Rethinking the product of nature doctrine as a barrier to biotechnology patents in the United States—and perhaps Europe as well1

Abstract

For more than a decade, gene patents have been the driving force behind the burgeoning American biotechnology industry. Many people—even otherwise sophisticated lawyers—assume that such patents cover only methods and therapeutic applications. They are shocked to learn that patents on genes themselves, as long as they are isolated from the body, are routinely allowed by the United States Patent and Trademark Office and acquiesced in by the courts. The practical consequences of this development are equally startling to the non‐patent community: gene patent holders can control not only commercial applications, but virtually all research involving the subject genes. Since genes are valuable as transmitters of information, the ultimate effect can be a monopoly on the use of that information. This, we believe, takes intellectual property protection to an unprecedented level. All challenges to gene patents in the United States have thus far been dismissed almost out of hand. One possible avenue of attack that has gotten little attention involves the ‘product of nature’ doctrine, whose roots in American patent law go back to the nineteenth century. In its strongest form, it holds that compounds and compositions of matter that are not materially different from naturally occurring products are not patentable subject matter. In this article, we explore the history and current status of this doctrine. After reviewing some of the critical scientific elements of gene patents, we ask whether the product of nature doctrine, properly argued, might be reinvigorated as a brake on the rush to patenting the human genome. We believe that it would be particularly useful for lawyers and regulators in Europe to examine the American experience, since the European position on gene patents seems still to be more open to debate.