Intellectual Property Today

Why don't some topics of conversation just die or at least fade away? I suspect it is because some things are so unsettling that we will simply always talk about them. One such topic is who owns our bodies.

Did you know that there is a website -- The home page of this website proclaims: "Who owns your body?Not you -- at least not any more: someone has rights to your DNA." To me, that is an enormous leap of logic. How could the patenting of an isolated piece of nucleic acid mean that someone owns my body? But the topic is in the news.

In 2006, Michael Crichton's book "Next" generated renewed interest in gene patenting. The Author's Note at the end of the novel, states that Mr. Crichton arrived at a few conclusions after researching his book, including, stop patenting genes.

The issue of whether to patent genes has been around for quite awhile and gained particular notoriety after the U.S. Supreme Court decision in Diamond v. Chakrabarty, 447 U.S. 303 (1980). Chakrabarty is often quoted as holding that "anything under the sun that is made by man" is patentable subject matter. I hate to be picky, but luckily others before me have pointed out that this is not what was stated. Unfortunately, it is still taken out of context. Actually, the Supreme Court wrote: "The Committee Reports accompanying the 1952 Act inform us that Congress intended statutory subject matter to "include anything under the sun that is made by man." In the next sentence, the Supreme Court wrote: "This is not to suggest that 101 has no limits or that it embraces every discovery."

So what's new beside Mr. Crichton's book? Regrettably, the conversations, Congressional hearings, proposed legislation and inaccuracies on this subject continue.

On October 30, 2007, there was another congressional hearing on the topic of gene patenting. The Hearing before the House Judiciary Committee's Subcommittee on Courts, the Internet, and Intellectual Property was entitled "Stifling or Stimulating - The Role of Gene Patents in Research and Genetic Testing." The hearing was likely a follow-up to Rep. Xavier Becerra's (D-CA) introduction of H.R. 977, "The Genomic Research and Accessibility Act."

H.R. 977 provides "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." When I first read the scope of the exclusion, I thought I must have read it wrong. The scope of the bill is extremely broad rendering unpatentable nucleic acids, proteins, diagnostic assays, and other "functions or correlations" of DNA sequences. Simply stated, it is an anti-patent bill.

During the October 30, 2007 hearing, four individuals presented testimony. None presented testimony in favor of the bill. The bill itself was, in fact, fairly well ignored. Let's hope it was ignored because it was dead on arrival.

Marc Grodman, CEO of Bio-Reference Laboratories, the largest independent regional laboratory in the Northeast, presented arguments in his testimony as to why he believed that "exclusive licensing of genetic associations" should be barred. Interestingly, he emphatically stated that he was not present to "attack the entire U.S. patent system, or even the patenting of genes or gene sequences per se."

Jon Soderstrom, managing director of the Office of Cooperative Research at Yale University and President-Elect for the Association of University Technology Managers (AUTM) pointed out in his testimony that "there is no evidence that widespread assertion of patent rights on genes has significantly hampered biomedical research." He also points to information which shows that "the licensing of DNA patents at US academic institutions has not led to the decline in academic cooperation and technology transfer that many observers have feared." In concluding, he stated that he was "confident that the scientific community . . . will continue to monitor whether gene patents are interfering with research." I don't doubt that his conclusion is correct. Monitoring for problems serves the community well. If problems are found, they should be addressed.

A third speaker, Lawrence Sung, Professor, University of Maryland and Partner, Dewey & LeBoeuf LLP, spoke on his own behalf and provided an overview of the topic. In conclusion, Dr. Sung noted "the potential for unintended consequences in any change to the patent laws, which might have disparate impact upon various technologies and industries, strongly suggests that such action should be approached with careful deliberation."

Jeffrey Kushan presented testimony on behalf of the Biotechnology Industry Organization. Mr. Kushan pointed out that patents are not granted on genes. However, he should have also pointed out that patents are not granted on nucleic acid sequences. The patent office views claims drawn specifically to sequences as unpatentable under 35 USC §101. Instead, patents are granted on nucleic acid molecules -- tangible molecules. I realize that this is semantics, but it is a very important concept when discussing patentability of DNA.

Patents are not granted on genes or sequences, but they are granted on novel chemical molecules, i.e. novel isolated DNA. Patenting of nucleic acids is no different than the patenting of other isolated molecules naturally occurring in one's body. It's that simple -- the patenting of isolated molecules doesn't mean that someone else owns my body. Let's hope Congress understands this point and does not confuse fiction and non-fiction when drafting and passing legislation.