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  Bio-Science Law Review   (United Kingdom)
  Volume 10, Issue 3, 2009
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  • ARTICLES
  • MORALITY AND THE PATENT SYSTEM: AN ANALYSIS OF ARTICLE 53(A) OF THE EUROPEAN PATENT CONVENTION AND THE US PATENT SYSTEM
        MATTHEW ABRAHAM
        p.95                                                                                        +cite        
        This article seeks to establish the need for a morality provision within the patent system. The morality provision within the European Patent Convention (Article 53(a)), is analysed and the appropriateness of its application is questioned. The application of Article 53(a) in recent cases is looked into in order to illustrate the tests adopted by the European Patent Office (EPO). The recent WARF decision is analysed and the reasoning there is questioned. It shall be shown that reliance on Article 53(a) in accordance with WARF is problematic as it allows the EPO to be arbiters of morality. It has been suggested that Article 53(a) ought to be removed to solve the problems that could arise following WARF. This article analyses the US patent system, which does not have a morality provision, to show that a complete removal of a morality provision could result in more complex problems. The analysis of the US patent system focuses on the issues raised by patent applications in regards to chimeras. An in depth scrutiny of the theoretical justifications for maintaining a morality clause within the patent system would reveal that patent law and morality in fact go hand in hand. To ignore this fact is to ignore the balance that a patent-system seeks to achieve between the interests of patent holders and society. This article therefore suggests a reconsideration of the WARF decision rather than the removal of Article 53(a) in order to prevent the EPO from becoming arbiters of morality.
  • PATENTING ENANTIOMERS - THE HOUSE OF LORD'S DECISION IN LUNDBECK v GENERICS AND A COMPARISON WITH THE DECISION OF THE DISTRICT COURT OF THE HAGUE
        BRIAN WHITEHEAD, STUART JACKSON AND RICHARD KEMPNER
        p.108                                                                                      +cite        
        The House of Lords has upheld the Court of Appeal's decision to overrule the decision of the Patents Court in Generics v Lundbeck, in which it held invalid Lundbeck's patent for a single enantiomer of citalopram ("escitalopram"). Citalopram was widely sold as the racemate because of the difficulty of resolving it. Kitchin J held a claim to a method of obtaining escitalopram valid, but held the product claims to be invalid for insufficiency because only one process for making the product was disclosed. The House of Lords has now confirmed that that principle ("Biogen insufficiency") is not of general applicability, and that the disclosure of one method of making a novel and inventive product is sufficient. A patentee who has a straightforward product claim granted therefore gets more than he has invented: that product made by any method, and all uses of the product, including those he had not thought of. The authors argue that a chemist would be surprised that an enantiomer long known and used as half of the racemate could be inventive. The strange result arises because of the finding that the method claim for resolution of escitalopram was not obvious, even though a chemist would have known that resolution would eventually be achieved by one or other standard method. The authors compare and contrast the outcome of the English proceedings with those in the Dutch courts, where it was held that the method of resolution was not inventive, and the issue of sufficiency therefore did not arise.
  • DIRECTIVE 2007/47/EC: WHAT ARE ITS IMPLICATIONS FOR EXISTING MEDICAL DEVICES?
        ELISABETHANN WRIGHT AND FABIEN ROY
        p.113                                                                                      +cite        
        As the new requirements introduced by Directive 2007/47/EC will enter into force on 21 March 2010, questions arise as to whether the current certificates of conformity delivered by the Notified Bodies will remain valid after this date. In some instances, the new provisions of the Directive may lead to a modification of the existing certificates, a circumstance that imposes medical devices manufacturers to obtain a new certificate of conformity in line with these new requirements. The present article tries to identify situations where certificates may not be valid after the entry into force of the new Directive. Taking position is however delicate as the European Commission remains unclear despite the publication of a document on the subject.
  • EMBRYONIC STEM CELLS, INDUSTRIAL USE OF EMBRYOS AND THE PROHIBITION ON GRANTING OF PATENTS IN SPAIN
        GONZALO ULLOA AND ÁNGEL GARCÍA VIDA
        p.116                                                                                      +cite        
        This work focuses on the patentability of inventions relating to human embryonic stem cells. More particularly, it examines the prohibition of granting patents in respect of inventions, the commercial exploitation of which would be contrary to public order or morality. After analyzing the different international reports on the question, and the decision of the Enlarged Board of Appeal of the European Patent Office in the case Stem Cells/WARF, it explores the patentability of this type of invention in Spain.

  • CASE COMMENTS
  • PHARMACEUTICAL SECTOR INQUIRY: EUROPEAN COMMISSION PUBLISHES FINAL REPORT
        MICHAEL JÜRGEN WERNER AND JONATHAN BALL
        p.120                                                                                      +cite        
        On 8 July the European Commission published its final report on its pharmaceutical industry inquiry. Although the final report is more balanced than the interim report published in November 2008, the findings remain the same: that public health authorities and consumers are paying high prices due to lengthy delays to the market entry of generics. Although the report identifies some causes of delay, such as the lack of a unified EU patent system, that cannot be blamed on pharmaceutical companies, the report focuses on the tactics used by originators to extend the commercial life of their products, including filing patent thickets and settling patent disputes with generic new entrants in ways that delay the generic entry to the market. The Commission promises to intensify its efforts in the pharmaceutical sector, and so both originators and generic companies should expect that issues such as patent settlements will be carefully scrutinised by the Commission and national competition authorities going forward.
  • CPVO BOARD OF APPEAL DECISION A 001/2008 THE IMPORTANCE OF BEING WELL REPRESENTED
        MICHAEL ROBERTS
        p.122                                                                                      +cite        
        The Board of Appeal of the Community Plant Variety Office (CPVO) has commented in a recent decision A 001 2008 that it is highly desirable for the proper conduct of CPVO business that competent and reliable representatives who are resident within the European Union are chosen by non-European applicants for a European Community Plant Variety Right (CPVR). The case under appeal involved a strawberry variety "Yuval" owned by Fertiseeds Ltd, and showed how failure to appoint a suitable representative can not only delay or derail processing of a CPVR application but also result in cancellation of a granted CPVR.

  • BOOK REVIEW
  • CHOOSING LIFE, CHOOSING DEATH: THE TYRANNY OF AUTONOMY IN MEDICAL ETHICS AND LAW
        CHARLES FOSTER
        p.124                                                                                      +cite