61 Pages Posted: 20 Feb 2005
This Article addresses the intersection of DNA and the patent system. An inquiry into DNA as patentable subject matter must consider the static and dynamic properties of the gene, the unit of DNA which is the focus of most patenting efforts and most controversy. The Article sets forth a theory of the gene for patent law that encompasses its dual identities of chemical and template, in effect, a splitting of the gene. The gene is both the static chemical compound and the dynamic template executed through the genetic code. While this definition can be accommodated as a statement of scientific reality, it has a particular impact on the legitimacy of the gene as a unit of intellectual property. The duality of DNA requires a bifurcated legal analysis that draws on both product-based and process-based doctrines of eligibility developed in patentable subject matter jurisprudence to derive analytic principles suitable for the complexity of the DNA molecule. This Article undertakes that analysis with reference to the patent jurisprudence for products of nature, laws of nature, natural phenomena, and computer algorithms.
A public domain is explicitly recognized in patent law by judicial exclusion of the laws of nature, natural phenomena, and abstract ideas from patent protection. The scrutiny of DNA from the perspective of its duality suggests that, although DNA can be characterized as a chemical compound for potential eligibility into the private domain of patents, its identity as a template executed through the genetic code reveals attributes with public domain requirements. By scientific and historical criteria, the genetic code can be characterized as a law of nature and as an essential component of the public domain in molecular biology. The Article concludes that the patenting of genes results in constructive preemption of the genetic code, a result that is contrary to the Supreme Court's dictate that the laws of nature are not patentable. This outcome undermines the legitimacy of genes as patentable subject matter.
Keywords: DNA, patent, gene, biotechnology, public domain, intellectual property
Suggested Citation: Suggested Citation
Kane, Eileen, Splitting the Gene: DNA Patents and the Genetic Code. Tennessee Law Review, Vol. 71, p. 707, 2004. Available at SSRN: https://ssrn.com/abstract=668628