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  Bio-Science Law Review   (United Kingdom)
  Volume 10, Issue 1, 2009
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  • OPINION
  • SCIENTIFIC STIMULUS
        BENJAMIN WALLFISCH
        p.3                                                                                          +cite        

  • ARTICLES
  • KEY TERMS FOR ROBUST LICENSING
        SUSIE MIDDLEMISS
        p.8                                                                                          +cite        
        Whatever the economic climate, licences warrant careful drafting since they are generally long-lasting agreements. In the biotechnology arena they also have on important role for both licensors and licensees in demonstrating commercial progress. This article looks at some of the key terms in licences and suggests ways to address the issues they raise.
  • PATENTING HUMAN EMBRYONIC STEM CELLS IN PERIL: THE DECISION OF THE ENLARGED BOARD OF APPEAL IN G 2/06
        SVEN J.R. BOSTYN
        p.13                                                                                        +cite        
        The Enlarged Board of Appeal has recently decided one of the most sensitive cases it has ever had on its hands, but probably not the last. The referral in the G 2/06 case related to the patentability of human embryonic stem cells (hESC). The main question was whether inventions pertaining to the hESC should be excluded from patentability in the basis of being contrary to order public and morality.
  • THE WRITTEN DESCRIPTION REQUIREMENT: LIMITING THE SCOPE OF BIOTECH GENUS CLAIMS IN THE UNITED STATES
        JOSEPH V. SAPHIA
        p.25                                                                                        +cite        
        Biotech products are moving towards the forefront of human therapeutics. As the commercial success of those products is realized, and the value of the biotech patents protecting those products increases, patent holders will increasingly face validity challenges to their patent portfolios. Based on recent decisions from the US Federal Circuit Court of Appeals, patent invalidity for lack of written description will be a recurrent theme. This article focuses on the recent case law applying the US written description requirement to biotech genus claims and explains how that requirement will be applied to such claims in the future.

  • CASE COMMENTS
  • MEDICAL DEVICES - SCOTTISH COURT OF SESSION DELIVERS OPINION ON CONSTRUCTION OF THE DEFINITION OF 'MEDICAL DEVICES' IN BORDERLINE CASES - HYALTECH DECISION
        EWAN TOWNSEND
        p.29                                                                                        +cite        
        The classification of a product as a medicinal product rather than a medical device imposes on its manufacturer the burden of performing clinical trials. This article reviews the Scottish Court of Session's decision on the correct construction of the definition of "medical device" in Regulation 2(1) of the Medical Devices Regulations 2002, which provides guidance on where and how to draw the line in borderline cases.
  • PHARMACEUTICAL SECTOR INQUIRY - PRELIMINARY FINDINGS
        MARK TRICKER AND MICHAEL JÜRGEN WERNER
        p.31                                                                                        +cite        
        On 28 November 2008, the European Commission presented its preliminary findings on the pharmaceutical sector inquiry, which it has been conducting since January 2008. The findings highlight a number of areas of concern both from a competition law perspective and from a regulatory perspective leading to (a) the delayed market entry of generic medicines following expiry of patents; and (b) the decline in innovative medicines reaching the market.
  • EMPLOYEE INVENTIONS - EMPLOYEE COMPENSATION VICTORY FOR MYOVIEW INVENTORS
        ALEX BATTESON
        p.35                                                                                        +cite        
        The English Patents Court has awarded £2.5 million to two inventors of the radioactive cardiac imaging agent Myoview under the employee compensation provisions of the Patents Act 1977 (Kelly v GE Healthcare [2009] EWHC 18: (Pat)). This represents a rare victory for a claimant under the legislation. The decision sets out the Court's approach to granting compensation under the provisions.

  • NEWS
  • EUROPEAN COMMISSION - Article 82 Guidance on Exclusionary Abuses of Dominance - Anti Piracy Regulation and Infringement AUSTRALIA - Patents - Senate inquiry into the impact of gene patents on Australian Healthcare GERMANY - New German Merger Control UNITED KINGDOM - Contracts - The Effectiveness of signatures in evidencing an agreement - Termination Patents - Employee Inventions
        p.37                                                                                        +cite    

  • BOOK REVIEW
  • INDIGENOUS HERITAGE AND INTELLECTUAL PROPERTY: GENETIC RESOURCES, TRADITIONAL KNOWLEDGE AND FOLKLORE
        SILKE VON LEWINSKI
        p.48                                                                                        +cite