Non-Destructive Technique for Generating Human Embryonic Stem Cells May Survive Recent Challenge to European Patent System
MARLBOROUGH, Mass. — Oct. 18, 2011 – Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, commented on the decision issued today by the European Court of Justice decision in the matter of Oliver Brüstle v Greenpeace. The Company believes that it will have minimal impact on ACT’s commercial efforts.
The ruling in the Brüstle v Greenpeace case follows a challenge by Greenpeace over a European patent granted for nerve cells generated from embryonic stem cells. In rendering its decision, the court specifically stated that “an invention must be regarded as unpatentable, even if the claims of the patent do not concern the use of human embryos, where the implementation of the invention requires the destruction of human embryos.” In this case, the inventor Oliver Brüstle sought patent protection for neurons generated from human embryonic stem cells, and failed to disclose any technique for generating the starting embryonic stem cells other than through destruction of an embryo.
“This decision is narrower than the popular press has made it out to be over the first few hours after it was released. While this decision represents an unfortunate step by the European Courts, we are encouraged from our early analysis, as well as statements from Greenpeace, that the decision’s impact is limited to patentability of inventions requiring the destruction of embryos or the use of cells derived as a consequence to the destruction of an embryo,” said Gary Rabin, chairman and CEO of ACT. “The Court appears to have clearly focused its decision on those processes relying on now dated traditional and destructive methods for generating embryonic stem cells from the inner cell mass of embryos, yet seems to provide for a continuing basis for patentability of process of generating human embryonic stem cells and products derived from those cells where non-destructive techniques can be used. ACT holds a unique position in the regenerative medicine field, having proprietary non-destructive means for generating human embryonic stem cell lines that not only should be patentable in view of this current European decision, but which have been validated for use in clinical trials in both the U.S. and Europe. It is our intention that each of our approved commercial products will ultimately be manufactured from stem cell lines generated without destruction of embryos.”
In its own press release today on the ruling, Greenpeace stated “the decision will affect stem cell research only partially, as in recent years, researchers have found several alternative methods for obtaining stem cells, without the need to destroy human embryos.”
“This is a huge setback for stem cell research in Europe,” said Robert Lanza, M.D., ACT’s chief scientific officer. “However, the Court went out of its way to stress that inventions are unpatentable if they ‘necessitate’ the destruction of human embryos. Therefore, this ruling does not appear to affect our single-blastomere technology, which does not require the destruction of embryos at any point. We will do whatever we can to ensure that therapies derived using these stem cells are made available to the patients in Europe who need them.”
Earlier this year, ACT announced a collaboration with Roslin Cells LTD (Scotland) for the establishment of a bank of embryonic stem cells using ACT’s non-destructive technology. Under the terms of the agreement, the two companies will work together to establish a bank of Good Manufacturing Practice (GMP)-grade human embryonic stem cell lines using ACT’s proprietary “single-cell blastomere” technique for deriving hESC lines without destroying embryos. Stem cell lines from the resulting bank will be made available for both research and commercial purposes.
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit www.advancedcell.com.
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