Abstract
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.....
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