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.

Beyond Cooperation and Competition: What Kind of Federalism for EU Social Policy? CES Germany & Europe Working Papers, No. 00.7, December 2000

The EU has become a loose kind ofsocial federation, a fact that has not been adequately taken into account due to the peculiarities ofthe Maastricht strategy for monetary integration. Yet, a new approach to the economic theory offederalism is required ifone wants to analyze the most pressing issues ofEU social policy. The social insurance view of redistribution and stabilization provides for such an approach. This view supports laboratory federalism in which it is the role ofthe EU Commission to contain systems competition in order to preserve "stability in diversity." The role ofthe EU level would be to promote horizontal and vertical learning processes and to make sure that stability concerns ofthe EU are taken seriously by member countries' governments. The minimum requirements framework for social policy that the EU Commission has adopted must be taken as a point of departure, even though it is a less than satisfactory approach from this point of view. Laboratory standardization, in contrast, would not set specific minimum requirements but meta-standards that protect systems functions and safeguard against systems failures.