The Biotechnology Industry Organization (BIO) has asked U.S. Department of Agriculture (USDA) Secretary Tom Vilsack to urge the Department of Justice, which is considering the federal government's position in litigation about patent protection for isolated DNA sequences, to "strongly defend the patentability of such basic biotech inventions."

In a lawsuit filed by the American Civil Liberties Union against a genetic diagnostic testing company, a federal district court has apparently determined that this material is not eligible for patent protection because it is derived from natural sources. According to the trade group’s letter, “the patented DNA molecules [at issue in the litigation] are important for clinical breast cancer testing—but the reasoning of the district court was so expansive that patents on animal, plant, bacterial or viral DNA preparations are now also in serious question.”

The case has been appealed to the Federal Circuit Court of Appeals; BIO notes that industry is uncertain “whether DOJ has sufficiently appreciated the implications of the case outside of the human clinical diagnostics area.” BIO contends that a negative outcome “would greatly and negatively impact our ability to meet the nutritional demands of an ever increasing world population, to mitigate harmful impacts of global climate change, and to reinvigorate the American economy through agriculture.” The organization also claims that patent protection is crucial “for the hundreds of small biotech start-ups on the cutting edge of biotechnology innovation.” See Biotech NOW, September 27, 2010.