Gene patents have a detrimental impact on health care and research.4 Gene patents can prevent more accurate, affordable and complex diagnostic tests from being developed.5 A survey of genetics labs found that 53 percent stopped doing research due to concerns about patented genes,6 and there has been a significant decline in published material on patented genetic information.7 The future of personalized medicine may be crushed by the weight of gene patent thickets if a company must ask permission from hundreds of patent holders to scan a single patient’s genome. (Try that with Apple's iPad patents.) Thousands of BRCA tests, for instance, find "variants of unknown significance"—mutations that might or might not portend cancer. In this respect, the appeals court largely agreed with Myriad Genetics when it determined that “isolated DNA” is patentable since it is not found in nature and is the result of a human process. . 5 A survey of genetics labs found that 53 percent stopped doing research due to concerns about patented genes, 6 and there has been a significant decline in published material on patented genetic information. It means … True, but, legally, tough luck. Blame the Constitution, which empowers Congress to give inventors "the exclusive right" to their discoveries;" the patent office, which interprets "discoveries" as including genes; and the courts, which have said similar patents "promote the progress of science," as the Framers wrote. I defer to others on the legal merits here. These patents harm patients and researchers, and they go against years of legal precedent holding that one cannot patent a “fact of nature.”. 4 (1997). Just because you take the kidney out of the body doesn’t mean you get to patent it.” v. U.S. Patent and Trademark Office et al., 132, U.S. District Court, Southern District of New York, March 29, 2010. Moreover, while these legal features of human gene patents do not lessen the concern that patenting may worsen existing inequalities between rich and poor countries, or between rich and poor people in the same country, they suggest that there is nothing about a legal patent that precludes government regulation of licensing agreements with these worries in mind. Unfortunately such toll booths were just given the go-ahead by a Federal appeals court., Why Gene Patents Are Bad for Patients and Science. Additionally, they argued that Myriad’s patents limited patients’ access to potentially life-saving genetic diagnostic tests and prevented researchers from looking at those genes to help their patients or to develop more effective and affordable tests. This brings us to the recent verdict, in which the judges were not asked to rule on whether gene patents are harmful but whether they are patentable. Ever since the first human gene was patented in 1982, there's been a near-universal "What??!!" Myriad's general counsel, Rick Marsh, insisted to me that this is not so. The primary issue with gene patenting is that the Supreme Court of the US has ruled that only artificial genes can be patented. No different than taking the kidney out of the body. 2Mildred K. Cho, Preparing for the Millennium: Laboratory Medicine in the 21st Century (American Association for Clinical Chemistry Press, 2d ed., 1998), pp. See why nearly a quarter of a million subscribers begin their day with the Starting 5. why is gene patenting bad? 3Joseph Stiglitz and John Sulston, "The Case Against Gene Patents", Wall Street Journal, October 7, 2010. "I can't afford it!" 4See Jon F. Merz, Antigone G. Kriss, Debra G. B. Leonard and Mildred K. Cho, “Diagnostic Testing Fails the Test”, Nature, February 7, 2002; David Blumenthal et al., “University-Industry Research Relationships in Biotechnology”, Science, June 13, 1986; David Blumenthal et al., “Withholding Research Results in Academic Life Sciences”, Journal of the American Medical Association, April 16, 1997; David Blumenthal et al., “Data Withholding in Academic Genetics”, Journal of the American Medical Association, January 23/30, 2002. Gene patents have a detrimental impact on health care and research. 