Current Law Journal Content
Washington & Lee Law School
Current Law Journal Content
an index to legal periodicals
Bio-Science Law Review
Volume 7, Issue 3, 2004/2005
WOULD YOU KNOW YOUR GMO? ΑN ASSESSMENT OF REGULATIONS 1830/2003, 65/2004 AND GMO UNIQUE IDENTIFIERS
The regulatory regime for Genetically Modified Organisms (GMO) in Europe has, as its cornerstone, Directive 2001/18/EC on the deliberate release of GMO. However, even prior to the coming into force of that Directive, its provisions in relation to labelling were deemed inadequate. In order to rectify this situation the Commission has implemented two supplemental Regulations - 1830/2003 (concerning the labelling and traceability of GMO) and 65/2004 (establishing a system for the assignment of unique identifiers for GMO). The latter being based upon the OECD Guidance for the Designation of Unique Identifier for Transgenic Plants, published in 2001. This article considers how these two regulations will work in practice and explains in detail how the unique alpha-numeric identifiers for each GMO will be created.
WHOSE DNA IS IT ANYWAY? TESTING GENETICS UNDER THE AUSPICES OF EU DATA PRIVACY LAW
Testing human DNA involves the processing of genetic data that can be used to identify individuals, link them to others and reveal complex information about the future health and development of those individuals. Genetic data is considered personal data under EU data privacy law, and its treatment is therefore subject to stringent rules and limitations. Processing of such data will in principle be allowed in exceptional circumstances only, for instance when necessary to protect an individual's vital interests. Arguably the processing of genetic data for the purposes of providing individuals with information on their genealogical origins would qualify as of exceptional circumstance. Genetic data should only be used if adequate, relevant and not excessive in relation to the purpose for which they are processed. As the offsetting concern under EU data privacy law is that on individual's genetic data might be disclosed without that individual's blessing, it is essential that explicit, free and informed consent is obtained prior to the actual testing. Idividuals should also be informed of their right to know and access their personal data resulting from genetic testing. In some cases, however, individuals should have too the right not to know the results of genetic testing. Processors of genetic date should be aware that genetic data are to be stored securely and for a limited period of time only.
PATENTS, JURISDICTION, ENFORCEMENT AND LICENSING
International patent litigation is expensive and time consuming for all parties and its avoidance may be one of the factors that motivates parties to enter into licensing arrangements. This article considers the basic rules relating to patents and jurisdiction and the extent to which these rules can be abrogated by the parties to a licence agreement. It then provides guidance on drafting the relevant aspects of licence agreements.
CAT PREVAILS AT FIRST INSTANCE
The CAT v Abbott decision is of great interest to the biotech industry, as it involves CAT, a small biotech company, taking on one of its large pharmaceutical company partners. The subject-matter of the dispute will also stimulate interest: the interpretation of a clause included to ease the burden of royalty-staking on the licensee. Although such cases inevitably turn on their particular facts, there are a number of lessons that can be learned by companies entering into collaboration agreements or licences that contain such clauses.
THE NEW GERMAN PATENT LAW FAILS TO TRANSPOSE EC DIRECTIVE 98/44/EC CORRECTLY
MARTIN GRUND AND MARTIN R. BRUDA
In this short article the authors highlight and examine a series of potential conflicts inherent in the manner in which the Biotech Directive (EC Directive 98/44/EC) has been incorporated into German Law. The authors outline the areas of potential concern.
UNITED KINGDOM - HFEA - Quintavalle v. HFEA challenge to HFEA authorisation of licence - IVF - selection 'embryos are in a suitable condition' - EUROPEAN COMMISSION - Abuse of dominant position AstraZeneca fined £60 million - misuse of patent and drug authorisation procedures to delay market entry for genetic competitors - EMEA - More guidelines on the approval of biosimilars published - EUROPEAN COURT OF JUSTICE - Parallel imports - rejection of reference from Greek competition authority Syfair v. Glaxosmithkline AEVE - UNU-IAS Report on Bioprospecting of Genetic Resources in the Deep Seabed