IP run amok comes full circle... //Alif -- I hate Missouri. Land of the free, home of the perjuriously deranged. ---------------------------------------------------------------------- http://www.medpagetoday.com/Genetics/GeneticTesting/27811 Court Greenlights Cancer Gene Patent By Emily P. Walker, Washington Correspondent, MedPage Today Published: July 29, 2011 WASHINGTON -- An appeals court here has ruled that a company that makes tests for breast and ovarian cancer can patent breast cancer gene sequences, in effect ruling that human genes can be patented. The U.S. Court of Appeals for the Federal Circuit -- a court that specializes in patent cases -- ruled that when a gene is isolated from the human body, it is "markedly different" and has a "distinctive chemical identify and nature" compared with the way it is found in nature. Friday's 2-1 decision overturns parts of earlier decisions by a U.S. District Court judge in New York City who ruled that patents on the BRCA 1 and 2 gene sequences -- and by extension all other human genes -- are invalid. The company that holds the patents, Utah-based Myriad Genetics, sells tests that assess a woman's risk of developing breast or ovarian cancer based on detection of mutations in the BRCA1 and BRCA2 genes. Other companies, researchers, or doctors that test for the mutation would be violating Myriad's patent. Companies can still do whole-genome sequencing without violating the patent. The American Civil Liberties Union (ACLU) and the Public Patent Foundation, along with a group of doctors, genetic scientists, and patients, first challenged Myriad's patents in 2009, arguing that isolating DNA from the body does not create something new and that things that exist in nature cannot be patented. During oral arguments and in documents, lawyers for the ACLU likened what Myriad is doing to removing a person's kidney and trying to patent it. Lawyers for Myriad, meanwhile, said it's more like making a baseball bat from a tree. Yes, the tree exists in nature, but the bat is an entirely new thing, with an entirely new use, that is made from nature. The company argued that isolating the BRCA1/2 genes from the entire human genome is actually creating something new because isolated DNA isn't found in nature. Plus, the company is creating something with a new utility that goes beyond the DNA merely sitting, unseen, in the body, it argued. The Obama Administration split with the U.S. Patent and Trademark Office (which originally granted Myriad its patent protection) and filed a friend-of-the-court brief siding with the ACLU, agreeing that "the mere act of isolating something" that already exists in nature is not enough to warrant patent protection. The court sided with Myriad, writing that the company's patents cover molecules that are markedly different and have a "distinctive chemical identify and nature" from molecules that exist in nature. Isolated DNA has been cleaved to make it just a fraction of a naturally occurring DNA molecule. "Thus, when cleaved, an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity," wrote Judge Alan Lourie in the court's opinion. The court did rule that one plaintiff, Harry Ostrer, MD, has standing to challenge Myriad's claims. Ostrer, director of the Human Genetics Program at New York University School of Medicine, in New York City, has said unequivocally he wants to immediately start BRCA testing, but cannot do so because Myriad holds the patents. The court ruled that two other physicians do not have standing because they have only asserted that, hypothetically, they'd like to start BRCA testing. "Simply disagreeing with the existence of a patent or even suffering an attenuated, non-proximate, effect from the existence of a patent does not meet the Supreme Court's requirement for an adverse legal controversy of sufficient immediacy and reality to warrant the issuance of a declaratory judgment," wrote Judge Alan Lourie. Judge William Bryson, dissented, and said that "extracting a gene is akin to snapping a leaf from a tree." The case may eventually make its way to the U.S. Supreme Court.