47–58. "Ordinarily, labs would test lots of people to determine the normal variation in a gene to see which variations are associated with disease," says geneticist Wendy Chung of Columbia University. See also Human International Genome Sequencing Consortium, “Initial Sequencing and Analysis of the Human Genome”, Nature, February 15, 2001; J. Craig Venter et al., "The Sequence of the Human Genome", Science, February 16, 2001. The defendants argued that patents are necessary to protect the time and money invested in identifying disease-gene correlations. But first, let's clarify what a patent is. But few isn't none. In May 2009, the American Civil Liberties Union filed a lawsuit against Myriad Genetics, which owned genes (BRCA1 and BRCA2) that correlate with increased risk for breast cancer and ovarian cancer. "The idea was to discover how mutations other than the common ones affect the gene," says Penn's Haig Kazazian. If allowed, labs could run the same genetic test for only a few hundred dollars.3 Myriad also sent cease-and-desist letters to researchers who were looking at the BRCA1/2 genes in their labs, providing diagnostic tests to patients and even providing patients second-opinion tests to confirm the test provided by Myriad. . Scared off, she stopped. 71, no. Such discoveries are manifestations of nature, free to all men and reserved exclusively to none.11 [emphasis added]. That is why Judge Sweet called attempts to define patented genes as novel as merely a “lawyer’s trick.”. Congress, which has constitutional authority over what is patentable, should pass legislation making it clear that genes are “facts of nature” and are therefore unpatentable. . Because no natural gene sequences can be patented, this prevents companies from focusing on direct research on human gene sequences, thus focusing on more potentially profitable, but less reliable, artificial genes that can be patented. The lawsuit was filed on behalf of researchers, genetic counselors, women patients, cancer survivors, breast cancer and women’s health groups, and scientific associations representing 150,000 geneticists, pathologists and laboratory professionals. This is especially important for smaller companies that may not have the financial support to compete with […] 10Association for Molecular Pathology et al. 4 Gene patents can prevent more accurate, affordable and complex diagnostic tests from being developed. v. U.S. Patent and Trademark Office et al. And the survey results may reflect the fact that many patents are cheap to license and are unrestrictive, says law professor Timothy Caulfield of the University of Alberta; that is, the patentholder allows anyone to work on the gene for only nominal payment. 8Michael J. Malinowski and Robin J.R. Blatt, "Commercialization of Genetic Testing Services: The FDA, Market Forces, and Biological Tarot Cards", Tulane Law Review, vol. The ACLU named the Patent Office as a defendant, too, since it had granted these patents. . 5Gene Patents and Licensing Practices and their Impact on Patient Access to Genetic Tests, report of the Secretary’s Advisory Committee on Genetics, Health and Society. Relevance. On the surface, the patents don't seem to impede research. 11Diamond v. Chakrabarty, U.S. Supreme Court, June 16, 1980. a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Nor does the fact that the exclusive patent prevents physicians from getting independent confirmation of genetic-test results, and women from getting a full second opinion. These patents, the industry claims, are necessary to bring expensive tests and products to market and improve patient health. The justification for patents is that they encourage innovation: make a discovery, reap the financial rewards. . Not to be heartless, but we have to put aside arguments that the patents hurt patients because Myriad charges so much ($3,400) for BRCA tests, which doctors recommend for women with a family history of breast or ovarian cancer. Because Myriad doesn't, and has such a fierce reputation for enforcing its BRCA rights, these patents are different. . Likewise, Einstein could not patent his celebrated law that E=mc. "The notion that Myriad has hindered research is incorrect." Although the patents give Myriad the right to prevent scientists from even looking at BRCA without permission, Myriad "has never told someone they cannot do [noncommercial] research on BRCA," he says. Sharon Begley is NEWSWEEK's science editor and author of The Plastic Mind: New Science Reveals Our Extraordinary Potential to Transform Ourselves and Train Your Mind, Change Your Brain: How a New Science Reveals Our Extraordinary Potential to Transform Ourselves. As Joseph Stiglitz and John Sulston explained in the Wall Street Journal, “the patenting of human genes is wrong as a matter of science and as a matter of economics.” Lets hope Congress keeps with good science, good economics and good public health policy by declaring, once and for all, that genes and DNA sequences are facts of nature, part of our common genetic heritage, and therefore unpatentable.