Human gene patents.

Abstract

The concept of a patent on a human gene seems foreign to most people. Even those who understand the fundamentals of the patent system seem bewildered and confused by many issues relating to human genes. This article describes the scope and limitations of gene patents and the types of exemptions that have been proposed or allowed. It addresses and clarifies these and other issues, including the often reported and misdirected question, Who "owns" one's genes? The paper reviews the historical origins of patents as a mechanism to provide incentives for innovation. It also discusses the legal criteria unambiguously supporting patenting of human genes that are isolated and purified apart from their naturally occurring context. Concerning enforcement and issues related to academic research, there is no U.S. statutory exemption for non-commercial research on patented subject matter, but a narrow, judicially-created exemption does permit use of patented subject matter for non-commercial purposes. Patents and licenses on gene-based diagnostic tests are properly enforceable and do not permit academic or other clinical practitioners to practice such tests without license or other authorization from the patent holder. The paper concludes that an effective legal system cannot draw sharp distinctions that some genes or uses are patentable to some parties while other genes are not. In addition, precluding certain genes from patentability would be shortsighted in that it would create prohibitions that might well be regretted in the future.