Gene and genetic diagnostic method patent claims: a comparison under current European and US patent law

• Published in: European journal of human genetics : EJHG Vol. 19; no. 10; pp. 1104 - 1107
• Main Authors: Huys, Isabelle, Van Overwalle, Geertrui, Matthijs, Gert
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.10.2011; Nature Publishing Group
• Subjects: 631/208/2489/144; 692/699/67/1347; 692/700/228/2050/1512; 706/648/270; Amicus curiae; Bioinformatics; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Breast cancer; Breast Neoplasms - genetics; Case law; Court hearings & proceedings; Cytogenetics; Diagnostic tests; Europe; Factor V - genetics; Female; Fragile X Syndrome - genetics; Fundamental and applied biological sciences. Psychology; Gene Expression; General aspects. Genetic counseling; Genes; Genetic analysis; Genetic Testing - legislation & jurisprudence; Genetic Testing - methods; Genetics; Genetics of eukaryotes. Biological and molecular evolution; Genomes; Gynecology. Andrology. Obstetrics; Human Genetics; Humans; Intellectual property; Inventions; Laboratories; Mammary gland diseases; Medical genetics; Medical sciences; Methods; Molecular and cellular biology; Patent applications; Patent law; Patents as Topic - legislation & jurisprudence; Pathology; Property rights; Research - legislation & jurisprudence; Short Report; Tumors; United States; United States; North America; Europe; America; New York; Netherlands; Belgium; United States > US; genetic services; genetic diagnostic testing; patents; breast cancer; Factor V Leiden; Fragile X syndrome; Chromosome fragility; Breast disease; Legislation; Breast cancer; Malignant tumor; Method; European; Mammary gland diseases; Genetic counseling; Gene; Genetics; Diagnosis; Technique; Comparative study; Cancer
• ISSN: 1018-4813; 1476-5438; 1476-5438
• DOI: 10.1038/ejhg.2011.76

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.