Vanderbilt Law Review

Article Title

Protecting the Frontiers of Biotechnology Beyond the Genome: The Limits of Patent Law in the Face of the Proteomics Revolution


Scientific knowledge and invention rapidly accelerated in the past few decades, resulting in an untold number of broken barriers and realized benefits. In 2001, scientists announced that the human genome, consisting of 30,000 to 40,000 genes, had been fully characterized. Arguably one of the most important scientific breakthroughs in history, this accomplishment came far sooner than anyone could have anticipated. Fueled by the enormous marketing potential in finding causes and cures for many diseases, the biotechnology industry invested heavily in the project with the hope of maximizing control of genetic intellectual property and its potential downstream value.

While the genomic revolution has steadily progressed, the ability of researchers to identify and characterize proteins has increased exponentially thanks to technological advancements. The culmination of the Human Genome Project only added to this advancement and shifted the focus from genetic characterization to the proteins they express. The research effort to characterize completely all proteins normally and abnormally expressed in the human body is roughly known as proteomics. Proteins hold vastly more promise than even genes for drug discovery and medical research, and proteomics has quickly "become the new darling of the investment community." As with genomics, the biomedical industry is rapidly attempting to claim as much patent territory in proteomics as possible.

Protein characterization is much more complex than gene characterization, however, and proteomics projects are much less certain to result in realized value. Further, proteomics patents raise their own unique issues and are almost certain to clash with genomics patents that may or may not cover the same claims. Patent law currently leaves those wishing to maximize their investment in biological molecules uncertain of their ability to obtain sufficient protection for their efforts. Once decided, however, the resolution of certain issues of patentability may give proteomics patent owners more protection than is warranted under the traditionally accepted patenting policy espoused in the Constitution of the United States. Increased incentive for private industry also threatens the time- honored research practices of scientific research, which supports the open exchange of ideas and information throughout the scientific community.

The future of biotechnology patents, therefore, is ripe for litigation and may become a significant problem if not approached in a distinctive manner. Due to the vast potential of discovery in proteomics, its increasing industrial and academic value, and the uncertainty of whether patent law will cover or allocate proper incentives for these discoveries, adoption of patent protection may not be the best approach to organize this field. Rather, some sort of sui generis protection necessary to achieve the balance traditionally envisioned by the patent laws.

Part II of this Note offers a brief overview of genomics, proteomics, and the current state of biotechnology and information technology in the field. This Part also provides a brief examination of the requirements necessary to obtain a patent. Next, the Note discusses current patent law as it applies to biotechnology and genomic patents. The United States Patent and Trademark Office, as well as the federal court system, has begun to recognize the complexity and uniqueness of the field of biotechnology, but the lag time between the development of technology and court decisions has cast a large amount of uncertainty over the field. Part IV examines the major problems and potential conflicts that may arise with this nascent technology and the reasons why current patent law may never be adequate for the proteomics industry. Finally, Part V argues that, while other fields may have survived infancy under a general patent law system, the proteomics field is better served by unique protection that recognizes the special problems inherent in the field but preserves the balance anticipated by the Constitution.