WSJ on gene patenting.
A federal appeals court on Friday will reconsider whether isolated human genes can be patented, in a case that could reshape how biotechnology companies develop sophisticated screening tests and treatments for cancer and other diseases.
The hearing marks the latest legal twist in the fight over a series of Myriad Genetics Inc. MYGN +0.50% patents relating to two genes. Mutations of the genes can signal that a woman faces greater risk of developing breast cancer or ovarian cancer. Myriad's patents allow it to be the exclusive U.S. commercial provider of genetic screening tests for the diseases.
The Salt Lake City-based company has battled for more than three years with patients and medical groups that filed a lawsuit arguing Myriad is trying to patent products of nature, which can't be patented.
The challengers, represented by the American Civil Liberties Union, won a trial-court victory in 2010, but their fortunes shifted last July when the U.S. Court of Appeals for the Federal Circuit largely sided with Myriad in a 2-1 decision. This spring, the U.S. Supreme Court ordered the Federal Circuit to revisit the case, in light of a new ruling by the justices that tightened rules on medical-testing patents.
The Supreme Court's ruling, which jolted the biotechnology industry, threw out two Prometheus Laboratories patents on a test to help doctors set drug dosages for patients with Crohn's disease. The court said the patents impermissibly sought to lay claim to laws of nature.
The ACLU says that decision bolsters its case against Myriad. "It's a major reaffirmation of the arguments we've been making all along," said ACLU attorney Sandra Park. Myriad says the high court's ruling shouldn't affect its earlier legal victory because its patents protect a real invention that is different from a natural gene.
The plaintiffs say some women can't afford Myriad's screening test, which costs more than $3,000, while others can't get second-opinion tests from other labs because the Myriad patents prevent it. They also say the patents have kept targeted cancer treatments off the market. The patents "may well be preventing life-saving research and treatment," the challengers said in a recent court brief.
Myriad says isolating the two genes—known as BRCA1 and BRCA2—that are at issue in the patent case was difficult and complex. Myriad's general counsel, Richard Marsh, says patents "provide the incentives for companies to spend the tremendous amounts of capital necessary" to produce such breakthroughs.
Mr. Marsh said it was "patently false" to claim the patents had deterred scientific research. Since the two genes were patented, scientists have published more than 9,000 research papers on them, he said. The company says a patient's average out-of-pocket cost for the screening test is less than $100.
Human beings have roughly 25,000 genes, which are DNA segments that represent basic units of heredity.
In ruling for Myriad last year, the Federal Circuit said the company wasn't patenting a product of nature because the process of extracting and isolating a gene from the human body made the gene different from DNA that exists naturally.
Judge Kimberly Moore, who penned a concurring opinion in the case, wrote that the Myriad patents "raise substantial moral and ethical issues related to awarding a property right to isolated portions of human DNA—the very thing that makes us humans, and not chimpanzees."
But the judge also said the U.S. Patent and Trademark Office has allowed patents on DNA sequences for decades and that disturbing the industry's long-held expectations risked impeding new innovations.
Tim Worrall, a patent lawyer at Dorsey & Whitney LLP, said a loss for Myriad could threaten DNA-related patents in sectors including agriculture, biopharmaceuticals and cosmetics. "The effect on the biotechnology industry would be really quite severe," he said.
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