Dor BioPharma Inc. patent news >
Wednesday August 14, 9:02 am Eastern Time
Press Release
SOURCE: DOR BioPharma, Inc.
DOR BioPharma Announces Key Ruling on European Vaccine Microsphere Patent
LAKE FOREST, Ill., Aug. 14 /PRNewswire-FirstCall/ -- DOR BioPharma Inc. (Amex: DOR - News; "DOR" or the "Company) announced today that the Company has been notified of a decision of the Technical Board of Appeal of the European Patent Office in the defense of European patent EP0 266 119 against an appeal by Chiron Corporation (Nasdaq: CHIR - News) to have the patent overturned. This is a key European patent that protects technology used in the development of orally administered vaccines. DOR and Elan Corporation, plc. (NYSE: ELN - News) through their joint venture, Innovaccines Corporation, obtained exclusive worldwide rights to patents licensed from the Southern Research Institute ("Southern Research") and the University of Alabama at Birmingham Research Foundation ("UAB") for orally administered vaccines, of which EPO 266 119 is one granted in European countries. The patents are based on discoveries made by scientists at Southern Research and UAB that permit the oral delivery of vaccines to humans. ADVERTISEMENT
In an action by the Technical Board of Appeal of the European Patent Office, the appeal by Chiron was remitted back to the Opposition Division, a procedure that allows challenged patent claims to be reviewed based on technical, scientific and legal merit. The claims in the patent were already upheld by the Opposition Division in 1997, before Chiron's appeal. European patent procedures permit interested parties to oppose issued claims within a specified time after patent issuance. The '119 patent covering microsphere vaccines that functionally deliver antigens to the immune inductive sites in the intestinal tract was originally issued in 1994 and opposed in 1995 by both Chiron Corporation and Alkermes, Inc. (Nasdaq: ALKS - News). After the patent was upheld by the Opposition Board, Chiron and Alkermes appealed the decision, while Alkermes later elected to withdraw from the appeal process.
DOR stated that "we consider the Southern Research/UAB patents in vaccine microsphere technology to be the dominant and most important intellectual property in this field." DOR further pointed out that the European patent process is lengthy and complicated. "The Company intends to vigorously protect this patent estate against any future challenges in Europe or elsewhere. We also consider the technology covered in this patent family will enable development of oral administered vaccines, representing a multibillion dollar potential market in new vaccines. The landmark developments in vaccines over the next decade will involve the development of numerous oral vaccines for infectious, cancers, and allergies." DOR also emphasized that the underlying technology has wide potential applications to existing vaccines that are administered by injection and developing new vaccines for such chronic viral diseases as AIDS and hepatitis C. The key feature of the technology is the manner in which antigens, key components of vaccines that stimulate specific immunity against disease, are protected against destruction in the intestine. Only several oral vaccines, such as polio, adenovirus, and typhoid fever, are currently licensed for use in the United States.
DOR BioPharma, Inc.
DOR BioPharma, Inc. is a drug-delivery company developing oral forms of compounds which have already been approved by the FDA. Its lead product, orBec®, is presently in separate multi-center pivotal phase III clinical trials for the treatment of intestinal graft-versus-host disease and other gastrointestinal inflammatory disorders. orBec® has also been granted "Orphan Drug" and "Fast Track" status from the FDA. For further information regarding DOR BioPharma, please visit the company's website located at www.dorbiopharma.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma's current expectations about its future results, performance, prospects and opportunities, including its product development and product pipeline. Where possible, DOR BioPharma has tried to identify these forward- looking statements by using words such as "anticipates," "believes" or similar expressions. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. DOR BioPharma cannot assure you that it will be able to successfully develop or commercialize products based on its technology, particularly in light of the significant uncertainty inherent in developing drug and drug delivery products, conducting clinical trials and obtaining regulatory approvals, that its technologies will prove to be safe and effective, that its cash expenditures will not exceed projected levels, that it will be able to obtain future financing or funds when needed, that it will be able to maintain the listing of its common stock on Amex, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully patent, register or protect its technology, trademarks and products, or that its business strategy will be successful. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR BioPharma's most recent reports on Form 10-QSB and Form 10-KSB. DOR BioPharma assumes no obligation to update or revise any forward-looking statements as a result of new information, future events, changed circumstances or for any other reason.
SOURCE: DOR BioPharma, Inc.
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