Opportunities In Human Embryonic Stem Cell (hesc) Products

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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 WARFs licensing fees to be unwieldy, which isnt 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.

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This article was published on 2010/12/04