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.

The Unified Court on Patents: The New Oxymoron of European Law. Egmont Paper No. 60, October 2013

None.

The policy dilemma of the unitary patent. Bruegel Working Paper 2014/13, 27 November 2014

This paper provides new evidence about the budgetary consequences – for patent offices – of the coexistence of the forthcoming Unitary Patent (UP) with the current European Patent (EP). Simulation results illustrate a dilemma between (1) high UP renewal fees to ensure enough financial income for all national patent offices (NPOs) and (2) low UP renewal fees to make the UP system affordable, with very few NPOs losing on financial revenues. The simulations help to understand the positions of several patent offices, and underline an alternative way to proceed with the negotiations while reducing financial risks for the whole system.

A flexible, scaleable approach to the international patent 'name game'. Bruegel Working Paper 2014/10i, September 2014

The inventors in PATSTAT are often duplicates: the same person or company may be split into multiple entries in PATSTAT, each associated to different patents. In this paper, we address this problem with an algorithm that efficiently de-duplicates the data. It needs minimal manual input and works well even on consumer-grade computers. Comparisons between entries are not limited to their names, and thus this algorithm is an improvement over earlier ones that required extensive manual work or overly cautious clean-up of the names.

Growing global brands in foreign markets: A brand equity perspective. Impact of national culture on trademark registrations in emerging economy: Evidence from Russia. ACES Working Papers, August 2010

In this study we explore how firms deploy intellectual property assets (trademarks) in international context and the impact of cultural characteristics on such activities. Trademarks capture important elements of firm's brand-building efforts. Using growth model, a special case of hierarchical linear model, we demonstrate that that stock of trademarks in foreign market increase future trademark activity. Also, we explore the moderating roles of two cultural dimensions, individualism and masculinity, on such relationships. The findings indicated that firms from countries closer to host market (Russia) on individualism dimension tend to register more trademarks in host market. The opposite result is observed for masculinity dimension.

Coalitions, Power and Institutional Change in Global Patent Politics. IES WORKING PAPER 2/2013

With the 1995 Agreement on Trade - related Aspects of Intellectual Property Rights (TRIPS), a centralised rule - system for the international governance of patents was put in place under the general framework of the World Trade Organisation (WTO). Since then, the number of patent – related institutions has increased monotonically on the multilateral, plurilateral and bilateral levels. I will explain this case of institutional change by focusing on the norm – setting activities of both industrialised and developing countries, arguing that both groups constitute internally highly cohesive coalitions in global patent politics, while institutional change occurs when both coalitions engage in those negotiating settings in which they enjoy a comparative advantage over the other coalition. Specifically, I make the point that industrialised countries’ norm – setting activities take place on the plurilateral and bilateral level, where economic factors can be effectively translated into political outcomes while simultaneously avoiding unacceptably high legitimacy costs; whereas developing countries, on the other hand, use various multilateral United Nations (UN) forums where their claims possess a high degree of legitimacy, but cannot translate into effective political outcomes. The paper concludes with some remarks on how this case yields new insights into ongoing debates in institutionalist International Relations (IR), as pertaining to present discussions on “regime complexity”.

Unified European Front: The Road towards a European Unitary Patent. EU Centre Singapore Working Paper No. 21, March 2014

For over forty years, European countries have held numerous conferences and signed multiple international agreements aimed at either creating a unitary patent which will be valid in all European countries upon issuance or establishing a specialized European court with jurisdiction over patents. This paper first outlines the need for a unitary patent in the European Union and then chronicles the measures taken to support and milestones toward the creation of a European-wide unitary patent system. The paper then discusses the few problems and pitfalls that have prevented European countries from coming to an agreement on such a patent system. Finally, the paper considers the closely related agreements of ‘Unitary Patent Package’, the challenges facing these agreements and examines if it would finally result in an EU Unitary patent system that benefits one and all.

The European Pharmaceutical Industry in a Global Economy: what drives EU exports of pharmaceuticals?. Bruges European Economic Research Papers (BEER) 31/2015.

The pharmaceutical industry is one of the most competitive sectors in the European Union. With its substantial investments in research and development, this industry represents a key asset for the European economy and a major source of growth and employment. However, despite the importance of the pharmaceutical sector for the European Union, few researchers have attempted to assess the determinants of the EU exports of pharmaceuticals. This paper aims at filling the aforementioned gap by examining what drives EU exports of pharmaceuticals. In order to tackle this question, this paper has derived hypotheses from the Gravity Model of Trade and the relevant academic literature on pharmaceuticals. Based on an econometric analysis, the research sheds light on the complex interaction of factors influencing the EU exports of pharmaceuticals. The paper finds that the protection of intellectual property in the receiving countries, their economic size, the importance of their health sector, and the quality of infrastructures constitute major drivers to the EU exports of pharmaceuticals. On the contrary, the research shows that transports costs as well as tariff barriers and non-tariff barriers tend to hinder the EU exports of pharmaceuticals.

