Genetic Sequence Patents: Historical Justification and Current Impacts

Abstract:     
In 1980, the United States Supreme Court in Diamond v. Chakrabarty authorized the patenting of a genetically-engineered living organism. The Court indicated that this was an invention, not a product of nature and said that “[t]he laws of nature, physical phenomena, and abstract ideas have been held not patentable. Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter.” Nevertheless, in an erroneous application of the case, the United States Patent and Trademark Office (USPTO) began allowing patents to be issued on genetic sequences when “isolated from their natural state and purified.” The proponents of gene patents claim that legal precedents allowing the patenting of isolated and purified products of nature justify the patenting of genetic sequences. They claim that the remaining genetic sequence is an “invention” since it has been “isolated” (taken out of the body) and “purified” (had non-coding regions removed). In this project, we tested that claim by analyzing U.S. court cases at all levels that either specifically or indirectly address the products of nature doctrine (including all cases that specifically claim that isolation and purification transforms an unpatentable product of nature into a patentable invention). In analyzing the patent cases, we assessed the application of the products of nature doctrine from the late-1800s until today and undertook research to identify the product or process claimed in each patent and the relationship of that product or process to something that occurred in nature.

Number of Pages in PDF File: 46

Keywords: gene patents, products of nature, process, USPTO, case law

Accepted Paper Series