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Genentech and Protein Design Labs settle antibody patent dispute.

Genentech, Inc. (South San Francisco, CA) and Protein Design Labs, Inc. have concluded a definitive agreement which resolves their dispute relating to Protein Design's antibody humanization patents and certain of Genentech's humanized antibodies.

Under terms of the agreement, Genentech has exercised licenses under the patent licensing master agreement between the parties for XOLAIR and for RAPTIVA antibody products. These exercises will result in payment of license exercise fees to PDL in January 2004. Royalty payments, including those related to 2003 sales of the newly licensed products, will begin in the first quarter of 2004. In addition, Genentech has agreed to exercise a license for its AVASTIN antibody product, contingent upon approval of that product by the United States Food and Drug Administration. In exchange, and as part of the broader settlement between the parties, Protein Design has agreed to certain royalty reductions for significant levels of annual aggregate sales of Genentech products licensed under the master agreement. The revised royalty rate structure would apply reciprocally to any Protein Design products licensed under the master agreement. The agreement resolves and settles both companies' disputes regarding infringement of these Genentech products and the validity and enforceability of Protein Design's patents. Additional terms were not disclosed. Separately, Protein Design also obtained additional rights for non-exclusive, royalty-bearing licenses under certain of Genentech's antibody patents.

Mark McDade, Chief Executive Officer, Protein Design, said, "This agreement provides important clarity surrounding Protein Design's royalty revenue stream and allows us to devote attention and resources to the continued development of our proprietary pipeline. We very much appreciate Genentech's efforts to arrive at a business solution that supports the long-term interests of both companies and our efforts to provide innovative new therapies for patients."

As disclosed previously, Genentech had advised Protein Design that it had determined that XOLAIR was not covered under the claims of Protein Design's relevant antibody humanization patents. The companies subsequently conducted confidential discussions regarding whether or not XOLAIR would be covered. The scope of discussions was expanded to include RAPTIVA and AVASTIN. On December 1 of this year, the companies reported that they had reached an agreement in principle to resolve the dispute.

Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. Sixteen of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes 12 biotechnology products in the United States.

Protein Design is a recognized leader in the discovery and development of humanized monoclonal antibodies for the treatment of disease. Protein Design currently has antibodies under development for autoimmune and inflammatory diseases, and cancer. Protein Design holds fundamental patents for its proprietary antibody humanization technology.

Protein Design Labs, Inc.


Genentech, Inc.

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Publication:BIOTECH Patent News
Geographic Code:1USA
Date:Dec 1, 2003
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