title: To be or not IP? Exploring limits within patent law for the constitutionalization of intellectual property rights and the governance of synthetic biology in human health.
abstract: The article explores limits within patent law for the constitutionalization of Intellectual Property Rights and the governance of synthetic biology in human health. To this end, it starts by explaining the inherent rationales of two fundamental limits within European patent law, namely (1) the boundary between discovery and invention (Art. 52 EPC); (2) the ordre public and public policy clause (Art. 53 (a) EPC). Both these exclusions from patent eligibility bear a normative function but rely on opposing inherent logics, functions, and regulatory aims. While in the first type of logics, "enabling access for all" is the guiding principle, in the second, converse logics, no one should have access to the technological knowledge in question. The second part contends that decisions on whether and how to grant patents in synthetic biology are not independent from institutional frameworks: The arena in which synthetic biology patenting will be dealt with will be decisive for whether and how boundaries will be deployed. From a political science perspective, the administrative, legislative and judicial arena can be distinguished. If synthetic biology will be negotiated in the legislative arena, in particular in the European Parliament, the probabilities will be higher that either the discovery clause or the ordre public clause will be applied. In contrast, patent offices and courts have, at least in the past decades, employed a narrow interpretation of these absolute exemptions from patentability and hardly ever used them. The third part asserts that metaphoric framing of synthetic biology is another crucial factor for patentability questions. Semantic framing may relate to the articulation and mobilization of consent or dissent, and thus public acceptance of synthetic biology. Whether applications of synthetic biology are conceived as "natural" or "synthetic" DNA may have an influence on whether patenting might become contested as "patenting life" or accepted as novel, and also on passing the inventive step and industrial application tests. Proceeding in such a manner can be regarded as "upstreaming" ethics, anticipatory impact assessment, and policy analysis in the biosciences and as a tool for constitutionalizing intellectual property rights.
authors.affiliation: FSP BIOGUM, Centre for Biotechnology, Society and the Environment-Medicine. Ingrid.Schneider@uni-hamburg.de
authors.forename: Ingrid
authors.initials: I
authors.lastname: Schneider
mesh_terms: D006801:Humans; D018973:Intellectual Property; D010067:Ownership / Q000331:legislation & jurisprudence*; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D058615:Synthetic Biology / Q000331:legislation & jurisprudence*