entities arguably serve a beneficial purpose in the patent system. Theoretically they should be able to help individual inventors and small businesses, in particular, obtain a return on their investment in research and development. To the extent patent assertion entities assert patent claims that should be held invalid, not infringed, or unenforceable; obtain unreasonable judgments or settlements; or fail to return a substantial portion of settlements and judgments to inventors, however, patent assertion entities highlight problems with the patent system. This Article thus contributes to the ongoing debate concerning patent assertion entities, first, by identifying three primary problems with the patent system that some patent assertion entities exploit: (1) poor patent quality, (2) problems with patent litigation, and (3) various asymmetries. Then, this Article evaluates the current state of affairs regarding patent reform legislation and, in a largely descriptive sense, considers the extent to which this legislation — some enacted, some pending — addresses these three primary problems. Finally and more broadly, given the patent reform legislation already enacted and the ways in which it has addressed these three primary problems, this Article calls for consideration of whether legislative reform rather than judicial or agency reform is the best avenue to address remaining problems with the patent system.