CARLSBAD, Calif. - (Marketwired – December 18, 2014) - International Stem Cell Corporation (OTCQB: ISCO), a California-based biotechnology company developing novel stem cell-based therapies and biomedical products, announced today that the Court of Justice of the European Union (CJEU), the European Union's highest court, has ruled in favor of the Company and that the Company’s core technology patent applications are not covered by the prohibition on patenting embryonic stem cells. This ruling confirms the opinion of the Advocate General published in July 2014.
"This definitive judgment clears the way for our stem cell patents to be approved in Europe while maintaining the position against patenting human embryonic stem cells,” said Andrey Semechkin, Ph.D., the Company's CEO and Co-Chairman. “ISCO now has the ability to obtain patent protection for its parthenogenetic stem cell technology in the EU, as it has already done in the US. A strong intellectual property estate is important for investors and potential partners as we begin our upcoming clinical study using human neural stem cells derived from parthenotes using the technology described in the patent applications.”
At issue were two patent applications filed by the Company, GB20060021068 and GB20060021069, which were rejected by the United Kingdom Intellectual Property Office (UKIPO) on the grounds that the disclosed technology, parthenogenetic stem cells and methods of making these stem cells, was excluded from patentability by the EU Directive on Legal Protection of Biotechnological Inventions. This directive excludes the patentability of the "uses of human embryos for industrial or commercial purposes." In the 2011 ruling in Brüstle vs. Greenpeace, the court defined a "human embryo" as cell types that are "capable of commencing the process of development of a human being", including in the definition (i) a fertilized human ovum, (ii) a non-fertilized human ovum that has had its nucleus replaced with a nucleus from a mature cell and (iii) a non-fertilized human ovum whose division and further development has been stimulated by parthenogenesis.
The Company appealed the UKIPO's decision, arguing firstly that the CJEU's ruling was scientifically incorrect with respect to parthenogenetic stem cells as chemically activated oocytes or "parthenotes" are incapable of developing into human beings, and secondly, as the CJEU ruling was only intended to ban patents on the use of organisms that could ultimately develop into human beings, parthenotes, which lacked such capacity, should not be regarded as human embryos for purposes of the Biotechnology Directive and should therefore be patentable under the EU law.
This final and definitive ruling by the EU’s highest court now formally separates parthenogenetic stem cells from embryonic stem cells, and removes the exclusion from patentability on the former while maintaining the ban on the later.
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com or follow us on Twitter @intlstemcell.
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Statements pertaining to anticipated developments, the potential benefits and scope of potential patent protection, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.
International Stem Cell Corporation
Dr. Simon Craw
Executive Vice President
Phone: (760) 940-6383
Tony Russo, Ph.D.
Phone: (212) 845-4251
Martina Schwarzkopf, Ph.D.
Phone: (212) 845-4292