The Supreme Court looks at gene patents, worries about biotech

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.

The Obama administration has suggested a potential middle ground, urging the Supreme Court to hold that companies can’t patent genes but they may be able to patent complementary DNA chains that they create in the process of isolating a DNA sequence. Myriad asserted that the cDNA molecules it produced were different from the cDNA found in nature because it extracted extraneous, non-protein-forming substances.

Chief Justice John G. Roberts Jr. and Justice Samuel A. Alito Jr. floated a different idea: Rather than declaring genes ineligible for patents, it could leave it to patent examiners to decide whether any particular sequence was too obvious to qualify for protection. Such an approach wouldn’t end lawsuits over the validity of specific gene patents, but it would be less disruptive to the industry than the ones favored by the ACLU and the administration.

The court’s sensitivity to the effect its decision might have on biotechnology and medicine isn’t unusual, said Tim Worrall, a biochemist and former federal patent examiner who’s now a patent attorney at Dorsey & Whitney in Denver. “You have an industry that has grown up in some ways around the ability to patent specific pieces of DNA that have been isolated,” Worrall said.

“I think the incentives that would be created or eliminated by eliminating the ability to patent either cDNA or DNA probes are significant,” he added. “And I think that could have long-term consequences in really limiting incentives to develop and pursue new diagnostics for new diseases and new indications that are much more complex than just one gene.”

Opponents of gene patents counter that researchers don’t need the incentive of a patent to identify specific gene sequences, considering the opportunities that information opens up. But allowing those sequences to be patented prevents all sorts of research, innovation and development that could be done on those building blocks, they say.

For the record, The Times’ editorial board has opposed patents on genes but has urged Congress to put that prohibition in place, not the courts.

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