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 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.

Compositional effects on productivity, labour cost and export adjustments. Bruegel Policy Contribution 2012/11, June 2012

Sectoral shifts, such as shrinkage of low labour productivity and the low-wage construction sector, can lead to apparent increased aggregate average labour productivity and average wages, especially when capital intensity differs across sectors. For 11 main sectors and 13 manufacturing sub-sectors, we quantify the compositional effects on productivity, wages and unit labour costs (ULCs) based and real effective exchange rates (REER), for 24 EU countries. Compositional effects are greatest in Ireland, where the pharmaceutical sector drives the growth of output and productivity, but other sectors have suffered greatly and have not yet recovered. Our new ULC-REER measurements, which are free from compositional effects, correlate well with export performance. Among the countries facing the most severe external adjustment challenges, Lithuania, Portugal and Ireland have been the most successful based on five indicators, and Latvia, Estonia and Greece the least successful. There is evidence of downward wage flexibility in some countries, but wage cuts have corrected just a small fraction of pre-crisis wage rises and came with massive reductions in employment even in the business sector excluding construction and real estate, highlighting the difficulty of adjusting wages downward.

The AstraZeneca Case. Research Papers in Law, 4/2007

Introduction. On June 2005, after a five year investigation, the Commission imposed a 60 millions euros fine on AstraZeneca (hereinafter AZ) for having abused its dominant position in several Member States in the market for proton-pump inhibitors (PPI)2. It was alleged that AZ misused the patent system and procedures for marketing pharmaceuticals to block or delay the entry of generic competitors and parallel traders to its ulcer drug Losec3. This decision is a seminal one. The political and legal importance of the CFI judgment that will review the case (and the ECJ appeal that is likely to follow) cannot be understated. On the one hand the incentive to innovate and to undertake R&D is at stake, on the other, the uncertain boundaries between competition and intellectual property law should once again be explored. In contrast to the US, where many cases concerning the abuse of regulatory and governmental procedures have already been dealt with competition authorities and courts, it is the first time in Europe that such conduct is subject to scrutiny through an anti-trust lens. Moreover, following the appeal brought by AZ against the Commission decision, the CFI will be confronted for the first time with an abuse of a dominant position in the pharmaceutical sector, which explains why this judgment is eagerly anticipated4.

Drug Reformulation Regulatory Gaming in Pharmaceuticals: Enforcement & Innovation Implications

This article examines drug reformulation regulatory gaming as a vehicle for analyzing the way in which European courts and the Commission are currently approaching innovation issues in the pharmaceutical sector. First, the economics literature regarding pharmaceutical innovation is briefly summarized. Next, the phenomenon of regulatory gaming is introduced, followed by an analysis of the two primary theories of harm being used to address drug reformulations as a competition concern. In comparing the recent General Court decision in AstraZeneca to earlier U.S. court cases addressing similar conduct, it is asserted that these approaches differ in significant ways with regards to preservation of innovation incentives as well as on the basis of institutional and evidentiary concerns. Finally, this discussion is then placed into the broader context of the ongoing debate regarding pharmaceutical innovation that first surfaced in the Syfait cases—in particular, the desirability of sector-specific competition law analysis of pharmaceutical innovation.