Rules for Patents

There is widespread agreement that the patent system in the United States is in need of reform. Most of the proposals for patent reform that have proliferated in recent years share two common assumptions: first, that patent policy is best made through case-bycase adjudication of the validity of individual patents; and, second, that the existing allocation of authority over patent policy, in which the courts are primarily responsible for interpreting and applying the broad language of the Patent Act, ought not to be disturbed. ThisArticle challenges both assumptions. I approach the problem of patent reform primarily as a problem of sound administration rather than innovation policy and argue that Congress should grant the Patent and Trademark Office (PTO) substantive rule-making authority. The administrative structure of the patent system has been largely unchanged since 1836. But the administrative tasks that a wellperforming patent system must carry out have changed markedly since that time. Most importantly, technology in the early- to midnineteenth century was relatively uniform. Today, by contrast, the process of innovation varies widely among different technologies and different industries. If the patent system is to meet its goal of providing incentives for innovation, it must self-consciously tailor the elements of patentability—both rules and standards—to those diverse circumstances. Optimal patent policymaking requires forward-looking deliberation and cost-benefit analysis based on technological and economic expertise; clarity and predictability so that entities making investment choices based on the property-like aspects of patents can be confident in the legal regime governing those rights; and transparency and accountability to ensure that the public interest—which is often distinct from the interests of patent holders—is taken into account. Unlike courts, agencies acting through rulemaking cangather and expertly analyze all of the relevant information to make express policy judgments based on costs and benefits, can decide issues prospectively and avoid piecemeal decision making, and can systematically engage the public in the policy-making process. Although agencies are subject to certain well-understood institutional pathologies, such as capture by powerful interests, on balance they are more likely to make effective patent policy than courts. Granting the PTO substantive rule-making authority would require significant changes to the structure and function of that agency, and to the role of the courts. The PTO would require the addition of a policy-making capacity separate but capable of drawing insights from the examination process. The courts in turn would play a constructive secondary role by surfacing issues that require attention in the interstices of agency rules and engaging in judicial review of those rules under traditional standards of administrative law

Exchanging Information Without Intellectual Property

Contracting over information is notoriously difficult. Nearly fifty years ago, Kenneth Arrow articulated a “fundamental paradox” that arises when two parties try to exchange information. To complete such a transaction, the buyer of information must be able to place a value on the information. But once the seller discloses the information, the buyer can take it without paying. The conventional solution to this disclosure paradox is intellectual property. If the information is protected by a patent or a copyright then the seller can disclose the information free in the knowledge that the buyer can be enjoined against making, using, or selling it without permission. This account of information exchange forms the basis for an increasingly popular argument in favor of strong and broad intellectual property rights for the purpose of overcoming the disclosure paradox and thereby facilitating the development and commercialization of ideas. That argument, however, rests on assumptions about the nature of information that are neither theoretically nor empirically justified. This article explains that, contrary to the conventional account of the disclosure paradox, information is not always nonexcludable and is not always a homogeneous asset. Instead, information is complex and multifaceted, subject to some inherent limitations but also manipulable by its holders. These characteristics give rise to a range of strategies for engaging in information exchange, of which intellectual property is only one. Information holders can use the characteristics of information itself as well as contractual and norms-based mechanisms and other legal or business strategies to achieve exchange. And examples drawn from fields as diverse and disparate as software and biotechnology show that entrepreneurs and inventors use these strategies alone or in combination to effectively link their ideas with capital and development skills, often without intellectual property playing a significant role in the transaction. Intellectual property is therefore not necessary to promote robust markets for information and is, in fact, just as contingent and context-specific a solution to the paradox as the alternatives described here. At the very least, then, there is reason to doubt that commercialization theories founded upon information exchange provide a standalone justification for intellectual property. This article urges caution in policy interventions that seek to respond to the disclosure paradox and sets the stage for future empirical research to better understand the dynamics of information exchange strategies and the social welfare costs and benefits that may accompany them

Reply - Commercialization without Exchange

In this brief reply to Prof. Ted Sichelman’s comments on my article Exchanging Information Without Intellectual Property, I argue that justifications for intellectual property that rely on the incentives exclusive rights offer for commercialization are not economically distinguishable from traditional theories based on incentives to invent or create in the first instance. Because innovation is not an event but a process, innovative activities may be subject to misappropriation – and therefore under-production – at multiple points along the supply chain that runs from conception to commercialization. The grant of exclusive rights is an intervention that can be made at any of these points. Whether granted early or late in the innovation process, the economic function of the intervention is the same. Similarly, the intervention is subject to similar critiques – most notably that their social welfare costs exceed their benefits and that alternative forms of incentive may be just as effective at lower social cost – regardless of when it is made. The incentives-based “commercialization theory” therefore is really just a version of traditional “reward theory” set later in time. In my work, I isolate and critique a different economic function that exclusive rights may serve with respect to commercialization: that of facilitating exchange

