Sixth Annual IP Scholars Forum

Software-based automation has raised living standards dramatically.  It makes factories more efficient, renders vast amounts of information accessible, and daily improves quality of life in barely noticed ways.  To realize these types of advances in health care, government and NGOs have begun to catalyze better data collection, retention, and analysis.  Life sciences companies need to report more data on drugs and devices. Hospitals and doctors are incentivized to use electronic health records via stimulus funding and rulemaking based on the HITECH Act’s meaningful use and certification requirements. How will traditional intellectual property laws interact with these initiatives?  Will the increasing need for cooperation and sharing of information alter the landscape of trade secrecy and other IP protections that have often siloed health data?  This paper will examine how providers are gradually finding alternative funding sources for the collection, retention, and analysis of data, as some traditional IP protections appear increasingly outdated in a world of “big data” and market-driven transparency.

On March 20, 2012, the United States Supreme Court, in Mayo v. Prometheus, invalidated patent claims on methods of diagnosis and treatment that relied on the measurement of human metabolic products. A week later, the Supreme Court vacated a decision by the Court of Appeals for the Federal Circuit that had upheld the patentability of isolated human genes, ordering the Federal Circuit to reconsider the patentability of such genes in light of the invalidity decision in Mayo v. Prometheus. These recent decisions mark the culmination of a long line of federal court decisions questioning the validity, and patentability, of patent claims to human genes, human embryonic stem cells, methods incorporating human thought, and physiological products of the human body.  The result appears to be confirmation that inventions intimately associated with the human body generally constitute unpatentable subject matter.  The contours and implications of this "human bar" to patentability will be explored.

Conventional wisdom treats biodiversity and biotechnology as rivalrous values.  The global south is home to most of earth's vanishing species, while the global north holds the capital and technology needed to develop this natural wealth. The south argues that intellectual property laws enable pharmaceutical companies and seed breeders in the industrialized north to commit biopiracy.  By contrast, the United States has characterized calls for profit-sharing as a threat to the global life sciences industry. Both sides magnify the dispute, on the apparent consensus that commercial exploitation of genetic resources holds the key to biodiversity conservation. Both sides of this debate misunderstand the relationship between biodiversity and biotechnology. Both sides have overstated the significance of bioprospecting.  It is misleading to frame the issue as whether intellectual property in the abstract can coexist with the international legal framework for preserving biodiversity.  As a matter of legal gymnastics, any lawyer can reconfigure intellectual property to embrace all of the intangible assets at stake, including raw genetic resources, advanced agricultural and pharmaceutical research, and ethnobiological knowledge.  The real challenge lies in directing the law of biodiversity conservation and the law of intellectual property toward appropriate preservation and exploitation of the global biospheric commons.  Commercial development aids biodiversity primarily by overcoming perverse economic incentives to consume scarce natural resources that may turn out to have greater global, long-term value. We continue to debate these issues not because we are rational, but precisely because we are not.  Indeed, legal approaches to biodiversity and to biotechnology are so twisted that they represent an extreme application of prospect theory.   Nearly half a century before Daniel Kahneman & Amos Tversky, Prospect Theory: An Analysis of Decision Under Risk, 47 Econometrica 263 (1979), the Supreme Court of the United States succinctly summarized contemporary prospect theory: "Threat of loss, not hope of gain, is the essence of economic coercion."  United States v. Butler, 297 U.S. 1, 82 (1936).  In plainer terms, losing hurts worse than winning feels good.  The law of biodiversity and biotechnology appear to reverse this presumption.  Biodiversity loss is staggering and undeniable.  Humans are responsible for the sixth great extinction spasm of the Phanerozoic Eon, a unit of geologic time spanning half a billion years.  Gains from bioprospecting are speculating and extremely concentrated.  There is no defensible basis for treating ethnobiological knowledge as the foundation of a globally coherent approach to economic development.  Yet the world expends its extremely small and fragile storehouse of political capital on this contentious corner of international environmental law.  Global economic diplomacy should be made of saner stuff.  The fact that it is not invites us to treat the entire charade as a distinct branch of behavioral law and economics: bioprospect theory.