SKGF_Presentation_Stem Cells The Patent Landscape_2005


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SKGF_Presentation_Stem Cells The Patent Landscape_2005

  1. 1. culturing a primordial germ cell in a composition comprising the same 4 Table. Tissue Specific Stem Cell Patents WARF patents are reportedly available for licensing Stem Cells – Introduction The passage of Proposition 71 in California has lead to the expectation that the massive new funding for stem cell research will factors. It might be possible to avoid infringing these patents if the pluripotential embryonic stem cells are not prepared by culturing the cells in the presence of the four factors. This patent will expire in 2014. Cell Type Adipose-derived stem cell Breast epithelial stem cells Patent Number 6,777,231 5,814,511 Assignee Regents of the University of California Michigan State University Reportedly,1 WARF is asking for a $100,000 up front fee and a $25,000 annual maintenance fee from companies that take out a commercial license. Geron has secured from WARF exclusive U.S. rights to The Patent lead to the discovery of many new therapeutic treatments, including Vanderbilt also owns related U.S. Application 08/813,829 (unpublished) and Endothelial stem cells 6,852,533 Cornell Research Foundation, Inc. develop therapeutics and diagnostics treatment for neurodegenerative diseases and traumatic injuries. One Published Application 2004/0071672. Dorsal root ganglion progenitor cells 6,835,567 Signal Pharmaceuticals, Inc. from human embryonic stem cell- might also expect many new patents protecting these discoveries. Hematopoietic progenitor cells; derived neural, cardiomyocyte and However, stem cell research has been ongoing for more than a decade Geron Corporation owns U.S. Pat. 6,642,048 which claims a method of CD34–, CD7+, Lin–, Lin–, CD45RA+ 6,537,807 Duke University pancreatic islet cells. Research rights and many patent applications have been granted already, even though proliferating human blastocyst-derived pluripotent stem cells in substantially Hematopoietic stem cells; Thy-1+ 5,061,620 SyStemix, Inc. Landscape Hematopoietic stem cells; Thy-1+, CD34+ have been offered to academic and there are as yet no FDA approved treatments. The implications of undifferentiated form, comprising culturing the cells in a growth 5,750,397 SyStemix, Inc. governmental researchers without such patents on research and development of therapeutic treatments environment essentially free of feeder cells, but that contains an extracellular Hematopoietic stem cells; CD34+, CD38–, HLA-DR+ 5,840,580 Becton Dickinson and Co. royalties or fees. However, WARF must be considered. matrix and a conditioned medium produced by a method comprising (a) reportedly charges $5,000 each Hematopoietic lymphoid and dendritic cells; culturing the cells in a tissue culture medium to give a conditioned medium, CD34+, CD45RA+, CD10+; time its subsidiary, WiCell In order to better understand the extent of patenting that has already and then (b) harvesting the conditioned medium, wherein the cells used to Robert W. Esmond and occurred, we undertook a search of all U.S. patents that use the terms condition the medium are from a non-malignant mouse cell line Hematopoietic dendritic cells; CD34+, CD45RA+, CD10+, Hematopoietic stem cells, c-kit–, Thy-1– 5,972,627 5,876,956 SyStemix, Inc. Johns Hopkins University School of Medicine Research Institute, supplies one of its cell lines to an academic “stem cell(s),” “progenitor cell(s),” “precursor cell(s),” “multipotent immortalized by genetic engineering or a non-malignant human cell line that Robert A. Schwartzman cell(s),” “pluripotent cell(s),” or “totipotent cell(s)” in their claims. proliferates in culture for at least 60 days. Also claimed is a composition of Hematopoietic stem cells, CD34+ Hematopoietic stem cells, HCC-1+ 5,681,559 5,677,136 SyStemix, Inc. SyStemix, Inc. researcher. Over 1400 patents were identified. Each patent was evaluated and undifferentiated pluripotent stem cells obtained from a human blastocyst, Sterne, Kessler, Goldstein & Fox P.L.L.C. classified as claiming (1) embryonic stem cells and embryonic stem proliferating in a growth environment containing an extracellular matrix and Hematopoietic progenitor cells CD34+, galactose-specific lectin+ 5,858,782 University of Michigan cell preparations, (2) methods for isolating stem cells, (3) tissue a medium conditioned as described in the method claim. It may be possible Hematopoietic stem cells (quiescent), CD34+ 5,807,686 University of Minnesota; Rhone-Poulenc About the Authors specific stem cells, (4) genetically engineered stem cells and methods to avoid infringing this patent by not cultivating the stem cells free of feeder Rorer Pharmaceuticals What Royalty Payments Will Be Due? of making, (5) methods of culturing and expanding stem cells, (6) cells, or by not using an extracellular matrix or conditioned medium as Keratinocyte stem cells 6,485,971 Peter MacCallum Cancer Institute Robert W. Esmond, J.D., Ph.D., is a director and Robert A. Schwartzman, Ph.D., is methods of differentiating stem cells, and (7) methods of making specified in the claims. This patent will expire in 2021. Liver stem cells 6,129,911 Rhode Island Hospital, A Lifespan Partner Do not express OC2 6,872,389 It is very possible that the commercial use of stem cell technology will a patent agent at Sterne, Kessler, Goldstein & Fox P.L.L.C. The content of this article tissue in vitro or in