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Supreme Court seems opposed to granting patents on human genes

WASHINGTON — The Supreme Court took up a deceptively simple question in a case brought by breast cancer patients and medical researchers: Are human genes patentable?

The answer appeared to be “no” during Monday’s oral arguments. The justices signaled that they probably will bar any grants of exclusive and profitable patents on human genes that prevent other scientists from testing these pieces of DNA.

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But the justices were aware the issue itself was anything but simple, and they sounded wary of going too far and taking away the financial incentives for companies and their scientists to explore new uses for DNA.

“The patent law is filled with uneasy compromises,” Justice Stephen G. Breyer said. “We do want people to invent. On the other hand, we’re very worried about them tying up … a thing that could be used for further advance.”

Biotech and pharmaceutical companies are carefully monitoring the case because a ruling rejecting the patentability of human genes could curb investment in gene-related research and new drugs.

The case before the court arose when cancer patients and medical researchers sued in 2009 to challenge the patents issued to Myriad Genetics in Salt Lake City. Its researchers discovered DNA sequences in two genes that signal a high risk for the development of breast or ovarian cancer.

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The company filed for a patent for one gene, called BRCA1 for BReast CAncer1, in 1994, and for another, called BRCA2 for BReast CAncer2, in 1995. Their flagship product, BRACAnalysis, tests for key mutations in both genes.

About 1 million patients have been tested so far. Myriad charges more than $3,000 for each test.

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Breyer and other justices insisted that “products of nature” could not be patented, whether it is a plant leaf that has medicinal potential or human DNA. “It’s important to keep products of nature free of restrictions,” he said.

It also is not enough to find a new substance, other justices said. What about “the first person who found a liver?” Justice Elena Kagan asked. Surely, that person could not have been given a patent on livers, with the exclusive right to test or treat them, she said.

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At the same time, the justices said inventors should be able to patent a new use for a natural substance.

Though a ruling against Myriad could have a chilling effect on investment in certain biotech and pharmaceutical companies, some industry experts said the immediate fallout may be muted because many of the current patents on genes, first sought in the 1990s, already have lapsed or are expiring soon.

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“This is an important juncture for the biotech industry, and this decision will set the tone from a patent standpoint,” said Karen Dow, a La Jolla patent lawyer who represents biotech companies and investors.

“We already have a problem with early-stage investors not wanting to invest in biotech and pharma companies because it takes so long to get a return on their investment. This ruling could have an even more chilling impact on that investment,” Dow said.

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The bigger worry, some experts said, would be a broadly written court ruling that casts doubt on patents for other naturally occurring proteins, antibodies and other building blocks used by biotech companies to develop new therapies and tests.

“If the court decides that products of nature aren’t patentable more broadly, how far does it go? It’s possible they are willing to cover more than just genes,” said Lisa Haile, a San Diego patent lawyer for the industry.

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Myriad said that the U.S. Patent and Trademark Office has granted more than 40,000 patents that were drawn from genetic material and that its patents were “the product of creative, human ingenuity.”

The company said its scientists “applied their inventive faculties to a previously undistinguished mass of genetic matter and created a new chemical entity.”

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A lawyer for the breast cancer patients disagreed.

“What exactly did Myriad invent? The answer is nothing,” Christopher Hansen of the American Civil Liberties Union told the justices.

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He conceded Myriad deserves credit for having “unlocked the secrets of two human genes,” but it does not deserve an exclusive patent for discovering a natural substance.

But Gregory Castanias, a lawyer for Myriad, said the Utah scientists had indeed invented something new. He cited the example of baseball bat. “A baseball bat doesn’t exist until it’s isolated from a tree. But that’s still a product of human invention,” he said, because the wood has been shaped and cut.

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Chief Justice John G. Roberts Jr. objected. “A baseball bat is quite different” because it is shaped from a tree.

“Here, what’s involved is snipping,” he said, referring to the gene sequences. “You snip off the top and you snip off the bottom, and there you’ve got it.”

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Like Roberts, most of the justices sounded skeptical of Myriad’s argument that “isolated DNA” can be patented. In recent years, the justices have faulted the U.S. Patent and Trademark Office for being too willing to grant patents. “The PTO seems very patent happy,” Kagan said Monday.

Scientists who are skeptical of the idea of patenting genes said they were hopeful after the arguments that the justices would overturn the Utah company’s claims.

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“I was on pins and needles the whole time,” said Dr. Wayne Grody, director of the Diagnostic Molecular Pathology Laboratory at the UCLA Medical Center, who was present at the arguments. “But at the end I thought, ‘The justices really get it.’ ... I felt that all of them who spoke weren’t comfortable with the idea of patenting a gene.

“The justices really focused on a gene as a product of nature. They kept making the analogy of finding a medicinal plant in the Amazon. You can’t just pick the plant up and patent it.”

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The ACLU and the Public Patent Foundation had argued that giving one company a monopoly over a distinctive gene sequence resulted in patients paying too much for testing, and it prevented them from getting a second opinion from other medical experts.

They had lost in the federal circuit court that oversees patent appeals. The court upheld Myriad’s patents in 2011 and again last year, despite the high court’s warning on the issue in a previous case. The patent judges held that isolating the particular gene that signals a risk of cancer was a “new and useful” invention that can be patented.

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Even though Myriad’s patents are due to expire within two years, the Supreme Court agreed to hear the ACLU’s contention that genes cannot be patented.

A decision in the case of Assn. for Molecular Pathology vs. Myriad Genetics can be expected by the end of June.

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david.savage@latimes.com

chad.terhune@latimes.com

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Savage reported from Washington; Terhune from Los Angeles. Times staff writers Karen Kaplan and Eryn Brown in Los Angeles contributed to this report.


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