Swiss Patent Jurisprudence 2012

The new Swiss Federal Patent Court, with nationwide first-instance jurisdiction over all civil patent matters, has been operating since January 1, 2012. This article reviews and contextualizes the most important patent cases published in 2012 by the Swiss Federal Patent Court and the Swiss Federal Supreme Court. More specifically, the article covers cases on issues such as the evidentiary status of party expert opinions, the formal requirements for requests for injunctive relief, the infringement and non-obviousness tests employed by the Swiss Federal Patent Court, the use of reports and statements from technical judges in lieu of expert opinions, and the procedural devices for the pre-trial taking of evidence, in particular the new patent-specific device of precise description. The author suggests that designing the Federal Patent Court to include technically trained judges may lead to a more automatic adoption of the practices and case law of the European Patent Office. The article concludes that the revamped Swiss patent litigation system has the potential of turning Switzerland into a competitive venue for the adjudication of patent matters in Europe.

The Good Society. A Comparative Study of Denmark and Switzerland

Denmark and Switzerland are small and successful countries with exceptionally content populations. However, they have very different political institutions and economic models. They have followed the general tendency in the West toward economic convergence, but both countries have managed to stay on top. They both have a strong liberal tradition, but otherwise their economic strategies are a welfare state model for Denmark and a safe haven model for Switzerland. The Danish welfare state is tax-based, while the expenditures for social welfare are insurance-based in Switzerland. The political institutions are a multiparty unicameral system in Denmark, and a permanent coalition system with many referenda and strong local government in Switzerland. Both approaches have managed to ensure smoothly working political power-sharing and economic systems that allocate resources in a fairly efficient way. To date, they have also managed to adapt the economies to changes in the external environment with a combination of stability and flexibility.

After Bali: WTO Rules Applying to Public Food Reserves

Once more, agriculture threatened to prevent all progress in multilateral trade rule-making at the Ninth WTO Ministerial Conference in December 2013. But this time, the “magic of Bali” worked. After the clock had been stopped mainly because of the food security file, the ministers adopted a comprehensive package of decisions and declarations mainly in respect of development issues. Five are about agriculture. Decision 38 on Public Stockholding for Food Security Purposes contains a “peace clause” which will now be shielding certain stockpile programmes from subsidy complaints in formal litigation. This article provides contextual background and analyses this decision from a legal perspective. It finds that, at best, Decision 38 provides a starting point for a WTO Work Programme for food security, for review at the Eleventh Ministerial Conference which will probably take place in 2017. At worst, it may unduly widen the limited window for government-financed competition existing under present rules in the WTO Agreement on Agriculture – yet without increasing global food security or even guaranteeing that no subsidy claims will be launched, or entertained, under the WTO dispute settlement mechanism. Hence, the Work Programme should find more coherence between farm support and socio-economic and trade objectives when it comes to stockpiles. This also encompasses a review of the present WTO rules applying to other forms of food reserves and to regional or “virtual” stockpiles. Another “low hanging fruit” would be a decision to exempt food aid purchases from export restrictions.

Design of a systematic approach to workplace exposure medical surveillance protocols

Current toxic tort cases have increased national awareness of health concerns and present an important avenue in which public health scientists can perform a vital function: in litigation, and in public health initiatives and promotions which may result. This review presents a systematic approach, using the paradigm of interactive public health disciplines, for the design of a matrix framework for medical surveillance of workers exposed to toxic substances. The matrix framework design addresses the required scientific bases to support the legal remedy of medical monitoring for workers injured as a result of their exposure to toxic agents. A background of recent legal developments which have a direct impact on the use of scientific expertise in litigation is examined in the context of toxic exposure litigation and the attainment of public health goals. The matrix model is applied to five different workplace exposures: dental mercury, firefighting, vinyl chloride manufacture, radon in mining and silica. An exposure matrix designed by the Department of Energy for government nuclear workers is included as a reference comparison to the design matrix. ^

Legal Change and the Social Value of Lawsuits

This paper integrates the literatures on the social value of lawsuits, the evolution of the law, and judicial preferences to evaluate the hypothesis that the law evolves toward efficiency. The setting is a simple accident model with costly litigation where the efficient law minimizes the sum of accident plus litigation costs. In the steady state equilibrium, the distribution of legal rules is not necessarily efficient but instead depends on a combination of selective litigation, judicial bias, and precedent.

