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The gatekeepers of hES cell products

Nature Biotechnologyvolume 23pages817819 (2005) | Download Citation


Does every road to commercial products derived from human embryonic stem cells run through Wisconsin?

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  1. 1

    Remarks by the President on Stem Cell Research, as made available by the White House Press Office, August 9, 2001.

  2. 2

    California and New Jersey have passed stem cell funding and regulation laws. The Massachusetts House of Representatives passed stem cell funding legislation by a margin large enough to override an expected veto by Governor Mitt Romney. New York, Connecticut, Illinois, Maryland, Pennsylvania and Delaware have had stem cell funding and regulation bills introduced in their respective legislatures.

  3. 3

    Investigators from ten laboratories in the US, Australia, India, Israel and Sweden initially derived stem cells from 71 individual, genetically diverse blastocysts that met the President's criteria for use in federally funded hES cell research.

  4. 4

  5. 5

    NIH Human Embryonic Stem Cell Registry.

  6. 6

    Exemplary Material Transfer Agreements (MTAs) and Memoranda of Understanding (MOUs) from NIH-qualified vendors of eligible stem cells are available from the NIH web site.

  7. 7

    WiCell-NIH MOU

  8. 8

  9. 9

    Miller, J. A call to legal arms: bringing embryonic stem cell therapies to market. Alb. L.J. Sci. & Tech. 13, 555 (2003).

  10. 10

    Wadman, M. Licensing fees slow advance of stem cells. Nature 435, 272–273, 2005.

  11. 11

    WARF letter to Tommy Thompson, US Secretary of Health & Human Services, August 5, 2004.

  12. 12

    Ligler, A. Egregious error or admirable advance: the memorandum of understanding that enables federally funded basic human embryonic stem cell research. 0037 Duke L. & Tech. Rev., 2001.

  13. 13

    Gallagher, K. Foundation could tap into California spending. Milwaukee J. Sentinel. February 20, 2005.

  14. 14

    Stem cell deal reached. News@UW-Madison; published online 9 January 2002,

  15. 15

    Vidergar, C.R. Biomedical patenting: permitted, but permissible? Santa Clara Computer & High Tech. L. J. 19, 253 (2002).

  16. 16

    Gertzen, J. Stem cell patents put UW agency in spotlight: foundation seeks to share technology, protect rights. Milwaukee J. Sentinel. August 26, 2001.

  17. 17

    35 USC § 102.

  18. 18

    See, for example, Pluripotential embryonic stem cells and methods of making same. US Patent no. 5,453,357 (1995). This patent's relevance is controverted by Geron and WARF.

  19. 19

    35 USC § 103.

  20. 20

    35 USC § 112, 1st paragraph.

  21. 21

    In 2004, the European Patent Office refused to issue a patent to WARF on the grounds its claims were applicable to hES cells, which are specifically excluded from patentability in Europe. WARF's patent application was considered contrary to morality because WARF's method would require the use of a human embryo as a starting material.

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  1. Whiteman Osterman & Hanna, LLP, One Commerce Plaza, Albany, 12260, New York, USA

    • Sander Rabin


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