Patenting DNA: Who Defines and Protects the Public Good?

Rebecca Eisenberg (2002) partially answers the question she poses about what accounts for the persistent lack of clarity about how patent law applies to DNA sequence technology with her analysis of the dynamic relationship between the "shifting landscape of discovery in genetics and genomic research" and the evolution of related patent law. However, because these scientific and legal changes are occurring concurrently with and in many cases are themselves altering the way that humans and their component parts are being viewed, described, and manipulated by a wide variety of stakeholders, consideration of ethical issues and public interest concerns can also help to answer her question.

Her choice of the issue of the patentability of information stored in computer-readable media is a suitable vehicle through which to examine the ongoing tension between law, ethics, and science in this period of "bioinformatics" (Rifkin 1999, xvi). The expansion of patent-eligible subject matter that she describes evokes questions about which factors must be considered to discover what is "responsive to the needs of the modern world," and about who among competing stakeholders and policy makers can best define and protect the "public good." The article makes clear that an integral part of claiming strategies by those seeking patents is to redefine and reinterpret concepts like "information," "natural phenomena," and "discovery", and that the task of patent attorneys is to help create and defend before the courts broadening claim-drafting strategies that include such conceptual changes. However, it has been suggested that even the most ethical patent attorneys may be incapable of making critical judgments that involve ethical dilemmas because they are working in a system that many claim has not adapted to the radically new kinds of claims now being foisted upon it (Shulman 1999, 43). While this might be true, it can also be argued that patent attorneys who represent those interested in acquiring a time-bound monopoly over what they have claimed have no duty to define or advocate for the public good.

I posit that protecting public interests necessarily includes justice and the avoidance of harm and ask whether we can rely on the U.S. Patent and Trademark Office (PTO) and the courts to make socially beneficial decisions involving DNA sequences and related patent claims within our information economy. Courts and the PTO have become targets of criticism insofar as they are the gatekeepers for the entrance of genetic material into the market (Hanson 1997, 11). It is inevitable that narrow control over access to information about genetic material will also evoke criticism, because two needs of the modern world are access to healthcare and to information about such care. If, as Eisenberg's analysis suggests, ever expanding patent-law strategies have the potential to jeopardize the ability of people to readily get information about, and, subsequently, have access to healthcare, questions of justice, ethics, and public welfare are raised.

While Eisenberg's article clearly discusses the overall trend of court decisions that expands the interpretation of the scope of patent-eligible subject matter, it is helpful to review aspects of a forerunner to this trend: the 1980 case of Diamond v. Chakrabarty (447 U.S. 303 [1980]) alluded to by Eisenberg. In this groundbreaking case, the Supreme Court ruled in a 5-4 decision that a live, genetically altered microorganism could be patented. The case has particular significance because, although Chakrabarty's application for a utility patent had been rejected in 1972 by the PTO, his legal team convinced the Court otherwise. Relying on 35 U.S.C. sec. 101, which provides for the issuance of a patent to a person who invents or discovers "any" new and useful "manufacture" or "composition of matter," the Court held that Charkrabarty's microorganism constitutes "manufacture" or "composition" of matter. However, the Court observed:

The choice we are urged to make is a matter of high policy for resolution within the...