Gene patents provide a perplexing question of what the best intellectual property scheme is for encouraging innovation in the genetic realm. David Lentini, a San Francisco patent lawyer, wrote in a February 19, 2007, “Letter to the Editor” of The New York Times, “Gene patents are vital to the biotechnology and pharmaceutical industries. Why would anyone risk the billions needed to transform basic science into lifesaving products if someone else could simply copy those products without risk?” Lentini makes an important point about the necessity of patent protection for innovation, but patenting the sequences themselves might actually deter the innovation he is striving for.

It’s worth considering his example in detail. First, is the patent incentive necessary for the discovery of the sequence? Probably not, given that researchers were searching for genes before they knew they could patent the sequence, and many genetics researchers, including Nobel laureate John Sultson, actually oppose gene sequence patents. Moreover, the discovery of gene sequences is substantially enabled by taxpayer funds. The National Institutes of Health contributed $5 million to sequencing the BRCA 1 gene, which was then patented by Myriad.

Second, if someone owns the sequence on a breast cancer gene, what is the incentive for another researcher to develop a better test or a gene therapy for breast cancer? Any such product will infringe the original patent, which means that, once the new product is created, the patent holder could charge an exorbitant amount for the use of the sequence in the therapy - or prevent the researcher from distributing the therapy. And it’s rare that a gene therapy developer needs to license just one gene. Multiple genes contribute to most diseases - and there are often separate patents on mutations of the genes. In an article in Science, Michael Heller and Rebecca Eisenberg express concern about the “privatization of upstream biomedical research.” They note that: “because patents matter more to the pharmaceutical and biotechnology industries than to other industries, firms in these industries may be less willing to participate in patent pools that undermine the gains from exclusivity. Moreover, the lack of substitutes for certain biomedical discoveries (such as patented genes or receptors) may increase the leverage of some patent holders, thereby aggravating holdout problems. Rivals may not be able to invent around patents in research aimed at understanding the genetic basis of diseases as they occur in nature.”

And what is the effect of gene sequence patents on the application of the scientific method of hypothesis generation, discovery, and replication? In one survey, half of gene patent holders said they would require a license for researchers to study the prevalence of mutations in the patented gene in the population. Twenty-eight percent of geneticists surveyed reported that they were unable to duplicate published research because other academic scientists refused to share information, data, or materials. This goes to the heart of science - which is based on confirmation of scientific data through replication.

Companies now sequence disease-causing bacteria and virus genes. In fact, in one situation, a company wants to introduce inexpensive, quick public health testing for a common infectious disease, but the company holding the patent on the infectious disease has forbidden it. In the future, a person might want to have hundreds or thousands of sections of their genome tested from a single blood sample, but patents on the underlying sequences make such a technology prohibitively expensive. Just do the math: Say a person wants to test herself for the 13 genes associated with asthma, maybe even throwing in tests for a few snippets of DNA related to treatment of her migraines and a dozen genes related to cardiovascular disease. At the Myriad rate per sequence tested, the test becomes unaffordable. The technology is already available but cannot be implemented due to the financial and practical limitations put in place by gene patent holders. Already, one in four laboratories has stopped performing certain genetic tests because of patent restrictions or excessive royalty costs. More than half had not developed a test for fear of running afoul of patent law.

Most drugs work on only a percentage of patients who use them. Patients get a prescription, try the pills for a while, and if the drugs are ineffective or harmful, they switch to another prescription. Physicians and patients have longed for a way to determine in advance which drugs are appropriate for which patients. Many groups, including the nonprofit Personalized Medicine Coalition, are working to assure better medical outcomes by using genetic markers to determine which medications or other treatment strategies are appropriate for which patients. But will patients actually get the benefit of pharmacogenomics - or will patents on genetic sequences stand in the way? One pharmaceutical company has fi led for a patent on the gene sequence that can be used to determine the effectiveness of its asthma inhaler. But the company says it will not develop the test - or let anyone else develop it. By controlling uses of a patented gene sequence, a company can continue to sell its drugs to more people by not weeding out those for whom it will be ineffective. But doctors express concern that, even if this company’s behavior is not representative of the industry as a whole, keeping a drug effectiveness test secret will mean that some patients will not be receiving the medication that is right for them.

These problems are so troubling that the American Society of Human Genetics, the American College of Medical Genetics, and the College of American Pathologists oppose gene patents, viewing them as a threat to medical advances and patient care. The World Medical Association takes the position that genes are the common heritage of mankind.

Beyond concerns about philosophy and altruism lurk compelling questions for CEOs. What is the best business model? Small biotech companies whose main asset is a particular gene patent vigorously defend the practice of patenting nucleotide sequences. But increasingly, big pharma wants to be able to use SNPs and sequences in drug target research without the risk of infringing dozens of patents. And companies like Affymetrix that produce chips and systems for DNA testing oppose the patenting of genes. Their technology - which makes it feasible to test for thousand of genes with a single chip - is not commercially viable if the royalty for each gene is in the thousands of dollars.

The ability to patent genetic sequences has also led medical researchers to patent other types of scientific information. Researchers from Columbia University and the University of Colorado patented the fact that a high level of homocysteine in a person’s body was correlated with vitamin B deficiency and patented a particular test for homocysteine levels. Someone else invented a better test for those levels,

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