Researchers, rejoice! A landmark agreement reached between the National Institutes of Health (NIH) and E.I. DuPont de Nemours and Co. (DuPont) has once and for all set down the terms for technology transfer that protect -- and respect -- the rights of all affected parties. There are two sets of conditions, one for academic use of the technology, another for commercial applications. And, although this agreement deals with one patented research tool in particular, it offers a blue print for the future of technology transfer between universities, biotech companies, pharmaceutical companies and government laboratories.

The new accord between the NIH and DuPont concerns the appropriate use of DuPont's OncoMouse transgenic animal technology, on which it received an exclusive license from Harvard University. (The technology is actually covered by several patents, both U.S. and foreign, that concern the process used to create the mouse, the mouse itself, and all other mammals genetically altered by the technology.)

The OncoMouse, which contains a recombinant activated oncogene sequence, holds the distinctive honor of becoming the first genetically modified animal to receive a U.S. patent (in 1984). But, perhaps more importantly, it's also become a critically important model system for studying cancer per se and for early-stage testing of potential anti-cancer drugs. And, 'til now, academics wishing to use the research tool in their own basic scientific undertakings were prohibited from doing so -- under fear of patent infringement.

That cloud of uncertainty has dissipated. Basic researchers working at the NIH, or in academic labs supported by the NIH, don't have to pay a fee to use the technology -- as long as it's for non-commercial purposes. NIH scientists may even freely transfer animals covered by the patented technology to other academics under a material transfer agreement. Importantly, the agreement imposes no limitations on scientific publications or "reach-through" rights (which give the patent holder royalties on future inventions) for academic and government scientists.

However, if government or academic labs supported by the NIH decide to transfer OncoMouse transgenic animal technology to commercial enterprises, the individual companies must also obtain a license directly from DuPont. (Click here for the full text of the agreement. Note that, although the Memorandum of Understanding is dated July 1, 1999, the final agreement was not actually signed until Jan. 18, 2000.)

The sticking point, and the one aspect that took the longest to resolve, apparently revolved around DuPont's unwillingness to allow broad, and unencumbered, dissemination of its technology from one academic institution to another. It wasn't until late December that the negotiators in the respective tech transfer offices finally settled this last issue.

For Harold Varmus, who wound up his term as director of the NIH at the end of 1999, the event was the culmination of a seven-year crusade to ensure that patents on research tools do not restrict the use of those tools by scientists doing basic research in government and academic labs. Commenting on the accord, Varmus said "It is good news that DuPont and the NIH have reached an agreement that will allow an important research tool to be shared among not-for-profit investigators. While the appropriateness and breadth of the OncoMouse patent are questionable and unresolved, the fact is that the patent exists and likely impedes scientific exchange that would promote knowledge. Removing that impediment is good. We hope, of course, that reasonable terms will be used to make the animals available to commercial firms, encouraging development of products useful to patients." Varmus, who is currently the president and CEO of Memorial Sloan-Kettering Cancer Center in New York, was the co-recipient of the 1989 Nobel Prize for Physiology or Medicine. He and J. Michael Bishop earned the Nobel Prize for their discovery of the cellular origin of retroviral oncogenes.

The OncoMouse agreement is the second between the NIH and DuPont: The first, reached in July 1998, concerns Cre-lox technology, a gene-splicing tool that is used in making "knock-out" mice and is particularly helpful in studying gene function. (The full terms of that agreement can be found by clicking here.)

(For details of the Cre-lox technology, and the issue of patenting research tools, please refer to the three-part series that Signals published in 1998. These include an article on patenting research tools, one on the Cre-lox controversy and a third on the NIH-DuPont Cre-lox agreement.)

originally published 01/20/2000