Key ruling issued on European vaccine microsphere patent.(Brief Article)

2002 OCT 2 - (NewsRx.com & NewsRx.net) -- DOR BioPharma, Inc., announced 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 (CHIR) 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, (ELN) through their joint venture, Innovaccines Corporation, obtained exclusive worldwide rights to patents licensed from the Southern Research Institute and the University of Alabama at Birmingham Research Foundation 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.

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., (ALKS). 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.

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