In the batch of decisions they released earlier today, the highest court in the land handed down an interesting and unanimous ruling concerning patent law that has some major potential to influence the research and business practices the burgeoning biotechnology industry. In Association for Molecular Pathology v. Myriad Genetics, all nine SCOTUS justices ruled that scientists cannot patent naturally-occurring human DNA, but struck some middle ground by adding that synthetically-created DNA — or cDNA — does indeed fall into the realm of patentable material. Via the NYT, the case concerned patents held by Utah-based Myriad Genetics for genes that correlate with the increased risk of hereditary breast and ovarian cancer that were being challenged by rights groups arguing that companies should not be able to lock up the uses of new DNA that could benefits patients if it was made widely available:
The patents were challenged by scientists and doctors who said their research and ability to help patients had been frustrated. The particular genes at issue received public attention after the actress Angelina Jolie revealed in May that she had had a preventive double mastectomy after learning that she had inherited a faulty copy of a gene that put her at high risk for breast cancer.
The price of the test, often more than $3,000, was partly a product of Myriad’s patent, putting it out of reach for some women. The company filed patent infringement suits against others who conducted testing based on the gene. The price of the test “should come down significantly,” said Dr. Harry Ostrer, one of the plaintiffs in the case decided Thursday. The ruling, he said, “will have an immediate impact on people’s health.” …
The decision hewed closely to the position of the Obama administration, which had argued that isolated DNA could not be patented, but that complementary DNA, or cDNA, which is an artificial construct, could. The patentability of cDNA could limit some of the impact on industry from the decision.
Pretty neat stuff — you can glance over decision, authored by Justice Thomas, here, and Lyle Denniston over at SCOTUSblog has some of the plain-English background on what went into the justices’ decision:
The Supreme Court long ago ruled that an inventor who discovers a phenomenon in nature, or figures out a “law of nature,” cannot get an exclusive right to use or sell that by obtaining a patent from the federal government. Natural phenomena are the basic tools with which every would-be inventor starts, so locking up the right to use them in a monopoly held by a specific patent owner will frustrate others who might want to look for new ways to interpret that phenomena, the Court has said.
The exclusion of natural substances from eligibility for patents was the theory on which the Court relied Thursday in its unanimous ruling that a company cannot get a patent monopoly on the use and study of human genes that it isolates in the bloodstream, and them takes them out — without changing their natural character — for research.
In a nutshell, the Court ruled that the company didn’t actually create anything, but only extracted the human DNA and then set it aside for study. I haven’t been following the case closely, but my biggest question was whether Myriad and similar companies would be able to profitably protect their research and retain their ability to compete — but the NYT adds that Myriad’s stock price was up about 10 percent in early trading, so it sounds like the Court allowing for the possibility of patents on synthetically created versions of those genes was at least something of workable compromise. Thoughts?