Innovation Prizes in Practice and Theory

Innovation prizes in reality are significantly different from innovation prizes in theory. The former are familiar from popular accounts of historical prizes like the Longitude Prize: the government offers a set amount for a solution to a known problem, like £20,000 for a method of calculating longitude at sea. The latter are modeled as compensation to inventors in return for donating their inventions to the public domain. Neither the economic literature nor the policy literature that led to the 2010 America COMPETES Reauthorization Act — which made prizes a prominent tool of government innovation policy — provides a satisfying justification for the use of prizes, nor does either literature address their operation. In this article, we address both of these problems. We use a case study of one canonical, high profile innovation prize — the Progressive Insurance Automotive X Prize — to explain how prizes function as institutional means to achieve exogenously defined innovation policy goals in the face of significant uncertainty and information asymmetries. Focusing on the structure and function of actual innovation prizes as an empirical matter enables us to make three theoretical contributions to the current understanding of prizes. First, we offer a stronger normative justification for prizes grounded in their status as a key institutional arrangement for solving a specified innovation problem. Second, we develop a model of innovation prize governance and then situate that model in the administrative state, as a species of new governance or experimental regulation. Third, we derive from those analyses a novel framework for choosing among prizes, patents, and grants, one in which the ultimate choice depends on a trade off between the efficacy and scalability of the institutional solution

Panel III: Politics and the Public in IP & Info Law Policy Making

We have been moving gradually from the theoretical to the practical. Having examined the impact of critical legal studies ( CLS ) in the academy and having discussed the intersection between scholarship and activism, we now turn to the nitty-gritty questions of how to actually enact change in intellectual property and information law and policy

Panel III: Politics and the Public in IP & Info Law Policy Making

We have been moving gradually from the theoretical to the practical. Having examined the impact of critical legal studies ( CLS ) in the academy and having discussed the intersection between scholarship and activism, we now turn to the nitty-gritty questions of how to actually enact change in intellectual property and information law and policy

A randomized, double-blind study of AMG 108 (a fully human monoclonal antibody to IL-1R1) in patients with osteoarthritis of the knee

INTRODUCTION: AMG 108 is a fully human, immunoglobulin subclass G2 (IgG2) monoclonal antibody that binds the human interleukin-1 (IL-1) receptor type 1, inhibiting the activity of IL-1a and IL-1b. In preclinical studies, IL-1 inhibition was shown to be beneficial in models of osteoarthritis (OA). The purpose of this two-part study was to evaluate the safety and pharmacokinetics (PK; Part A) and clinical effect (Part B) of AMG 108 in a double-blind, placebo-controlled, multiple-dose study in patients with OA of the knee. METHODS: In Part A, patients received placebo or AMG 108 subcutaneously (SC; 75 mg or 300 mg) or intravenously (IV; 100 mg or 300 mg) once every 4 weeks for 12 weeks; in Part B, patients received placebo or 300 mg AMG 108 SC, once every 4 weeks for 12 weeks. The clinical effect of AMG 108 was measured in Part B by using the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index pain score. RESULTS: In Part A, 68 patients were randomized, and 64 received investigational product. In Part B, 160 patients were randomized, and 159 received investigational product. AMG 108 was well tolerated. Most adverse events (AEs), infectious AEs, serious AEs and infections, as well as withdrawals from the study due to AEs occurred at similar rates in both active and placebo groups. One death was reported in an 80-year-old patient (Part A, 300 mg IV AMG 108; due to complications of lobar pneumonia). AMG 108 serum concentration-time profiles exhibited nonlinear PK. The AMG 108 group in Part B had statistically insignificant but numerically greater improvement in pain compared with the placebo group, as shown by the WOMAC pain scores (median change, -63.0 versus -37.0, respectively). CONCLUSIONS: The safety profile of AMG 108 SC and IV was comparable with placebo in patients with OA of the knee. Patients who received AMG 108 showed statistically insignificant but numerically greater improvements in pain; however, minimal, if any, clinical benefit was observed. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov with the identifier NCT00110942.Stanley B Cohen, Susanna Proudman, Alan J Kivitz, Francis X Burch, John P Donohue, Deborah Burstein, Yu-Nien Sun, Christopher Banfield, Michael S Vincent, Liyun Ni, and Debra J Zac

