Are your cooperative research agreements in compliance with the CREATE Act? The 2004 U.S. law spells out the legal means to protect your IP from losing its patentability through disclosure to research partners at outside institutions. But ensuring your research agreements fall within the Act’s safe harbor is not as simple as labeling all collaborations “joint research agreements” and filing those documents away. Some TTOs have begun routinely including CREATE Act language in their licensing and confidentiality agreements to provide blanket coverage, but the blanket may have some holes in it, experts say. “In limited cases, there may be some benefit. But in my opinion, such language will not likely have the desired effect,” comments Alan Bentley, director of commercialization in the Cleveland Clinic’s Office of Innovations. “Rarely are license agreements relied upon to cover research collaborations between licensor and licensee, which would include specifying a statement of work and research budget with overhead.”

Jim Reed, an attorney with San Francisco’s Squire Sanders & Dempsey, says TTOs should follow two basic rules when drafting agreements for CREATE Act coverage: use the exact words that appear in the statute to define your JRA, “and state an intent that the agreement qualify as a JRA under 35 U.S.C. § 103(c).” Even when legal guidelines are followed, however, that Act offers less than certain safety because of its ill-defined restrictions regarding research that may not yet have a clear application or field of use, he cautions. “The Act’s requirement that qualifying JRAs be within the ‘field of the claimed invention’ seems to present the most uncertain aspect of whether the Act can apply,” Reed comments. “It assumes a priori knowledge of the universe of inventions that might arise from the research — especially for inventions that are made unilaterally by a party to the agreement. On the one hand, disclosing parties will naturally be reluctant to define the research field very broadly; in the case of publicly funded research, that may not even be an option. On the other hand, if the field is defined too narrowly, whether intentionally or as a condition for receiving the research grant, the Act may not provide the safe harbor originally expected for patents pursued in the future.” The full article describing CREATE Act compliance issue and specific recommendations appears in the August issue of Technology Transfer Tactics. For subscription information, CLICK HERE.

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