If you wanted to patent your sister, you would be disappointed. She, like most other humans, is a product of nature and is therefore outside the realm of patentability. Yet, 20 percent of all human genes have been patented — a significant portion of your sister. The expectation that inventions should be novel apparently notwithstanding, for two decades the United States Patent and Trademark Office has issued patents for portions of our genetic makeup to genetics corporations and laboratories. And the theft of our own genes is frustrating the research at universities and slowing the progress of medicine.
No part of the human genome belongs to any one person or organization. Pending in the federal court system is a lawsuit filed by the American Civil Liberties Union and the Public Patent Foundation arguing just that. The scientific community is watching closely because, should the case ultimately be ruled in favor of the ACLU, gene patents spanning two decades could be invalidated and the human genome would once again belong to humanity.
Patents are important in many fields for encouraging research and development. They give patent holders control over their inventions for 20 years in exchange for full public disclosure of the invention’s details. The former aspect provides an incentive while public disclosure places others in a position to develop and patent a better invention.
Gene patents are the same. Gene patent holders make money by selling genetic screening tests for the genes they have patented. A patient who wishes to be checked for disease-causing mutations associated with Long QT syndrome (which can cause sudden death), for example, can only buy that test from the company, which has patented the genes on which those mutations occur.
But there’s a flaw in the idea of patenting the genes themselves. With genes, there’s no way to improve the patented item — at least not for the purposes of medical diagnosis. The premise of genetic screening is to look at the genes as they are and use that information to determine a person’s susceptibility to a certain disease. For diagnostic purposes, the development of “Genome 2.0” doesn’t make much sense, and so the patents don’t, either.
More frustratingly, not only do gene patents fail to encourage research, but when patent rights are abused, they actually stifle it. Enter Myriad Genetics, the company that holds the patents for the famous BRCA1 and BRCA2 genes — mutations on which are strongly associated with a susceptibility to breast and ovarian cancers. Since it received its patents in the 1990s, Myriad has used the power of the patent to refuse other laboratories permission to further research or test the genes and charges more than $3,000 for every antiquated cancer screening test it provides.
Myriad has a monopoly over testing and research on the BRCA1 and BRCA2 genes. If a woman can’t afford Myriad’s test for the mutations associated with cancer or would like a second opinion from a different genetics company before, say, having a hysterectomy, she is out of luck. For her to remove her own genes and look at the sequence would be a violation of patent law. Scientists who oppose gene patents have thus argued that what Myriad and other companies have is a patent on knowledge, not a novel invention.
Supporters of gene patents argue that temporary monopolies imposed by patents are necessary to reward those companies which have made considerable investments in research and development. But Lee Silver, professor of molecular biology and public policy at Princeton University, says likely “95 percent of patents on genes are worthless in an economic sense,” as reported by CNN.com in May. Obscure diseases, unlike breast cancer, simply lack the testing numbers sufficient to turn a profit from a gene patent. Clearly gene patents fail to do their job of encouraging research and improving health.
In theory, the legal argument against gene patenting is strong. Maybe 2010 will be the year gene patenting is finally ended by the federal judiciary. But if it isn’t, it will be up to us to make the moral argument good enough for Congress.
Sadly, the real reason you can’t patent your sister isn’t so much legal precedent. It’s that someone already has.
Nicholas Clift is an Engineering freshman.