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[Those who] appreciate the majesty and beauty of the wilderness and of wild life, should strike hands with the far-sighted who wish to preserve our material resources … in an effort to keep all living creatures from wanton destruction. This end can only be achieved through wise laws and by a resolute enforcement of those laws. President Theodore Roosevelt wrote those words in 1903, and they embody his call for a public policy concept almost unheard of at the time: the conservation of America’s vast, yet finite, natural resources. If Roosevelt were with us today, he might use similar words to implore sound stewardship of another vast, yet finite, resource: the human genome. In the years since 1903, the national debate over natural resources took place against a framework of real property law as construed by legislatures, courts and administrative institutions. The debate over allocating and controlling elements of the genome will play out through these same institutions. With the genome, intellectual property will provide the framework. The central question has and will continue to be how best to strike the balance between individual ownership and public access for research. The U.S. Patent and Trademark Office issues patents on naturally occurring gene sequences. Conventional wisdom holds that these patents are not only legal, but highly desirable from a public policy perspective, as they have attracted investment to the biotech sector and are fueling the development of next-generation diagnostics and therapeutics. But the problem with conventional wisdom is that, left unchecked, it almost invariably evolves to the point where the convention far outweighs the wise. Are these gene patents allowing us to practice sound public management of the genome? Or are they gradually siphoning off a finite natural resource and making it unavailable for basic research? My experience at Affymetrix — experience with the legal, scientific, economic and ethical issues involved — has led me to conclude that gene patents are not in the best interest of science or the global society it seeks to serve. The legal theory supporting gene patents is rooted in the notion that they aren’t patents on the naturally occurring gene per se, but on an isolated and purified form of the gene. That language dates from a 1911 case, Parke-Davis v. H.K. Mulford, decided by the 2nd U.S. Circuit Court of Appeals. In the modern world of genomics, that logic is a distinction without a difference. If you accept this argument, then would it not follow that you could patent a human heart once you removed it and preserved it? A human gene is created first in nature, the same way other parts of human bodies are, and the fact that it’s isolated, cloned and purified doesn’t change that root of origin. Moreover, with the sequencing of the human genome, finding a new gene is now a process that involves little invention. Powerful supercomputers have replaced the lab bench as the source of discovery of genes, so the patents issued are really on information. A 22-year-old case, Diamond v. Chakrabarty, is often cited as proof that the U.S. Supreme Court has approved gene patents. That decision requires perspective. Chakrabarty is quite narrow, a decision based not on naturally occurring human gene sequences, but on a bacterium engineered by humans to digest oil in spills. In fact, the Supreme Court has yet to hear a case which squarely addresses the human gene sequence issue. This debate, of course, goes beyond the letter of the law and extends to science and research policy, where it takes on very practical aspects. The genome is enormously complex, and the only thing we can say about it with certainty is how much more we have left to learn. At the same time, we’re learning that many diseases are caused not by the action of single genes, but by the interplay among multiple genes. Just last month, for example, scientists announced that they had decoded the genetic structures of one of the most virulent forms of malaria and that it may involve interactions among as many as 500 genes. So, with good reason, researchers want to look at more of the genome, not less. What happens when the technical ability to analyze the whole genome collides with the legal ability to wall off parts of the genome through patents? In practical terms, what can scientists do when they receive letters demanding that they stop important research unless they pay fees and obtain licenses from the patent holders on genes? One option is to negotiate the license, but that can be time-consuming, complicated and costly. Remember, too, that patent holders are generally under no obligation to grant a license, expeditiously or otherwise. These complications can increase exponentially if the scientist is looking at multiple genes covered by patents or groups of genes covered by multiple patents. In other research and development efforts, someone can invent around a patent — find another way of doing the same process that doesn’t infringe on the original invention. Scientists, however, shouldn’t have to research around a discovery. Some researchers may ignore these letters under the theory that as long as the research is nonprofit in nature, there is a de facto research exemption in the United States to protect the researcher. However, the exemption is really a gentleperson’s agreement — it exists only as long as the patent holder chooses to be gentle. Many in the industry argue that gene patents are essential in attracting investment to biotech companies. The argument is debatable. In today’s market, the commercial value of a gene sequence alone is often not enough to attract capital. Private and public investors alike are now more interested in determining whether a company can successfully bring worthy products to market based on genomic research. These changing investment criteria are true not only for new entrants, but for seasoned players as well. Celera Genomics and Incyte Genomics Inc., two companies with many patents on gene sequences, have recently announced that they are entering the drug development business — demonstrating the existence of this new market approach. The growing number of gene patents is a vexing problem for the private sector, not just for public research. Licensing is as difficult for research and development companies as for scientists working in a university setting. Protective patent litigation is draining and expensive (some 30 percent above the average cost of other business litigation). Considering both the expense and the risks of bringing new technologies and therapeutics to market, we have to ask if these licensing and litigation costs are an efficient allocation of the research and development sector’s resources. The human genome also presents us with profound ethical questions. Some people believe that you can’t assign ownership or exclusionary rights to something as central to life as the human genome. Others believe you should not be able to commoditize and monetize part of the human body. Still others believe that genes are part of the common heritage of humankind, and thus owned by all of us. Creating exclusionary rights in a few companies or countries will inevitably lead to a disparity between those that can and cannot afford the advances that are emerging from genomics research. All of these are interesting and credible points of view and deserve to be represented in the debate about intellectual property rights. To ignore them — to pretend as if this debate were simply about the economics of biotechnology — would be a failure to recognize the value and history of the human genome as a natural resource. To return to Theodore Roosevelt, in a 1903 speech at Stanford University about conservation, he said, “There is nothing more practical in the end than the preservation of beauty.” Almost 100 years later, those same words simply but ably describe our goal of wisely allocating the intellectual property of the genome, a “thing of beauty” and a human natural resource if ever there was one. Barbara A. Caulfield is executive vice president and general Counsel at Santa Clara, Calif.’s Affymetrix Inc. From 1991 to 1994 she served as a federal judge in the Northern District of California.

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