Analysis
It is a natural human trait — of judges, too — when one doesn’t quite grasp a very complex idea, to reach for something commonplace for comparison. For the nine Justices of the Supreme Court, imperfectly versed in biochemistry, it was most useful on Monday to talk about how a baseball bat gets created, and how the sap of a plant in a forest in the Amazon might be analyzed for its powers to cure human disease. But those very analogies strongly suggested that an inventor probably cannot get a patent for taking something out of the human body, and manipulating it without changing its nature.
Throughout a sometimes achingly complex argument over bio-science, the down-to-earth images of shaping a bat out of a tree limb, or swallowing the sap of an Amazon plant to test its medicinal value appeared to put the Court closer to resolving a truly fundamental issue of patent law, on the right to get a monopoly for tinkering with Mother Nature’s products.
At issue in the case of Association for Molecular Pathology v. Myriad Genetics (docket 12-398) is whether Myriad was legally entitled to a patent on isolated fragments of DNA — naturally occurring human genes — that were extracted from blood for a laboratory search for evidence suggesting a risk in women of hereditary breast or ovarian cancer.
On a practical level, the Court seemed to be worried about two conflicting possibilities: if it clamps down too hard on patent eligibility for experimenting with natural products, it will kill the financial incentive for scientific innovation, but if it expands patent eligibility for such experiments too broadly, it will scare off other inventors who might also make breakthroughs if research were not inhibited by a patent monopoly.
Choosing between two alternative concerns appeared to be challenging enough that some of the Justices went looking for ways to avoid going too far in either direction, to find a way to decide this case that doesn’t settle too much too quickly. Before the Court is the simple but profound question: are human genes patentable? The Justices, however, found out quickly just how complex that question can be, and how difficult it will be to come up with a complete answer.
Justice Samuel A. Alito, Jr., suggested that the Court might be wise not to try to decide the whole issue of when manipulating nature can be treated as human invention. Chief Justice John G. Roberts, Jr., commented that the Court might be asking the wrong patent question at this point, and perhaps should order a look into whether the Myriad patents should fail because its method of extracting genes would have been obvious to any trained scientist in the field.
But, if there was one inclination that emerged most strongly on the legal side of the argument, it is that the Court is not going to accept the recommendation of Myriad’s attorney that it dilute the long-standing doctrine that a product of nature is simply not eligible for a patent. Washington attorney Gregory A. Castanias, arguing for Myriad, dropped several broad hints that the exclusion had lost its utility in modern science.
Another inclination, though it was not as firmly established in the argument, was not to write an opinion as broadly as suggested by the attorney for the challengers to Myriad’s patents, Christopher A. Hansen, an American Civil Liberties Union lawyer from New York. Hansen wanted a flat declaration that human genes are not patentable — period. The Justices who pressed him closely left the impression that the suggestion was both too simple, and possibly too inhibiting for inventors and their financial backers.
U.S. Solicitor General Donald B. Verrilli, Jr., asked the Court to go almost as far as Hansen did on naturally occurring gene extraction, but urged the Court to allow the patenting of synthetic DNA molecules — something that Justice Anthony M. Kennedy cleverly described as “economy-class gene.” (Myriad’s challengers oppose patents even on synthetic gene combinations.)
No one on the Court was in doubt that Myriad would have been entitled to a patent if it found some unique way to make use of the genes it has isolated, but the Justices drew a sharp distinction between creative applications and the core natural item, the gene itself. But that is a legal distinction, between a natural product and its uses, and the Myriad case in some ways involves a patent that sort of straddles the two.
With Justices Stephen G. Breyer and Sonia Sotomayor displaying what appeared to be the nearest approximation of some scientific understanding of human genetics, the other Justices who took an active part generally tried to stay away from those specifics, and to find ways to simply describe what Myriad’s scientists had done with its extraction of human genes.
Chief Justice Roberts came up with a simplification that other Justices found quite useful. All that Myriad had done, he suggested, was taking a string of molecules out of the body, and “snipping” it off.
But the Court got even more comfortable stepping away from any scientific analysis, and pondering examples of how to turn a product of nature into something that would benefit society. There were two that captivated the Court: the baseball bat that is something that comes from nature — a tree — but becomes something very different, and the leaf or sap of an Amazonian plant that has curative potential for human disease.
The Justices worked, and at times over-worked, those examples, but it was clear that they were regarded as highly serviceable ways to think about Myriad’s patents. And that might well be ominous for Myriad, since each of the examples made highly vivid the existence of two products: the natural one, and then something else that someone had the genius to create out of it. The tree can’t be patented, and neither can the plant while it grows in the forest in the Amazon, the Justices kept pointing out.
Myriad, of course, has argued that it did invent something with the extracted genes, but its lawyer struggled on Monday to try to differentiate that from the tree and the bat, and the Amazon plant and its sap.
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