Data Management Policies and Issues with Life Science Data

Data management and sharing are relatively new concepts in the health and life sciences fields. This presentation will cover some basic policies as well as the impediments to data sharing unique to health and life sciences data.

Overview of Data Management Planning Tools

These Data Management Plans are more comprehensive and complex than in the past. Libraries around the nation are trying to put together tools to help researchers write plans that conform to the new requirements. This session will look at some of these tools.

Compliance: E-Science Mandates and Policies

Data collected under federally funded research is subject to compliance rules and regulations. Policies affecting what you can and cannot do with your data, who is responsible, and what role your institution plays can vary with funding agencies and the type of data collected. This talk will address many of the compliance issues associated with research data, as well as funder mandates that you need to be aware of to ensure compliance.

April 25, 2012

Geneva Henry, Executive Director of the Center for Digital Scholarship, Rice University. Data rights and ownership of digital research data can impact how you use data, how others use data you've collected, and how rights are determined in collaborative research. Copyright rules governing data vary from one country to the next, making data ownership in international collaborations particularly murky. Licensing the use of data sets from the start is one way to address these issues early and provide a means for easily sharing datasets that can be cited and properly attributed. This talk with introduce issues associated with digital research data governance and how to protect your rights with data you work with.

Indian Patent Policy and Publich Health : implications from the Japanese Experience

The introduction of pharmaceutical product patents in India and other developing countries is expected to have a significant effect on public health and local pharmaceutical industries. This paper draws implications from the historical experience of Japan when it introduced product patents in 1976. In Japan, narrow patents and promotion of cross-licensing were effective tools to keep drug prices in check while ensuring the introduction of new drugs. While the global pharmaceutical market surrounding India today differs considerably from that of the 1970's, the Japanese experience offers a policy option that may profitably be considered by India today. The Indian patent system emphasizes the patentability requirement in contrast to the Japanese patent policy which relied on narrow patents and extensive licensing. R&D by local firms and the development of local products may be promoted more effectively under the Japanese model.

Patent policy and public health in developing countries: lessons from Japan

The introduction of pharmaceutical product patents in India and other developing countries is expected to have a significant effect on public health and local pharmaceutical industries. This paper draws implications from the historical experience of Japan when it introduced product patents in 1976. In Japan, narrow patents and promotion of cross-licensing were effective tools to keep drug prices in check while ensuring the introduction of new drugs. While the global pharmaceutical market surrounding India today differs considerably from that of the 1970's, the Japanese experience offers a policy option that may profitably be considered by India today. The Indian patent system emphasizes the patentability requirement in contrast to the Japanese patent policy which relied on narrow patents and extensive licensing. R&D by local firms and the development of local products may be promoted more effectively under the Japanese model.

Features of IP rights enforcement in Korea and China

This report examines recent updates to the regulation and enforcement of intellectual property (IP) rights in Korea and China, in particular patent rights including invention, utility, and design rights. This paper also discusses some features and issues of the actual IP enforcement situation in those countries in comparison with Japan.

Impact of product-related environmental regulations / voluntary requirements on Thai firms

The rules governing the trade of goods in global markets have shifted toward non-tariff measures related to environmental and chemical safety. Unlike traditional environmental/safety requirements, the scope of modern regulations covers products’ environmental performance and chemical safety. To comply with these modern regulations, production practices along the entire supply chain must be realigned to manage certain chemical substances incorporated into the final product. This paper examines the implications of product-related environmental and chemical safety regulations on different firms operating in Thailand.

Causation and Harm in a Multicomponent World

On September 17, 2015, the Federal Circuit issued another decision in the epic Apple v. Samsung smartphone war. This was the fourth court decision in the ongoing saga to deal with injunctions. Apple IV explained the level of proof necessary to satisfy the "causal nexus" requirement. This requirement had emerged as a response to patent litigations involving products with thousands of features, the vast majority of which are unrelated to the asserted patent. To prove a causal nexus, patentees seeking an injunction have to do more than just show that the infringing product caused the patentee irreparable harm. The harm must be specifically attributable to the infringing feature. In Apple IV, the Federal Circuit noted that proving causation was "nearly impossible" in these multicomponent cases. So it decided to water down the causal nexus requirement saying that it was enough for Apple to show that the infringing features were "important"and customer sought these particular features. This lower standard is an ill-advised mistake that leaves multicomponent product manufacturers more susceptible to patent holdup. My critique takes two parts. First, I argue that a single infringing feature rarely, if ever, "causes" consumers to buy the infringer’s multicomponent products. The minor features at issue in Apple IV illustrate this point vividly. Thus, the new causal nexus standard does not accurately reflect how causation and harm operate in a multicomponent world. Second, I explain why the court was so willing to accept such little evidence of real injury. It improperly applied notions of traditional property law to patents. Specifically, the court viewed patent infringement as harmful regardless of any concrete consequences. This view may resonate for other forms of property where an owner's rights are paramount and a trespass is considered offensive in and of itself. But the same concepts do not apply to patent law where the Supreme Court has consistently said that private interests must take a back seat to the public good. Based on these principles, the courts should restore the "causal nexus" requirement and not presume causation.

