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  Bio-Science Law Review   (United Kingdom)
  Volume 10, Issue 2, 2009
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  • ARTICLES
  • KEY TERMS FOR ROBUST COLLABORATIONS
        SUSIE MIDDLEMISS
        p.51                                                                                        +cite        
        Following on from the first part of 'Key Terms for Robust Collaborations' which appeared in Volume 10 Issue 1. The issues discussed there also apply to collaborations. In addition, there are particular considerations that apply to collaboration agreements. This article looks at the areas specific to collaboration agreements. The key features of a collaboration in comparison with a straight IP licence is that both parties are working together and, typically, cross-licensing. This often requires a closer working relationship with regular contact. The best prospects of success stem from a sound working relationship but it is important that the agreement properly reflects the terms agreed by the parties and contains an 'exit' strategy for both parties, particularly in an unpredictable economic environment. It can be difficult to maintain a constructive relationship while negotiating clauses that are only likely to be relevant if there is a breach or termination, but it is crucial that these arrangements are tackled early on.
  • WHAT'S THE USE?!
        MATTHEW SPENCER
        p.56                                                                                        +cite        
        It seems that, once again, Biotechnology has outpaced the law. In recent times both the European Patent Office and the National Courts of the member states have considered the validity of patent claims directed to novel proteins, where the functional characterisation of the protein was carried out in silico. Such patent claims rely upon prediction of function based upon sequence alignment with other proteins belonging to the same family. The statutory requirement of industrial application is reviewed, particularly in the context of Directive 98/44/EC and the apparent requirement for a use to be associated with a claimed gene or protein. The way in which an apparently simple statutory requirement, namely that the invention must be one which can be made or used in any kind of industry, has been interpreted to deal with speculative functions is considered in the context of a number of decisions. This is done with a view to providing some guidance to applicants regarding the requirement far a credible utility to be presented in the application as originally filed.
  • THE NEW CHINESE PATENT LAW AND THE LIFE SCIENCE SECTOR
        JONATHAN SELVADORAY AND NICOLAS ZHU
        p.62                                                                                        +cite        
        Entering into force on 1 October 2009, the revised PRC Patent Law ("New Patent Law") provides significant amendments to the current patent law, those amendments being both general to the patent regime and specific to the life science industry. The article describes those amendments, which include the introduction of a "confidentiality review" for patent applications in foreign countries for technology developed in China and, the modification of the concept of "novelty of industrial design". Particular amendments which will specifically affect life science companies are also detailed. Such amendments include the introduction of a legal compliance requirement and a disclosure obligation in applications for patents based on genetic resources, the modification of the compulsory licence clause, explicit clarification of parallel import practices and the incorporation of a Bolar provision. The difficulties that the provisions of this New Patent Law may give rise to at the time of its interpretation and implementation by individuals and courts, are considered in the article. The New Patent Law reflects the dilemma that China has been facing for some time now, in its efforts to become an innovative country whilst also addressing major concerns such as accessibility to and affordability of medicines.

  • CASE COMMENT
  • HIGH COURT UPHOLDS UK'S STRICT APPROACH ON PAEDIATRIC EXTENSION TO SPCs
        JONATHAN BALL AND ELIZABETH BARNETT
        p.66                                                                                        +cite        
        El Du Pont de Nemours & Company has had its appeal seeking to reverse the refusal of grant of a paediatric extension to the term of its SPC for the active ingredient in Cozaar® rejected by the English High Court. The court upheld the UK Intellectual Property Office's strict approach in refusing to grant the extension where the applicant could not submit with its application issued marketing authorisations updated to include the paediatric data in all Member States. The decision highlights the risk of being refused extension for reasons outside the applicant's control where Member States are slow to issue market authorisations.

  • NEWS
  • EUROPEAN REPORTS - ECJ Advertising - Information 'Designed to Promote' Medicines ECJ Borderline Products - Clarification on EU Regulatory Products AUSTRALIA - Plant Breeder's Rights - Federal Review of Enforcement of Plant Breeder's Rights SOUTH AFRICA - Bio-Prospecting - Biodiversity Act Amendments UNITED KINGDOM - Advertising - Promotion of Traditional Herbal Medicines: Biotechnology - Funding - The Cooksey Report: Electronic Signatures - Signing Documents - A Guide from the UK Law Society: Listed Companies - 'Take-private lite': Patents - Paediatric Extension to your SPC Patents - Avoiding Duplication - Co-ordination between National Courts and the EPO: Equity Capital Markets - Changes to Facilitate Capital Raisings in the UK Markets: Unlicensed Medicines - The Review of Unlicensed Medicines
        p.70                                                                                        +cite    

  • BOOK REVIEW
  • HUMAN RIGHTS AND THE WTO. THE CASE OF PATENTS AND ACCESS TO MEDICINES
        HOLGER HESTERMEYER
        p.89                                                                                        +cite