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The biotechnology industry is urging the Supreme Court to overturn a lower court decision (Bilski v. Doll) that narrowed the means of determining whether a process is eligible for patent protection, arguing that the new standard is likely to exclude unforeseen innovations. In October 2008, the U.S. Court of Appeals for the Federal Circuit ruled that a method or process is patent-eligible only if it is tied to a specific machine or if it transforms a particular article into a different state or different thing altogether. Tom DiLenge, general counsel at the Biotechnology Industry Organization, says the appellate court decision is at odds with the broad standard for process patent eligibility set by the Supreme Court three decades ago. “If the Court of Appeals’ contrary approach in the Bilski case is permitted to stand, it would create uncertainty that would negatively impact investment in biotechnology and thus stifle future growth of this remarkably beneficial industry,” DiLenge says. “Requiring that biotechnology process claims be tied to a machine or a transformation could jeopardize already-issued biotechnology claims and will create uncertainty surrounding future grants of biotechnology patents in these areas.”
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