This morning marked a reunion of sorts for the parties involved in a controversial dispute over whether isolated human genes are patentable. The U.S. Court of Appeals for the Federal Circuit ruled last year that they are, but was ordered by the U.S. Supreme Court to take another look in light of new, possibly related precedent.
The defendants in the case, which include Myriad Genetics Inc., have been fighting challenges to patents on two genes associated with breast and ovarian cancer. The American Civil Liberties Union and the Public Patent Foundation filed the original suit in May 2009, claiming the genes are "products on nature" and can't be patented.
Following the federal circuit's ruling last July that such genes are patentable, the Supreme Court issued a decision in March in Mayo Collaborative Services v. Prometheus Laboratories Inc. In Mayo, the court found that the patents at issue in that case involved the "laws of nature," which they ruled couldn't be patented. Shortly after issuing the Mayo decision, the high court vacated the federal circuit's ruling in Myriad and asked it to reconsider the case in light of its findings in Mayo.
The Mayo case involved a diagnostic method for determining the proper dosage of a drug based on how it was metabolized by an individual patient. The Supreme Court found that the method essentially directed doctors to adjust dosages based on the "laws of nature." Since the method didn't present inventive applications of natural laws, the court found that it couldn't be patentable.
Jones Day partner Gregory Castanias, arguing for Myriad, said this morning that the federal circuit clearly found in its original decision that Myriad's patents involved "non-naturally-occurring, human-made inventions." That was the line drawn in other cases the court relied on at the time, he told the court, and "nothing in the Supreme Court's recent Mayo decision changes that line."
"We think the panel continues to understand our arguments," he said in an interview this afternoon. "I don't see any reason to believe that any of the judges had moved away from our position."
ACLU senior attorney Christopher Hansen argued for the plaintiffs. The organization has argued that allowing patents on the genetic material at issue puts up a barrier to testing and research on breast and ovarian cancer. The ACLU argued that Mayo does apply to the Myriad case because the high court gave weight to the issue of pre-emption, or whether the patent at issue prevents scientists from working with a law or product of nature.
In an interview this afternoon, ACLU senior attorney Sandra Park said that she thought the court this morning pressed Myriad on why isolating a gene was the same as inventing something new. "What we've been arguing is the DNA, simply because it's been isolated or removed from the cell, doesn't make it an invention," she said.
Edward Reines, a partner at Weil, Gotshal & Manges, said that the intellectual property community is closely watching the Myriad case. He said that there's a concern that restrictions on patenting personalized medicine "create disincentives for American innovation in that area." Reines said that he didn't expect to see "big changes" from the federal circuit, which could set the stage for the case to go before the Supreme Court.
"It didn't appear that any of the judges had a sea change in their views on the subject," said Reines, who has been following the case and filed an amicus brief early on unrelated to the merits.
Judges William Bryson, Alan Lourie and Kimberly Moore heard the case.