Current Law Journal Content
Washington & Lee Law School
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  Bio-Science Law Review   (United Kingdom)
  Volume 6, Issue 4, 2003/2004
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  • GMO REGULATION IN EUROPE: A PRIMER FOR PATENT APPLICATIONS
        Tim Sampson
        p.131                                                                                      +cite        
        The new regulatory regime governing the release and marketing of genetically modified organisms is now fully operative in Europe and, as such, must now become a practical consideration for those filing patents for GMOs. This article explores a number of issues regarding the design of the GMO's genetic constructs and presentation of molecular data that might, without care, present real difficulties when seeking such patents and later regulatory approval.
  • BIOGENERICS: A MOVE TOWARDS REGULATION OF THE UNKNOWN
        Zelda Pickup and Andrew Whitworth
        p.139                                                                                      +cite        
        Copycat versions of biopharmaceuticals will become more prevalent due to a growing number of biopharmaceutcials facing patent expiry. This article examines the European Medicines Agency's guidelines for demonstrating that biogenerics have a similar profile to an original biopharmaceutical in terms of quality, safety and efficacy and the impact of these guidelines on biogeneric manufactureres.
  • FROM GATT TO G.A.T.T. - 50 YEARS OF EUROPEAN BIO-IP (PART 2)
        Margaret Llewelyn
        p.142                                                                                      +cite        
        These two articles will provide an outline of some of the developments in bio-intellectual property rights ('bio-IPRs') post-Crick and Watson. As space precludes detailing all aspects of bio-IPR provision the (inevitably personal) focus will be on what can be protected rather than on the scope of the right granted or issues of infringement. Part II examines the developments in Bio-IP from the 1980's through to today.