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Genes and patents

At stake in a court case is whether any human gene or test based on it can be covered by a patent.

January 10, 2010

Medical science's expanding knowledge of the human genome has opened a promising new field of "personalized" therapeutics tailored to patients' genetic makeup. But researchers don't have complete freedom to explore human genes. According to the Hastings Center, a bioethics think tank, 3,000 to 5,000 patents have been issued on various gene sequences. Proponents claim that those patents are advancing the cause of personalized medicine, but the American Civil Liberties Union says they have the opposite effect. This month, U.S. District Judge Robert W. Sweet is scheduled to hear arguments in a case pitting the ACLU -- joined by scientists and cancer patients -- against the U.S. Patent and Trademark Office and Myriad Genetics, a company that holds patents to two human genes linked to breast and ovarian cancer. At stake is whether any human gene or test based on it can be covered by a patent.

The civil libertarians make a compelling argument that genetic material is nature's work, not man's, and that the sort of patent granted to Myriad could be used to slow medical advancements by limiting access to crucial research tools and data. But gene patents raise important questions of policy that Congress should decide, rather than just legal issues for judges to settle.

Patents, like other forms of intellectual property, grant inventors a temporary monopoly over their creations. That's a lot of power, but supporters of the patent system say it is justified by the incentive it provides to develop new medicines, breakthrough technologies and other advanced products. The flip side, though, is that the control wielded by patent holders can deter others from pushing innovations further and applying them in unexpected ways.

According to the patent office, patents can be obtained for "practically everything which is made by man and the processes for making the products," but not naturally occurring substances. The office has carved out an exception, however, for genetic sequences that are isolated, purified and put to a novel use. That's what Myriad did with BRCA1 and 2 -- it managed to extract from a chromosome the unique sequence of nucleotide bases that constitute each gene, then strip off all the cellular material attached to it. Myriad used the isolated genes to develop tests that could determine whether a patient has BRCA1 and 2 or selected mutations.

The tests are important because the BRCA1 and 2 genes are involved in the body's natural defenses against tumors, and women who have damaged versions of those genes are significantly more vulnerable to breast and ovarian cancers. Myriad's patents give it a monopoly over the tests; only labs that have obtained a license from the company can perform them. Researchers who support the ACLU's lawsuit say Myriad's patents stop them not only from conducting the tests but from doing more research into the genes' links to breast cancer and other diseases.

Lawyers for the ACLU and the Public Patent Foundation contend that gene patents violate the Constitution, which empowers Congress to grant monopolies over inventions "to promote the progress of science and useful arts." If that's the goal, they argue, it defeats the purpose to allow companies such as Myriad to patent a gene sequence. All scientific patents have this potential -- the question is whether the incentives created by the patents would lead to more advancements than if there were no such incentives. In the case of gene patents, the ACLU argues, the answer is a resounding no -- limiting access to gene sequences delays the development of new genetic tests and, potentially, the relevant treatments. The plaintiffs also contest the patents that cover Myriad's tests, arguing that correlating a naturally occurring gene to a naturally occurring condition amounts to nothing more than observing a law of nature.

Myriad says it has encouraged researchers to continue exploring the BRCA genes because their work makes the patents more valuable. The more that's discovered about the genes' correlation to disease, the more useful its tests become. Myriad also argues that without patent protection, companies won't invest the millions of dollars needed to persuade doctors to use novel genetic tests and insurers to pay for them. In other words, patents promote investment in the scientific exploration that leads to medical breakthroughs.

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