The Italian Merck Case. Research Papers in Law, 1/2007

From the Introduction. Regulation 1768/921 created supplementary protection certificates (hereinafter, ‘SPCs’) for medicinal products (hereinafter, “pharmaceuticals”) protected by patents. SPCs afford the same exclusive rights as those conferred by patents once these expire and may be granted for a maximum of five years.2 Italy enacted similar legislation in 1991, the most salient difference between both texts being that, pursuant to Law No. 349/91,3 holders of Italian patents for pharmaceuticals could be granted supplementary protection for a maximum period of 18 years after the expiration of the patent. Following the enactment of Regulation 1768/92, SPCs granted by the Italian authorities were brought in line with the period provided for in that text. However, pharmaceuticals for which supplementary protection was sought in the lapse between the adoption of Law No. 349/91 and Regulation 1768/92 (around 400 products) continued to enjoy the protection provided for in the former text.4 Several steps were taken by the Italian authorities to progressively reduce the length of protection granted to these products.

With or without you...judging politically in the field of Area of Freedom, Security and Justice? Research Papers in Law, 3/2007

From the Introduction. The study of the European Court of Justice’s (ECJ) case law of the regarding the Area of Freedom Security and Justice (AFSJ) is fascinating in many ways.1 First, almost the totality of the relevant case law is extremely recent, thereby marking the first ‘foundational’ steps in this field of law. This is the result of the fact that the AFSJ was set up by the Treaty of Amsterdam in 1997 and only entered into force in May 1999.2 Second, as the AFSJ is a new field of EU competence, it sets afresh all the fundamental questions – both political and legal – triggered by European integration, namely in terms of: a) distribution of powers between the Union and its member states, b) attribution of competences between the various EU Institutions, c) direct effect and supremacy of EU rules, d) scope of competence of the ECJ, and e) measure of the protection given to fundamental rights. The above questions beg for answers which should take into account both the extremely sensible fields of law upon which the AFSJ is anchored, and the EU’s highly inconvenient three-pillar institutional framework.3 Third, and as a consequence of the above, the vast majority of the ECJ’s judgments relating to the AFSJ are a) delivered by the Full Court or, at least, the Grand Chamber, b) with the intervention of great many member states and c) often obscure in content. This is due to the fact that the Court is called upon to set the foundational rules in a new field of EU law, often trying to accommodate divergent considerations, not all of which are strictly legal.4 Fourth, the case law of the Court relating to the AFSJ, touches upon a vast variety of topics which are not necessarily related to one another. This is why it is essential to limit the scope of this study. The content of, and steering for, the AFSJ were given by the Tampere European Council, in October 1999. According to the Tampere Conclusions, the AFSJ should consist of four key elements: a) a common immigration and asylum policy, b) judicial cooperation in both civil and penal matters, c) action against criminality and d) external action of the EU in all the above fields. Moreover, the AFSJ is to a large extent based on the Schengen acquis. The latter has been ‘communautarised’5 by the Treaty of Amsterdam and further ‘ventilated’ between the first and third pillars by decisions 1999/435 and 1999/436.6 Judicial cooperation in civil matters, mainly by means of international conventions (such as the Rome Convention of 1981 on the law applicable to contractual obligations) and regulations (such as (EC) 44/20017 and (EC) 1348/20008) also form part of the AFSJ. However, the relevant case law of the ECJ will not be examined in the present contribution.9 Similarly, the judgments of the Court delivered in the course of Article 226 EC proceedings against member states, will be omitted.10 Even after setting aside the above case law and notwithstanding the fact that the AFSJ only dates as far back as May 1999, the judgments of the ECJ are numerous. A simple (if not simplistic) categorisation may be between, on the one hand, judgments which concern the institutional setting of the AFSJ (para. 2) and, on the other, judgments which are related to some substantive AFSJ policy (para. 3).

