Protesters hold banners demanding a ban on the patenting of human genes… (Mladen Antonov / AFP/Getty…)
When the Supreme Court took up the question Monday of whether genes could be patented, the justices were clearly concerned about preserving innovation in medicine and biotechnology. But the issue presented by Myriad Genetics' patents on the BRCA genes cuts both ways, leading to a potential split among the justices.
On the one hand, allowing patents on a gene could prevent companies from developing new tests and drugs related to that sequence until the patent expires. On the other, barring patents could deter companies from making the huge investments needed to isolate sequences and determine their role in the body.
Opponents of the patents, led by the American Civil Liberties Union and some medical researchers, argue that human gene sequences should not be eligible for patents, period. The "product of nature" doctrine, they say, bars patents on anything that Mother Nature invents; to obtain a patent, companies have to alter a gene, as they do with recombinant DNA, to create something new and useful.
Myriad and its supporters, including some in the biotech industry, counter that sequences should be patentable because they do not exist in isolation inside the body. Although the processes used to isolate a sequence are well known among scientists, Myriad argues that a significant amount of work is required to figure out such things as where the sequence begins and ends and how to produce a gene molecule that's medically useful.
During Monday's oral argument, several justices seemed worried about the implications of allowing patents over something extracted from nature. The example used by Justices Stephen G. Breyer and Elena Kagan was that of an explorer who discovers a plant in the Amazon rain forest that has medicinal properties. They questioned why, if a gene extracted from the body could be patented, why not a plant extracted from South America? Or a chromosome, or a piece of the liver?
As Breyer put it: "It's important to keep products of nature free of the restrictions that patents there are, so when Captain Furneaux goes to the Amazon and discovers 50 new types of plants, saps and medicines, discovers them, although that expedition was expensive, although nobody had found it before, he can't get a patent on the thing itself. He gets a patent on the process, on the use of the thing, but not the thing itself."
The Myriad patents include one on a small segment of DNA that is particularly useful in telling whether a woman is susceptible to specific strains of breast and ovarian cancer. Myriad's lawyer, Gregory A. Castanias, told the court that though the sequence may be the same as the one in a woman's body, the patentable invention came in figuring out which portion of a very long string of nucleotides actually was relevant to the risk of cancer.
Several justices still seemed troubled by the idea of letting companies patent a sequence that could be "snipped" from a human chromosome. On the other hand, some also said they worried that companies would not make expensive excursions into the unknown if they couldn't patent what they found and ensure a return on their investment.
When the ACLU's lawyer, Christopher A. Hansen, said scientists may still be motivated by curiosity and the chance of a Nobel Prize, Kagan responded: "I hoped you were going to say something else, which is that, notwithstanding that you can't get a patent on this gene, that -- that there are still, you know, various things that you could get a patent on that would make this kind of investment worthwhile in the usual case. But if that's the case, I want to know what those things are rather than you're just saying, you know, we're supposed to leave it to scientists who want Nobel prizes. And I agree that there are those scientists, but there are also, you know, companies that do investments in these kinds of things that you hope won't just shut them down."
Hansen ultimately was bailed out by Justices Anthony M. Kennedy and Sonia Sotomayor, who suggested that the incentive might be the opportunities that isolating a particular gene sequence create to develop patentable processes or uses of the gene.