Groups Ask High Court to Invalidate Gene Patents
(CN) - Doctors, researchers and cancer patients asked the U.S. Supreme Court to invalidate patents for two genes associated with hereditary breast and ovarian cancer, claiming the patents "exclude the rest of the scientific community" from beneficial genetic testing and research.
Utah-based Myriad Genetics patented two human genes known as BRCA1 and BRCA2, whose study can predict the risk of getting breast and ovarian cancer in women with a history of the disease in their families.
Because mutations in the two genes are associated with a significantly higher risk of hereditary breast and ovarian cancer, studying the genes may help women who are predisposed to BRCA gene mutations decide on a plan of treatment or prevention, including increased surveillance or preventive mastectomies or ovary removal.
Medical professionals, research organizations and several patients diagnosed with or at risk for cancer filed a federal lawsuit in 2009, claiming the U.S. Patent and Trademark Office should not have allowed Myriad to patent the genes and methods of isolating and comparing them.
They said Myriad's exclusive control over the genes and their variations inhibited scientific research and prevented patients from accessing their own genetic information. They also accused Myriad of dictating the cost of genetic testing in the United States, preventing other labs from offering new and better testing, and making it impossible for patients to get second opinions on their cancer risk.
Myriad defended its patents on the grounds that they covered only isolated genes, which were different from genes in the human body.
A federal judge invalidated Myriad's patents in 2010, finding that human genes are "products of nature" that cannot be patented. In isolating the genes, Myriad did not alter their essential characteristics, U.S. District Judge Robert Sweet ruled. He also invalidated the company's patents on methods of comparing the genes, and dismissed the claims against the U.S. Patent and Trademark Office.
The Federal Circuit reversed, but the U.S. Supreme Court last year ordered it to rehear the case in light of its ruling in a similar case, which found that natural processes cannot be patented.
After rehearing the case, a divided panel of the Federal Circuit again concluded that Myriad's claims to isolated BRCA genes and to a process for screening potential cancer therapeutics could be patented.
The majority opinion noted that isolated DNA is structurally different from the DNA found in nature, because the process of removing the molecules from the body breaks chemical bonds. It also pointed to the U.S. Patent and Trademark Office's longstanding practice of granting gene patents and the industry's reliance on that practice.
Despite a dissenting opinion noting that Myriad merely extracts the BRCA genes from nature, the federal appeals court ruled that the company's patents did not claim laws of nature.
Following the Federal Circuit's decision last month, the plaintiffs, represented by the American Civil Liberties Union, asked the U.S. Supreme Court to rehear the case and decide whether human genes may be patented.
"Until the patent eligibility of isolated genes is clarified, important stakeholders will be forced to act -- or will be chilled from acting -- without clear legal guidance," the petition states. "These include the clinicians and scientists who want to undertake testing and research involving the patented genes in order to improve diagnosis and treatment for patients."
The petitioners argue that patents on isolated DNA violate well-established Supreme Court precedent and the U.S. Constitution, which prohibit the patenting of laws of nature, natural phenomena, products of nature and abstract ideas.
They claim that Myriad's BRCA patents deter all research and clinical testing on the genes, impede innovation, and prevent patients from getting a second opinion before making life-changing medical decisions.
"Unlike patents on drugs which can be invented around by developing another drug that treats the same condition, patents on isolated DNA bar access to every person's genetic information," the petition states.
"Myriad also prevents others from providing testing at a lower price, or for free, and only 130 million of America's 308 million people can currently receive insurance coverage for their testing," the plaintiffs add.
They claim that Myriad refuses to share data about the genes and their relation to breast and ovarian cancer, preventing new advances in genetic testing.
"Because Myriad has authority to prevent research on a part of the human body and to prevent development of new or better clinical tests, the consequences for women's health are enormous," the petition states. "This case does not question the patentability of new instruments, drugs, or methods of diagnosis or treatments. Instead, it concerns perhaps the most basic elements of biology, human genes.
"The Federal Circuit in this case reached the wrong result because it asked the wrong questions," the petitioners add. "It focused on trivial changes to DNA incidental to isolation that fall far short of 'markedly different characteristics from any found in nature.' It failed to identify what is inventive about these claims. And, it failed to consider their preemptive effects while giving undue weight to patentees' interests."
If Myriad is allowed to keep its method patents for the BRCA genes, the petitioners argue, it could prevent other scientists from finding a treatment for cancer.