The Biotechnology Industry Organization (BIO) and its IntellectualProperty Committee are taking their case for equal treatment of thebiotechnology industry to the U.S. Patent and Trademark Office(PTO) on Monday in San Diego."This is an extraordinary opportunity for the industry because theissues at the hearing focus solely on the intellectual propertyconcerns of the biotech industry," Chuck Ludlum, BIO's vicepresident for government relations, told BioWorld. "The schedulingof the hearing represents a substantial interest on the part of thecommissioner on patents and trademarks, Bruce Lehman, and hisstaff. BIO has organized a major effort to set the biotech agenda onthese issues for several years to come."At issue is BIO's belief that the PTO discriminates againstbiotechnology inventions by applying a higher standard, such as therequirement for data from human clinical trials on the efficacy of aninvention before its utility is established.BIO said that goes beyond the established threshold forpatentability of other technologies. Usually, evidence of areproducible practical utility use, rather than a specificcommercially viable end use, is enough as a matter of patent law."We are not asking for, and do not need, an amendment to thepatent law on the issue of utility," Ludlum said. "We are onlyasking that the current law be administered by the PTO in a non-discriminatory way."BIO will present a 200-plus page document titled, "Critical synergy:the biotechnology industry and intellectual property." Ludlumcalled it a "comprehensive, extraordinarily detailed document citinghundreds of cases to support our point of view." Among the issuescovered will be utility, operability, non-obviousness, experimentaluse and plant patent issues.Ludlum said he doesn't know that the PTO has ever held a hearingsuch as this for a particular industry. "It's a demonstration of thepriority they give our concerns," he said.Some 16 witnesses will testify under the BIO banner, and Ludlumexpects another 10 to 15 others to testify. He said the witnesseshave been selected to provide diverse, thorough and specific insightinto the biotechnology industry's concerns."In a fundamental way, it's a critical capital-formation issue,"Ludlum said. "Without intellectual property protection, we have noargument as to why investors should risk their capital."This is having an adverse impact on the economic health of theU.S. biotechnology industry, threatens individual companies'proprietary interest in their own inventions, undermines confidenceamong investors and erodes financial investment in theseinventions, and ultimately, could threaten the very existence ofmany biotechnology firms."The hearing is scheduled for 9 a.m. at the PTO office in San Diego.n

-- Jim Shrine

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