Policy Options for Improving the Functioning and Efficiency of the Digital Single Market in the Field of Copyright. CEPS Special Report No. 121, 19 November 2015

This study explores the existing policy problems and the possible options for reforming the EU copyright framework as provided by EU Directive 29/2001 on Copyright in the Information Society (InfoSoc Directive) and related legislation, with a specific focus on the need to strengthen the Internal Market for creative content. We find two main policy problems: i) the absence of a Digital Single Market for creative works; and ii) the increasing tension between the current system of exceptions and limitations and the legal treatment of emerging uses of copyrighted content in the online environment. Without prejudicing a future impact assessment that might focus on more specific and detailed policy options, our analysis suggests that ‘more Europe’ would be needed in the field of copyright, given the existing sources of productive, allocative and dynamic efficiency associated with the current system. Looking at copyright from an Internal Market perspective would, in this respect, also help to address many of the shortcomings in the current framework, which undermine legal certainty and industrial policy goals.

The Implementation, Application and Effects of the EU Directive on Copyright in the Information Society. CEPS Special Report No. 120, 19 November 2015

This study provides an ex-post evaluation of the EU copyright framework as provided by EU Directive 29/2001 on Copyright in the Information Society (InfoSoc Directive) and related legislation, focusing on four key criteria: effectiveness, efficiency, coherence and relevance. The evaluation finds that the EU copyright framework scores poorly on all four accounts. Of the four main goals pursued by the InfoSoc, only the alignment with international legislation can be said to have been fully achieved. The wider framework on copyright still generates costs by inhibiting content production, distribution and creation and generating productive, allocative and dynamic inefficiencies. Several problems also remain in terms of both internal and external coherence. Finally, espite its overall importance and relevance as a domain of legislation in the fields of content and media, the EU copyright framework is outdated in light of technological developments. Policy options to reform the current framework are provided in the CEPS companion study on the functioning and efficiency of the Digital Single Market in the field of copyright (CEPS Special Report No. 121/November 2015).

Regulation on ‘cross-border portability’ of online content services: Roaming for Netflix or the end of copyright territoriality? CEPS Commentary, 15 February 2016

In a communication to the Parliament and the Council entitled “Towards a modern, more European copyright framework” and dated 9 December 2015,1 the European Commission confirmed its intention to progressively remove the main obstacles to the functioning of the Digital Single Market for copyrighted works. The first step of this long-term plan, which was first announced in Juncker’s Political Guidelines2 and the Communication on “A Digital Single Market strategy for Europe”,3 is a proposal for a regulation aimed at ensuring the so-called ‘cross-border portability’ of online services giving access to content such as music, games, films and sporting events.4 In a nutshell, the proposed regulation seeks to enable consumers with legal access to such online content services in their country of residence to use the same services also when they are in another member state for a limited period of time. On the one hand, this legislative proposal has the full potential to resolve the (limited) issue of portability, which stems from the national dimension of copyright and the persisting territorial licensing and distribution of copyright content.5 On the other hand, as this commentary shows, the ambiguity of certain important provisions in the proposed regulation might affect its scope and effectiveness and contribute to the erosion of the principle of copyright territoriality.

La valutazione della proprietà intellettuale: il calcolo dei danni da violazione

La trattazione si propone di affrontare, in una prospettiva economico-aziendale, la questione relativa alla quantificazione del corretto risarcimento per reintegrare i danni economici conseguenti a violazioni dei diritti di proprietà industriale. L’obiettivo della tesi è, in particolare, quello di individuare le principali metodologie di valutazione degli intangibile assets, con particolare riferimento ai casi di loro contraffazione e indebita appropriazione da parte di terzi. Tra le diverse categorie di intellectual property, nel lavoro è affrontata con un maggior grado di dettaglio quella specifica del marchio, il bene intangibile più violato. L'indagine teorico-concettuale svolta nei primi capitoli trova un riscontro empirico nei diversi casi di violazione relativi a sentenze dei tribunali delle imprese italiani, presi in esame nell’ultima parte della tesi. L'analisi effettuata ha permesso, in particolare, di comprendere l'iter logico effettivamente adottato per la quantificazione del danno in sede di giudizio.

Innovation and Development in the Age of Climate Change Adaptation: Open or Closed?

Change Adaptation: Open or Closed? Paper read at the Second African International Economic Law Network Conference, 7-8 March 2013, Wits School of Law, Johannesburg, South Africa. In a time of rapid convergence of technologies, goods, services, hardware, software, the traditional classifications that informed past treaties fail to remove legal uncertainty, or advance welfare and innovation. As a result, we turn our attention to the role and needs of the public domain at the interface of existing intellectual property rights and new modes of creation, production and distribution of goods and services. The concept of open culture would have it that knowledge should be spread freely and its growth should come from further developing existing works on the basis of sharing and collaboration without the shackles of intellectual property. Intellectual property clauses find their way into regional, multilateral, bilateral and free trade agreements more often than not, and can cause public discontent and incite unrest. Many of these intellectual property clauses raise the bar on protection beyond the clauses found in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). In this paper we address the question of the protection and development of the public domain in service of open innovation in accord with Article 15 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) in light of the Objectives (Article 7) and Principles (Article 8) set forth in TRIPS. Once areas of divergence and reinforcement between the intellectual property regime and human rights have been discussed, we will enter into options that allow for innovation and prosperity in the global south. We then conclude by discussing possible policy developments.

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.

Le Droit d'auteur.

"Revue mensuelle de l'Organisation mondiale de la propriété intellectuelle."