Lawyers representing researchers, pathologists and women's health groups urged a federal appeals court in Washington today to uphold a ruling that said a genetics company’s patents on two human genes are invalid and unconstitutional.
For more than an hour today, the U.S. Court of Appeals for the Federal Circuit grappled with the case, narrowly assessing whether an isolated gene is substantively different from DNA itself, and more broadly looking at how the resolution of the case has potential consequences for the biotechnology industry.
The U.S. Patent and Trademark Office has allowed patents for genomic DNA for more than 30 years. In the appeals court, the U.S. Justice Department, splitting from the PTO, said the genes at issue in the case are not patent eligible. The appeals court today was asked to determine whether isolated genes are products of nature or man-made inventions. Methods of identifying and isolating DNA may be patented.
The American Civil Liberties Union in May 2009 sued, among other defendants, Myriad Genetics Inc. and the University of Utah Research Foundation in the U.S. District Court for the Southern District of New York. The ACLU said Myriad’s control of patents on two genes associated with breast and ovarian cancer restricts research and patient access to medical care.
Last year, Senior Judge Robert Sweet ruled in favor of the plaintiffs, saying Myriad’s claims on two isolated DNA molecules, are ineligible. The ruling set up a high-stakes legal fight in the Federal Circuit, where interested groups, including the U.S. Justice Department, filed friend of the courts briefs. The ACLU said the case is not about genetic engineering, but, rather, the validity of patent claims on human genes.
Arguing for Myriad today in the appeals court, Jones Day partner Gregory Castanias of Washington tried to convince the panel—Judges William Bryson, Alan Lourie and Kimberly Moore—that the they should reverse Sweet’s ruling on jurisdictional grounds.
Castanias argued there is no controversy between Myriad and the plaintiffs. In court papers, Myriad’s attorneys said “there is no adversity here—just a complaint manufactured to serve the ends of two public-advocacy groups.” Castanias quipped that “it does take two to have a declaratory controversy.”
Addressing the merits, Castanias said the isolated DNA molecules are new compositions of matter that do not exist in the body. “These are not products of nature,” said Castanias, who leads the firm’s Federal Circuit practice. “They are not the products of God, if you will.”
The ACLU’s Christopher Hansen, senior national staff counsel, said there are physicians who are “ready, willing and able” to conduct tests on the genes but fear running up against Myriad.
“Myriad and its amici seek to cast this case as signaling the demise of advances in health and even the entire patent system,” the plaintiffs’ lawyers said in court papers. “The district court properly rejected these apocalyptic and hotly disputed predictions.” The plaintiffs’ lawyers said they are challenging “only a small number of patent claims on the basis of long-standing doctrine. [The] plaintiffs do not challenge the patentability of new drugs, devices or sequencing methods.”
Acting Solicitor General Neal Katyal, arguing today in the appeals court, said the Justice Department took a narrow position in the litigation, one that went contrary to the long-standing practice of the patent and trademark office. He offered an analogy that if a person discovered that pollen cures cancer, the inventor has discovered a cure for cancer. “They haven’t discovered pollen,” Katyal said.
Moore questioned Katyal on whether Congress is better suited to address the question of patent-eligibility of genes. Katyal dismissed the idea. “This is a pure question of law,” he said.
The appeals court did not immediately rule.