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.

A relação entre o direito e a teoria econômica na jurisprudência do cade sobre tabelas médicas

Dissertação (mestrado)—Universidade de Brasília, Faculdade de Direito, Programa de Pós-Graduação em Direito, 2015.

O direito antitruste na economia digital : implicações concorrenciais do acesso a dados

Dissertação (mestrado)—Universidade de Brasília, Faculdade de Direito, Programa de Pós-Graduação em Direito, 2016.

Oitenta anos de produção e comercialização dos vinhos do Dão

Mestrado em Economia

The law of unfair business competition, including chapters on trade secrets and confidential business relations; unfair interference with contracts; libel and slander of articles of merchandise, trade names, and business credit and reputation,

Mode of access: Internet.

The law of unfair competition and trade-marks.

Includes Federal legislation.

Legislative restriction on the carrying trade of the railways of the state of New York : viewed in connection with outside competition : addressed to the citizens of the city and state of New York.

Cover title: Legislative restrictions on the carrying trade of the railways of the state of New York.

The World Trade Organization, competition policy, and developing countries: A cross -country examination of domestic policy actions

This dissertation addresses the following research question: in a particular policy area, why do countries that display unanimity in their international policy behavior diverge from each other in their domestic policy actions? I address this question in the context of the divergent domestic competition policy actions undertaken by developing countries during the period 1996-2007, after these countries had quite conspicuously displayed near-unanimity in opposing this policy measure at the World Trade Organization (WTO). This divergence is puzzling because (a) it does not align with their near-unanimous behavior at the WTO over competition policy and (b) it is at variance with the objectives of their international opposition to this policy at the WTO. Using an interdisciplinary approach, this dissertation examines the factors responsible for this divergence in the domestic competition policy actions of developing countries. ^ The theoretical structure employed in this study is the classic second-image-reversed framework in international relations theory that focuses on the domestic developments in various countries following an international development. Methodologically, I employ both quantitative and qualitative methods of analysis to ascertain the nature of the relationship between the dependent variable and the eight explanatory variables that were identified from existing literature. The data on some of the key variables used in this dissertation was uniquely created over a multi-year period through extensive online research and represents the most comprehensive and updated dataset currently available. ^ The quantitative results obtained from logistic regression using data on 131 countries point toward the significant role played by international organizations in engineering change in this policy area in developing countries. The qualitative analysis consisting of three country case studies illuminate the channels of influence of the explanatory variables and highlight the role of domestic-level factors in these three carefully selected countries. After integrating the findings from the quantitative and qualitative analyses, I conclude that a mix of international- and domestic-level variables explains the divergence in domestic competition policy actions among developing countries. My findings also confirm the argument of the second-image-reversed framework that, given an international development or situation, the policy choices that states make can differ from each other and are mediated by domestic-level factors. ^

Synopolies: The use of cryptographic technologies to impede competition in multiple jurisdictions

Many jurisdictions have developed mature infrastructures, both administratively and legislatively, to promote competition. Substantial funds have been expended to monitor activities that are anticompetitive and many jurisdictions also have adopted a form of "Cartel Leniency Program", first developed by the US Federal Trade Commission, to assist in cartel detection. Further, some jurisdictions are now criminalizing cartel behaviour so that cartel participants can be held criminally liable with substantial custodial penalties imposed. Notwithstanding these multijurisdictional approaches, a new form of possibly anticompetitive behaviour is looming. Synergistic monopolies („synopolies‟) involve not competitors within a horizontal market but complimentors within separate vertical markets. Where two complimentary corporations are monopolists in their own market they can, through various technologies, assist each other to expand their respective monopolies thus creating a barrier to new entrants and/or blocking existing participants from further participation in that market. The nature of the technologies involved means that it is easy for this potentially anti-competitive activity to enter and affect the global marketplace. Competition regulators need to be aware of this potential for abuse and ensure that their respective competition frameworks appropriately address this activity. This paper discusses how new technologies can be used to create a synopoly.

