Human Genes, Baseball Bats, and Chocolate Chip Cookies

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Last Monday the U.S. Supreme Court heard arguments on whether human genes may be patented. Whether the Court will address the issue head on or find a way to narrow the impact of its decision is anybody’s guess.

The scientific complexities of isolating and understanding genetic material are enough to make even a Supreme’s head spin. So the justices kicked around more understandable analogies during oral argument – chocolate-chip cookies, baseball bats and plants in the Amazon to name a few. None of them proved wholly satisfactory.

supremecourt-washingtondc1This debate represents a classic battle between encouraging businesses to engage in expensive research versus worries that allowing genes to be patented would stifle innovation and competition. On one side, scientists and research companies argue patents encourage medical innovation and investment that saves lives. On the other, patient rights groups and civil libertarians counter that patent holders are “holding hostage” the diagnostic care and access of information available to high-risk patients.

An expansive ruling could have practical ramifications that could ripple into the lives of every American — not just women at risk for rare breast cancer. The decision might also affect pharmaceuticals, vaccines and genetically modified crops, despite the fact that the patents at issue are due to expire over the next two years.

The case concerns patents held by Myriad Genetics, a Utah company, on genes that correlate with increased risk of hereditary breast and ovarian cancer. The central question for the justices in the case, Association for Molecular Pathology v. Myriad Genetics, No. 12-398, is whether isolated genes are “products of nature” that may not be patented or “human-made inventions” eligible for patent protection.

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In granting the patents, the United States Patent and Trademark Office agreed with Myriad’s claim that, by extracting the genes from the human body, the company had invented an “isolated” DNA markedly different (and thus patentable) from the native DNA. The patents were challenged by scientists and doctors who said their research and ability to help patients has been frustrated.

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Last year, a divided three-judge panel of a federal appeals court in Washington ruled for Myriad. Each judge issued an opinion, and a central dispute was whether isolated genes are sufficiently different from ones in the body to allow them to be patented.

The ruling followed a unanimous Supreme Court decision last year that said medical tests relying on correlations between drug dosages and treatment are not eligible for patent protection. Natural laws, Justice Stephen Breyer wrote for the court, may not be patented standing alone or in connection with processes that involve “well-understood, routine, conventional activity.”

Justice_Sonia_Sotomayor
Justice Sonia Sotomayor

Solicitor General Donald B. Verrilli Jr., representing the federal government, said last year’s decision, Mayo Collaborative Services v. Prometheus Laboratories, suggested that the correct answer in the case argued Monday was that merely isolating a gene was not sufficient for patent protection. But manipulating a gene to create something not found in nature would be.

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That distinction, coupled with possible patents for particular uses of genes, seemed attractive to several justices.

Justice Sonia Sotomayor likened an isolated gene to an ingredient in a kitchen pantry.

“I can bake a chocolate-chip cookie using natural ingredients – salt, flour, eggs, butter,” she said. “And if I combust those in some new way, I can get a patent on that. But I can’t imagine getting a patent simply on the basic items of salt, flour and eggs.”

Gregory A. Castanias, lawyer for Myriad, proposed a different analogy.

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

Chief Justice John G. Roberts Jr. did not appear convinced.

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CHIEFJUSTICE
Chief Justice John G. Roberts Jr.

Justice Samuel Alito asked about “the leaves of a plant that grows in the Amazon and it’s discovered that this has tremendous medicinal purposes.”

“Let’s say,” he said, that “it treats breast cancer.”

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Steven R. Hansen, the lawyer challenging the patent, said the mere discovery and extraction of the plant should not make it eligible for patent protection.

Justice Sotomayor suggested that an isolated gene was “just nature sitting there.”

This case is one of the most important and complex disputes in a generation involving the intersection of science, law, and commerce. The sharpness of the disagreement revealed in the conflicting views within the government itself. The patent office sees the patents as valid and consistent with its duty to protect and promote invention. Solicitor General Donald Verrilli Jr. and the Justice Department oppose them on grounds that what nature makes cannot be patented and Myriad’s isolation of DNA did not change it enough to alter nature and be eligible for a patent.

Come this June the Supreme Court may tell us whether a human gene is more like a chocolate chip cookie or a baseball bat. Stay tuned.