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.

Searching for harm or harming search? A look at the European Commission’s antitrust investigation against Google. CEPS Special Report No. 118/September 2015

As the European Commission’s antitrust investigation against Google approaches its final stages, its contours and likely outcome remain obscure and blurred by a plethora of nonantitrust-related arguments. At the same time, the initial focus on search neutrality as an antitrust principle seems to have been abandoned by the European Commission, in favour of a more standard allegation of ‘exclusionary abuse’, likely to generate anticompetitive foreclosure of Google’s rivals. This paper discusses search neutrality as an antitrust principle, and then comments on the current investigation based on publicly available information. The paper provides a critical assessment of the likely tests that will be used for the definition of the relevant product market, the criteria for the finding of dominance, the anticompetitive foreclosure test and the possible remedies that the European Commission might choose. Overall, and regardless of the outcome of the Google case, the paper argues that the current treatment of exclusionary abuses in Internet markets is in urgent need of a number of important clarifications, and has been in this condition for more than a decade. The hope is that the European Commission will resist the temptation to imbue the antitrust case with an emphasis and meaning that have nothing to do with antitrust (from industrial policy motives to privacy, copyright or media law arguments) and that, on the contrary, the Commission will devote its efforts to sharpening its understanding of dynamic competition in cyberspace, and the tools that should be applied in the analysis of these peculiar, fast-changing and often elusive settings.

Saving the Monopsony: Exclusivity, Innovation and Market Power in the Media Sector. Research Papers in Law, 7/2006

From the Introduction. The Media Sector has experienced a technological revolution in the last 15 years. Digital encoding of television signals made possible a more efficient use of the radiospectrum. Digital terrestrial television (hereinafter, “DTT”) allows now for the reception of a significant number of free-to-air channels.1 Moreover, the use of new transmission platforms (hereinafter,“platforms”), namely cable and direct-to-home satellite (hereinafter, “DTH”) paved the way for the arrival in Europe of pay-TV operators, which finance their activities mainly via subscription fees. This changing technological landscape is subject to further evolution in the near future, as incumbent telecommunications operators become increasingly interested in making available broadcasting content2 as part of their broadband offer and 3G mobile handsets can be used for the reception of TV signals....The present paper seeks to ascertain whether the Commission “regulatory approach” towards the exclusive sale of premium content is a sound one, in particular in view of the constant technological evolution outlined above. The assumptions underlying landmark Commission decisions will be compared with recent developments of the media sector in Italy. In the NewsCorp./Telepiù case, decided in 2003, the Commission imposed very strict conditions to allow the merger giving birth to Sky Italia, on the assumption that the operation created a lasting near-monopsony in the different upstream markets for the acquisition of premium intervened against the media conglomerate Mediaset (which controls, inter alia, the main three private free-to-air channels in Italy) for an alleged abuse of dominant position.17 In fact, and contrary to the forecasts made by the Commission, Mediaset was in a position to acquire the broadcasting rights of the main Italian football teams, thereby excluding the incumbent (and near-monopolist) pay-TV operator, Sky Italia. This may go to show that the reality of the sector is more complex and evolves faster than one may infer from the Commission practice, thus putting into question its stance regarding exclusivity. The experience of the evolution of the Italian media sector will be used as the starting point for the evaluation of alternative regulatory options.

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.

Shifting Between Hegemony and Dominance? A Neo-Gramscian Analysis of the EU as a Structural Foreign Policy Actor: The Singular Case of the Cariforum-EU Economic Partnership Agreement. Bruges Regional Integration & Global Governance Paper 01/2014

The groundbreaking scope of the Economic Partnership Agreement (EPA) between the European Union (EU) and Cariforum (CF) irrefutably marks a substantive shift in trade relations between the regions and also has far-reaching implications across several sectors and levels. Supplementing the framework of analysis of Structural Foreign Policy (SFP) with neo-Gramscian theory allows for a thorough investigation into the details of structural embeddedness based on the EU's historic directionality towards the Caribbean region; notably, encouraging integration into the global capitalist economy by adapting to and adopting the ideals of neoliberal economics. Whilst the Caribbean – as the first and only signatory of a ‘full’ EPA – may be considered the case par excellence of the success of the EPAs, this paper demonstrates that there is no cause-effect relationship between the singular case of the ‘full’ CF-EU EPA and the success of the EPA policy towards the ACP in general. The research detailed throughout this paper responds to two SFP-based questions: (1) To what extent is the EPA a SFP tool aimed at influencing and shaping the structures in the Caribbean? (2) To what extent is the internalisation of this process reflective of the EU as a hegemonic SFP actor vis-à-vis the Caribbean? This paper affirms both the role of the EU as a hegemonic SFP actor and the EPA as a hegemonic SFP tool. Research into the negotiation, agreement and controversy that surrounds every stage of the EPA confirmed that through modern diplomacy and an evolution in relations, consensus is at the fore of contemporary EU-Caribbean relations. Whilst at once dealing with the singular case of the Caribbean, the author offers a nuanced approach beyond 'EU navel-gazing' by incorporating an ‘outside-in’ perspective, which thereafter could be applied to EU-ACP relations and the North-South dialogue in general.

The Putin doctrine: The formation of a conceptual framework for Russian dominance in the post-Soviet area. OSW Commentary No. 131, 28.03.2014

The statements made in recent weeks by Russian officials, and especially President Vladimir Putin, in connection with Moscow’s policy towards Ukraine, may suggest that the emergence of a certain doctrine of Russian foreign and security policy is at hand, especially in relation to the post-Soviet area. Most of the arguments at the core of this doctrine are not new, but recently they have been formulated more openly and in more radical terms. Those arguments concern the role of Russia as the defender of Russian-speaking communities abroad and the guarantor of their rights, as well as specifically understood good neighbourly relations (meaning in fact limited sovereignty) as a precondition that must be met in order for Moscow to recognise the independence and territorial integrity of post-Soviet states. However, the new doctrine also includes arguments which have not been raised before, or have hitherto only been formulated on rare occasions, and which may indicate the future evolution of Russia’s policy. Specifically, this refers to Russia’s use of extralegal categories, such as national interest, truth and justice, to justify its policy, and its recognition of military force as a legitimate instrument to defend its compatriots abroad. This doctrine is effectively an outline of the conceptual foundation for Russian dominance in the post-Soviet area. It offers a justification for the efforts to restore the unity of the ‘Russian nation’ (or more broadly, the Russian-speaking community), within a bloc pursuing close integration (the Eurasian Economic Union), or even within a single state encompassing at least parts of that area. As such, it poses a challenge for the West, which Moscow sees as the main opponent of Russia’s plans to build a new order in Europe (Eurasia) that would undermine the post-Cold War order.