Overview:  Human embryonic stem cells (hESCs) are stem cells derived from the inner cell mass of a blastocyst, which is a stage reach 4-5 days post fertilization. They are the most pluripotent of all stem cell types and can develop into over 200 different cell types of the human body, providing tremendous therapeutic potential.

Human ESCs were first derived from mouse embryos in 1981 by Martin Evans and Matthew Kaufman, and independently by Gail R. Martin. In 1995, the first successful culturing of primate embryonic stem cells occurred at the University of Wisconsin-Madison. Another breakthrough followed at the University of Wisconsin-Madison in November 1998 when a group led by Dr. James Thomson developed a technique to isolate and grow human embryonic stem cells derived from human blastocysts.

As a result of these significant accomplishments at the University of Wisconsin, the Wisconsin Alumni Research Foundation (WARF) filed a series of landmark patents that have affected the intellectual property landscape ever since. These “composition of matter” patents concerning primate embryonic stem cells are controversial because they are so broad that they cover all human embryonic stem cell lines in the United States, not just the specific stem cell lines developed by James Thompson.

Since this time, WARF has been the major “gatekeeper” determining which research product companies have been allowed to conduct research and create commercial products using hESCs. WARF has also been in control of what pharmaceutical companies have been able to develop hESC therapies. Since obtaining its landmark patents in 1998, WARF has only entered into licensing agreements with 27 commercial partners for its intellectual portfolio related to isolating and differentiating hESCs, of which only 15 have been disclosed. 300 academic laboratories have also received agreements for using the technology without charge.

The low number of licensing agreements suggests that many companies find WARF’s licensing fees to be unwieldy, which isn’t surprising given that disclosed fees have ranged from $75,000 to more than $250,000, plus annual payments and royalties. While Invitrogen, Becton Dickinson and Chemicon have disclosed licensing agreements with WARF, many research products companies have to explore less costly alternatives – such as circumventing the claims, conducting research off-shore, potential use of abnormal karyotypes, developing embryonic stem cell products for other species, and pursuing strategic collaborations.

This market report explores the complex IP landscape affecting development of human embryonic stem cell products, providing clear guidance for companies that want enter the product area.

In addition, it contains:

• Discussion of key advances in hESC research
   

• A breakdown of hESC research applications, including shared priorities and priorities by segment
   

• Historical and future growth projections for the hESC market
   

• U.S. and international hESC patent analysis
   

• Competitive analysis of providers of hESC research tools
   

• Overview of specialty pharma companies developing hESC therapies
   

• Overview of toxicology testing legislation impacting use of hESC in toxicology applications
   

• A breakdown of hESC research product categories
   

• Suggestions for novel NSC research products, including cells, kits, assays, media and reagents
   

• Guidance for companies that wish to offer hESCs products
   

• And more…

I. Background

A. Human Embryonic Stem Cells (hESC)
B. Brief History
C. Use in Treatment of Disease
D. Human Embryonic Stem Cell Line Availability

II. Available Stem Cell Lines

A. NIH Registry Approved
B. Sources of Additional Published hESC Lines
C. Sources of Additional Unpublished hESC Lines


III. Applications

A. Basic Stem Cell Biology
B. Cellular Therapies

1. Overview
2. Heart Regeneration
3. Pancreatic Islet Cell Replacement
4. Neural Regeneration
C. Tissue Engineering
D. Toxicology Testing

IV. Application Priorities

A. Overall

1. Cell-Based Therapies: Greatest shared priority across research community

a. Beneficial hESC Characteristics
b. hESC Safety Concerns
c. hESC Characterization in Vitro
d. hESC Characterization in Vivo

2. Toxicology Assessment: Another area of huge potential

a. Overview
b. Commercial Interest

B. By Segment

1. Academic
2. Biotech
3. Pharma

V. Patent Environment

A. Landmark hESC Patents: WARF “Composition of Matter” Patents

1. Background
2. Licensing of WARF Patent Rights

a. Overview of WARF Licensees
b. Most Recent WARF Licensee: Pfizer, Inc. (May 2009)

