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  Bio-Science Law Review   (United Kingdom)
  Volume 11, Issue 2, 2010
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  • Editorial
  • DISCOVERY AND INVENTION: WHERE IS THE BOUNDARY BETWEEN THEM AND SHOULD WE CARE?
        TIM ROBERTS
        p.35                                                                                        +cite        

  • ARTICLES
  • ASTRAZENECA AND LOSEC: JUDGMENT OF THE GENERAL COURT
        CHRISTOPHER STOTHERS, MARK GARDNER
        p.39                                                                                        +cite        
        This article considers the potential impact of the European Commission's decision and the General Court's judgment in AstraZeneca, particular in the light of the Commission's Pharmaceutical Sector Inquiry which concluded on 8 June 2009. After setting the scene, it looks at three key aspects: dominant position, Supplementary Protection Certificates and deregistration of marketing authorisations. It concludes that the decision and judgment bring with them an unwelcome level of uncertainty which risks discouraging innovation and further weakening the pharmaceutical sector in Europe.
  • INTELLECTUAL PROPERTY, HUMAN RIGHTS AND BIOTECHNOLOGY - A REVIEW
        MICHAEL BLAKENEY
        p.49                                                                                        +cite        
        Michael Blakeney in this review article examines three books that cover the current trends in development of Intellectual Property Rights, the embedding of Human Rights and Intellectual Property through the TRIPS agreements and how IP rights have evolved to encompass the biotech revolution.

  • CASE COMMENT
  • REFLECTIONS ON THE ERBITUX DECISION: COMBINATION PRODUCTS, COMBINATION THERAPIES AND SPCs
        ANDREW BROWN, DUNCAN CURLEY
        p.54                                                                                        +cite        
        The development of monoclonal antibodies (mAbs) for the treatment of serious illnesses such as cancer has been one of the notable success stories in medicine in recent years. Twenty-two mAbs have been approved for use in patients in the USA and a number of them are now blockbusters. Furthermore, as physicians have become more experienced with the use of these products in patients, the number of ways in which mAbs may be used in the clinic has expanded and patient demand for them has increased. This case comment outlines the commercial and regulatory backdrop to an interesting case on the eligibility of one of the major mAb products - cetuximab - marked in Europe as Erbitux - to a period of supplementary patent protection in the UK. Regulation (EC) No. 469/2009 (the "SPC Regulation") provides a scheme for the grant of a supplementary protection certificate ("SPC") to the holder of a patent in order to extend the rights conferred by that patent in respect of a specified medicinal product for a period not exceeding five years. As is well known, the purpose of the SPC Regulation is to compensate the patent holder for the delay in commercialising its products, due to it having to obtain regulatory approval before marketing and selling its product to physicians and other healthcare providers.

  • NEWS
  • FRANCE - Patents - Employee Inventions - UNITED KINGDOM - Tax - R&D Tax Credit and Taxation of IP - Consumer Protection - MHRA Guidance on Consumer Websites Offering Medicinal Treatment Services - EPO - Patents - Patent Pending? EPO Decision Provides Guidance - Rules - Some Clarification from the EPO - EUROPEAN UNION - Data Protection - Surveillance in the Sick Society: Pharmacovigilance and the Data Protection Directive - EC Pharmacovigilance Measures Adopted - EUROPEAN COURT - Legal Professional Privilege - CJEU Decision on Legal Professional Privilege and In-House Layers
        p.59                                                                                        +cite