title: Battle brewing over the BRCA1/2 gene patents.
abstract: The revolutionary discovery of the DNA and the successful mapping of the human genome have allowed scientists worldwide to engage in an unprecedented research on the cutting-edge biomedical technology such as the genetic engineering (gene-splicing or recombinant DNA). However, as is often the case with modern bio-technologies, genes related innovation is heavily dependent on strong patent protection primarily due to high costs of research and commercialisation in this area. The aim of this paper is to provide a description of the District Court Ruling in the case of Association for Molecular Pathology et al v United States Patent and Trademark Office et al (ACLU v Myriad). In doing so, the article provides information on the relevant background at issues, including a brief introduction to general patentability requirements in relation to genes and the controversy surrounding the patentability of genetic material. The analysis of the complaint filed in the ACLU v Myriad case and the details of the District Court Ruling follows. The paper concludes with an outlook of the future legal actions involving Myriad's BRCA1/2 and the assessment of the potential impact that the BRCA1/2 District Court Ruling and subsequent appeal(s) may have on the American patent law.
authors.affiliation: IPR University Centre, Helsinki University, Helsinki, Finland. amina.agovic@helsinki.fi
authors.forename: Amina
authors.initials: A
authors.lastname: Agovic
mesh_terms: D019398:Genes, BRCA1; D024522:Genes, BRCA2; D006801:Humans; D010330:Patents as Topic / Q000331:legislation & jurisprudence; D014481:United States