by Timothy B. Lee - Apr 14, 2013Will the Supreme Court end human gene patents after three decades?
Court considers invalidating breast cancer gene patents—and thousands of others.
Since the 1980s, patent lawyers have been claiming pieces of humanity's genetic code. The United States Patent and Trademark Office has granted thousands of gene patents. The Federal Circuit, the court that hears all patent appeals, has consistently ruled such patents are legal.
But the judicial winds have been shifting. The Supreme Court has never ruled on the legality of gene patents. And recently, the Supreme Court has grown increasingly skeptical of the Federal Circuit's patent-friendly jurisprudence.
Meanwhile, a growing number of researchers, health care providers, and public interest groups have raised concerns about the harms of gene patents. The American Civil Liberties Union estimates that more than 40 percent of genes are now patented. Those patents have created "patent thickets" that make it difficult for scientists to do genetic research and commercialize their results. Monopolies on genetic testing have raised prices and reduced patient options.
On Monday, the high court will hear arguments about whether to invalidate a Utah company's patents on two genes associated with breast cancer. But the legal challenge, spearheaded by the American Civil Liberties Union and the Public Patent Foundation, could have much broader implications. A decision could invalidate thousands of patents and free medical researchers and clinicians to practice medicine without interference from the patent system.Life-or-death stakes
The ACLU has cast a Utah biotech company called Myriad Genetics as the villain in its campaign against gene patents. Almost two decades ago, the University of Utah (a defendant in the original lawsuit) sequenced two genes, called BRCA1 and BRCA2, that are associated with an elevated risk of breast cancer. The University patented their findings before eventually licensing them to Myriad. Since the company began using said patents, it has enjoyed a de facto monopoly
over testing and research related to the genes. Currently, Myriad even has a monopoly on the implications of various genetic differences, though some people are trying to undercut that as well.
"When Myriad genetics began cracking down and closing labs, no one else could offer the test," said Ellen Matloff, a cancer genetic counselor in an ACLU-produced video. Researchers began to suspect that Myriad's test was giving false negatives for some mutations of the BRCA genes. But Matloff says that when she asked for permission to offer a supplemental test for patients who got a negative result from Myriad's test, she was told that doing so would violate Myriad's patent.Full blogACLU Video - The Fight To Take Back Our GenesHow a rogue appeals court wrecked the patent system
Federal Circuit Appeals Court marks 30 years of spreading the "patent gospel."