The Supremes Get It Right, Naturally.
It’s hard not to be cynical about the Supreme Court. For all their highfalutin rhetoric, the nine justices usually vote no differently than nine party hacks dredged up from a local Democrat or Republican campaign office would. Imagine my delight, then, to see a unanimous 9-0 decision yesterday in the Myriad gene-patenting case. The ruling not only squashes a ridiculous, overreaching policy with an air of authority, it seems to recognize the new biological (and financial) reality of genes and DNA.
A recap: In the early 1990s, a company in Utah named Myriad Genetics isolated two genes, BRCA1 and BRCA2, that, when mutated, greatly increase a woman’s chance of developing breast and ovarian cancer. (Flaws in these genes recently convinced Angelina Jolie to have both her breasts removed.) Myriad did outstanding work in discovering the genes, certainly. Unfortunately, it squandered a lot of goodwill by staking a legal claim not only to the two genes but to all possible methods of finding mutations in those genes and all possible methods of linking those genes to breast cancer. It basically asked for infinite scope to make money off the BRCAs—and got it. Worse, it aggressively enforced its patents for years.
A consortium of scientists and the American Civil Liberties Union eventually sued to invalidate the patents a few years ago. And while the BRCAs were the most high-profile genes to win patent protection, they certainly weren’t the only ones. By some estimates, 40 percent of human genes have been patented, and every single one of those patents was at stake in this case.
Legally, the case revolved around a distinction between what’s natural and what’s manmade. But the whole point of the biotech industry is to blur those boundaries, and Myriad did. In short, Myriad isolated the BRCA genes—snipped them out of the longer DNA chain in which they were ensconced. And in doing so, it claimed it had created something that didn’t exist in nature. That’s true, as far as it goes. But by that logic, if you discovered a new plant in the Amazon and “isolated” it by tearing up its roots and taking it home, you’d also have created something “unnatural” and therefore patentable.
This struck many observers (yours truly included) as not only absurd but repugnant. These genes exist inside every single one of us, in every single cell—and you’re telling us that we don’t really own them? (As Jonas Salk once said, when asked about patenting the polio vaccine: Can you patent the sun, too?) Disgust aside, the patent also probably hurt consumers. Myriad could charge whatever price it wanted for the BRCA tests, and kept prices higher by several thousand dollars.
Perhaps worse, the mere existence of such patents, on any genes, has a chilling effect on scientists: they never know when they could get a cease-and-desist letter and have to abandon years of research. True, many scientists ignored such concerns and did research anyway; and Myriad itself didn’t harass basic research scientists. But that’s only because Myriad chose not to. Other companies (or patent trolls) might not be so benevolent. Regardless, the mere threat of being sued for studying genes distracted scientists, and diverted money and effort away from research and into legal wrangling.
Now, the Supreme Court has eliminated most of those hassles at a stroke. And the ruling is all the more remarkable because it reflects—probably unwittingly, but still—the new reality of how genes and DNA work.
That reality traces back to the Human Genome Project, which officially wrapped up one decade ago, in 2003. And just like most of us expected to seeing flying cars by now, many of us expected a spate of miracle cures based on all that genetic information. That hasn’t happened, to say the least—and probably won’t happen anytime soon.
One reason why these cures haven’t materialized is that genes like the BRCA twins turned out to be unusual. These are single genes that, when mutated, greatly increase your risk for developing a specific disease. But most diseases don’t work like that. Most diseases involve, well, a myriad of genes that interact within a larger system, with flaws in any one gene contributing only a modest amount to your risk of developing diabetes or heart disease or whatever. Scientists therefore have to examine all those genes en masse to cure or ameliorate the disease. And if you think it’s a headache to navigate the legal niceties of doing research on one gene, the headache grows exponentially the more genes that are involved. That’s especially true because, unlike in other areas of technology, you can’t “invent around” genetic patents. There might be five good ways of developing a touchscreen for a phone—but there’s only one gene X or Y in your body.
Myriad’s strongest arguments were that invalidating gene patents would discourage investment by private-sector companies. That remains to be seen. And in the meantime, there are a few things to keep in mind. First, at least some of the current economic activity involved with gene patents is bogus. An editor of mine once compared this activity to land speculation: companies patent a gene and then sit on it, doing nothing useful, merely hoping to sell the rights to the highest bidder at the peak of a bubble.
Second, it’s important to remember what this ruling doesn’t do. Myriad can still make money testing for flaws in the BRCA genes—it will simply face competition now, and will presumably have to lower its price. Moreover, this ruling didn’t blanketly invalidate all gene patents. In fact, it specifically upheld patents on certain types of DNA sequences that really do not exist in nature. Nor does it hinder a company’s ability to develop—and make loads of money off of—new ways to isolate or sequence DNA, or new processes that use DNA to cure diseases. They can have at it.
This is exactly the Solomonic outcome that the Obama administration had pleaded for in its oral arguments last fall—and the entire Supreme Court agreed. The lion has lain down with the lamb, in other words, and the unanimity seems so surreal that I might as well keep dreaming. In some sense, the Myriad case was only one skirmish in a larger, more general battle over U.S. patent policy. That policy, which grants strong monopoly rights over a fixed period of time, served the country well for two centuries, and it still makes sense for certain types of chemical and mechanical inventions. The policy doesn’t work so well any more in the electronics industry, where patents are more or less a joke—regularly infringed upon by all parties and conducive to nothing but a round robin of attorneys, all mutually suing each other. Reforming patent law in a meaningful way—and perhaps even recognizing that different industries need different kinds of patents—would probably take an act of a unified Congress and/or God. In other words, it’s a long shot. But until yesterday I would have said the same thing about the chances of patent reform in biotech, too.