3. WARF Patent Exemption: Federal Rights to hESC Research
4. U.S. WARF Patent Challenges
5. Circumventing WARF Patent Rights Using Geographic Limitations

B. Global Stem Cell Patent Landscape
C. U.S. Patents of Importance

1. Geron Corporation Patents
2. Regents of the University of California Patents
3. BresaGen, Inc. Patents
4. Regeneron Pharmaceuticals, Inc.
5. Vanderbuilt University Patents

D. Worldwide Patents of Importance

1. ES Cell International PTE Ltd. Patents (Singapore)
2. DNAVEC Research Inc. Patents (Ibaraki, JP)
3. University of Edinburgh Patents (Edinburgh, GB)

E. Summary of the hESC Intellectual Property Landscape

VI. Historical and Future Growth Projections

A. PubMed Analysis

1. Historical Analysis (Trailing 10 Years)
2. Future Growth Predictions (5-Year Forecasts)
3. Breakdown of ESC Research by Species

B. CRISP Analysis
C. Patent Analysis

1. All Fields
2. Abstract Only

VII. hESC PRODUCT COMPETITORS

A. Cellartis AB

1. Human embryonic stem cell lines
2. Monoclonal Antibodies for hESC Research
3. Differentiated Cell Products
4. Associated hESC products

B. Vitrolife

C. Tataa Biocenter

D. Invitrogen

1. hESC Culture Media & Reagents
2. hESC-qualified Basement Membrane Extract
3. hESC cDNA Libraries
4. hESC Reporter Cells
5. hESC PCR Kits
6. hESC Stem Cell Antibodies
7. hESC Stem Cell Growth Factors

E. Stem Cell Technologies

1. hESC Culture Media & Reagents
2. hESC Primary & Secondary Antibodies

F. BD Biosciences

G. Chemicon

1. hESC Culture Media and Reagents
2. hESC Lines
3. hESC Kits
4. hESC Antibodies

H. R&D Systems


I. SA Biosciences

J. Thermo Scientific

K. Australian Stem Cell Centre

VIII. Specialty Pharmaceutical Companies developing hESC Therapies

A. Geron
B. Novocell
C. Cell Cure Neurosciences Ltd
D. Cell Dynamics International
E. Advanced Cell Technology

IX. Featured Labs (Potential Customers)

A. Academic Labs
B. Private Labs
C. Government Labs
D. International Labs

X. Toxicology Testing Legislation

1. European Union to Ban Animal-Testing for Cosmetic Development in 2009


2. Responses to the European Ban on Animal Testing for Cosmetic Development

a. Overview
b. Skin Irritation
c. Eye Irritation
d. Skin Sensitisation
e. Mutagenicity/Genotoxicity
f. Reproductive Toxicity

3. EU Legislation Regarding Animal-Based Testing for Drug Discovery

XI. Product Development Suggestions

A. Product Categories

1. hESCs
2. hESC Derivative Cells
3. hESC Reporter Cells
4. hESC Antibodies
5. hESC Characterization & PCR Kits
6. hESC Qualified BME
7. hESC cDNA Libraries
8. hESC Growth Factors
9. hESC Media and Culture Reagents

B. Product Ideas & Suggestions
1. Areas of Underdeveloped Competition
2. Mouse ESC Products
3. iPS Cells Products
4. Non-animal-derived Culture Reagents for hESCs
5. Strategic Collaborations
6. Products for generating Pure ESC populations
7. hESC Toxicity Assay Kit


XII. Events of Interest

A. Annual Wisconsin Stem Cell Symposium
B. World Stem Cells & Regenerative Medicine Congress
C. World Stem Cell Summit 2010
D. Stem Cells 2010, Achieving Success in Science and Commercialization
E. International Society for Stem Cell Research, Upcoming Events

1. This Year (2010)
2. Next Year (2011)