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Patent Office Issues Certificates to Uphold WARF Stem Cell Patents
Action Concludes Reexam for University of Wisconsin-Madison's Most Important Base Embryonic Stem Cell Discoveries
Madison, Wis. – The United States Patent and Trademark Office has issued Reexamination Certificates for the two most important base embryonic stem cell patents held by the Wisconsin Alumni Research Foundation (WARF). This action officially concludes a reexamination process for these patents that began in October 2006, and was decided in WARF's favor in March of this year.
The patent office issued certificates for patents ?780 and ?806, which date back more than a decade to the breakthrough discovery of the isolation and culture of primate and human embryonic stem cells made at the University of Wisconsin-Madison. This ruling is not appealable, which means that the claims of these patents stand confirmed and enforceable.
"We are extremely pleased that the patent office has officially concluded these reexaminations," states Carl Gulbrandsen, WARF managing director. "Due to the patent office's extremely thorough and detailed reexaminations, we feel our patents are stronger than ever and affirm that Dr. James Thomson's groundbreaking discoveries are patentable inventions."
Thomson, the renowned stem cell researcher and pioneer, is a professor of anatomy at the UW-Madison and recently was appointed director of regenerative biology at the Morgridge Institute for Research, part of the new Wisconsin Institutes for Discovery.
The challenge to the patents was brought by the New York-based Public Patent Foundation and the California-based Foundation for Taxpayer and Consumer Rights. A third patent, ?913, also was included in the challenge and was upheld earlier this year. However, as this more recently issued patent follows a slightly different process, it still is subject to appeal by the third-party requestor.
Gulbrandsen noted that patent protection is vital for attracting the significant private sector investment necessary to develop commercial applications for stem cells. "Human embryonic stem cells provide researchers powerful tools for testing drugs at the cellular level, which may lead to astonishing advances in pharmaceutical development, particularly in the field of personalized medicine, and reduce reliance on animal testing. They also have the potential to offer new treatments and cures for devastating diseases such as diabetes, Parkinson's, Alzheimer's and spinal cord injuries that afflict millions of people around the world," he states.
"But, it takes millions upon millions of dollars to develop and bring new medical discoveries to market, and without patents to protect their investments and the opportunity to generate profits, companies will not commit resources to the lengthy and costly development and clinical trials process."
Since the announcement that its patents were upheld, WARF has seen increased interest in licensing its stem cell technologies. It currently has completed 30 license agreements with 25 companies, including an agreement just signed with Invitrogen Corporation last month. Gulbrandsen notes that any revenues WARF earns from licensing these and other technologies to companies is used to support further research at the UW-Madison.
In addition, WARF continues to support the distribution of cell lines and methodologies for isolating and culturing human embryonic stem cells to researchers through its affiliate, the nonprofit WiCell Research Institute. WiCell, which hosts the National Stem Cell Bank, has fulfilled more than 900 free academic licenses for patent rights to stem cells and has shipped cells to more than 500 researchers in 25 countries and 40 states.
Academic scientists using these cell lines and methodologies face no restrictions on patenting or publishing their own novel work. Currently, two vials containing approximately six million stem cell that are capable of establishing multiple new colonies are priced for academic researchers at $500.
WARF was established as the world's first university-based technology transfer office in 1925. As a private, nonprofit foundation, it supports world class research at the University of Wisconsin-Madison by funding research, protecting the intellectual property of the university faculty, staff and students and by licensing inventions resulting from their work to benefit humankind.