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More than 100 biotech patent applications-part of a land rush to protect bits of identifiable genetic markers-will most likely be thrown out as inventions lacking practical use, as a result of a recent decision by the U.S. Court of Appeals for the Federal Circuit. The Monsanto Co. case, closely watched by the biotechnology industry, 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-a component of DNA. “This was the big policy decision that everyone was waiting for,” said George C. Yu, litigation attorney for Affymetric Inc., a leading provider of gene array technology in Emeryville, Calif. The company weighed in as one of several amicus participants supporting the position adopted by the court’s recent 2-1 vote in In re Dane K. Fisher and Raghunath V. Lalgudi, No. 04-1465. Had the patent rights been granted, it “would allow a patent owner to lay claim to enormous development downstream,” said Joseph Keyes Jr., a Washington attorney for the Association of American Medical Colleges who supplied amicus arguments. 100 pending cases There are probably more than 100 pending patent cases of pure EST applications that 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. In addition, the specifications submitted by Monsanto scientists Dane K. Fisher and Raghunath V. Lalgudi identified more than 30,000 ESTs in the maize leaves at issue in the suit, but they claimed only five. “If the five claimed had been patentable, then they would have been able to file on the remaining 30,000 if they chose,” Walsh said. In another five separate patent applications, Monsanto alone had more than 650,000 ESTs identified that could have been subject to patent protection, he said. “In this field, ability to guess has outpaced the ability to do,” said Genentech Inc. attorney Jeffrey Kushan of Sidley Austin Brown & Wood. “Tons of information is generated, but turning [it] into real products is more elusive,” he said. The genetic tags at issue are contained in the billions of cells in a maize plant, which help generate the different proteins that the plant uses for color, flavor, leaf size or disease fighting. Genes are located on chromosomes in the nucleus of each cell and are made of DNA. The double helix formation of DNA is composed of strands of nucleotides, the court explained. An EST is a short sequence of nucleotide. Knowing the chemical identity of the genetic tags is an important first step to allow researchers to monitor gene changes and other actions in the plant. Simply identifying the 300 or so strings of nucleotides in an expressed genetic tag does not suffice to show a practical utility, it is only part of the gene map, according to Federal Circuit Chief Judge Paul R. 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 pointed out that the government and amici expressed concern that allowing EST patents without proof of utility “would discourage research and delay scientific discovery.” A sharp dissent In dissent, Judge Randall R. Rader said that ESTs have a utility “as research tools in isolating and studying other molecules.” “Admittedly, ESTs have use only in a research setting,” he said, but added that their value as a tool is “beyond question.” Monsanto spokesman Ben Kampelman said that the company is still reviewing its options for appeal but has made no decision. “We believe that the patent system will be more predictable and sound by having full judicial review of the law that is applied to the patenting of ESTs, even though it may not have come out in our favor,” Kampelman said. 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 after considerable internal debate and public comment in 2000, according to patent office solicitor John Whealan. The appellate court adopted the “utility” rationale of the leading case of 40 years ago, Brenner v. Manson, 383 U.S. 519 (1966), which has been applied to the electrical and chemical industries among others, but never to biotechnology, Whealan said.

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