title: Gene and genetic diagnostic method patent claims: a comparison under current European and US patent law.
abstract: The paper focuses on the fundamental debate that is going on in Europe and the United States about whether genes and genetic diagnostic methods are to be regarded as inventions or subject matter eligible for patent protection, or whether they are discoveries or principles of nature and thus excluded from patentability. The study further explores some possible scenarios of American influences on European patent applications with respect to genetic diagnostic methods. Our analysis points out that patent eligibility for genes and genetic diagnostic methods, as discussed in the United States in the Association of Molecular Pathology versus US Patent and Trademark Office decision, is based on a different reasoning compared with the European Patent Convention.
authors.affiliation: Research Centre for Pharmaceutical Care and Pharmaco-Economics, Department of Pharmaceutical Sciences, University of Leuven, Leuven, Belgium.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Huys
authors.forename: Geertrui
authors.initials: G
authors.lastname: Van Overwalle
authors.forename: Gert
authors.initials: G
authors.lastname: Matthijs
mesh_terms: D001943:Breast Neoplasms / Q000235:genetics; D005060:Europe; D005165:Factor V / Q000235:genetics; D005260:Female; D005600:Fragile X Syndrome / Q000235:genetics; D005796:Genes; D005820:Genetic Testing / Q000331:legislation & jurisprudence* / Q000379:methods; D006801:Humans; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D012106:Research / Q000331:legislation & jurisprudence; D014481:United States
chemical_list: C095381:factor V Leiden; D005165:Factor V