Notes on cases in Plymouth, Barnstable and Duke Counties, 1785

Includes notes on cases of property law, and assault and battery.

Citizenship Deprivation: A Normative Analysis. Liberty and Security in Europe No. 82, 19 March 2015

Most critical analyses assess citizenship-deprivation policies against international human rights and domestic rule of law standards, such as prevention of statelessness, non-arbitrariness with regard to justifications and judicial remedies, or non-discrimination between different categories of citizens. This report considers instead from a political theory perspective how deprivation policies reflect specific conceptions of political community. We distinguish four normative conceptions of the grounds of membership in a political community that apply to decisions on acquisition and loss of citizenship status: i) a ‘State discretion’ view, according to which governments should be as free as possible in pursuing State interests when determining citizenship status; ii) an ‘individual choice’ view, according to which individuals should be as free as possible in choosing their citizenship status; iii) an ‘ascriptive community’ view, according to which both State and individual choices should be minimised through automatic determination of membership based on objective criteria such as the circumstances of birth; and iv) a ‘genuine link’ view, according to which the ties of individuals to particular States determine their claims to inclusion and against deprivation while providing at the same time objections against including individuals without genuine links. We argue that most citizenship laws combine these four normative views in different ways, but that from a democratic perspective the ‘genuine link’ view is normatively preferable to the others. The report subsequently examines five general grounds for citizenship withdrawal – threats to public security, non-compliance with citizenship duties, flawed acquisition, derivative loss and loss of genuine links – and considers how the four normative views apply to withdrawal provision motivated by these concerns. The final section of the report examines whether EU citizenship provides additional reasons for protection against Member States’ powers of citizenship deprivation. We suggest that, in addition to fundamental rights protection through EU law and protection of free movement rights, three further arguments could be invoked: toleration of dual citizenship in a political union, prevention of unequal conditions for loss among EU citizens, and the salience of genuine links to the EU itself rather than merely to one of its Member States.

Crimea one year after Russian annexation. EPC Policy Brief, 24 March 2015

On 18 March 2014, the Lower House of the Russian Parliament approved a Treaty to annex the Ukrainian Black Sea Peninsula of Crimea by 443 to 1 votes. This act violated Ukraine's sovereignty, representing a fundamental breach of international law; the Helsinki Final Act of 1975 and the terms of the 1994 Budapest Memorandum, whereby the nuclear arsenal stationed on Ukraine's territory after the collapse of the Soviet Union was relinquished in exchange for security assurances of its sovereign territorial integrity. Russia, the US, France and the UK all signed. The annexation also violated a number of bilateral agreements between Ukraine and Russia. Russia's actions were immediately condemned by the international community. A 13 March European Parliament Resolution "firmly condemns Russia's act of aggression in invading Crimea, which is an inseparable part of Ukraine and recognised as such by the Russian Federation".

What TRIPS is and what is is not

For industry people, journalists, activists, lawyers, diplomats, national legislators, and students of the World Trade Organization's Agreement on Trade-related Aspects of Intellectual Property (TRIPS) has awesome proportions. These are magnified by the fact that these groups lack detailed knowledge of either IP as such or international trade law. IP involves a broad spread of academic specialists and practitioners covering heterogeneous complex regimes of patents, copyright, trade marks, design, undisclosed information (trade secrets), and geographical indications. IP, and subsequently TRIPS, is the meeting point of many stakeholders and actors with conflicting interests spread between market aspirations and concepts of public good. In a globalized economy with deep interconnections across sectors, national borders challenged by inchoate technologies, dynamic social stakeholders, and converging technologies, it is fundamental to have a clear and uncluttered understanding of this Agreement. That is because TRIPS impinges on trade in many products of daily life, from pharmaceuticals to entertainment electronics, as well as mitigating and adaptive technologies for climate change and sustainable development. Given its saliency and ubiquity in economic life, TRIPS has often generated misunderstanding and controversy in the public debate. To complicate matters, technical and legal issues at the interface of technology, IP, and trade remain the province of an eclectic band of specialists and on the radar of interest groups with goals on opposite poles.