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Washington & Lee Law School
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Bio-Science Law Review
Volume 8, Issue 1, 2005/2006
PATENTLY TOO FAR? University inventions - lessons from Cambridge
BIOSIMILAR WARFARE: THE ARRIVAL OF GENERIC BIOPHARMACEUTICALS - THE OMNITROPE DECISION
Over the last 20 years the fruits of the biotechnology revolution have become available in the form of biopharmaceuticals. These complex products have so far been the preserve of innovative companies. Recently, however, a generic biopharmaceutical product made by Sandoz (Omnitrope) has been approved for marketing in Europe, the United States and Australia. It is the first of its kind. The European authorisation flows from the 2004 overhaul of the medicinal products legislation, which introduced a specific route of approval for biosimilars. It is accompanied by a raft of guidelines concerning the procedures for biosimilar authorisations. A second product authorisation swiftly followed. In contrast, the United States approval was granted under extreme pressure as a special case. The FDA stated that it is not to be regarded as a template for other products, because of an anomaly in the authorisation of the reference product and particular features of this protein. In this article, Isabel Teare reviews these developments, and considers what the future holds and what effect this may have on innovative producers.
TRANSBOUNDARY MOVEMENT OF GENETICALLY MODIFIED ORGANISMS REGULATION (EC) 1946/2003: A REVIEW
The regulatory framework in respect of Genetically Modified Organisms (GMO) within the Community is complex and to appreciate it fully requires an understanding of numerous recent Regulations. In this article (the second in a series of three) the regulatory framework in respect of GM food and GM feed under Regulation (EC) 1829/2003 is analysed and considered in the context of various other Community legislation governing GMO, in particular the deliberate release Directive 2001/18/EC, and regulatory bodies, such as the Standing Committee on the Food Chain and Animal Health. The labelling requirements for GM food and feed are also discussed, where these go beyond those obligated far GM products in general under Regulation (EC) 1830/2003 (see "Would you know your GMO? An assessment of Regulations 1830/2003, 65/2004 and GMO Unique Identifiers", [2004/2005] 3 B.S.L.R., 113-117).
PLANT VARIETY PROTECTION IN EGYPT
In 2002, Egypt passed Law 82/2002, collecting existing intellectual property legislation as well as adding new areas of protection to meet international obligations under the WTO/TRIPS agreement. This paper examines the text of the new law to determine whether protection of plant varieties is effective, and sufficiently accommodates breeders' and farmers' rights. Inconsistency with international agreements may leave the law open to challenge, but TRIPS review, under Articles 27.3(b) and 71.1, presents opportunities for developing countries like Egypt to address important concerns. TRIPS Articles 7 & 8 may also be relied upon. Egypt is keen to attract foreign investment and needs transfer of technology and research and development appropriate for its unique agricultural sector. However, an EU-Egypt bilateral agreement requiring membership of UPOV 1991, narrows options for sui generis plant variety legislation. Such TRIPS plus protection seems undesirable and may endanger farmers' rights to continue traditional farming practices.
AUSTRALIA - Relaxation of Patent Certificate Requirements for Registration of Therapeutic Goods - UNITED KINGDOM - Patents - Industrial Application of Gene-based Inventions in the United Kingdom clarifies by the UK Patent Office Patents - The Enforcement Directive in the UK and damages in patent actions - ΕΜΕΑ - Biosimilars - EUROPEAN COMMISSION - Competition Law - delaying generic drug entry and the restriction of parallel trade - the AstrZeneca Decision - WTO - GMO update EU's de facto moratorium
TERRELL ON THE LAW OF PATENTS (16TH EDITION), SIMON THORLEY, QC, RICHARD MILLER, QC, GUY BURKILL, QC, COLIN BURISS