Identification of a New Class of Molecules, the Arachidonyl Amino Acids, and Characterization of One Member That Inhibits Pain

In mammals, specific lipids and amino acids serve as crucial signaling molecules. In bacteria, conjugates of lipids and amino acids (referred to as lipoamino acids) have been identified and found to possess biological activity. Here, we report that mammals also produce lipoamino acids, specifically the arachidonyl amino acids. We show that the conjugate of arachidonic acid and glycine (N-arachidonylglycine (NAGly)) is present in bovine and rat brain as well as other tissues and that it suppresses tonic inflammatory pain. The biosynthesis of NAGly and its degradation by the enzyme fatty acid amide hydrolase can be observed in rat brain tissue. In addition to NAGly, bovine brain produces at least two other arachidonyl amino acids: N-arachidonyl gamma-aminobutyric acid (NAGABA) and N-arachidonylalanine. Like NAGly, NAGABA inhibits pain. These findings open the door to the identification of other members of this new class of biomolecules, which may be integral to pain regulation and a variety of functions in mammals

The non-thermal superbubble in IC 10 : the generation of cosmic ray electrons caught in the act

Superbubbles are crucial for stellar feedback, with supposedly high (of the order of 10 per cent) thermalization rates. We combined multiband radio continuum observations from the Very Large Array (VLA) with Effelsberg data to study the non-thermal superbubble (NSB) in IC 10, a starburst dwarf irregular galaxy in the Local Group. Thermal emission was subtracted using a combination of Balmer Hα and VLA 32 GHz continuum maps. The bubble’s nonthermal spectrum between 1.5 and 8.8 GHz displays curvature and can be well fitted with a standard model of an ageing cosmic ray electron population. With a derived equipartition magnetic field strength of 44 ±8 μG, and measuring the radiation energy density from Spitzer MIPS maps as 5±1×10−11 erg cm−3, we determine, based on the spectral curvature, a spectral age of the bubble of 1.0 ± 0.3 Myr. Analysis of the LITTLE THINGS HI data cube shows an expanding HI hole with 100 pc diameter and a dynamical age of 3.8 ± 0.3 Myr, centred to within 16 pc on IC 10 X-1, a massive stellar mass black hole (M > 23 M⊙). The results are consistent with the expected evolution for a superbubble with a few massive stars, where a very energetic event like a Type Ic supernova/hypernova has taken place about 1 Myr ago. We discuss alternatives to this interpretationPeer reviewe

The stellar kinematics and populations of boxy bulges: cylindrical rotation and vertical gradients

Boxy and peanut-shaped bulges are seen in about half of edge-on disc galaxies. Comparisons of the photometry and major-axis gas and stellar kinematics of these bulges to simulations of bar formation and evolution indicate that they are bars viewed in projection. If the properties of boxy bulges can be entirely explained by assuming they are bars, then this may imply that their hosts are pure disc galaxies with no classical bulge. A handful of these bulges, including that of the Milky Way, have been observed to rotate cylindrically, i.e. with a mean stellar velocity independent of height above the disc. In order to assess whether such behaviour is ubiquitous in boxy bulges, and whether a pure disc interpretation is consistent with their stellar populations, we have analysed the stellar kinematics and populations of the boxy or peanut-shaped bulges in a sample of five edge-on galaxies. We placed slits along the major axis of each galaxy and at three offset but parallel positions to build up spatial coverage. The boxy bulge of NGC3390 rotates perfectly cylindrically within the spatial extent and uncertainties of the data. This is consistent with the metallicity and alpha-element enhancement of the bulge, which are the same as in the disk. This galaxy is thus a pure disc galaxy. The boxy bulge of ESO311-G012 also rotates very close to cylindrically. The boxy bulge of NGC1381 is neither clearly cylindrically nor non-cylindrically rotating, but it has a negative vertical metallicity gradient and is alpha-enhanced with respect to its disc, suggesting a composite bulge comprised of a classical bulge and bar (and possibly a discy pseudobulge) [abridged] Even this relatively small sample is sufficient to demonstrate that boxy bulges display a range of rotational and population properties, indicating that they do not form a homogeneous class of object.Comment: MNRAS accepted. 10 page