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Washington & Lee Law School
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  Bio-Science Law Review   (United Kingdom)
  Volume 9, Issue 2, 2006/2007
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  • ARTICLES
  • THE FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007
        ERIKA LIETZAN, MICHAEL S. LABSON AND SHAW SCOTT
        p.39                                                                                        +cite        
        On September 27, 2007, the President signed into law the Food and Drug Administration Amendments Act of 2007 ('FDAAA'). This law, containing 11 titles, amends the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. In particular, it reauthorises and amends the prescription drug user fee programme and the medical device user fee programme, it also reauthorises and modifies the pediatric exclusivity and pediatric assessment programmes applicable to new drugs. It includes new provisions aimed at providing incentives to device manufacturers to create medical devices for pediatric patients. It enhances FDA's authority to regulate the safety of approved drugs, expands the National Institutes of Health registry of clinical trials, requires the development of a database for results of those trials, and addresses conflicts of interest on FDA advisory committees. It also includes new provisions regarding the safety of human and pet food. This article summonses the most significant provisions of the FDAAA applicable to drugs and medical devices.
  • AN OVERVIEW OF THE NEW EUROPEAN PATENT CONVENTION (EPC 2000) AND ITS POTENTIAL IMPACT ON EUROPEAN PATENT PRACTICE
        STACEY J. FARMER AND MARTIN GRUND
        p.53                                                                                        +cite        
        Almost 30 years have passed since the signing of the first European Patent Convention in 1973 ('the EPC 1973'). This article reviews changes introduced through the EΡC 2000, which entered into force on 13 December 2007, and analyses its impact on current European patent practice.
  • INTERPRETING ORDRE PUBLIC AND MORALITY IN A PATENT LAW CONTEXT: WHICH IS THE CORRECT APPROACH?
        TINE SOMMER
        p.62                                                                                        +cite        
        As an exception to patentability European Patent Law refers to morality and 'ordre public' as a legal standard. The most important provision on the morality standard is Article 53(a) EPC, interpreted by the EPO Boards of Appeal over several decades. However, since the adoption of Directive 98/44/ΕC on the legal protection of biotechnological inventions, in 1998, the European Court of Justice has also been empowered to rule on the interpretation of the moral standard. The EPO and the EC are two separate institutions, each with decision-making power with regard to their Member Stats. Since the Directive Article 6 complements Article 53(a) EPC, as implemented in the Implementation Regulations Rule 28 EPC 2000, there are potential conflicts between the EU, The EPO and Member States subject to both systems. The author highlights the interpretation of the moral standard and questions if this mix of competence benefits patent law development.

  • NEWS
  • NEW ZEALAND - Swiss-type claims - SOUTH AFRICA - Bío-prospecting and the South African Patents Act - UNITED KINGDOM - Patents - UK IP0 opinions - Embryology - HFEA approval of Cytoplasmic Hybrid projects - Tax - New CGT regime News - EUROPEAN UNION - EU ratifies amendments to TRIPS on compulsory licences
        p.75                                                                                        +cite    

  • B00K REVIEWS
  • EUROPEAN PLANT INTELLECTUAL PROPERTY, MARGARET LLEWELYN AND MIKE ADCOCK
        p.89                                                                                        +cite