An Equilibrium Model of Lawmaking

This paper embeds a model of lawmaking in an equilibrium framework in which the demand for trials is rationed by court delay. The lawmaking process depends on a combination of selective litigation, judicial bias, and precedent. The steady state equilibrium of the model determines both the length of delay and the distribution of legal rules. Comparative statics show that an increase in the supply of trials reduces delay but may or may not increase the proportion of efficient rules. An increase in the fraction of judges biased in favor of the efficient rule, however, will likely improve efficiency on both counts.

Bilateral Accidents with Intrinsically Interdependent Costs of Precaution

The standard economic model of bilateral precaution postulates an interdependency between the care taken by injurers and victims that operates through the effects of each on the expected accident loss. This paper considers situations in which each party's precaution affects not only expected accident loss, but also directly affects the other party's cost of taking precaution. Generalizing the economic model of tort law in this way allows for a more complete analysis of when standard tort rules can and cannot induce optimal precaution. When this additional externality is introduced into a model of unilateral harm (where all accident losses are borne by the victim), none of the standard tort liability rules induces socially optimal behavior by both parties. Moreover, under a contributory negligence rule, the only equilibrium is in mixed strategies; this gives rise to the possibility of litigation in equilibrium. A 'tort-like' liability rule that induces socially optimal behavior by both parties is then characterized; this involves a payment by victims to non-negligent injurers whenever an accident occurs. The model is then extended to consider the case of bilateral harm (where both parties suffer accident losses). It is shown that, as long as both parties can sue to recover their accident losses, all negligence-based tort rules lead to socially optimal behavior by both parties.

The Social versus Private Incentive to Sue

The private value of lawsuits is based on plaintiffs' expected recovery at trial compared to their filing costs, whereas the social value consists of the incentives suits create for injurers to invest in accident avoidance. Generally, there is no relationship between these two values: there may be either too many or too few suits from a social perspective. Thus, there is scope for corrective measures, although there is no simple policy. Extending the model to consider a negligence rule rather than strict liability, and to allow for pretrial settlements, leads to some modified conclusions but does not alter the basic insights.

A Note on Optimal Care by Wealth-Constrained Injurers

This paper clarifies the relationship between an injurer's wealth level and his care choice by highlighting the distinction between monetary and non-monetary care. When care is non-monetary, wealth-constrained injurers generally take less than optimal care, and care is increasing in their wealth level under both strict liability and negligence. In contrast, when care is monetary, injurers may take too much or too little care under strict liability, and care is not strictly increasing in injurer wealth. Under negligence, the relationship between injurer care and wealth is similar in the two formulations. However, when litigation costs are added to the model, the relationship between injurer care and wealth becomes non-monotonic under both liability rules.

Do Exposure Suits Produce a 'Race to File'? An Economic Analysis of a Tort for Risk

Conventional tort law does not allow victims of exposure to a toxic substance to seek compensation until they develop actual symptoms of illness. This may effectively bar recovery because at the time the illness arises, injurers may be judgment proof. One possible response is to allow a tort for risk that allows victims to seek expected damages at the time of exposure. However, critics charge that this could create a 'race to file' wherein victims rush to file suit to ensure that they will get a share of the injurer's limited assets. We show that such a race may or may not occur in equilibrium, and that when it does occur, not all victims choose to file at exposure if bankruptcy is an inevitable result. If bankruptcy is not inevitable, it is possible that a tort for risk will trigger bankruptcy, although a no-bankruptcy equilibrium always exists and Paretodominates the bankruptcy equilibrium. We examine the consequences of the various tort-for-risk equilibria on the compensation of exposure victims, litigation costs, and injurer care.

A Note on the Social versus Private Value of Suits when Care is Bilateral

This paper re-examines the social versus private value of lawsuits when both injurers and victims can take care. The basic conclusions of that literature remain valid in this context: the private and social values generally differ, and there is no necessary relationship between them, meaning that there may be either too many or too few suits. Introducing the possibility of victim care does, however, alter the calculation of the deterrent effect of lawsuits. In particular, because allowing suits tends to reduce the incentives for victims to invest in precaution, the social value of prohibiting suits increases in direct relation to the productivity of victim care in lowering accident risk.

Federally regulated institutional review boards: The aspects of a "model" IRB---Is the current system in need of a tune up or complete overhaul?

