Spectators observe as The New York Genome Center hosts the Life Technologies' "Ion Bus" in Times Square In New York City on April 25, 2012. The "Ion Bus" is a fully functional DNA sequencing lab outfitted onto a tour bus to help the public understand the benefits of genomic science to medicine and human health. -- UPI/John Angelillo | License Photo
WASHINGTON, April 21 (UPI) -- The U.S. Supreme Court is deciding under what conditions a company can patent the building blocks of life -- or in some cases the building blocks of death -- for profit.
An eventual decision in the case may affect the healthcare of millions, and the billions in profits such patents bring. An estimated 40 percent of human DNA is patented, and the U.S. Patent and Trademark Office has awarded patents on human genes for more than 30 years.
But if DNA exists in nature -- exists in people's bodies -- may a company claim the sole right to medical procedures involving particular pieces of DNA?
In argument last week, justices expressed skepticism about patents on isolated DNA.
The case involves Myriad Genetics of Salt Lake City, which holds patents for isolated DNA covering gene mutations BRCA1 and BRCA2. When present, the mutations indicate a high possibility of developing breast and ovarian cancer. The patents also cover ways of isolating the genes to test for the presence of the mutation.
DNA, or deoxyribonucleic acid, contains the genetic instructions -- or information -- that determine the development of living organisms.
Critics complain that Myriad's diagnostic analysis makes it impossible for women to confirm their test results elsewhere while others cannot afford the $3,000 cost of Myriad's test. If insurance covers the procedure -- not always the case -- it brings the cost down to $100.
A coalition of healthcare professionals, patients and the American Civil Liberties Union filed suit in New York in 2009, saying such patents restrict science and make it difficult for women to get crucial medical care.
Though a federal judge ruled for the plaintiffs on the grounds that the patents cover products of nature, a panel of U.S. Court of Appeals for the Federal Circuit in Washington -- which hears intellectual property cases -- ruled 2-1 for Myriad. The panel trimmed the coalition plaintiffs down to one New York physician-researcher, saying the others didn't have standing, and ruled the patents on isolated DNA were valid.
The coalition then asked the Supreme Court for review.
In its petition, the coalition told the justices, "Myriad has exercised its authority as a patent holder to prohibit standard clinical testing of the BRCA1/2 genes, to inhibit scientific research involving the genes, and to prevent patients from accessing their own genetic information. Myriad's patents have allowed it to dictate the cost of genetic testing, stopped other laboratories from creating and offering new and improved testing procedures and made it impossible to obtain second opinions that could better inform patients of their cancer risk. Myriad and other gene patent holders have gained the right to exclude the rest of the scientific community from examining the naturally occurring genes of every person in the United States."
Women with BRCA1 and BRCA2 mutations face up to an 85 percent cumulative risk of breast cancer as well as an up to 50 percent cumulative risk of ovarian cancer. "The existence of BRCA1 and BRCA2 mutations is therefore an important consideration in the provision of clinical care for breast and/or ovarian cancer," the petition said.
In one of its own briefs to the high court, the company said: "The claimed isolated molecules of deoxyribonucleic acid are particular molecular compositions designed based on the Myriad inventors' identification and characterization of the structure of the BRCA genes, and separated from other cellular content by the inventors based on those designs. These molecules are used to detect and analyze mutations in human tissue, which aid in determining a patient's genetic predisposition risk to breast and ovarian cancers."
The brief asked the Supreme Court to decide whether "the Federal Circuit correctly [applied federal law] to conclude that these particular molecules" are "products of human ingenuity 'having a distinctive name, character [and] use,' particularly where the general legal rule followed by courts for 30 years has been to allow such patent claims, where the U.S. Patent and Trademark Office has issued similar patents since at least 1982 and confirmed in the 2001 Utility Guidelines that such isolated molecules are patent-eligible as human-made inventions under [federal law] where investors and technology companies have placed significant reliance in these settled property rights over the last 30 years, where the alternative dividing line is indefensible under law or science, and where the challenged claims do not pre-empt or preclude the use of alternative technologies to identify a patient's cancer predisposition?"
The brief argued the Federal Circuit "correctly determined that Myriad's claims are drawn to patent-eligible compositions of matter" that fall squarely within the provisions of the 1952 federal Patent Act.
"Myriad's claims are statutorily patent-eligible," the brief said. "Each claim is, on its face, to a chemical 'composition of matter,' or a 'new and useful improvement thereof.' [The coalition members] have never disputed this."
The Obama administration filed its own brief in the case suggesting a middle way, one which the justices may well heed.
The brief from the U.S. Solicitor General's Office said: "Synthesized genetic materials such as cDNA molecules [manipulated DNA] are patent-eligible subject matter while isolated but otherwise unmodified genomic DNA is not."
The relevant federal statute "embraces only 'human-made inventions' that do not monopolize laws or products of nature," the brief said, adding, "Artificial DNA molecules, including cDNAs, are human-made inventions eligible for patent protection.
Further, the brief said, "Neither the [patent office's] practice of issuing patents for isolated DNA, nor Congress' failure to overturn that practice, provides a sufficient reason to hold that isolated DNA is patent-eligible."
Myriad's patents cover isolated DNA, but are due to expire in a couple of years, and advancing science eventually may render such patents irrelevant.
During last week's argument, most observers said a majority of the Supreme Court appeared skeptical of the company's argument -- but the justices' comments from the bench are not always indicative of how they will vote.
Any decision in the case should come before the justices recess for the summer at the end of June.
After the argument, members of the challenging coalition said in a statement they could smell victory.
"Myriad did not invent the human genes at issue in this case, and they should not be allowed to patent them. The patent system was designed to encourage innovation, not stifle scientific research and the free exchange of ideas, which is what these patents do," ACLU attorney Chris Hansen, who argued the case, said.
"The Patent Office's policy of granting companies complete control over portions of our bodies is both morally offensive and a clear violation of the law," said Daniel B. Ravicher, executive director of the Public Patent Foundation and co-counsel in the lawsuit. "Genes are the foundation of life, they are created by nature, not by man, and that is why we were here today at the Supreme Court, to make sure they are not controlled by corporations through the patent system."