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Gene Patenting

The 1953 discovery of the DNA double helix revolutionized the biomedical world and catalyzed the advent of an entirely new group of disciplines—from genomics, the study of entire genomes, to more specialized areas including toxicogenomics, nutrigenomics, pharmacogenomics, and so on—that as a group promised profound changes in disease prevention, diagnosis, and treatment. The development of genomics was catalyzed by the initiation of the Human Genome Project, an unprecedented international collaboration launched in 1990, which proposed to map the human genome, understand the genetic basis of disease, and create a freely accessible body of data to support continuing research and progress. Some of these advances have become the subject of controversies, and one of the most recent debates, with profound medical, legal, scientific, and social implications, revolves around gene patenting. While genetics-related controversies regularly surface in the news and public discussion, the legal ownership of genetic information is a highly technical subject in its own right and will be explored in this entry.

The patent system was originally established to encourage scientific advancement. A patent is a “negative right” that protects the patent holder's property rights by excluding others from manufacturing, selling, or using the patented product, while at the same time promoting progress by allowing free access to the details of the invention. By providing inventors exclusive property rights for a limited period of time, which is usually 20 years in the United States and the European Union, this system enables them to capitalize on their invention. In return for this protection, inventors must disclose the details of their invention to competitors and to the public. Public access to the details of the invention is intended to enhance future advancement and to prevent duplication and the associated waste of resources.

While it is widely accepted that the existing patent system is in the public interest and its contribution to innovation is proven, its suitability in context of the human genome is the topic of intensive debates.

Criteria for Patentability

The basic criteria for patentability in the United States are usefulness, nonobviousness, and novelty, while the equivalent criteria in the European Union are novelty, inventive step, and industrial applicability. These two sets of requirements are very similar, and the differences are mostly in terminology. By this definition, natural chemical compounds, natural species of plants and animals, and abstract ideas cannot be patented. The patentability of human genes is rooted in a 1912 precedent in which a patent was granted for the isolation and purification of adrenaline, a hormone that did not exist in nature in that exact form and that, after purification, could be used for the medical treatment of humans. In that case, the court held that a substance, after it is purified from nature, is pat-entable, and under the same precedent, even though a human gene itself cannot be patented, a DNA sequence that is purified or isolated from it was deemed patentable.

It is often difficult to clearly define the criteria distinguishing naturally occurring compounds from products of invention. Linda J. Demaine and Aaron X. Fellmeth, writing in Science, describe how a patent for purified alumina was denied in the 1930s, based on the fact that the product was only slightly more pure than the natural form of the compound and was not deemed to be particularly inventive. However, while live organisms were considered a naturally occurring phenomenon and, as such, not patentable, this was changed in 1980 with the landmark Supreme Court decision in Diamond v. Chakrabarty. In this case, a patent application filed by a microbiologist, Ananda Chakrabarty, involved a bacterium that was engineered to break down crude oil and had potential applications in treating oil spills. The patent was initially rejected based on the consideration that living things cannot be patented.

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