The Political Economy of Patent Policy Reform in the United States

During the 1980s and 1990s, important legislative, judicial, and diplomatic initiatives emanated from the United States, strengthening patent and copyright enforcement systems both domestically and in the broader world economy. The political influences that led to these changes are interesting in their own right. Even more interesting, however, is the fact that governmental emphasis on patent systems increased in the wake of impressive new findings from economic studies showing that patents played a surprisingly minor role in well-established corporations' decisions to invest in research, development, and technological innovation. The opposing movements of the political and behavioral science currents will be a principal theme of this article.

The Myths of Data Exclusivity

This article contributes to an ongoing academic and public policy dialogue over whether and on what terms U.S. law should provide “data exclusivity” for new medicines. Five years after a new drug has been approved on the basis of an extensive application that may have cost more than one billion dollars to generate, federal law permits submission of a much smaller application to market a duplicate version of the drug. This second application is a different type of application, and it may cost no more than a few million dollars to prepare. A similar sequence is true for biological medicines: twelve years after approval of an application that may have cost over one billion dollars to generate, the law permits approval of a smaller and less expensive application for a duplicate. Scholars, courts, and policymakers use the phrase “data exclusivity” to describe the period before the new pathway opens – a nod to the fact that applications of the second type rely on the research submitted by the first entrant. The primary “myth” of data exclusivity is that it is a benefit provided by the government for the benefit of first entrants. This article reframes data exclusivity instead as a period of time during which all firms are subject to the same rules governing market entry. It uses this insight as the foundation for an exploration of the complex web of legal, regulatory, and practical factors that may influence whether and on what terms firms enter the market with duplicates during and after that period, and for a systematic comparison of the new drug exclusivity and biological product exclusivity schemes in order to propose an approach that could prompt strategic decisions – both during and after that period – that will contribute to dynamic social welfare

A Common Law Lawyer on the Supreme Court: The Opinions of Justice Stevens

Autonomous driving has been an important topic of research in recent years. In this thesis we study its application to Heavy Duty Vehicles, more specically, vehicles consisting of a truck and a trailer. An overview study is done on three fundamental steps of an autonomous driving system, planning, trajectory tracking and obstacle avoidance. In the planning part, we use RRT, and two other variants of the algorithm to nd trajectories in an unstructured environment, e.g., a mining site. A novel path optimization post-processing technique well suited for use with RRT solutions was also developed. For the trajectory tracking task several well-known controllers were tested, and their performance compared. An extension is proposed to one of the controllers in order to take into account the trailer. The performance evaluation was done on scaled truck systems in the Smart Mobility Lab at KTH. The obstacle avoidance is done with the aid of a simple, yet functional Model Predictive Controller. For this purpose, we developed dierent formulations of the optimization problem, corresponding to distinct optimization goals and vehicle models, in order to assess both the quality of the MPC, and of the assumed truck model. The outcome of this thesis is a fully autonomous system, able to plan and move in constrained environments, while avoiding unpredicted obstacles. It was implemented using a 1:32 scale remote controlled truck, commanded by a desktop computer

Molecular clouds and stellar feedback: an investigation of synthetic line and continuum emission maps

Molecular clouds are complex systems and the search of adequate observational measurements to trace their evolution is still an open problem. In this thesis, we use produce synthetic emission maps of the 12CO 1-0, 13CO 1-0, [CI] 1-0, and [CII] lines, as well as of the FIR continuum emission, to test to which extent these emission measurements can be used as tracers of the evolutionary stage of molecular clouds. We use numerical simulations of molecular clouds performed within the SILCC-Zoom project. These simulations include detailed stellar feedback due to ionizing radiation, external magnetic fields, and a chemical network evolved on-the-fly. We compare two different chemical networks, NL97 and NL99, and we find that NL97, even though it does not include neutral carbon, more accurately reproduces the abundances of CO and C+. We then use NL97 in the rest of the work. We introduce a novel post-processing procedure for the C+ abundance using CLOUDY, essential in HII regions to account for the higher ionization states due to stellar radiation. Furthermore, we show that assuming chemical equilibrium results in H and H2 being underestimated and overestimated, respectively, by up to a factor of 2. The abundances of C+ and CO are also, respectively, underestimated and overestimated. This is reflected and amplified in the estimation of the CO and [CII] luminosity as well. We also investigate the capability of the L_CO/L_[CII] luminosity ratio to trace the H2 mass fraction in the clouds, but find no clear trend. We then investigate the [CII]/FIR ratio in HII regions and in entire clouds with stellar feedback. In young HII regions the drop of the [CII]/FIR intensity ratio is mainly due to the strong FIR emission produced by hot and dense dust, and the contemporary saturation of the [CII] line. In more evolved HII regions, the second ionization of carbon is the main reason for the low [CII]/FIR ratio. The evolution of this ratio is reflected in the evolution of the L_[CII]/L_FIR luminosity ratio in the entire clouds. This evolution can be schematized in three phases. Overall, L_[CII]/L_FIR is well correlated with the total stellar luminosity L_*tot. The relation between L_[CII]/L_FIR andL_*tot can be fitted with a power-law. When L_*tot is large, i.e., in evolved clouds which formed many massive stars, L_[CII]/L_FIR is particularly low, determining an observable [CII]-deficit in these clouds. However, this relation breaks when the total FIR luminosity stars decreasing as a consequence of the cloud dispersal caused by the stellar feedback. The aspect of HII regions in molecular clouds strongly depends on the geometry of the cloud, and on the line of sight. Indeed, a certain HII region can have different properties when observed from different LOS, and apparent HII regions, which are actually only the result of projection effects, can be observed

Unofficial Legislative History of the Biologics Price Competition and Innovation Act 2009, An

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCIA) which created a regulatory pathway for, and scheme for litigation of patent issues relating to, “biosimilar” biological products. This article discusses the history of the BPCIA and explains its provisions. Section I provides background and a history of the regulation of drugs and biological products in the United States. Section II describes the growing interest in biosimilar approval from the early 2000s through September 2006, when the legislative debate began in earnest. Section III describes the legislative and stakeholder process from September 2006 to enactment, and section IV discusses the BPCIA in some detail. These sections show, and the conclusion in section V explains, that the regulatory and intellectual property issues addressed in the final 2010 legislation were debated, discussed, explored, and vetted by stakeholders — including the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), Democrats and Republicans in both House and Senate, the United States Pharmacopoeia, the generic industry, the biosimilar industry, trade associations, professional organizations like the Drug Information Association (DIA), and European regulators — for (in some cases) as many as ten years. Moreover, as these sections also show, like the Hatch-Waxman amendments of 1984, the final legislation represents a true compromise of competing interests

Ilo Marie Grundberg, Janice Gray v. The Upjohn Company : Brief of Appellant

Appendix to Brief of Petitioner The Upjohn Company on certified question

Ilo Marie Grundberg, Janice Gray v. The Upjohn Company : Brief of Appellant

Appendix to Brief of Petitioner The Upjohn Company on certified question

The Lyric of Lafracoth

A medieval historical fiction in dramatic form for older adolescents and adults, this verse play depicts a person of conscience in early 12th century Ireland. This work is intended for late adolescents and adults who have either acquired or are engaged in higher education. The author envisions uses in classrooms, drama and book clubs in which conscience sensitive character analyses and discussions of moral life in and out of religious contexts are deemed worthy of pursuit