Can human genes be patented? Supreme Court weighs in on question
Can human genes be patented? That's the question the Supreme Court is asking in a case over a genetic test, even though it may seem like a moot question since the U.S. Patent and Trademark Office has already granted patents on at least 4,000 human genes to various universities and companies, including Myriad Genetics, which discovered and decoded two human genes linked to breast and ovarian cancer.
Moreover, patents now cover some 40 percent of the human genome, according to a scientific study led by Christopher Mason of Weill Cornell Medical College.
Nevertheless, the American Civil Liberties Union and the Public Patent Foundation filed a lawsuit in 2008, challenging seven patents owned by Myriad Genetics on those two human genes. A federal judge ruled that the patents were invalid, but an appeals court overruled that decision – and the case has since landed in the Supreme Court.
On Monday, the U.S. Supreme Court will hear oral arguments on the case that pivots around the question of whether or not human DNA can be claimed as intellectual property and remain off limits to everyone without the permission of the patent holder.
When Myriad patented its discovery of two human genes linked to breast and ovarian cancer, it gave the Utah biotechnology company a 20-year monopoly over use of the genes for research, diagnostics and treatment. That monopoly prompted a group of researchers, medical groups and patients to sue the company on grounds that the patent was invalid.
The importance of this case for the future of science and medicine cannot be stated enough. For Myriad and its cohorts in the biotech and pharmaceutical industries, patents are the means that make genetic discoveries possible. However, their foes, which include top medical organizations and Nobel Prize-winning scientists, argue that Myriad's patent inappropriately blocks research and medical diagnostic testing.
The case involves a test that has helped guide more than a million women in their medical decisions. It can determine whether the composition of their genes makes them more likely to get breast or ovarian cancer.
Since the federal government has already granted similar patents on at least 4,000 human genes, Myriad contends that companies would be less willing to spend the money necessary for making genetic discoveries without the protection that patents provide.
"Countless companies and investors have risked billions of dollars to research and develop advances under this promise of stable patent protection," says attorney Gregory Castanias, who will argue the case for Myriad at today’s hearing.
Those on the other side oppose patenting DNA material.
"Human genes should not be patented," says Nobel Prize winner, James Watson, who co-discovered the double helix structure of DNA. "Life's instructions ought not be controlled by legal monopolies created at the whim of Congress or the courts," he adds.
Researchers at the University of Maryland, however, argue to the contrary. "The costs are outweighed by the benefits stemming from the fruits of increased inventive activity," they state in their friend-of-court brief.
So why all the fuss over patents since courts in this country have issued them for over 200 years? It all boils down to what the patent protects.
Specifically, U.S. law grants patents to protect inventions, not creations of nature. Therefore, this case boils down to whether Myriad obtained its patent on something already in the body or created something new.
The ACLU is representing the group of scientists, doctors and patients suing Myriad, claiming the company has merely removed something from the body that was already there: namely, the DNA sequence consisting of the two genes linked to breast and ovarian cancer. Thus, the ACLU argues, the patent covers a creation of nature, so it cannot be protected by a patent – even though Myriad claims that removing it is what makes it useful.
"Gold does not become patentable once taken out of a stream because it can be used in jewelry. Kidneys do not become patentable once taken out of a body because they can be transplanted," says Christopher Hansen of the ACLU.
According to the ACLU, Myriad's patent creates a monopoly that not only interferes with a woman’s ability to seek a second opinion based on another test of the genetic material, but discourages other laboratories from pursuing research on the patented genes.
"Myriad has given women false negative results while also barring other laboratories from testing genes to verify the accuracy of Myriad's results," says Hansen.
Moreover, the ACLU argues that many women lack the necessary insurance coverage and cannot afford the test, which costs approximately $3000 under patent protection. It would cost less if there wasn’t a patent, as competition would make the test cheaper, according to the ACLU.
On the other hand, Myriad argues that removing the gene sequence from the body requires breaking the chemical bonds that keep it in place, and doing so would end up creating new chemical material.
Meanwhile, the case will be decided based on what the U.S. Supreme Court determines regarding whether or not the human genetic material patented by Myriad is consistent with U.S. patent law as set forth by Thomas Jefferson in 1791 as a "new and useful art, machine or composition of matter or any new or useful improvement."
SOURCE: Supreme Court of the United States, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al (Brief fof Petitioners); New York Southern District Court, Association For Molecular Pathology et al v. United States Patent and Trademark Office et al (Declaratory Judgement, filed May 12, 2009, Cause Number: 1:2009cv04515)