vivo with stem cells as well as implants and require payments to multiple parties including: Lymphohematopoietic progenitor stem cells; reflects the present thoughts of the authors and should not be attributed to the firm prosthetics. The most important patents that may dominate the Geron also owns U.S. Pat. 6,800,480 which claims a composition My10– 5,256,560 University of Saskatchewan or any of its former, current or future clients. Furthermore, this article is not an therapeutic use of stem cells will be discussed briefly. comprising undifferentiated human embryonic stem cells proliferating on an Mesenchymal stem cells; CD45+ 6,387,367 Osiris Therapeutics, Inc. • Owners of patents on isolated stem cells and methods for their isolation. opinion and is not an admission as to the scope, validity, enforceability or extracellular matrix and free from feeder cells. This patent may be avoided Mesenchymal stem cells 5,486,359 Osiris Therapeutics, Inc. • Owners of patents that claim methods of cultivating stem cells. infringement of any of the patents mentioned herein. by cultivating the stem cells in the presence of feeder cells or in the absence Mesenchymal stem cells 5,827,735 MorphoGen Pharmaceuticals, Inc. • Owners of patents that claim methods for proliferating stem cells. of extracellular matrix. This patent will expire in 2018. Mesenchymal stem cells 5,908,782 Osiris Therapeutics, Inc. • Owners of patents that claim methods of differentiating stem cells. Pluripotent Mullerian duct-derived • Owners of patents that claim isolated, differentiated stem cells. Patents That May Dominate the Geron also owns U.S. Pat. 6,642,048 which claims a method for epithelial cells 6,416,999 Raven Biotechnologies, Inc. • Owners of patents that claim genetically modified stem cells. Abstract proliferating embryonic stem cells in a culture medium conditioned by Myeloid progenitor cells; c-kithi, IL-7Rα– 6,465,247 Stanford University • Owners of patents that claim the therapeutic method being Use of Stem Cells culture of a non-malignant human cell line that proliferates in culture for at Myeloid progenitor cells; Thy-1–, IL-7Rα– Neural progenitor cells 6,761,883 5,753,505 Stanford University Emory University commercialized. The patent landscape is already littered with a large number least 60 days. This patent may be avoided by not culturing stem cells in Neural stem cells 5,851,832 Neurospheres, Ltd. • Owners of patents that claim specialized methods for administering the of granted U.S. patents relating to stem cells. There are a Four companies/institutions have patents and patent applications that claim such a conditioned medium. This patent expires in 2021. stem cells. Neuronal progenitor cells 6,251,669 Emory University embryonic stem cells and methods for their isolation. Wisconsin Alumni • And, if the therapy was developed with California state money, the state of number of broad patents owned by a handful of U.S. Research Foundation’s (WARF) U.S. Patent No. 5,843,780 claims a purified Neuronal progenitor cells that do not express companies and institutions that may dominate the growing Amrad Corporation Limited owns U.S. Pat. 5,166,065 which claims a a Hu protein 6,852,532 University of Utah Research Foundation California as well. preparation of primate embryonic stem cells which (1) is capable of method for the isolation of embryonic stem cells from mammalian Lineage-restricted neuronal precursor cells; and use of stem cells. Other patents cover more limited stem proliferating for over one year, (ii) maintains a karyotype in which all of the E-NCAM+ 6,734,015 University of Utah Research Foundation Such royalty stacking may make the therapeutic use of stem cells cell technology, including particular uses of stem cells and embryos comprising deriving and maintaining the embryos in a culture prohibitively expensive. chromosomes characteristic of primates are present and not noticeably medium comprising recombinant leukemia inhibitory factor. This patent Central nervous system neural stem cells 5,968,829 Cytotherapeutics, Inc. tissue specific stem cells. Anyone who wishes to develop stem altered through prolonged culture, (iii) maintains the potential to may be avoided by cultivating the stem cells in the absence of Neuronal progenitor cells 6,812,027 Cornell Research Foundation, Inc. cells for therapeutic purposes must be concerned about differentiate into derivatives of endoderm, mesoderm, and ectoderm tissues Central nervous system neuron-restricted whether licenses to these patents will be necessary or even throughout the culture, and (iv) will not differentiate when cultured on a recombinant leukemia inhibitory factor. This patent will expire in 2009. Since any therapeutic methods employing embryonic stem cells will precursor cells Ventral mesencephalon neuron progenitor cells 6,787,353 5,411,883 University of Utah Research Foundation Somatix Therapy Corp. Is a Patent Pool the Answer? available. Where there are multiple patents that relate to a fibroblast feeder layer. The ‘780 patent also claims methods for isolation of likely not come to market until well after 2009, it is unlikely that this Neural crest stem cells 5,589,376 California Institute of Technology a primate embryonic stem cell line by (a) isolating a primate blastocyst, (b) A patent pool is an “agreement of two or more owners of different items of particular stem cell therapy, royalty stacking may be patent will impede the commercialization of embryonic stem