Band 6, Heft 5

Coherence has an important influence on the ability of a set of international regulations to function effectively. This paper examines the degree of coherence among the international regulations relevant to applications and impacts of biotechnology, and outlines problems that may arise from a lack of coherence among this regulatory set.

Since 1992 the USPTO has been issuing gene patents based on the premise that a gene sequence consists of patentable subject matter and meets the requirements set forth in 35 USC § 101 et seq. Various scholars and international societies have recently questioned the USPTO's stance, raising both normative concerns as well substantive problems associated with the number and scope of gene patents on the availability and access of diagnostic tests as well as their effect on scientific innovation and method validation. This paper examines recent Congressional testimony, USPTO's deference to Congress' inaction, and the possibility of judicial remedy through currently pending litigation of Association for Molecular Pathology et. al. v. United States Patent and Trademark Office, et. al. The author argues that the pending litigation may, and should, break the current stalemate and prompt re-examination of the current US patenting guidelines to arrive at a solution that integrates important policy considerations related to innovation, access, and validation.

Through the last decade there was an enormous revolution in the field of forensic genetic. The Author reviews some of the methodologies used in the definitions of DNA profiling tackling the principles of recombinant DNA techniques. The potentiality of polymorphic DNA fragments in vertebrates is focused as well as the revolution implied in forensic medicine. The resource to DNA-DNA hybridization combined to oligonucleotide probes is emphasized leading to the production of an individual bar code with the resource of genomic polymorphism which leads to a pattern known as genetic fingerprinting. Other techniques for individual identification and paternity testing are focused as well as the use of short tandem repeats (STR's). Mitochondrial DNA sequencing use to complement nuclear DNA typing may also be profitable in certain instances. Relevant problems within the context of the use of these techniques in forensic medicine and law suits are discussed. Final considerations viewing the resource to DNA technology within the scope of the last two decades are referred regarding the resource to DNA profiles not only in the US but in Europe in general and in Portugal in special having lead to compensation and uncover of justice errors.