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Encumbrance II: Cre-Lox and The Strings Attached!
A scientist at DuPont developed a great tool for site specific recombination of DNA in eukaryotic cells, reverently called Cre-Lox. It very elegantly regulates the expression of engineered genes at Lox sites through activation of a regulatory sequence that controls the expression of the recombinase Cre gene. Cells can be grown up then turned on to make the transcript of choice. Fabulous! (See US Patent 4,959,317). DuPont is very interested in keeping an eye on its proprietary Cre-Lox technology. Not to say that it is not available for research use, but the company requires both field-of-use and dissemination restrictions on Cre-Lox-containing materials, even at non-profit institutions. The dissemination to non-profit institutions requires a special MTA and licensing Cre-Lox materials requires pre-approval from DuPont. When JHU entered into a rare In-license with DuPont in 1997, we enjoyed a broad field- of-use yet were restricted as to dissemination and under obligation to keep track of everyone using Cre-Lox materials. The dissemination restriction became an issue not solely for JHU, due to the requirement to provide materials produced with PHS grant funds to requesters, but also for the wider research community. The welcomed remedy for all PHS grant recipients came in the form of a Memorandum of Understanding between DuPont and the Public Health Service dated July 1988. This document provided permission for limited dissemination. In addition, it provided non-profit institutions already licensed to Cre-Lox the option to amend their existing Agreements to reflect the terms of this Memorandum. Great with respect to dissemination, but additional restrictions were placed on the fields of use. For JHU, the most problematic restriction in the new field-of-use terms was prohibition of use of Cre-Lox in generation of mouse embryonic stem cell libraries and other pluripotential mouse cells for the purpose of preparing a library. LTD wished to amend the Agreement to permit dissemination but endeavored not to forfeit the DNA library field-of-use. The story ends on a good note as LTD was able to successfully negotiate an Amendment dated April 5, 2004 with DuPont that gave JHU the field-of-use necessary for our important stem cell research, for dissemination as required by PHS, and to place Cre-Lox materials in the Johns Hopkins Special Collection at the ATCC. The strings attached relate to the need to regularly report to DuPont a list of researchers using Cre-Lox and use of stipulated language in an MTA . For this reason LTD asks anyone using Cre-Lox to just provide us your name and Department. Incoming MTAs will be evaluated as to the approved language needed and a specific Cre-Lox outgoing MTA will be used when we disseminate JHU materials with outsiders. This seems a small price to pay in exchange for retention of an important field-of-use. For more information please contact: |
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