Sunday, March 13

The Stem Cells Patent Landscape

Stem cells have been in the news a great deal recently, both for their medical promise and the difficult ethical questions the use of embryonic stem cells present. This article from Goodwin Procter LLP via Mondaq discusses some of the science, medical treatments, ethics, politics and the IP status of the business of stem cells, stating:

"The patent landscape for both adult and embryonic stem cells is very crowded, with hundreds of issued patents having claims to methods of isolating stem cells, methods of propagating stem cell lines, methods of differentiating stem cell lines, and methods of using stem cells in treatment.

On the embryonic stem cell patent front, the University of Wisconsin holds the dominant patent position in primate embryonic stem cell line production. The Wisconsin Alumni Research Foundation ("WARF"), founded to handle the University’s patents and technology transfer, holds patents affecting 64 stem cell lines, including extensive rights to five lines.

Among companies, Geron Corporation is a significant player that to date has a portfolio of 240 stem cell patents. Geron obtained an exclusive license from WARF for its human embryonic stem cell technology, which ultimately ended up in litigation that was settled in 2002. Under its present license from WARF, Geron holds exclusive rights to develop certain therapeutic and diagnostic human embryonic stem cell products.

WARF and Geron have agreed to grant research rights to their existing human embryonic stem cell patents and applications to academic and governmental researchers without royalties or fees. Third-party for-profit companies may form collaborations with Geron or obtain licenses to Geron’s intellectual property on market terms. WiCell Research Institute, a WARF subsidiary, distributes the cell lines. WARF and WiCell Research Institute agreed to reasonable terms for such distribution in a Memorandum of Understanding with the NIH on September 5, 2001.

The adult stem cell patent landscape is also very crowded, with hundreds of patents directed to various aspects of the technology. For example, Osiris Therapeutics, a clinical stage biotechnology company founded to commercialize adult stem cells derived from bone marrow, has 42 issued patents directed to certain technologies, including methods of isolating and differentiating such cells, and methods of using the cells as immunosuppressants, for cartilage regeneration, and for repair of connective tissue."

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