Institutional Review Boards (IRBs) are the primary gatekeepers for the protection of ethical standards of federally regulated research on human subjects in this country. This paper focuses on what general, broad measures that may be instituted or enhanced to exemplify a "model IRB". This is done by examining the current regulatory standards of federally regulated IRBs, not private or commercial boards, and how many of those standards have been found either inadequate or not generally understood or followed. The analysis includes suggestions on how to bring about changes in order to make the IRB process more efficient, less subject to litigation, and create standardized educational protocols for members. The paper also considers how to include better oversight for multi-center research, increased centralization of IRBs, utilization of Data Safety Monitoring Boards when necessary, payment for research protocol review, voluntary accreditation, and the institution of evaluation/quality assurance programs. ^ This is a policy study utilizing secondary analysis of publicly available data. Therefore, the research for this paper focuses on scholarly medical/legal journals, web information from the Department of Health and Human Services, Federal Drug Administration, and the Office of the Inspector General, Accreditation Programs, law review articles, and current regulations applicable to the relevant portions of the paper. ^ Two issues are found to be consistently cited by the literature as major concerns. One is a need for basic, standardized educational requirements across all IRBs and its members, and secondly, much stricter and more informed management of continuing research. There is no federally regulated formal education system currently in place for IRB members, except for certain NIH-based trials. Also, IRBs are not keeping up with research once a study has begun, and although regulated to do so, it does not appear to be a great priority. This is the area most in danger of increased litigation. Other issues such as voluntary accreditation and outcomes evaluation are slowing gaining steam as the processes are becoming more available and more sought after, such as JCAHO accrediting of hospitals. ^ Adopting the principles discussed in this paper should promote better use of a local IRBs time, money, and expertise for protecting the vulnerable population in their care. Without further improvements to the system, there is concern that private and commercial IRBs will attempt to create a monopoly on much of the clinical research in the future as they are not as heavily regulated and can therefore offer companies quicker and more convenient reviews. IRBs need to consider the advantages of charging for their unique and important services as a cost of doing business. More importantly, there must be a minimum standard of education for all IRB members in the area of the ethical standards of human research and a greater emphasis placed on the follow-up of ongoing research as this is the most critical time for study participants and may soon lead to the largest area for litigation. Additionally, there should be a centralized IRB for multi-site trials or a study website with important information affecting the trial in real time. There needs to be development of standards and metrics to assess the performance of the IRBs for quality assurance and outcome evaluations. The boards should not be content to run the business of human subjects' research without determining how well that function is actually being carried out. It is important that federally regulated IRBs provide excellence in human research and promote those values most important to the public at large.^

The role of municipalities in air toxics regulation: The Houston experience

The federal regulatory regime for addressing airborne toxic pollutants functions fairly well in most of the country. However, it has proved deficient in addressing local risk issues, especially in urban areas with densely concentrated sources. The problem is especially pronounced in Houston, which is home to one of the world's biggest petrochemical complexes and a major port, both located near a large metropolitan center. Despite the fact that local government's role in regulating air toxics is typically quite limited, from 2004-2009, the City of Houston implemented a novel municipality-based air toxics reduction strategy. The initiatives ranged from voluntary agreements to litigation and legislation. This case study considers why the city chose the policy tools it did, how the tools performed relative to the designers' intentions, and how the debate among actors with conflicting values and goals shaped the policy landscape. The city's unconventional approach to controlling hazardous air pollution has not yet been examined rigorously. The case study was developed through reviews of publicly available documents and quasi-public documents obtained through public record requests, as well as interviews with key informants. The informants represented a range of experience and perspectives. They included current and former public officials at the city (including Mayor White), former Texas Commission on Environmental Quality staff, faculty at local universities, industry representatives, and environmental public health advocates. Some of the city's tools were successful in meeting their designers' intent, some were less successful. Ultimately, even those tools that did not achieve their stated purpose were nonetheless successful in bringing attention and resources to the air quality issue. Through a series of pleas and prods, the city managed to draw attention to the problem locally and get reluctant policymakers at higher levels of government to respond. This work demonstrates the potential for local government to overcome limitations in the federal regulatory regime for air toxics control, shifting the balance of local, state, and federal initiative. It also highlights the importance of flexible, cooperative strategies in local environmental protection.^

Patenting genes and gene sequences: Analysis of public health implications and the law

