In lieu of an abstract, here is a brief excerpt of the content:

The American Journal of Bioethics 2.3 (2002) 12-13

[Access article in PDF]

Open Peer Commentaries

Intellectual Property and Products of Nature

Mark Sagoff
University of Maryland 1

In her searching analysis Rebecca Eisenberg (2002) writes, "DNA sequences are not only molecules, they are also information." The information that genes reveal "can open the door to future discoveries." Eisenberg asks whether intellectual property rights should extend to "information about the natural world, as distinguished from tangible human inventions that make use of that information."

Several controversies illustrate this question. The most notorious involves a patent application filed by Human Genome Sciences (HGS) in 1995 on a gene that codes for a cell receptor, the use of which was unknown to the company at the time. An independent group of researchers a little later identified the so-called viral receptor as one to which the HIV virus attaches. They also learned that a protein that suppresses infection is generated by a defective version of the gene. When HGS eventually received the patent, it announced to investors in a press release that it owned rights to "the critical entry point [into cells] for the AIDS virus" (Waldholz 2000). The firm claimed not just the gene but the use of the information it provided—information others had discovered. HGS implied that it must license any commercial therapy for AIDS that relies on information about the receptor, even though its patent did not specify any such "utility" for the gene.

Bruce Alberts (2000), president of the National Academy of Sciences, has written, "Those who would patent human DNA sequences [stake claims] to everything that might later be discovered about the genes and proteins associated with the sequence." This should not be surprising. A patent extends intellectual property rights to the ideas or knowledge incorporated in an invention. A gene or genetic sequence plainly embodies a design and, with it, a great deal of knowledge and information. Thus, to patent a gene or sequence is to claim—as with any invention—commercial rights to the knowledge that it represents. A patent is a patent whether on a gene or on an ordinary invention and, either way, extends to the new knowledge the invention incorporates. This is the case even though the owner of a gene patent does not design but simply copies the "invention" from nature and thus may not know what it does or how it functions.

Eisenberg proposes that genes are patentable because they are "tangible human inventions." Traditionally, a patent issues not simply on a tangible object but on a design, idea, or "inventive step" that it embodies. For example, King Gillette designed an instrument to keep a very thin and flexible blade rigid enough to shave whiskers. His patent specification described the crucial idea or inventive step, namely, to "secure [the] blade to a holder" so that "it receives a degree of rigidity sufficient to make it practically operative." 2 To be sure, Gillette brought a device to the Patent Office, but he also brought a design that enabled him to construct the device from basic materials. The safety razor would not exist without the idea or design on which it is based. The patent was issued on that idea or design. There is little need to distinguish between that idea or design and the tangible device, because the one led to and is embodied in the other.

With respect to gene patents, as Eisenberg observes, a gulf divides the tangible object from the design, idea, or inventive step it embodies. Genes exist whether or not anyone knows how to design or construct them from simpler materials. The patentee, indeed, does not construct a gene from basic materials on the basis of a new idea. The patentee need only go through the motions—now fairly automatic—of cloning, copying, or plagiarizing a genetic sequence from nature. This is the reason a gulf opens between the tangible object and the relevant knowledge, between the molecule and the inventive conception or design. The patentee copies the object from nature and may be clueless about what it does...