Notion of gene patenting raises eyebrows at Supreme Court

 

McClatchy Newspapers

Supreme Court justices pushed back Monday against the idea of patenting human genes during oral arguments that ranged from baseball bats and chocolate chip cookies to imaginary plants in the Amazon.

Amid a tangle of competing metaphors, conservative and liberal justices alike seemed to recoil at patenting isolated genes taken from the human body. Even if separated through clever technology, justices suggested, the genes in question remain a product of nature rather than an invention of man.

“Here, you’re just snipping, and you don’t have anything new,” Chief Justice John Roberts Jr. told Gregory A. Castanias, an attorney for Myriad Genetics of Salt Lake City. “You have something that is a part of something that existed previous to your intervention.”

Underscoring the court’s ideologically diverse concerns, liberal Justice Elena Kagan joined the conservative Roberts in offering examples that were critical of human-gene patenting. Repeatedly, and skeptically, Kagan asked whether a company might patent a medically useful plant removed from its habitat deep in the Amazon.

The question is telling, because the Supreme Court previously has declared that laws of nature and “natural phenomenon” may not be patented.

“Are you saying you could patent the plant because it takes a lot of ingenuity and a lot of effort to find it?” Kagan asked Castanias, adding that, “It’s still the same thing, but now that you’ve isolated it, in fact it has lots of great purposes.”

The case considered Monday is the first to confront the Supreme Court directly with the question of whether the human gene may be patented, although more than 4,000 such patents already have been issued.

Genes are segments of DNA. The human body contains about 22,000 genes, which define traits such as eye color and sex and can influence whether an individual develops conditions such as obesity, diabetes and Alzheimer’s disease.

Scientists with Myriad used mapping tools to identify genes associated with mutations that predispose patients to breast and ovarian cancers. Scientists called these the BRCA1 and BRCA2 genes. Myriad obtained a number of patents relating to the isolated BRCA genes, enabling the company to control research and to charge for its genetics-based tests for breast cancer.

The company, backed by others in the multi-billion-dollar biotechnology and pharmaceutical industries, argues that the isolated gene can be distinguished from what’s found in the body.

“A baseball bat doesn’t exist until it’s isolated from a tree,” Castanias said Monday. “But that’s still the product of human invention, to decide where to begin the bat and where to end the bat.”

Roberts, though, retorted that “you have to invent” a bat, whereas “you don’t have to invent the particular segment of the (genetic) string. You just have to cut it off.” Justice Sonia Sotomayor made a somewhat similar point, using the example of creating a new chocolate chip cookie. The cookie might be patented, she said, but not the ingredients.

“I can’t imagine getting a patent simply on the basic items of salt, flour and eggs, simply because I’ve created a new use or a new product from those ingredients,” Sotomayor said.

Patents, moreover, impose serious standards. Other researchers say Myriad warned them away from BRCA gene work with cease-and-desist letters, while some breast cancer patients alleged that Myriad made it prohibitively expensive for them to afford needed cancer testing.

“Myriad unlocked the secrets of two human genes,” American Civil Liberties Union attorney Christopher A. Hansen acknowledged Monday. “But the genes themselves, where they start and stop, what they do, what they are made of and what happens when they go wrong are all decisions that were made by nature, not by Myriad.”

With justices also citing the importance of protecting intellectual property and providing researchers with proper incentives, the court seemed intrigued by a middle-ground position that the Obama administration proposed. The administration wants human gene patents limited to a more narrow type of genetic material, called cDNA, that’s been synthesized in the laboratory, and the suggestion captured the attention of Sotomayor and Justice Anthony Kennedy, among others.

“A patent on cDNA leaves the isolated DNA available for other scientists and others in the medical profession to try to generate new uses,” Solicitor General Donald Verrilli said.

As is his custom, Justice Clarence Thomas was the only one of the nine justices not to speak or ask questions during the 65-minute oral argument.

A decision in the case, called Association for Molecular Pathology v. Myriad Genetics, is expected by the end of June.

Email: mdoyle@mcclatchydc.com; Twitter: @MichaelDoyle10

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