At issue is whether or not isolated DNA is patent eligible under the U.S. Patent Law and the implications of that determination on public health. The U.S. Patent and Trademark Office has issued patents on DNA since the 1980s, and scientists and researchers have proceeded under that milieu since that time. Today, genetic research and testing related to the human breast cancer genes BRCA1 and BRCA2 is conducted within the framework of seven patents that were issued to Myriad Genetics and the University of Utah Research Foundation between 1997 and 2000. In 2009, suit was filed on behalf of multiple researchers, professional associations and others to invalidate fifteen of the claims underlying those patents. The Court of Appeals for the Federal Circuit, which hears patent cases, has invalidated claims for analyzing and comparing isolated DNA but has upheld claims to isolated DNA. The specific issue of whether isolated DNA is patent eligible is now before the Supreme Court, which is expected to decide the case by year's end. In this work, a systematic review was performed to determine the effects of DNA patents on various stakeholders and, ultimately, on public health; and to provide a legal analysis of the patent eligibility of isolated DNA and the likely outcome of the Supreme Court's decision. ^ A literature review was conducted to: first, identify principle stakeholders with an interest in patent eligibility of the isolated DNA sequences BRCA1 and BRCA2; and second, determine the effect of the case on those stakeholders. Published reports that addressed gene patents, the Myriad litigation, and implications of gene patents on stakeholders were included. Next, an in-depth legal analysis of the patent eligibility of isolated DNA and methods for analyzing it was performed pursuant to accepted methods of legal research and analysis based on legal briefs, federal law and jurisprudence, scholarly works and standard practice legal analysis. ^ Biotechnology, biomedical and clinical research, access to health care, and personalized medicine were identified as the principle stakeholders and interests herein. Many experts believe that the patent eligibility of isolated DNA will not greatly affect the biotechnology industry insofar as genetic testing is concerned; unlike for therapeutics, genetic testing does not require tremendous resources or lead time. The actual impact on biomedical researchers is uncertain, with greater impact expected for researchers whose work is intended for commercial purposes (versus basic science). The impact on access to health care has been surprisingly difficult to assess; while invalidating gene patents might be expected to decrease the cost of genetic testing and improve access to more laboratories and physicians' offices that provide the test, a 2010 study on the actual impact was inconclusive. As for personalized medicine, many experts believe that the availability of personalized medicine is ultimately a public policy issue for Congress, not the courts. ^ Based on the legal analysis performed in this work, this writer believes the Supreme Court is likely to invalidate patents on isolated DNA whose sequences are found in nature, because these gene sequences are a basic tool of scientific and technologic work and patents on isolated DNA would unduly inhibit their future use. Patents on complementary DNA (cDNA) are expected to stand, however, based on the human intervention required to craft cDNA and the product's distinction from the DNA found in nature. ^ In the end, the solution as to how to address gene patents may lie not in jurisprudence but in a fundamental change in business practices to provide expanded licenses to better address the interests of the several stakeholders. ^

Poderes locales y gobierno central ante el cambio de régimen en Buenos Aires : Cartas de ciudadanía, cargos públicos y práctica de oficios, 1812-1815

En la presente ponencia nos proponemos analizar la situación jurídica y política de algunos extranjeros que ocupaban cargos públicos o realizaban oficios civiles en el Rio de la Plata. En este contexto, los criterios para definir quién era un vecino-ciudadano dependían de la posibilidad de mantener o perder cargos públicos, o de ejercer ciertos oficios en los pueblos de la campaña. Se estudiarán dos casos en los cuales se presentaron situaciones análogas para los que no eran reconocidos pertenecientes a la comunidad política, es decir para los extranjeros. Aquellos que no lograban la obtención de una carta de ciudadanía se veían obligados a dejar sus cargos u oficios. Sin embargo, los reglamentos y las decisiones del gobierno en estos casos se vieron superados por las prácticas y situaciones concretas. Otro de los casos estudiados en esta ponencia se corresponde con un litigio en Chascomús un fuerte y pueblo de la campaña de Buenos Aires, en la frontera con el mundo indígena. Allí, un hombre de origen catalán le es impedido ejercer su oficio de panadero, limitándolo a la producción de pastelería fina. La decisión fue tomada por el comandante del fuerte ante un pedido de un grupo de panaderas que se consideraban 'patricias', señalando el origen español de dicho panadero para limitarlo en el ejercicio del oficio. El conflicto nos ofrece varias aristas interesantes sobre los mecanismos del ejercicio del poder que estamos viendo en otros trabajos, pero aquí nos detendremos en la definición del grupo de pertenencia y en la utilización de los conceptos de patria y patriotas