Monday, Aug 21, 1995

Genentech Receives Favorable Ruling on Process Patent Applicaiton for Recombinant Human Factor VIII:C

South San Francisco, Calif. -- August 21, 1995 --

Genentech, Inc. (NYSE:GNE) today announced that the United States Patent and Trademark Office (PTO) ruled in favor of Genentech and against Genetics Institute and Chiron Corporation regarding the process patent application for making the presently marketed recombinant human Factor VIII:C protein and for a vector comprising DNA encoding that protein. Recombinant and naturally derived human Factor VIII:C protein is a clotting factor widely used in the treatment of hemophilia. The recombinant form has the advantage of always being free of the AIDS and hepatitis virus. The DNA encoding Factor VIII:C is being studied for use in gene therapy.

The interference between a Genetics Institute patent and a Genentech patent application was declared on March 27, 1990, and a Chiron application was added on September 20, 1991. The PTO ruling determines that Genentech is the first inventor of the process for the production of recombinant human Factor VIII:C and vectors used in its manufacture and is entitled to the patent claiming the invention. The claims cover the DNA that encodes the Factor VIII:C protein and other aspects of the invention.

"After about five years of litigation, it is very satisfying to Genentech that the company and the inventors, Drs. Wood, Capon, Lawn and Vehar, are now being credited for their major contribution to this area of medicine," said Stephen Raines, Genentech's vice president for Intellectual Property.

In 1984, Genentech granted to Bayer A.G. a royalty bearing exclusive license to market recombinant human Factor VIII:C (initially sold in the United States by its affiliate Cutter Biological, a division of Miles Labs, Inc.) and in December, 1992, Genentech granted a coexclusive right to Bayer for use of the protein-encoding DNA in gene therapy.

Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant medical unmet needs. The company has headquarters in South San Francisco, California and is traded on the New York and Pacific Stock Exchanges under the symbol GNE.

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