The patent expiry as a major inflection point in a branded Rx drug's life and strategies to counter generic competition - exemplified at Pfizer's blockbuster drug Lipitor in the USA

A large number of expensive, but highly profitable branded prescription drugs will go off-patent in the USA between 2011 and 2015. Their revenues are crucial to fund the immense costs associated with the development of an innovative drug. The rising cost pressure on pharmaceutical stakeholders has increased the demand for more affordable medications, as provided by the branded drug's generic counterpart. Yet, research based incumbents are moving beyond the traditional late lifecycle strategies and deploy more aggressive tactics in order to protect their brands, as seen with Pfizer's Lipitor!. It is doubtful, whether these efforts will help the blockbuster business model to resist current market conditions.

O uso da força no Direito Internacional = Use of force in Public International Law

Versão online da Revista Brasileira de Estudos Políticos, Belo Horizonte, nº 107, pp. 149-200, jul./dez.2013

Relatório de estágio curricular no Ministério Público na Comarca de Setúbal

This report represents four months of study on activities in the public prosecution service at the Local Instance of Setúbal judiciary district, started in September 2014 and completed of the same year. This report was prepared considering all the teachings of criminal law courses and criminal procedural law, doctrine, jurisprudence and all the practical experience experienced with prosecutors. In this context, their traineeship provided contact with different procedural stages: the investigation stage that allowed to understand better the progress of the processing of summary proceedings; the expedient distribution of urgent cases; the investigation stage, as regards the procedural impulse assistant and the accused; and the trial stage. This last phase allowed contact with different types of crimes especially road crimes and the crime of domestic violence. The analysis carried out the summary proceedings in the Public Ministry service would acquire relevant information to explain the incidence of road crimes. Topics will be addressed that were found on stage during the various procedural stages, as the implementation of new judicial map. The relationship between the prosecution and the Criminal Police Bodies was also an issue to be addressed. The work also raises awareness of the issue of archives in order to find out the position of assistant.

As peculiaridades da democratização da região do Cáucaso do Sul no contexto da Política Europeia de Vizinhança

O período após o colapso da União Soviética foi o tempo da procura de novas identidades na nova realidade e de escolha de novos parceiros e aliados, o tempo da construção de novos estados e de formulação das regras e normas nacionais. Após o desmoronamento da ideologia soviética - um facto reconhecido oficialmente durante o período da Perestroika –, as pessoas sentiram uma necessidade de preencher o vácuo ideológico e desenvolver uma nova identidade. Foi proclamada a rejeição da estrutura política administrativa herdada da União Soviética e do sistema de economia planificada, e desenvolvida a tendência para a construção do estado democrático fundado numa economia de mercado. As expectativas relativas às transformações no período pós-soviético estavam relacionadas com o Ocidente (EUA e UE), e a construção do estado soberano foi fundada em modelos ocidentais de estado de direito, ‘boa governança’ e a economia de mercado. A UE desempenhou um papel importante na democratização dos estados da região do Sul do Cáucaso através de vários projetos e programas bilaterais e multilaterais no âmbito da Política Europeia de Vizinhança e da Parceria Oriental. Embora as reformas democráticas tenham sido realizadas com vista ao estabelecimento de uma Constituição democrática, à implementação de eleições democráticas e ao desenvolvimento da sociedade civil, fortaleceram, também, ainda mais, a natureza autoritária do poder, impediram a criação de um estado de direito, reforçaram violação dos direitos e das liberdades humanas. (NODIYA, 2003: 30; BAKHMAN, 2003: 17; BADALOV, 2003: 20). Deste modo, o processo da promoção da democracia através das reformas nos três estados do Sul do Cáucaso conduziu à criação de estados de “conteúdo autocrático misto, mas de forma democrática” (CHETERYAN, 2003: 41). Embora seja possível identificar as semelhanças entre os três estados da região do Sul do Cáucaso nas reformas do processo de desenvolvimento, os métodos e meios de implementação de reformas nas realidades dos estados regionais pela administração nacional foram bastante diferentes, por razões associadas às especificidades de cada um (DELCOUR e WOLCZUK, 2013: 3). Cada país é caracterizado pelas suas peculiaridades ao nível da situação geopolítica e diversidade do potencial económico – fatores que definem a trajetória política e económica do estado no período pós-soviético e, em certa medida, influenciam o modo como se desenvolvem as relações com a UE e, portanto, o processo de adoção das reformas e a sua introdução a nível nacional.

