An economic assessment of patent settlements in the pharmaceutical industry

This article demonstrates that in recent years, patent settlements between branded and generic manufacturers involving "reverse payments" from branded manufacturers to generic manufacturers have received close antitrust scrutiny, driven by concerns that such settlements harm consumers by delaying the entry of lower-priced generic drugs. The authors note that such settlements will be a focus of the Obama Administration's antitrust enforcement policy, yet there is a growing consensus among the courts that such settlements are anticompetitive only under narrow sets of circumstances. In this article, the authors present an analytical framework for evaluating the competitive effects of patent settlements, including those involving reverse payments, and demonstrate that these settlements can benefit consumers. Thus, the authors conclude that while continued scrutiny of such settlements is important, broad brush treatments are inappropriate and only a more individualized evaluation can correctly determine the competitive effects of a particular settlement agreement.     

New pitfall for the pharmaceutical industry

Legal context This article reviews the Commission decision thatfined AstraZeneca 60 million for abuse of Article 82 EC. Itlooks at the decision in the context of the EU legal frameworkfor pharmaceuticals and considers the legal basis for the Commissiondecision. Key points The article highlights the key points of the allegedabusive practices that do not appear to be consistent with theEU regulatory legal framework and the ECJ jurisprudence in particular,read in conjunction with the principle of commercial freedom. Practical significance The Commission decision (if upheld bythe courts) would have an significant impact on the way thatpharmaceutical companies run their business. This would constitutean unprecedented interference with the principle of commercialfreedom afforded to pharmaceutical companies and specificallyrecognised by the ECJ.     

Bitter pill for the pharmaceutical industry

In Case C-431/04 of 4 May 2006 the European Court of Justiceruled that a combination of an active ingredient and an excipientcannot be understood as ‘combination of active substances’in the sense of Article 1(b) of Council Regulation 1768/92 andthus is not entitled to SPC protection.     

Exploring the flexibilities in TRIPS: lessons from India's pharmaceutical patent law

This article examines the extent to which the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) permits countries to utilize two key flexibilities, i.e. the exclusion of new forms of known drugs from patent protection and local working requirements to facilitate access to affordable medicines and foster domestic pharmaceutical innovation. It examines how India has implemented and recently utilized these two key flexibilities and concludes with the view that other developing countries can equally follow the Indian model.     

Antitrust issues in the settlement of pharmaceutical patent disputes, Part II

The settlement of patent disputes in the pharmaceutical industry, and the possible antitrust issues arising therefrom, are of notable concern to the Federal Trade Commission. In this Comment, based on his second speech on the subject, Commissioner Leary re-examines some of this earlier positions under the light of the Commission's further experience with these matters, and provides the industry with some additional objective standards under which it may legally operate. With the Hatch-Waxman Act as a backdrop for patent settlements between manufacturers of patented drugs and potential generic entrants to the market, the Commissioner reviews a variety of scenarios that may or may not be permissible. After initially noting the circumstances of presumptively valid settlements, Commissioner Leary reviews the often complex settlement structures that will be deemed unlawful when and if the finding of reverse payments is evidenced. Finally, the Commissioner concludes with a brief examination of other settlement structures and offers his general views as to their likely legality.     

Challenging pharmaceutical industry political power in Maine and Vermont

A comparison of the Vermont and Maine cases of attempting to control pharmaceutical prices in the year 2000 shows that the Maine legislators were more successful in challenging pharmaceutical industry political power. This comparison shows that challenging the industry was aided by (1) mobilizing public support through grassroots organizations, (2) including independent pharmacists in negotiations over the legislation, and (3) developing state purchasing power leverage.     

Managing competition between individual and organizational goals in cross-sector research and development centres

Research of potential socio-economic value is commonly conducted within cross-sector (government, university, business) centres. Success depends on partners whose objectives and strategies may converge or compete. Yet little empirical evidence exists on: (a) how individual researchers perceive the benefits of their participation, (b) how far the structures and functions of particular collaborative R&D centres coalesce around of researchers’ expectations and, (c) what problems arise for researchers who opt for a ‘second job’ in the centre. The paper presents a qualitative analysis of a survey of respondents from public sector organizations involved in Australian Cooperative Research Centres. A novel frame for analysing these data is the study of inter-organizational relationships (IOR). We use the perspective of the individual research scientists to illuminate the important management issues of trust, governance, and competition between functional domains, which emerge from IOR and which have been inadequately recognised in the context of collaborative R&D centres. The findings have implications for the management and of the centres, for the careers of research scientists and for public policy.     

TRIPS下药品专利权与公共健康权的冲突和平衡

随着发达国家拥有的药品专利越来越集中,发展中国家因为得不到有效的药品而所遭受的危及公共健康权的疾病越来越多的情况下,TRIPS中的药品专利保护和公共健康权冲突加剧。本文以利益平衡为方法,论述了TRIPS利益保护的失衡以及如何采取措施使其平衡,从而达到有效保护公共健康权的目的。     

AIDS drugs & the pharmaceutical industry: a need for reform.

The pharmaceutical industry has long enjoyed substantial profits despite increased requirements for drug approval and various attempts to regulate the industry. Drug companies have avoided effective regulation by blaming high prices on the costs of research and development. The search for drugs effective in combatting HIV and AIDS related illnesses has provided a stark background on which to view the actions and justifications of drug companies. Despite increased cooperation between government and the drug industry and expedited approval of several useful drugs, these drugs are still prohibitively expensive. This Article explores the history and economics of the drug industry and proposes a system of national price regulation for all drugs.     

Technology transfer to the hardwood industry: Testing new strategies

The National Agricultural Library and the Extension Service, US Department of Agriculture, are collaborating on a technology-transfer strategy with the hardwood industry. The strategy is based on the premises that 1) industry associations can serve as vehicles for identifying industry-wide needs, 2) non-traditional research bases are fertile sources of alternative technologies, 3) technology agents can uncover existing technologies and evaluate the feasibility of commercializing them, and 4) state-of-the-art reports and promotion of new cost-saving technologies provide industry with new products and new processes. He has been a program director for Public Technology, Inc. and the executive director of the Federal Laboratory Consortium for Technology Transfer. Dr. Maher is the current president of the Technology Transfer Society's Washington, DC, Chapter.     

The path to cheaper and safer drugs: revamping the pharmaceutical industry in light of GlaxosmithKline's settlement.

The State of New York's ability to secure a settlement from GlaxoSmithKline in which they agreed to publish summaries of completed trials is a step in the right direction. It is likely that other pharmaceutical companies will follow suit and establish Clinical Trial Registers for their own drugs. In order to make such a transition positive, however, the government could consider further remedies, including mandating that pharmaceutical companies publicly disclose all premature terminations of clinical trials. If such a policy is not adopted, firms may have an incentive to withdraw funding for projects that are likely to produce negative results. In order to reduce pharmaceutical companies' ability to misrepresent the results of clinical trials, the FDA could begin rating drugs on the basis of their cost-effectiveness, efficacy and safety. Such a policy would have the effect of both improving patient outcomes and reducing the cost of pharmaceuticals.