Bayh-Dole Act and Tech Transfer Issues

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Bayh-Dole Act. Permits non-benefits and little organizations to claim their creations made with government reserves

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Bayh-Dole Act and Tech Transfer Issues FLC Mid-Atlantic Regional Meeting October 23, 2007 John Raubitschek US Army Patent Attorney

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Bayh-Dole Act Allows non-benefits and private ventures to claim their innovations made with government reserves – 35 USC 202(a)- (c) Authorizes offices to patent and permit their developments – 35 USC 207 & 209 Allows mien of rights in joint creations including elected workers – 35 USC 202(e). Preceding 2000, offices could just "exchange or dole out" their rights to the temporary worker. Presently, joint developments can be alloted or authorized to or by an office even without subsidizing understanding.

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Bayh-Dole Act (cont'd) 35 USC 202(e) may struggle with USG's leftover rights in non-chose innovations under 35 USC 202(c)(2) Another contention may emerge if non-benefit or private venture contractual workers working for USG on CRADAs make a development since colleague would not have rights to those creations DoC tended to this issue on April 2, 2004 (69 FR 17299) with a substitute arrangement to standard patent provision in 37 CFR 401.14 obliging temporary workers to give partner a possibility for a permit. This was a move from the DoD proposition to take title to the contractual workers' innovations and eminence impart to their designers. DOC questioned the DoD proposition as being conflicting with rolling out the base improvements in the statement as portrayed in 37 CFR 401.3(b). 37 CFR 401.3(a)(5), it could be said, approves organizations to do a DEC. The substitute arrangement is incorporated into FAR "plain dialect" amendment anticipated that would be distributed soon as a last run the show.

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DECs All offices, with the exception of DoE, DoD and NASA, are required to utilize the Bayh-Dole statement FAR 52.227-11 for all contractual workers However, organizations may alter condition in "remarkable conditions" in the wake of making an assurance or DEC Legislative history – S. Rep. 96-480 (1979), p 32. DECs ought to be utilized sparingly, for instance when use by people in general of an item is required by a UDG control or when organization arrangements to completely subsidize and elevate development to showcase. Be that as it may, office ought to characterize its particular fields of utilization and painstakingly structure conceded conclusions with the goal that it doesn't decimate motivations to market in fields not important to office.

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DECs - Procedures What activity requires a DEC? Any "limitation or disposal of the privilege to hold title to any subject development" 37 CFR 401.3(a)(2) The prerequisite that a temporary worker permit an outsider, for example, a prime, would require a DEC Modification or fitting of the patent rights statement as depicted in 37 CFR 401.5 does not require a DEC What is the essential support for a DEC – Modification will better advance the approach and destinations of the Bayh-Dole Act The updated proviso ought to begin with the fundamental patent condition and make just such changes as are important to address the excellent conditions or concerns which prompted to the utilization of the exemption (37 CFR 401.3(b)). At the end of the day, it would not be proper to begin with the title proviso in 52.227-13.

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DECs (cont'd) 401.3(a) requires composed assurance with explanation of actualities supporting the conditions distinguished in the exemption exist and address with specificity how substitute arrangements will better accomplish B-D goals Must give temporary worker alternative for more noteworthy rights under 401.15 or 52.227-13(b)(2) Copy of DEC must be sent to contractual worker (planned) with offer rights under 401.4 (30 working days) or under 35 USC 202(b) and 203 (60 days to COFC); advance chose by head of office or designee Copy must be sent w/i 30 days of agreement honor to DoC (Assistant Sec. for Tech Policy, now abrogated) and SBA (Chief Counsel for Advocacy), if private company If DoC thinks there is an example conflicting with B-D, tells head of organization and OFPP which may prescribe restorative activity GAO may ask for offices to give data on DECs

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DECs - FAR Agency head makes a DEC – FAR 27.303(d)(ii); 37 CFR Part 401 does not indicate specialist level aside from requests Covers all temporary workers Appeals chose by head of office or designee at level above individual making DEC w/i 45 working days or 30 working days if there is truth finding If advance raises honest to goodness disagreement about material certainties, office must direct reality finding as per office methods to be finished w/i 45 working days Contractors may show up with guidance, submit confirm, display witnesses and stand up to office witnesses Must host a translated record unless gatherings postpone

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DEC Activity Most DECs originate from Energy and NIH has done "6 or less" DECs – GAO Report 98-126 DoC got sees from NIH (3) and DOE (3); just protested DEC by Energy in U.S. Propelled Battery Consortium – a $200M cost impart battery program for electric autos to the enormous 3, which took title to all innovations for car applications. B-D subs would get sensible eminences for utilization of their creations by other than USABC and EPRI.

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GAO Analysis of DECs GAO Report 84-26 dissected 7 DECs (Energy – 6 and NASA - 1) GAO surveyed DECs until statute was changed in 1984 to allocate duty to DoC Under its statute, NASA took title to Cal Tech's creations under an agreement granted preceding B-D yet restored a while later. Cal Tech asked for DEC for uniform treatment of developments. GAO did not question DEC. Thus, GAO concurred with 4 Energy DECs where the subs' creations were possessed by the prime temporary worker in a honor made before B-D. GAO couldn't help contradicting Energy DEC identifying with an agreement for atomic waste transfer and capacity on the grounds that the office has no present plan to move the innovation in perspective of existing government approach identifying with capacity of atomic waste GAO likewise couldn't help contradicting two Energy DECs since it didn't acknowledge reason for withholding patent rights, i.e. that members required an eminence free permit in creations by colleges and independent ventures.