StemCells to Begin Patent Reexamination Process with U.S. Patent and Trademark Office
Company Notes PTO’s Preliminary Rejection of Claims Was Expected;
Reiterates Confidence in Outcome
PALO ALTO, Calif., September 17, 2007, – StemCells, Inc. (NASDAQ: STEM) today announced it will begin a patent-reexamination process with the U.S. Patent and Trademark Office (PTO) following the agency’s decision, which was expected, to preliminarily reject all claims in the company’s four patents which are the subject of its lawsuit against Neuralstem, Inc.
In June, StemCells announced the four patents were pending reexamination by the PTO based on petitions from Neuralstem. StemCells also noted defendants often petition for reexamination as a tactic to delay litigation and that patents can be reexamined based upon any prior art not previously considered, regardless of whether the prior art is ultimately found to be relevant.
The company also noted the PTO often initially rejects reexamined patents, but then subsequently upholds patent claims in later stages of the review and appeals process. StemCells noted that only one of the more than one hundred and thirty claims in the four patents needs to survive in order for the litigation to continue.
“We fully expected the PTO’s preliminary decision. In a patent reexamination, the patent office will routinely reject all claims under reexamination in order to shift the responsibility of proof back to the patent holder. We remain confident that we will be able to reaffirm the novelty of these inventions and that broad claims protecting the manufacture and use of neural stem cells will emerge from this process,” said Martin McGlynn, president and chief executive officer of StemCells. “At that time, we will press forward with our case against Neuralstem.”
Mr. McGlynn added, “We have a very deep and broad patent portfolio that provides us with multiple layers of protection in the neural stem cell field. Nothing about this litigation or its outcome will hamper our freedom to operate or our ability to pursue our business objective of developing and commercializing neural stem cell technology.” StemCells owns or has exclusive licenses to 53 issued or allowed U.S. patents and more than 150 granted or allowed patents worldwide.
About StemCells, Inc.
StemCells, Inc. is a clinical-stage biotechnology company focused on the discovery, development and commercialization of cell-based therapeutics to treat diseases of the central nervous system, liver and pancreas. The Company’s programs seek to repair or repopulate neural, liver or other tissue that has been damaged or lost as a result of disease or injury. StemCells has pioneered the discovery and development of HuCNS-SC™ cells, its highly purified, expandable population of human neural stem cells. StemCells is currently conducting a Phase I clinical trial of its proprietary HuCNS-SC™ product as a treatment for neuronal ceroid lipofuscinosis (NCL). NCL, which is often referred to as Batten disease, is a rare and fatal neurodegenerative disease that affects infants and young children. Further information about the Company is available on its web site at: www.stemcellsinc.com.
Apart from statements of historical facts, the text of this press release constitutes forward-looking statements regarding, among other things, the future litigation strategies of StemCells, Inc. (the “Company”) and its ability to raise capital, conduct clinical trials and pursue its research and product development efforts. The forward-looking statements speak only as of the date of this news release. StemCells does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management’s current views and are based on certain assumptions that may or may not ultimately prove valid. The Company’s actual results may vary materially from those contemplated in the forward-looking statements due to risks and uncertainties to which the Company is subject, including uncertainty whether results obtained in the animal models and in vitro studies of infantile NCL or other diseases and conditions will be able to be translated into treatment for humans; uncertainty as to whether HuCNS-SC will prove safe in the current clinical trial; uncertainty as to whether the FDA or other applicable regulators or review boards will permit the Company to continue clinical testing in NCL or in future clinical trials of proposed therapies for other diseases or conditions despite the novel and unproven nature of the Company’s technology; uncertainties regarding the Company’s ability to obtain the increased capital resources needed to continue its current research and development operations and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals; uncertainty regarding the validity and enforceability of the Company’s patents, which may be questioned or contested through requests for reexamination and other legal proceedings; and other factors that are described under the heading “Risk Factors” in Item 1A of the Company’s Annual Report on Form 10-K.
#########################
CONTACT: StemCells, Inc.
Rodney Young
Chief Financial Officer
650-475-3100, Ext. 105
irpr@stemcellsinc.com
or
Ashton Partners
Mike Geczi or Lauren Sobut
312-553-6700
SOURCE: StemCells, Inc.
|
