University-Industry Partnerships and the Licensing of the Harvard Mouse

PATENTS Managing innovation: university-industry partnerships and the licensing of the Harvard mouse Sasha Blaug1,Colleen Chien1 & Michael J Shuster DuPont’s Oncomouse patent licensing program continues to cause a stir in academia and industry. ver the last several decades, technology restructuring in the 1980s resulting in optimized for mutual near- and long-term Oand technological innovation have reduced industry R&D spending and scarcer benefits to the parties? Recently this dialog gradually replaced manufacturing and agri- federal R&D funding. Increased technology has been focused on DuPont’s licensing of culture as the main drivers of the US econ- transfer has sparked a debate on univ- the transgenic ‘Harvard mouse,’ subse- omy. The unparalleled system of American ersities’ roles in the national economy: on quently trademarked as the Oncomouse6. research universities1 and their association the extent to which these relationships affect http://www.nature.com/naturebiotechnology with industry are important drivers of the the mission of universities to carry out The Oncomouse patents new economy. The relationship between and disseminate the results of basic DuPont’s patent licensing program for universities and industry is multifaceted, research, and on how universities can man- ‘Oncomouse technology’ has caused a stir in encompassing exchanges of knowledge, age their partnerships, collaborations and academia and industry for over a decade7. expertise, working culture and money. technology transfer without compromising These patents broadly claim transgenic Whereas the transfer of technology from their mission. nonhuman mammals expressing cancer- universities to industry has been going on In the basic research paradigm, inves- promoting oncogenes, a basic research tool for more than a century, ties between uni- tigators’ inquiries are directed toward dev- widely used in the fight against cancer. The versity and industry have grown during the eloping an understanding of scientific Oncomouse technology provides an impor- past three decades, coinciding with the phenomena. Results from basic research tant tool useful for the initial testing of growth in biotechnology2. sometimes lay a foundation for advance- many new and promising cancer treatments. These university-industry interactions ments of enormous commercial signifi- Balancing academic access to this tool with can generally be categorized as collab- cance. However, as technology-based ind- DuPont’s rights to the technology has © 2004 Nature Publishing Group orations and research partnerships, with ustries have grown and become more com- proved to be a challenging undertaking that industry supplying financial support to plex, so has the relationship between univer- presents an interesting backdrop against universities in exchange for options on sities and industry. Issues arising related to which policy considerations implicated by developed technologies and inventions. The intellectual property, rights to publish research tool licensing can be viewed. most successful interactions result in dis- research results and academic freedom have DuPont’s increasingly aggressive approach coveries being licensed to and developed by caused many to reexamine university- to licensing Oncomouse technology ulti- industry in exchange for upfront and down- industry partnerships in relationship to mately made academic institutions and the stream monies3.Indeed, the current para- their value to public health, education and US National Institutes of Health (NIH) cry digm for biotech development is based on the economy. foul in response to concerns that compli- such partnering4.These partnerships have Much of the discourse concerns how and ance with onerous license terms would seri- been encouraged and stimulated by several whether the partnerships and subsequent ously affect the basic research mission of factors: passage of legislation, most notably licensing can be strategically designed and universities and hinder the search for new the Bayh-Dole Act of 1980, corporate managed to promote innovation, technol- cancer therapies. In 1999, after four years of ogy development, proper risk-rewards negotiations8, the NIH and DuPont arrived incentives and public health5. One aspect of at a memorandum of understanding Sasha Blaug is at Fenwick & West LLP, this partnering that has come under (MOU) that allowed NIH researchers and Silicon Valley Center, 801 California Street, scrutiny is deals that give the funding corpo- grantees to use the Oncomouse technology Mountain View, California 94041, USA. ration ‘first rights’ to develop and commer- for basic research without charge, provided Colleen Chien and Michael J Shuster are at cialize results from sponsored university that