cells. Neutrophil precursor cells 5,955,357 Nexell Therapeutics Inc. intellectual property to license one another and/or third parties.”2 Thus, a necessary. Finally, a proposal to set up a patent pool for stem isolating cells from the inner mass of the blastocyst, (c) plating the inner cell Pancreatic progenitor cells 6,436,704 Raven Biotechnologies, Inc. mass on embryonic fibroblasts, (d) dissociating the mass into dissociated Pancreatic islet progenitor cells; Express ErbB2 6,753,153 Scripps Research Institute patent pool for stem cell patents could be a one stop shop for all patent rights cell patents will be discussed. The Johns Hopkins University owns U.S. Pat. 6,090,622 which claims necessary to commercialize a therapy. Of course, all of the needed patent cells, (e) replating the dissociated cells on embryonic feeder cells, (f) human pluripotential embryonic germ cells. Hopkins also owns U.S. Pat. Pluripotent cells 5,914,268 National Jewish Center for Immunology & isolating colonies with compact morphologies and cells with high nucleus to Respiratory Medicine owners would have to agree to be part of the pool. 6,562,619 which claims a method for producing a differentiated cell Peripheral blood progenitor cells 5,541,103 Klinikum der Albert-Ludwigs-Universitat cytoplasm ratios and prominent nucleoli, and culturing the cells of selected population from human embryonic germ cells. These patents will expire Freiburg While some patent pools may be considered anti-competitive and colonies. WARF’s U.S. Pat. 6,200,806 claims a purified preparation of in 2017. Renal stem cells 6,410,320 University of Michigan objectionable, the U.S. government has published guidelines that can be used human embryonic stem cells and a method of isolation thereof similar to Renal stem cells 5,458,588 General Hospital Corporation to determine when a patent pool is pro-competitive and probably acceptable. Strategists and Advisors specializing in the protection, transfer, that claimed in the ‘780 patent. These patents will expire in 2015. Tufts University researchers have reportedly isolated cells from bone Retinal stem cells 6,117,675 HSC Research and Development Limited The factors which suggest that a pool is pro-competitive include whether it: Partnership and enforcement of Intellectual Property Rights. marrow that have many of the hallmarks of embryonic stem cells. Tufts • Integrates complementary technologies. WARF also owns related U.S. Published Application 2003/0008392. has reportedly filed a patent application to protect their discoveries. Skeletal progenitor cells 6,517,872 Yada Research and Development Co., Ltd. Ramdt University • Clears blocking positions. However, since the claims of this patent may well change substantially by However, no published applications were identified by our search on the Stem cells; FGFR+, not ES cells 6,767,737 New York University • Reduces transaction costs. the time it issues as a patent, if it ever does issue, the claims will not be USPTO database. Stem cells which give rise to blood cells; • Avoids costly infringement litigation. discussed herein. A discussion of what claims might issue from pending CD34–, MHC-I–, MHC-II– 5,744,347 Ohio University Edison Biotechnology Institute • Promotes the dissemination of the technology. U.S. applications is beyond the scope of this poster. T lineage progenitor cells; CD8int, CD4int, c-kithi, high bcl-2, There are other considerations as well that go beyond the scope of this poster. Vanderbilt University owns U.S. Pat. 5,453,357 which claims a composition CD8lo, CD4lo, c-kithi, high bcl-2 5,821,108 Stanford University However, the establishment of a patent pool for stem cells would be a comprising (a) pluripotential embryonic stem cells and (b) fibroblast growth welcome development for anyone developing a stem cell therapeutic method. factor, leukemia inhibitory factor, membrane associated steel factor and Tissue Specific Stem Cell Patents T lymphocyte precursor cells; CD34+, CD7+, Leu 8+ 5,622,853 Becton Dickinson and Co. soluble steel factor. Also claimed is a method of making a pluripotential stem cell comprising administering a growth enhancing amount of basic Forty eight patents were identified that claim various tissue specific stem fibroblast growth factor, leukemia inhibitory factor, membrane associated cells. The large majority of such patents are directed to hematopoietic stem References Summary steel factor, and soluble steel factor to embryonic ectoderm cells under cell cells. Other types of stem cells claimed in these patents include adipose- growth conditions. This patent will expire in 2012. Vanderbilt’s U.S. Pat. derived, dorsal root ganglion, epithelium, keritinocyte, liver, mesenchymal, 1 Waldman, M., “Licensing fees slow advance of stem cells,” Nature 435:272–273 (May, 2005). The patent landscape is littered with issued patents that may affect the ability 5,690,926 claims isolated non-murine mammalian pluripotential cells mullerian duct-derived, myeloid, neural, pancreatic islet, renal, retinal, and 2 Antitrust Guidelines for the Licensing on intellectual Property,” issued by the U.S. Department of to practice therapeutic methods with stem cells. Careful review of the patent which, among other things, are derived from a primordial germ cell by skeletal stem cells. These patents include those in the following table. Justice and the Federal Trade Commission, April 6, 1995. literature will be essential at the beginning of any research project.