Your Genes Aren’t For Sale

SCOTUS ruled today that naturally occurring human genes can’t be patented. Lyle Denniston summarizes:

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 then takes them out — without changing their natural character — for research.

In a later post, Denniston considers the real-world consequences of the case:

The decision was a major blow to a company that believed it had a right to be the sole user and analyst of two human genes, mutations in which show a high risk, for women found to have them in their blood, of breast and ovarian cancer.  But the ruling will give medical and scientific researchers, and family doctors, greater opportunity to help women patients discover their potential vulnerability to those types of cancer.

In a way, the ruling was a silent tribute to screen actress Angelina Jolie, who recently gained huge notoriety not for her acting but for voluntarily having her breasts surgically removed after discovering that she had the threatening mutations in her body.  She, of course, was able to pay the high cost of that test; now, women of less means will be able to afford it, and that was a key motivation for challenging Myriad’s patent rights.

McArdle frets that SCOTUS “just outlawed the business model of companies like Myriad,” which “spends about $50 million a year on R&D.” She wonders how best to encourage innovation going forward:

One way, of course, is to simply throw more federal money into research grants. Or we could investigate prizes: millions of dollars for anyone who identifies a gene that helps us target a specific disease process. The problem is with setting the value of the rewards—what constitutes a disease process worth targeting, and how do we know when we’ve found a worthwhile connection? Companies have an easy answer to that: “Someone will pay me to test for it.” Governments have to consult more nebulous standards. Investors may not be willing to waste money on those standards—or they may be too willing, because we’ve set the price too high. Or we may simply spend a lot of money on stuff that turns out to not be all that useful.

And, finally, Joshua Keating wonders whether other countries will follow the US’s lead:

In fact, Australia’s Federal Court ruled in favor of Myriad in February after a very similar suit was brought by a cancer foundation there. In that case, the justices ruled that “the two genes, isolated from their natural cells in which they were found, constituted a “manner of manufacture” and could therefore be patented.” That decision is currently being appealed and the government is considering legislation to limit genetic patents.

In Europe, the patentability of genetic materially is legally protected by the EU’s Biotech Directive, which holds that “biological material which is isolated from its natural environment or produced by means of a technical process” may be patentable “even if it previously occurred in nature.”

Earlier Dish on the case here.