Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent

The ownership of preexisting genes and other biochemicals raises important questions about the scope and purpose of patent law - what it is designed to accomplish and how biotechnology fits within that design. More fundamentally, whether patent law is properly applied to products not independently created by a patent applicant implicates questions about the limits of intellectual property ownership, policy decisions about whether natural substances and processes should reside in the public or private sphere, choices about the value placed upon publicly available knowledge, and the microeconomic effects of limiting patents to some kinds of biotechnological innovations while excluding patents on others. Are patents on naturally occurring phenomena, such as discovered DNA sequences, proteins, plasmids, and other biological chemicals, truly as uncontroversial and "simply necessary" as a matter of public policy as many legal commentators, the biotechnology industry, and the Patent and Trademark Office Director himself have argued? Are patents on naturally occurring substances of any kind authorized by the relevant legislation and case law? The answers are far from obvious, and their importance merits a more careful and detailed examination of the legal and policy underpinnings of the patenting of genes and other biotechnological innovations than has so far been undertaken. This Article provides the first comprehensive examination of this issue. The authors argue that the strong recent trend in the case law and literature toward viewing gene patents as uniformly desirable and legally proper rests upon a prevalent misinterpretation of a triad of key patent law concepts.