Impact of taxes on competition: the legal status quo in the European Union

Dissertação de mestrado em Direito dos Negócios, Europeu e Transnacional

Tensile stress–crack width law for steel fibre reinforced self-compacting concrete obtained from indirect (splitting) tensile tests

In this work, the fracture mode I parameters of steel fibre reinforced self-compacting concrete (SFRSCC) were derived from the numerical simulation of indirect splitting tensile tests. The combined experimental and numerical research allowed a comparison between the stress-crack width (σ - w) relationship acquired straightforwardly from direct tensile tests, and the σ - w response derived from inverse analysis of the splitting tensile tests results. For this purpose a comprehensive nonlinear 3D finite element (FE) modeling strategy was developed. A comparison between the experimental results obtained from splitting tensile tests and the corresponding FE simulations confirmed the good accuracy of the proposed strategy to derive the σ – w for these composites. It is concluded that the post-cracking tensile laws obtained from inverse analysis provided a close relationship with the ones obtained from the experimental uniaxial tensile tests.

Patente farmacêutica: especificidades e tutela

Dissertação de mestrado em Direito dos Contratos e da Empresa

O reforço da democracia local no âmbito da reforma da administração autárquica

Dissertação de mestrado em Direito das Autarquias Locais

Silent Patent Ductus Arteriosus Aneurysm

Ductus arteriosus aneurysm, a rare and potentially fatal condition, has been reported as a complication after surgical ductus arteriosus closure. Its spontaneous appearance as a septic complication, which was common in the presurgical and preantibiotic era, has been rarely reported in the contemporary literature. Persistence of silent ductus arteriosus in healthy children and adults is a frequent condition that currently has an increasing diagnostic possibility due to the availability of more accurate investigative methods, especially echocardiography. We report the case of a 1-year-old child, in whom no previous heart disease was known, who developed a giant aneurysm of the ductus arteriosus during a staphylococcal infection. This complication appeared after craniotomy for emptying an accidental subdural hematoma. This report associates the persistence of ductus arteriosus with a complication considered rare, which has a rapidly fatal evolution.

Regímenes Internacionales y Derechos Humanos. La incidencia del sistema interamericano de protección en la legislación y jurisprudencia argentinas. International Regimes and Human Rights. The incidence of inter-American system in Argentine law and jurisprudence.

El nuevo escenario internacional produce lo que se ha dado en caracterizar como la globalización del derecho, especialmente en el ámbito de los derechos humanos. En este contexto se analiza la incidencia del Sistema Interamericano de protección de los Derechos Humanos con especial énfasis en el derecho de la información, desde la optica del derecho interno. Nos preguntamos acerca de cómo se presenta la tensión entre la lógica estatal con su rasgo de afirmación en la soberanía y monopolio en la creación de la jurisdicción doméstica, con la doctrina del derecho internacional de los derechos humanos, que consecuentemente conduce hacia una globalización jurídica de estos temas. Esto refleja un debilitamiento en el monopolio de creación y aplicación del derecho por parte de los Estados. A partir de este dato del escenario internacional buscamos determinar la incidencia de los informes de la Comisión Interamericana de Derechos Humanos y los pronunciamientos de la Corte Interamericana en materia de derecho de la información y su influencia en la jurisprudencia y creación de legislación en nuestro país. The new internacional scenario produces wtah has come to be characterized as the globalization of law, especially in the field of the human rights. In this context we analyze the impact of the Inter-American system of human Rights, whit particular emphasis on media law in domestic law

Die Reform des Urheberrechts in Bezug zum Ausnahmebereich Schule und Lehre

"Jeder hat das Recht auf Schutz der geistigen und materiellen Interessen, die ihm als Urheber von Werken der Wissenschaft, Literatur oder Kunst erwachsen." Die folgende Ausarbeitung wird sich ausführlich auf die Anwendung des Urheberrechts im Ausnahmebereich der Schule und Lehre beziehen. Dabei werden einerseits die nationalen, europäischen und internationalen Vorgaben betrachtet und andererseits die Umsetzung in das nationale Recht, mit der die Verwendung und die Stärkung von Urheberrechten in den Mittelpunkt gestellt wurden. Die umgesetzten Regelungen wurden gemäß der vorliegenden Reihenfolge im Urhebergesetz vorgenommen. Zunächst die wichtigsten relevanten Regelungen und nachfolgend grob weitere Bereiche, die in der Anwendung des Ausnahmebereiches der Schule und Lehre praktisch einen geringeren Bezug haben.

When ESDP confronts ENP: security sector reform as a bridge in the EU’s foreign policy

The European Neighbourhood Policy’s birth has taken place in parallel with the renewed momentum of the European Security and Defence Policy, which has launched 14 operations since 2003. Both policies’ instruments have converged in the neighbouring area covered by ENP: Georgia, in the East and the Palestinian Territories in the South. In both cases, the Security Sector Reform strategies have been the main focus for ESDP and an important objective for ENP. In this paper, two objectives are pursued: first, to assess the EU’s involvement in both cases in SSR terms; and second, to analyse whether the convergence of ESDP operations with a broader EU neighbourhood policy implies that the former has become an instrument for the a EU external action.