Public access versus proprietary rights in genomic information: what is the proper role of intellectual property rights?

Lauded as "the sine qua non of 21st-century biology," bioinformatics (formerly referred to as computational biology) is a burgeoning discipline at the intersection of information technology and the life sciences. The February 2001 announcement of the complete sequencing of the human genome represents the signature event in the relatively short history of bioinformatics. The central goal of bioinformatics is to organize, analyze, and generally make sense of the massive quantities of genetic data and information that resulted from this tremendous scientific achievement.This article examines the proper role of intellectual property rights (IPRs) in bioinformatics. IPRs are property rights in intangible "knowledge goods," such as inventions and discoveries, which convey to their owners the right to prevent unauthorized uses of the identified property. Just as the owner of a parcel of land has an exclusive possessory interest to prevent others from trespassing, so too does the owner of an intellectual property right have the power to prevent unauthorized uses of her invention or discovery.Many have criticized the notion of establishing and enforcing any IPRs in the fruits of the human genome project, characterizing it as an endeavor intended to benefit all mankind. Regardless of one's philosophical and economic views on that larger question, which this article does not attempt to answer, many IPRs in genomic material such as genes and gene fragments have already been obtained or at least applied for by private sector firms. This latter-day "gold rush" is ongoing despite the parallel movement to put as much genetic information into the public domain as possible.Given that IPRs already exist in genomic material and are likely to be enforced (at least if it is economically rational to do so), the inquiry should shift to consideration of the manner in which society can ensure unrestricted access and use of the genetic data and information, for purposes of research and development that leads to new innovation in health care-critically important therapeutics, diagnostics, methods of streamlined drug screening, and the like. Any proposed framework must balance the public health rationale for unrestricted access against the possibility of damaging powerful incentives for investment in the research and development leading to these innovations. This article does not purport to suggest a single answer to this complex balancing of interests, but rather proposes several different responses for further consideration.Part II of this article provides an overview of the various forms of intellectual property protection that are potentially relevant to bioinformatics research and development. Part III specifically focuses on the issues of statutory subject matter and the utility requirement of patentability as relevant to bioinformatics-related inventions. Part IV surveys some of the possible responses to public access concerns raised by the ownership of patents in the life sciences. Part V considers how patent rights will intersect with the rise of industry standards in the life sciences, which will likely proliferate through advances in bioinformatics, as has been the case in the electronics and computing industries.