Stem Cell Patent Alert
USPTO Rejects Broad Human Stem Cell PatentsBy Lisa A. Haile and Stacy Taylor The United States Patent and Trademark Office has now issued rejections in three broad human stem cell patents that have been a point of controversy in the scientific and legal communities. The rejections were issued March 30, 2007. The patents, owned by the Wisconsin Alumni Research Foundation, referred to as WARF, were challenged in July 2006 by the Foundation for Taxpayer and Consumer Rights in Santa Monica and the New York-based Public Patent Foundation, with supporting declarations from a leading stem cell research scientist. Last year, the European Patent Office rejected WARF’s European patent claims on different grounds, which are now on appeal. WARF’s Patent Claims Cover Isolation Process and the Stem CellsThe WARF patents were issued in 1998, 2001, and 2006 for studies done by University of Wisconsin scientist James Thomson. The patent claims cover not only methods for obtaining stem cells from fertilized embryos, but also cover the embryonic stem cells themselves. WARF has an active licensing program in place based on these three patents, requiring all researchers working with human embryonic stem cells in the United States to pay a license fee to WARF. WARF has come under extensive criticism from the stem cell community for its insistence on license terms that many see as sufficiently onerous to slow the progress of embryonic stem cell research. In response, WARF has established a reduced royalty rate for nonprofit organizations and offers licensee scientists training in embryonic stem cell work. Even so, a number of organizations are choosing to conduct their embryonic stem cell research programs outside the United States, a decision attributed by some to a desire to avoid the reach of the WARF patents. Patent Holder Not the First to Describe Stem Cell Isolation or Its Process, Said ChallengersThe basis of the challenges was that the patents on human embryonic stem cells should not have been granted so broadly because James Thomson was not the first one to describe the isolation of the stem cells or the process for isolation. To support their petition, the petitioners for reexamination of the patents cited several prior art documents, including papers published between 1982 and 1990 that detail a process for deriving embryonic stem cells from mammals. In addition, Dr. Jeanne Loring of the Burnham Institute, a well respected and world renowned stem cell research scientist, submitted supporting evidence to the USPTO. This Rejection Does Not Bode Well for WARFWhile an initial rejection of the claims by the USPTO in any patent application is not uncommon, a situation in which the examiners are clearly second-guessing their original decision to issue a patent does not bode well for WARF. The USPTO issued rejections based not only on prior art documents filed with the petition for reexamination, but also based on additional references newly found by the USPTO which brought into question the novelty and non-obviousness of Thomson’s original patent claims. WARF will have an opportunity to submit a response to the USPTO in the coming months and, following that, it will also have an opportunity to appeal any final ruling. In the meantime, the human embryonic stem cell research community is cautiously optimistic that one of the perceived highest barriers to progress in this field may ultimately be removed and investors may be more willing to support stem cell companies in the United States. Published by DLA Piper US LLP This publication is intended to provide clients with information on recent legal developments. It should not be construed as legal advice or legal opinion on specific facts. Pursuant to applicable Rules of Professional Conduct, it may constitute advertising. You are receiving this communication because you are a valued client or friend of DLA Piper US LLP. To unsubscribe from this mailing list, reply to this message with REMOVE in the subject line. Written requests may be sent to:
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