Patenting Strategies of the EU Pharmaceutical Industry -Crossroad between Patent Law and Competition Policy. Research Papers in Law, 1/2011

From the Introduction. The pharmaceutical sector inquiry carried out by the European Commission in 2008 provides a useful framework for assessing the relationship between the patent system on the one hand and competition policy and law on the other hand. The pharmaceutical market is not only specifically regulated. It is also influenced by the special characteristics of the patent system which enables pharmaceutical companies engaged in research activities to enter into additional arrangements to cope with the competitive pressures of early patent application and the delays in drug approval. Patents appear difficult to reconcile with the need for sufficient and adequate access to medicines, which is why competition expectations imposed on the pharmaceutical sector are very high. The patent system and competition law are interacting components of the market, into which they must both be integrated. This can result in competition law taking a very strict view on the pharmaceutical industry by establishing strict functional performance standards for the reliance on intellectual property rights protection granted by patent law. This is in particular because in this sector the potential welfare losses are not likely to be of only monetary nature. In brief, the more inefficiencies the patent system produces, the greater the risk of an expansive application of competition law in this field. The aim of the present study is to offer a critical and objective view on the use or abuse of patents and defensive strategies in the pharmaceutical industry. It shall also seek to establish whether patents as presently regulated offer an appropriate degree of protection of intellectual property held by the economic operators in the pharmaceutical sector and whether there is a need or, for that matter, scope for improvement. A useful starting point for the present study is provided by the pharmaceutical sector competition inquiry (hereafter “the sector inquiry”) carried out by the European Commission during the first half of 2008. On 8 July 2008, the Commission adopted its Final Report pursuant to Article 17 of Regulation 1/2003 EC, revealing a series of “antitrust shortcomings” that would require further investigation1.

Legal privilege for in-house lawyers in the light of AKZO: a matter of law or policy? Research Papers in Law, 05/2011

From introduction. This paper discusses the arguments in favour of extending legal privilege to in-house lawyers in the light of the CJEU‟s judgement in AKZO. The previous jurisprudence is unambiguous, as the Court clearly stated in AM & S that the confidentiality of written communications between an undertaking and its lawyer is protected under Union law only when two cumulative conditions are fulfilled: they must be connected to the exercise of the client‟s rights of defence and the lawyer must be independent, that is, “not bound to the client by a relationship of employment”.1 This protection also applies to internal notes confined to reporting the content of communications with independent lawyers containing legal advice.2

La disoccupazione giovanile in tempo di crisi: un monito all’Europa (continentale) per rifondare il diritto del lavoro? = Youth Unemployment in Recessionary Times: a Caveat to (Continental) Europe to Reconstruct its Labour Law. WP C.S.D.L.E. "Massimo D'Antona" .INT - 91/2012

The current debate taking place in continental Europe on the need to reform labour law to reduce the duality between labour market insiders and outsiders, thus giving new employment opportunities to young people seems to be, at its best, a consequence of the crisis, or at its worst, an excuse. The considerable emphasis placed on the power of legislation to reduce youth unemployment prevents real labour market problems from being clearly identified, thus reducing the scope to adopt more effective measures. Action is certainly required to help young people during the current crisis, yet interventions should not be exclusively directed towards increased flexibility and deregulation. This paper questions the “thaumaturgic power” wrongly attributed to legislative interventions and put forward a more holistic approach to solve the problem of youth employment, by focusing on the education systems, school-to-work transition and industrial relations. As a comparative analysis demonstrates, in order to effectively tackle the issue of youth employment, it is not enough to reform labour law. High quality education systems, apprenticeship schemes, efficient placement and employment services, cooperative industrial relations and flexible wage determination mechanisms are the key to success when it comes to youth employment, not only in times of recession.

