Several months ago Representative Xavier Becerra from Southern California, and Rep. Dave Weldon of Florida introduced the Genomic Research and Accessibility Act (H.R. 977) in the U.S. House of Representatives.  As drafted, the bill would amend title 35 of the U.S. Code as follows:

Sec. 106. Prohibition on patent of human genetic material


a) 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.


b) Table of Contents- The table of sections of chapter 10 of title 35, United States Code, is amended by adding at the end the following: "106. Prohibition on patent of human genetic material."


c) Applicability- The amendment made by subsection (a) shall not apply to a patent issued before the date of the enactment of this Act.

The proposed bill would prohibit the patenting of DNA or RNA sequences and any proteins encoded by the sequences.  According to the sponsors of the bill, this a desirable and important result.  “One-fifth of the blueprint that makes up you … me … my children … your children … all of us … is owned by someone else,” Rep. Becerra said. “And we have absolutely no say in what those entities do with our genes. This cannot be what Watson and Crick intended.”

“The practice of gene patenting is preventing critical research from advancing because scientists are wary of trespassing patent laws,” Rep. Weldon said. “This not only violates the spirit of the Human Genome Project, it hinders the discovery of medical breakthroughs that could save lives. Our bill is a common sense measure to ensure that genes yet unpatented remain the province of science.”

“Thus, if we enact this bill into law quickly, we will reach balance in less than two decades – a patent-free genome that does not hinder scientific research, business enterprise, or human morality,” Rep. Becerra said.

“We seek simply to fix a regulatory mistake,” Rep. Becerra said. “Genes are a product of nature; they were not created by man, but instead are the very blueprint that creates man, and thus, are not patentable. Gene patenting would be the analogous equivalent to patenting water, air, birds or diamonds.

“Enacting the Genomic Research and Accessibility Act does not hamper invention, indeed, it encourages it. The proliferation of scientific prowess, medical innovation, and economic advancement will all occur if the study of genes is allowed to happen unabated. Incredible manifestations of intellectual property will result: medicines, machines, processes – most deserving of recognition, some potentially life-saving, and all worthy of a patent.”

The debate over whether nucleic acid sequences should be patentable is not new.  Indeed, the debate began shortly after the initiation of the Human Genome Project, a U.S.-initiated and funded undertaking through the Department of Energy and the National Institutes of Health and in collaboration with geneticists from China, France, Germany, Japan and the United Kingdom.  The Project’s efforts have led to the discovery of approximately 35,000 genes.  Twenty percent of those genes have already been granted patents by the United States Patent and Trademark Office.

The bill is currently in committee in the house and will surely face massive opposition from the biotechnology industry.