the research did not directly benefit Fenwick & West LLP, 275 Battery Street, research discoveries. commercial interests or a for-profit institu- San Francisco, California 94111, USA. Because substantial federal support is tion9.However, this did not stop DuPont 1Indicates joint first-authorship. often used to develop academic research from continuing to make aggressive licens- e-mail: [email protected] or before industrial partnering, how can the ing demands on academic and research [email protected] agreements governing these partnerships be institutions. NATURE BIOTECHNOLOGY VOLUME 22 NUMBER 6 JUNE 2004 761 PATENTS In response to such demands, the the patents arising out of Leder’s work were On July 1, 1999, DuPont and NIH signed University of California asserted that it is assigned to Harvard, DuPont was entitled to the memorandum of understanding allow- entitled to the same royalty-free use of the an exclusive license (with a right to subli- ing “public health service” scientists to use Oncomouse technology accorded to the cense) to all inventions in consideration of Oncomouse-related patent rights in bio- NIH. Citing specific provisions of the 1999 its financial support. Initially, DuPont’s medical research free of charge provided MOU, the University of California coun- license fees for use of the mouse in basic that such use was not “for any commercial tered DuPont’s demands with an offer to research were nominal, and the license car- purpose or for the direct benefit of any for- take a license to the Oncomouse technology ried with it very few restrictions16.Use of profit institution”20.The MOU went on to on the same no-cost terms and conditions the technology proliferated quickly. DuPont enumerate two specific activities that would provided to the NIH as described in the collaborated with Charles River Labora- fall into this exception if undertaken for a MOU. On October 28, 2003, NIH informed tories to further develop the Oncomouse commercial purpose or the direct benefit of DuPont that it felt that the University of and other transgenic cancer-prone mice. a for-profit institution: testing compounds California’s position was “consistent with But in the mid-1990s, DuPont began negoti- or using the mice to produce products. The the intent, terms and conditions” of the ating licenses with substantial monetary fees terms and conditions of the MOU were to 1999 MOU. With this pronouncement, the from commercial entities and licenses from apply to research conducted by the public University of California and NIH have put academics that were unusually restrictive17, health service or “recipient institutions,” into serious question DuPont’s ability to col- for example, requiring universities and their defined as organizations that received NIH lect royalties for the use of the Oncomouse researchers to file frequent reports on their funds to conduct research. technology by universities and nonprofit use of the technology. It also reportedly institutions conducting cancer research. The University of California solution Although this agreement apparently solved Development of the Oncomouse On July 1, 1999, DuPont and the problem for the NIH, DuPont contin- at Harvard NIH signed the memorandum of ued to make demands on universities21.The Building on the original transgenic work of importance of the mice as a basic testing http://www.nature.com/naturebiotechnology understanding allowing “public Gordon and Ruddle at Yale10, the tool created an uncomfortable situation for Oncomouse (or Harvard mouse) was devel- health service” scientists to use academic institutions, creating huge pres- oped in the laboratory of Harvard professor Oncomouse-related patent rights sures for some to take a license from Philip Leder in the early 1980s (ref. 11). DuPont rather than jeopardize ongoing This transgenic mouse expressed the mouse in biomedical research free of research. mammary tumor virus (MMTV)-myc charge provided that such use Universities that DuPont approached oncogene, and so was prone to developing a received NIH funds, and therefore were variety of different tumors12.In 1988, the was not “for any commercial properly considered “recipient institutions” Harvard mouse became the basis for the purpose or for the direct benefit covered by the MOU. But DuPont argued first US patent granted to a higher organ- that university research sponsored by com- ism13.Subsequent patents broadly claimed of any for-profit institution.” mercial entities, or “sponsored research,” an entire class of transgenic nonhuman should be subject to license terms beyond mammals and methods to produce them14. the MOU. DuPont asserted that such © 2004 Nature Publishing Group These patents claim not only transgenic asked researchers to seek DuPont’s approval research

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