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More than 100 biotech patent applications — part of a land rush to protect bits of identifiable genetic markers — most likely will be thrown out as inventions lacking practical use because of a Sept. 7 decision by the U.S. Court of Appeals for the Federal Circuit. In re Fisher and Lalgudi is the court’s first application of the patent protection standard of “substantial and specific” utility to nucleotide sequences known as expressed sequence tags, or ESTs. “This was the big policy decision that everyone was waiting for,” says George Yu of Affymetrix Inc. The company was one of several amici supporting the position adopted by the court’s 2-1 vote. More than 100 pending patent cases of pure EST applications are likely to be thrown out, according to Stephen Walsh, the assistant solicitor who argued the case for the U.S. Patent and Trademark Office. Plus, the specifications submitted by Monsanto Co. scientists Dane Fisher and Raghunath Lalgudi identified more than 30,000 ESTs in the maize leaves at issue, but claimed only five. “If the five claimed had been patentable, then they would have been able to file on the remaining 30,000,” Walsh says. In another five patent applications, he adds, Monsanto alone had more than 650,000 ESTs identified. The genetic tags at issue are contained in the billions of cells in a maize plant. DNA is composed of strands of nucleotides. An EST is a short sequence of nucleotide. Knowing the chemical identity of these genetic tags is an important step to allow researchers to monitor gene changes and other actions in the plant. But simply identifying the 300 or so strings of nucleotides in a genetic tag does not suffice to show a practical utility, according to Federal Circuit Chief Judge Paul Michel. “Granting a patent to Fisher for its five claimed ESTs would amount to a hunting license because the claimed ESTs can be used only to gain further information about the underlying genes,” Michel wrote. He noted that the government and amici expressed concern that allowing EST patents without proof of utility “would discourage research and delay scientific discovery.” The Patent Office has been grappling with whether to recognize ESTs as patentable since the biotech rush to identify genetic tags a decade ago. The government established guidelines in 2000, according to Patent Office solicitor John Whealan. The appellate court adopted the Supreme Court’s “utility” rationale in Brenner v. Manson (1966), which has never before been applied to biotechnology, Whealan says.
Pamela A. MacLean is a San Francisco-based reporter for the National Law Journal , an ALM publication, and where this article first appeared.

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