18.06.2003

To all EBMT Centers

Dear Sir/madam,
Osiris Therapeutics Inc. has applied for a patent on the isolation and ex vivo expansion of mesenchymal stem cells in Europe. We feel that a patent by one commercial company on the isolation procedure would have a negative effect on the research in this field. The therapeutic option health care providers can offer their patients could also become limited.
For these reasons, we urge that the patent does not include the non-commercial generation of stem cells. It is important to show that a large part of the European research community supports our protest. We hope you will join us in this effort by signing the page in the enclosed document and return it to us by fax number +46-8-7466699. We will forward all signed letters to the patent bureau in Nürnberg.
Yours sincerely,

Katarina LeBlanc, MD, PhD Olle Ringdén, MD, PhD
Professor of Transplantation Immunology Centre for Allogenic Stem Cell Transplantation
Huddinge University Hospital

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Louis, Pöhlau, Lohrentz & Segeth
Postfach 3055
90014 Nürnberg
Germany

Regarding patent application number 2247990

Osiris Therapeutics Inc, Baltimore, Maryland, USA has applied for patents to include the isolation and therapeutic use of human bone marrow derived mesenchymal stem cells in regenerative medicine and in the treatment of immune responses in transplantation.
The intent of Osiris Therapeutics Inc is to provide “off the shelf” un-matched donor-derived mesenchymal stem cells for health care providers.
It is our belief that a European patent by Osiris Therapeutics for the isolation and generation of mesenchymal stem cells could negatively impair the academic freedom of the European research community. It will also impair the freedom of choice for European medical patients eligible for cellular therapy if the patents were to include the non-commercial generation of mesenchymal stem cells so that:

1. European research centers become unable to perform independent clinical trials to evaluate the therapeutic potential of mesenchymal stem cells
2. European medical centers cannot generate autologous mesenchymal stem cells as a treatment option in contrast to the un-matched donor-derived mesenchymal stem cells produced by Osiris Therapeutics Inc.
3. European medical centers are prevented from generating mesenchymal stem cells derived from one specific donor (of the patient’s choice) to one specific recipient.
4. European medical centers are prevented from using, in clinical trials and as treatment, mesenchymal stem cells cultured ex vivo for a shorter time than the mesenchymal stem cells offered by Osiris therapeutics Inc. Clinical studies performed indicate that a longer time in culture negatively affect the optimal regenerative potential. (Horwitz et al. Proc Nat Acad Sci 2002; 99, 8932-8937).
5. European medical centers become financially unable to offer adult bone marrow-derived stem cells as a treatment option to medical patients due to an increased cost of purchasing the cells rather that generating them locally.
6. European medical centers become unable to offer adult bone marrow-derived stem cells as a treatment option to medical patients due to high costs of shipping human cellular material.

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