This Article introduces the scientific background necessary to understand the practice of gene sequence patenting from a technical perspective. This Part will dispel a number of misconceptions related to the practice of gene sequence patenting, specifically what a gene patent represents and the limited bundle of exclusionary rights a gene sequence patent provides. This Part will also explain, from a technical perspective, the difference between non-patent eligible native DNA sequences and patent eligible man-made cDNA gene sequences. Part III introduces and attempts to synthesize the century-long products of nature doctrine, which supplies the standard for composition patent eligibility under section 101 of the patent statute. Additionally, this Part includes a discussion of the heightened utility standards promulgated by the USPTO and adopted by the In re Fisher court, which has severely limited the practice of patenting upstream subject matter such as gene fragments and ESTs. Part IV of this Article constructs an alternative standard for patent eligibility of genetic composition claims which simultaneously applies an information preemption analysis in concert with a functional and physical difference analysis under the products of nature doctrine. This Part further explains Judge Sweet’s erroneous application of the “markedly different” standard under the products of nature doctrine to only the informational character of native DNA and the cDNA sequences claimed in Myriad’s patents. Part V of this Article introduces the underlying patent prospect theory used to justify the granting of patent rights. This Part describes the theory of the tragedy of the anticommons and its application to the biotechnology industry. In doing so, this Part introduces theories which suggest that the proliferation of patents in areas of upstream research, such as gene sequences, may amplify the risk of the tragedy of the anticommons. Part V further explains how factors such as large public agency control of upstream subject matter, enforcement costs on patent holders, and the stricter utility requirements promulgated by the USPTO all act to mitigate anticommons effects. Finally, this Part provides an overview of mitigating options, such as a statutory experimentation defense and expanded march-in rights, available to Congress to help stave off any threat of an anticommons market malfunction.
Matthew A. Poulsen,
Jurisprudential and Economic Justifications for Gene Sequence Patents,
90 Neb. L. Rev.
Available at: https://digitalcommons.unl.edu/nlr/vol90/iss1/1