title: Legal issues for chem-bioinformatics models.
abstract: Chem-Bioinformatic models connect the chemical structure of drugs and/or targets (protein, gen, RNA, microorganism, tissue, disease...) with drug biological activity over this target. On the other hand, a systematic judicial framework is needed to provide appropriate and relevant guidance for addressing various computing techniques as applied to scientific research in biosciences frontiers. This article reviews both: the use of the predictions made with models for regulatory purposes and how to protect (in legal terms) the models of molecular systems per se, and the software used to seek them. First we review: i) models as a tool for regulatory purposes, ii) Organizations Involved with Validation of models, iii) Regulatory Guidelines and Documents for models, iv) Models for Human Health and Environmental Endpoint, and v) Difficulties to Validation of models, and other issues. Next, we focused on the legal protection of models and software; including: a short summary of topics, and methods for legal protection of computer software. We close the review with a section that treats the taxes in software use.
authors.affiliation: Department of Especial Public Law, Financial and Tributary Law Area, Faculty of Law, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain. aliuskaduardo@yahoo.es
authors.forename: Aliuska
authors.initials: A
authors.lastname: Duardo-Sanchez
authors.forename: Humberto
authors.initials: H
authors.lastname: Gonzalez-Diaz
mesh_terms: D001669:Biochemical Phenomena / Q000502:physiology*; D019295:Computational Biology / Q000331:legislation & jurisprudence*; D003309:Copyright / Q000331:legislation & jurisprudence; D033161:Government Regulation; D006801:Humans; D008954:Models, Biological; D010330:Patents as Topic / Q000331:legislation & jurisprudence; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D021281:Quantitative Structure-Activity Relationship; D012984:Software / Q000331:legislation & jurisprudence*
chemical_list: D004364:Pharmaceutical Preparations