Shyntum Yvonne, Kalkreuter Edward
Pabst Patent Group LLP, Atlanta, Georgia 30361, USA.
Tissue Eng Part B Rev. 2009 Mar;15(1):87-90. doi: 10.1089/ten.teb.2008.0456.
U.S. patents directed to stem cell technologies have generated a high degree of interest and controversy. Many patents relating to stem cell technology have faced reexamination, litigation, or both. The U.S. Patent and Trademark Office (USPTO) recently upheld three Wisconsin Alumni Research Foundation (WARF) stem cell patents after reexamination requested by a third-party challenger in 2006. StemCells, Inc., and Neuralstem, Inc., both filed suits with respect to their patents related to neural stem cells. StemCells filed a suit on July 24, 2006, alleging infringement of its patents collectively referred to as "the neural stem cell patents," by Neuralstem, Inc. Neuralstem, Inc., filed a suit against StemCells, Inc., on May 7, 2008, alleging inequitable conduct during prosecution of StemCells' U.S. Patent No. 7,361,505. Both suits are yet to be decided. Pharmastem Therapeutics, Inc., had attempted to enforce its U.S. Patent Nos. 5,192,553 and 5,004,681, which resulted in invalidation of the patents in 2007. It remains to be seen what effect (if any) the recent increases in funding of stem research and the important U.S. Supreme Court decision on KSR v. Teleflex, Inc. (making it more difficult to establish nonobviousness of patentable subject matter) will have on challenges to stem cell patents.
涉及干细胞技术的美国专利引发了高度关注和争议。许多与干细胞技术相关的专利面临着重新审查、诉讼，或两者皆有。美国专利商标局（USPTO）在2006年应第三方挑战者的请求进行重新审查后，最近维持了威斯康星校友研究基金会（WARF）的三项干细胞专利。StemCells公司和Neuralstem公司都就其与神经干细胞相关的专利提起了诉讼。StemCells公司于2006年7月24日提起诉讼，指控Neuralstem公司侵犯了其统称为“神经干细胞专利”的专利。Neuralstem公司于2008年5月7日对StemCells公司提起诉讼，指控StemCells公司在其美国专利第7,361,505号的审查过程中存在不公平行为。两起诉讼均有待裁决。Pharmastem Therapeutics公司曾试图执行其美国专利第5,192,553号和第5,004,681号，但这导致这些专利在2007年被宣告无效。干细胞研究近期资金投入的增加以及美国最高法院关于KSR诉Teleflex公司案的重要裁决（使得确定可专利主题的非显而易见性变得更加困难）对干细胞专利挑战会产生何种影响（如果有影响的话）仍有待观察。
