Geron prevails in patent interference against ACT in stem cell area
Geron Corporation announced January 6, 2005 that the Board of Patent Appeals and Interferences of the U.S. Patent and Trademark Office has issued a final judgment ending patent interference number 104,746 between Geron and Advanced Cell Technology Corporation ("ACT") of Worcester, Mass. The Board ended the interference by entering judgment against ACT on all counts in the priority phase of the interference, thereby invalidating U.S. Patent No. 5,945,577, which is licensed to ACT from the University of Massachusetts.
Geron obtained rights to the pioneering nuclear transfer technology, originally used to clone Dolly the sheep, when it acquired Roslin Bio-Med (now Geron Bio-Med) in 1999. As part of that acquisition, Geron obtained a worldwide license from the Roslin Institute to the nuclear transfer patent portfolio and assumed management of the patent applications. Under Geron's management, patents covering the technology have been issued in the United States, Europe, Australia and several other jurisdictions. Geron requested that the U.S. Patent Office declare interferences between some of Geron's pending nuclear transfer patent applications and certain ACT patents because, in Geron's view, the technology claimed in those patents was first invented at the Roslin Institute and was covered by the patent portfolio licensed to Geron.
** US 5,945,577, although assigned to the University of Massachusetts as represented by its Amherst Campus, makes no mention of any federal funding and thus may not represent a Bayh-Dole situation. The application was filed January 10, 1997. The first claim recites:
An improved method of cloning a non-human mammal by nuclear transfer comprising the introduction of a non-human mammalian donor cell or a non-human mammalian donor cell nucleus into a non-human mammalian enucleated oocyte of the same species as the donor cell or donor cell nucleus to form a nuclear transfer (NT) unit, implantation of the NT unit into the uterus of a surrogate mother of said species, and permitting the NT unit to develop into the cloned mammal, wherein the improvement comprises using as the donor cell or donor cell nucleus a proliferating somatic cell that has been expanded in culture, or a nucleus isolated from said somatic cell.
The specification states:
The production of live lambs following nuclear transfer of cultured embryonic disc cells has also been reported (Campbell et al., Nature, 380:64-68 (1996)). Still further, the use of bovine pluripotent embryonic cells in nuclear transfer and the production of chimeric fetuses has been reported (Stice et al., Biol. Reprod., 54:100-110 (1996); Collas et al, Mol. Reprod. Dev., 38:264-267 (1994)). Collas et al demonstrated that granulosa cells (adult cells) could be used in a bovine cloning procedure to produce embryos. However, there was no demonstration of development past early embryonic stages (blastocyst stage). Also, granulosa cells are not easily cultured and are only obtainable from females. Collas et al did not attempt to propagate the granulosa cells in culture or try to genetically modify those cells.
As of January 6, 2005, the '577 patent has been cited by 10 US patents, most recently by US 6,781,030 (assigned to Tufts, and referencing GM35395, awarded by the National Institutes of Health, making the '030 a Bayh-Dole situation. The '577 patent claims priority to several provisional applications: This application claims the benefit of priority to U.S. Provisional Application No. 60/149,317, filed on August 17, 1999, entitled, "Induced Enucleation Methods To Clone Non-Human Animals," by Baguisi et al.; U.S. Provisional Application No. 60/131,061, filed on Apr. 26, 1999, entitled, "Use of Telophase Oocytes to Clone Non-Human Animals," by Baguisi et al; U.S. Provisional Application No. 60/131,328, filed Apr. 26, 1999, entitled, "Transgenic and Cloned Mammals," by Baguisi, et al.; and U.S. Provisional Application No. 60/106,728, filed Nov. 2, 1998, entitled, "Transgenic and Cloned Mammals," by Echelard, et al., the entire teachings of which are incorporated herein by reference. )