It's Hard to Find a Good Pair of Genes: So Why Make Them Free for the Taking?

Abstract

In the past decade, significant advances have been made in the identification and development of genes, particularly the human gene. The Human Genome Project challenged the scientific world to finish a complete sequence of the human genealogical makeup; and its successor, HapMap, provides a model for mapping the human genome and identifying those particular genes which may be successfully modified to improve the quality of human life. Genetic research remains at the forefront of scientific discovery. The preference has been to give these discoveries a direct pathway to the public domain, bypassing all claims of intellectual property. Although simple in concept, in practice, scientists have recognized the inherent value in genomic data and have attempted to exert monopolistic rights over those portions of the genes which they have discovered.

An exemplar of this controversy is Celera Genomics, which raced the Human Genome Project to achieve the blueprint of the human genome. It lost the race, but managed to secure hundreds of patents over gene sequences in the meantime, including those sequences allegedly building on the discoveries by Human Genome Project scientists. The problems that the Celera situation illustrates have led scholars and scientists to question the wisdom of directing the entry of genetic data into the public domain. Once in the public domain, the principle that no person can profit from the information begins to deteriorate. However, the existing intellectual property structures are not necessarily beneficial to genetic research. The seemingly opposite goals achieved by either not protecting or protecting genetic databases have caused several scholars to propose alternate schemes, most using the same constrained intellectual property frameworks that predate the discovery of DNA.

This Article examines the attempts to force genetic information either into the public domain or into an intellectual property regime for which it is not entirely suited. Part II examines the background behind those attempts, examining in particular the public domain, patent, copyright, trade secret, and contract law, and examines identified problems with each of the legal paths heretofore suggested. Part III reviews some possible changes suggested by scholars in the area. Part IV reviews sui generis database protections as they have applied to databases in Europe and other places and how it could be used effectively in the field of human genomic research. Finally, Part V reviews how such a system would work and suggests a scheme comprising a sui generis right with compulsory licensing.

Keywords: intellectual property, human genome, genetic data, genes, public domain, HapMap, Celera, genomics, patents, gene sequences, genetic databases, database protections

JEL Classification: K10, K39