Intellectual Property

Our patent portfolio consists of dozens of US patents, hundreds of foreign equivalents and active patent prosecution in over 14 distinct patent families claiming different types of stem and progenitor cells, cell culture media, stem cell research tools and techniques, and similar technologies. Our comprehensive patent portfolio includes seminal technology in cell biology including three patents identified by Nature Biotechnology as being among the five most fundamental neural stem cell patents as well as four patents identified as being among the top 20 most significant patents in stem cell research.¹ We have also identified numerous protected trade secrets, especially in the area of cell manufacturing, and have a growing list of registered trademarks, especially to support our commercial sales of SC Proven^® products.

While many of our patents were exclusively licensed from world-leading stem cell researchers and their institutions, a substantial number of our patents were homegrown, with StemCells scientists as named inventors. Key among these are various antibody enrichment patents and our patents claiming the use of leukemia inhibitory factor (LIF) to improve the proliferation of neural stem cells.

Our suite of patented technology includes:

Neural Stem and Progenitor Cells

We believe StemCells, Inc. has the preeminent neural stem cell patent portfolio. Our issued neural stem cell patents broadly cover human neural stem cells irrespective of whether they were derived from embryonic, juvenile or adult tissue, or derived using presently known iPS technologies. Our neural stem and progenitor cell patents cover: (i) compositions of matter, (ii) methods of manufacture (isolation, proliferation, purification, genetic modification, etc.), and (iii) methods of use (use as therapeutics, as tools for drug screening and testing, etc.).

In the chart below, we show just some of our US neural IP portfolio:

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Human Liver Engrafting Cells

Central to our Liver Program, our hLEC^™ human liver engrafting cells are covered by a growing liver cell patent family with a 2002 priority date. Several of these patents have already been allowed or issued in various key geographies, such as the United States, Europe, Australia and Japan. Issued claims cover the manufacture of our hLEC cells (using antibody enrichment), the use of these cells (including as a medicament and for drug screening), genetic modification of these cells and compositions of matter. There are pending applications in the United States, Europe, Australia, Japan, Canada, Hong Kong and the PRC, to claim these cells, whether derived using iPS technologies or otherwise. Highlighted US patents within this group include:

• US Patent No. 7,211,404, entitled “Liver engrafting cells, assays, and uses thereof,” which covers the isolation and use of an enriched population of hepatic liver engrafting cells
• US Patent Application (allowed) 11/502,210, entitled “Human liver engrafting cells, isolated from adult liver tissue” which covers compositions of enriched populations of hepatic liver engrafting cells

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Tools IP

Supporting our preeminent neural IP position and growing liver IP position is a growing tools patent portfolio that covers various stem cell-centric technologies. While the Company has had tools IP for some time, such as patents claiming genetic modification of cells, antibody enrichment methodologies, technologies for drug screening, etc., the acquisition of assets from Stem Cell Sciences in April 2009 added more than 15 new patent families covering various technologies, including technologies relating to embryonic stem cell culture, induced pluripotent stem (iPS) cells, and neural stem cells, as well as a gene insertion technology for use in drug discovery and development.

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Reprogramming and Stem Cell Maintenance

A number of our patents pertain to the reprogramming of somatic stem cells into induced pluripotent stem (iPS) cells, and the maintenance of stem cell populations. These include patents claiming the use of small molecule inhibitors to reprogram and maintain cells in their pluripotent ‘ground state,’ and the seminal Nanog patent, which resulted from the discovery of this key homeodomain protein.

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Rat Pluripotent Stem Cells

Recent groundbreaking work has demonstrated the derivation and culture of rat embryonic stem cells as a critical tool for the generation of germline competent ‘knock-out’ or ‘knock-in’ rats for scientific research and drug discovery. It is now possible to create gene-targeted rats using pluripotent stem cells, thereby bringing rats into the realm of sophisticated disease modeling similar to what has been done commercially with mice. Our tools IP covers both rat ES and rat iPS cells as well as genetically engineered rats derived from these cells.

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Stem Cell Selection

The genetic manipulation of stem cells through the introduction of a selectable marker under the regulation of a stem cell-specific promoter enables the isolation, selection and expansion of pure populations of stem cells. Our IP covers this.

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Stem Cell Manipulation (IRES)

The genetic engineering of embryonic stem cells through the use of an Internal Ribosome Entry Site (IRES) in combination with a selectable marker allows for the accurate monitoring of the expression of endogenous genes. The application of this technology in embryonic stem cells enables this technology to be used in the creation of transgenic models.

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Media and Reagents

Many of our products for the culture and differentiation of stem cells are covered by our patents, as are certain pipeline culture media products.

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