Reflections on quasi-loss of nationality in comparative, international and European perspective. CEPS Liberty and Security in Europe No. 66/August 2014

This paper focuses on situations in which a person is said never to have had the nationality of a country, even though (s)he assumed (and in many cases the authorities of the country concerned shared that assumption) that (s)he possessed that nationality. Contrary to situations of loss of nationality, where something is taken away that had existed, quasi-loss involves situations in which nationality was never acquired. This contribution seeks to examine whether a person should under certain circumstances be protected against quasi-loss of nationality. In order to do so, the paper first maps out situations of quasi-loss in EU member states, describing typical cases in which a person never acquired the nationality of the country, although (s)he was at some time considered as a national. Drawing on this taxonomy, the paper attempts to uncover whether national, European and international laws offer some protection, and if yes, to which extent, for situations of quasi-loss. It concludes with outlining best practices which Member States should comply with in handling such situations.

The EU’s Rule of Law Initiative for Central Asia: From Initiative to More Substance? EUCAM Policy Brief No. 18, June 2011

All five Central Asian states are weak in terms of rule of law, good governance and democracy. The EU chose to devote specific attention to the rule of law through a regional initiative with Central Asian partners' participation. What is the current state of the initiative and is the EU on track?

Law and Foreign Direct Investment. IES WORKING PAPER 4/2011

In this paper we examine the effect of law on foreign direct investment outflows with a specific interest in the relationship between international investment law and domestic private property laws. Our results indicate that FDI investor is indifferent to host country property rights, hence shareholder protection by law is not a significant determinant of FDI outflows. We argue that FDI, in contrast with other types of capital flows, can effectively mitigate the agency problem through majority ownership and control, hence reduce exposure to ex-post expropriation by the affiliate. On the other hand, FDI investor remains exposed to risk of expropriation by the host government and is strongly sensitive to the enforcement of law in the host country. In contrast with recent literature we conclude that there are no causal relationship between bilateral investment treaties and FDI.

The Legal Status and Influence of Decisions of International Organizations and other Bodies in the European Union. College of Europe Research Paper in Law 01/2014

Introduction. The European Union’s external action is not only defined by its influence on international developments, but also by its ability and the need to respond to those developments. While traditionally many have stressed the EU’s ‘autonomy’, over the years its ‘dependence’ on global developments has become more clear.2 International law has continued to play a key role in, not only in the EU’s external relations, but also in the Union’s own legal order.3 The purpose of this paper is not to assess the role or performance of the EU in international institutions.4 Rather it purports to reverse the picture and focus on a somewhat under-researched topic: the legal status of decisions of international organizations in the EU’s legal order.5 While parts of the status of these decisions relate to the status of international agreements and international customary law, it can be argued that decisions of international organizations and other international bodies form a distinct category. In fact, it has been observed that “this phenomenon has added a new layer of complexity to the already complex law of external relations of the European Union”.6 Emerging questions relate to the possible difference between decisions of international organizations of which the EU is a member (such as the FAO) and decisions of organizations where it is not (irrespective of existing competences in that area – such as in the ILO). Questions also relate to the hierarchical status of these decisions in the EU’s legal order and to the possibility of them being invoked in direct or indirect actions before the Court of Justice. This contribution takes a broad perspective on decisions of international organizations by including decisions taken in other international institutions which do not necessarily comply with the standard definition of international organizations,7 be it bodies set-up by multilateral conventions or informal (transnational / regulatory) bodies. Some of these bodies are relatively close to the EU (such as the Councils established by Association Agreements – see further Section 5 below); others operate at a certain distance. Limiting the analysis to formal international organizations will not do justice to the manifold relationships between the European Union and various international bodies and to the effects of the norms produced by these bodies. The term ‘international decisions’ is therefore used to refer to any normative output of international institutional arrangements.

Non-intervention; the law and its import in the Americas /

"A Law-Institute of the Americas study."

The United States and the expansion of the law between nations /

"Reprinted from University of Pennsylvania law review, vol. 64, December, 1915."

The Central law journal [microform].

Vols. 65-96 include "Central law journal's international law list."

Journal of the Society of Comparative Legislation.

Includes an annual "Review of legislation".

A selection of cases and other readings on the law of nations, chiefly as it is interpreted and applied by British and American courts,

Includes lists of readings.

Journal of the Society of Comparative Legislation.

Includes annual "review of legislation" covering the years 1895-1917.