ACLU – Association for Molecular Pathology v. Myriad Genetics

by Sabrina I. Pacifici on April 14, 2013

“On May 12, 2009, the ACLU and the Public Patent Foundation (PUBPAT) filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer, BRCA1 and BRCA2, are unconstitutional and invalid. On November 30, 2012, the Supreme Court agreed to hear argument on the patentability of human genes [via SCOTUSblog]. The Court will hear these arguments on April 15, 2013. 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, we have argued that human genes cannot be patented because they are classic products of nature. The suit charges that the gene patents violate the First Amendment and stifle diagnostic testing and research that could lead to cures and that they limit women’s options regarding their medical care. The U.S. Patent and Trademark Office (PTO) has granted thousands of patents on human genes – in fact, about 20 percent of our genes are patented. A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene. As a result, scientific research and genetic testing has been delayed, limited or even shut down due to concerns about gene patents…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. The lawsuit charges that patents on human genes violate the First Amendment and patent law because genes are “products of nature” and therefore can’t be patented.”

  • See also Edifying Thoughts of a Patent Watcher: The Nature of DNA, Dan L. Burk. 60 UCLA L. Rev. Disc. 92 (2013). “In the pending case Myriad Genetics v. Association for Molecular Pathology , the U.S. Supreme Court will consider the patentability of human genes under the “product of nature” doctrine. Patentable subject matter is generally held to encompass materials and artifacts created by humans, and not that which exists independently in nature. However, it is not clear that this is a meaningful or helpful distinction. Given on one hand that the concept of a gene is a human construct, and on the other hand that all human creations are drawn from the material environment, the question of gene patenting is better addressed as a matter of innovation policy than of imponderable labeling.”
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