Debate Brewing over Patentability of Human Genes

Congress is currently faced with legislation that may preclude anyone from patenting genes. Expert opinion on this legislation has been mixed. Some experts base their arguments on the policy reasons that justify granting a patent: to encourage innovation and discovery by rewarding researchers. These experts opine that patenting genes may increase investments in businesses and prevent free riders from stealing ideas. Other experts take the opposite stance, arguing that patenting a human genome may violate the Supreme Court holding in Diamond v. Diehr that "laws of nature, natural phenomenon and abstract ideas" are not patentable. These experts are of the opinion that the human gene is a natural phenomenon and that protection should instead be granted to researchers at the test and drug level.

As current Patent Office practice stands, an individual may patent sequences of the human genome. Approximately 20% of the complete human genome is protected by issued patents. With this number steadily increasing, some practitioners in the field are concerned that allowing the USPTO to issue patents on the human genome may create monopolies and may even stifle research efforts. However, evidence of such an effect has been lacking. Regardless, U.S. Representative Xavier Becerra has introduced "The Genomic Research and Accessability Act," and this legislation is currently in front of the House Judiciary subcommittee on Courts, the Internet and Intellectual Property. Specifically, the bill seeks to amend title 35 of the United States Code to include section 106 which reads "Notwithstanding any other provision of law, no patent may be obtained for a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies." If this bill is enacted, a patent issued before the enactment date would not be subject to the restrictions of the bill.