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Washington & Lee Law School
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  Bio-Science Law Review   (United Kingdom)
  Volume 6, Issue 5, 2003/2004
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  • Exploitation on Research Tool Patents in Plant Biotechnology: Access Through Application of the Experimental Use Exception
        David J. Faye
        p.179                                                                                      +cite        
        In recent times, scholars have become more vocal about a worrying trend that threatens to hinder the progress of science at a fundamental level: access to key data and research tools used in the development of new scientific initiatives has become increasingly limited, due in large part to a proliferation of patent rights. This problem has had a significant impact on the plant biotechnology sector, where scientists require access to research tools in order to advance agricultural programs and improve the situation of subsistence farmers. Part 1 of this article reviews the general danger to science that is posed by the industry's shifting ideology and the increasingly proprietary nature of research tools. Part 2 will propose a renewed focus on the experimental use exception to patent infringement as a possible means of ameliorating these problems in the plant biotechnology field.
  • GMO Challenges at the WTO
        Victoria Harris, Iciar Chavarri and Debra Hueting
        p.189                                                                                      +cite        
        In May 2003, the United States, Canada and Argentina launched a WTO dispute concerning the EC's moratorium and national bans against GM products. This dispute has attracted the attention of the world's media since it impacts on transatlantic relationships and will influence the future of GM food and feed products in the EU. This article examines the issues raised by this WTO dispute and follows the progress of the case to date. It also questions whether the EC's latest package of GM legislation containing traceability and labelling requirements for GM products will represent a further restriction on trade. The EU's latest requirements are likely to be costly for businesses and so are already proving to be unpopular. It may only be a matter of time before this package also presents industry with enough problems to fuel another dispute before the WTO.
  • Recent Legislative Changes Affecting IP Litigation In Europe
        Nigel Jones, Katja Grabienski, Gavin Marriott and Colin McCall
        p.192                                                                                      +cite        
        This articles considers the potential impact of recent legislative changes, the EU Intellectual Property Enforcement Directive and the UK Patent Act 2004, on the way in which intellectual property rights are litigated in Europe. Its primary focus is on the impact in the United Kingdom, particularly as the second of the legislative changes addressed has direct effect only in that country. However it also considers the broader implications of the changes.
  • Regulatory Data Protection: Essentially Similarity to Not Essentially Dissimilar?
        Olivier Lemaire
        p.197                                                                                      +cite        
        Extending the exclusivity of pharmaceutical products through line extensions has always been part of the life-cycle management strategy of innovative pharma companies. Likewise, obtaining a marketing authorization for the most recent version of a successful innovative product through the abridged procedure has always been key to the success of generic manufacturers. On 29 April 2004, the ECJ issued a judgment in the case of Novartis v. SangStat which is critical for the future of these strategies. The ECJ was asked to provide guidance as to whether a competent regulatory authority was entitled to rely on data relating to a reference product (product A) and its supra-bioavailable line extension (product B) in order to approve a non-bioequivalent generic version (product C). The ECJ answered this question in the affirmative, relying on somewhat complex and contradictory reasoning. In doing so, the ECJ preempted the concept of a "global marketing authorization" recently introduced in the European pharmaceutical legislation. This article sheds some light on this complex issue and analyses the Court's reasoning and the contradictions inherent therein.