When the Supreme Court ruled in 2013 against a company that tried to patent a diagnostic screening method for mutated genes that lead to breast cancer, it opened a golden age for testing.
Five other labs quickly joined the field with their own tests, slashing costs from the $4,000 price tag Myriad Genetics had been charging when it claimed the patent to as little as a few hundred dollars.
Now civil liberties groups fear Congress is about to put a lid on things, as lawmakers attempt a major rewrite of patent law.
Sens. Thom Tillis, North Carolina Republican, and Chris Coons, Delaware Democrat, who have written a draft to overhaul the system, say they are trying to bring clarity after a series of Supreme Court rulings left confusion.
But they say they do not want to open the door to gene patenting.
Mr. Tillis said no one can patent something that’s not new, and the humane genome is not only not new, but it’s been mapped before, and is “available for public use” already. He called the complaints a distraction.
“Let’s stop what I consider efforts to derail what we are doing,” he said at a hearing this week.
At issue is Section 101 of the U.S. Patent Act, which governs what can be patented. As it reads now, the section says anyone who invents or discovers a “new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof” can get a patent.
For years, that was deemed to generally rule out patents on abstract ideas or things found in nature. But experts say a 2012 decision invalidating a patent based on drug dosage, the 2013 ruling on breast cancer gene testing case and a 2014 decision on software patents have left things a jumble.
Thus the need for the rewrite, the senators say.
But civil liberties groups say the lawmakers go too far when they propose in their draft that all court cases offering tests for determining patent eligibility “are hereby abrogated.”
The American Civil Liberties Union and allied groups say that wording risks upsetting the court’s unanimous rulings.
Several legal scholars appear to agree, saying unless the lawmakers add an exception for products of nature, the court’s Myriad ruling would not survive.
Mark Lemley, a law professor at Stanford University, said the draft bill requires that an invention result from “human intervention.”
“It is not clear that a court would read that language to bar Myriad’s isolated genomic DNA sequences, particularly given that the statute says it is to be construed to favor patent eligibility,” said Mr. Lemley.
Lori Andrews, a professor at Chicago-Kent College of Law, said it would violate what the Founding Fathers — such as Thomas Jefferson, who as secretary of state pushed for the first Patent Act in 1793 — wanted.
“Jefferson was adamant that abstract ideas, as well as the handiwork of nature, not be restricted by patents,” she said.
Mr. Tillis, chairman of a subcommittee that oversees the latter, has held three hearings to get feedback on his draft bill, and received some warnings about the risks of expanding patenting.
“Brand-name drug companies could seek to patent every conceivable implementation — from isolated genes to computerized methods of research and development — to lengthen their patent monopolies far beyond the periods contemplated by Congress,” Jeffrey Francer, general counsel for the Association for Accessible Medicines, told lawmakers.
He said that could reverse attempts to lower drug prices and deny patients access to diagnostics and treatments.
Mr. Tillis said the feedback they’ve gotten from the hearings will be incorporated in a final bill, which they expect to introduce in July.
“We need further refinements,” he said.
The draft proposal has bipartisan support from House lawmakers, including Rep. Doug Collins, Georgia Republican, Rep. Hank Johnson, Georgia Democrat, and Rep. Steve Stivers, Ohio Republican.
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