Protecting Electronic, Biologic Intellectual Property: It's the Electronic Sequence, Stupid!

Abstract

In recent years, it has not been uncommon to hear a researcher from a biotechnology company or university state: “We patented gene X.” What does this statement mean? Assuming the researcher is referring to a composition patent for gene X, then, under American patent laws, the patent holder has acquired the right to exclude others from making, using, selling or importing the chemical composition of gene X. Most modern gene patents cover both the nucleic acid composition (DNA) of gene X and the encoded polypeptide (protein) product. No one disputes that a patent holder with a claim to the composition of gene X can enforce his rights against others that make, use, sell or import gene X. But what if someone makes, uses, sells, or imports the electronic sequence information of gene X, in the form of an electronic gene sequence? In this case, the composition patent offers little or no protection. Is there alternative protection under current American intellectual property law? This paper begins by comparing and contrasting electronic gene sequence information with traditional biologic or chemical matter. It then analyzes non-patent areas of intellectual property law, looking for alternative protection. The next section focuses on patent law and its possibilities or limitations for gene sequence protection. The paper concludes that congressional action may be necessary to fill in the intellectual property gaps for electronic sequence information.