Building an effective trade practices commission : the role of Professor Robert Baxt AO

Bob Baxt, the third Chairman of the Trade Practices Commission, served for a single three year term from 1988 to 1991. He followed Bob McComas, who had deliberately adopted a non-litigious approach to preserving the competitive process, believing that he understood business as an insider and that much of what it did was not anti-competitive, when correctly viewed. Baxt was far more pro-active in his approach, and more closely aligned with that of the first Chairman, Ron Bannerman. Baxt sought to push the frontiers of investigation and precedent, and perhaps, more significantly, sought to influence his Ministers, the government, public servants and public opinion about the need to expand the coverage of the Trade Practices Act, increase penalties and properly resource the Commission so that it could perform its assigned roles. This article examines Baxt’s early and on-going role in teaching Australian students and professionals through his interdisciplinary Trade Practices Workshops, the political context of Baxt’s tenure, including his relations with the Attorney-General ,Michael Duffy, and his skilful handling of the Queensland Wire case.

UK Design as a Global Industry : International Trade and Intellectual Property

The importance of design to the UK economy is widely recognised. It is one of the key pillars of the knowledge economy, it plays an important role in the innovation process, and it is one of a number of specialisms that help to set the UK apart from global competition. But despite this importance, the nature of design-intensive industries – the businesses that practice and sell design – is remarkably hard to pin down. This uncertainty renders it hard to analyse, and makes it difficult to develop clear, consistent policies to support the designers. The Hargreaves Review recommended that more research was needed to develop a clear evidence base for improving the intellectual property system for design. This report forms part of that evidence base. It examines how UK design figures in the global economy, and considers how the intellectual property system can best support its growth.

The Australian Consumer Law

Reform of Australia’s inconsistent Commonwealth, State and Territory consumer laws is now a reality. The 1 January 2011 commencement of the Australian Consumer Law (ACL), within the Competition and Consumer Act 2010, is the culmination of a long process of consultation. Unifying and rationalising the plethora of laws, this new Act sees the disappearance of the “Trade Practices Act” and the amendment of a raft of State and Territory legislation; the new national regime informed by them operates in their stead. This is indisputably the most comprehensive change in the history of the Trade Practices Act 1974. This book aims to assist practitioners, academics and students understand the Australian Consumer Law regime and its impact. It summarises the history and constitutional basis of the ACL, explaining how the ACL will be implemented, amended and enforced. In addition it explores how the various general and specific protections interrelate, and the scope of their overlap, and considers the content of the ACL, and the principal changes from the provisions of the Trade Practices Act.

Trade, travel and disease : the role of law in pandemic preparedness

In 2009 the world experienced an influenza pandemic caused by the H1N1 virus. While the pandemic was milder then expected, it nonetheless provided the world with an opportunity to do real-time testing of pandemic preparedness. This paper examines the threats to human health posed by infectious diseases and the challenges for the global community in development of effective surveillance systems for emerging infectious diseases. In 2005 a new revised version of the International Health Regulations (IHR) was adopted. The requirements of the IHR (2005) are outlined and considered in light of the constraints facing resource-poor countries. Finally, the paper addresses the role of domestic law-making in supporting public health preparedness and articulates a number of ethical principles that should be considered when developing new public health laws.

Robbery under arms: Copyright law and the Australia-United States free trade agreement

TThis article considers the radical, sweeping changes to Australian copyright law wrought by the Australia–United States Free Trade Agreement 2004 (AUSFTA). It contends that the agreement will result in a “piracy of the public domain”. Under this new regime, copyright owners will be able to obtain greater monopoly profits at the expense of Australian consumers, libraries and research institutions, as well as intermediaries, such as Internet service providers. Part One observes that the copyright term extension in Australia to life of the author plus 70 years for works will have a negative economic and cultural impact — with Australia’s net royalty payments estimated to be up to $88 million higher per year. Part Two argues that the adoption of stronger protection of technological protection measures modelled upon the Digital Millennium Copyright Act 1998 (U.S.) will override domestic policy–making processes, such as the Phillips Fox Digital Agenda Review, and judicial pronouncements such as the Stevens v Sony litigation. Part Three questions whether the new safe harbours protection for Internet service providers will adversely affect the sale of Telstra. This article concludes that there is a need for judicial restraint in interpreting the AUSFTA. There is an urgent call for the Federal Government to pass ameliorating reforms — such as an open–ended defence of fair use and a mechanism for orphan works. There is a need for caution in negotiating future bilateral trade agreements — lest the multinational system for the protection of copyright law be undermined.