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Genentech and Protein Design Labs settle antibody patent dispute.

Genentech, Inc. (South San Francisco South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , CA) and Protein Design Labs, Inc. have concluded a definitive agreement which resolves their dispute relating to relating to relate prepconcernant

relating to relate prepbez├╝glich +gen, mit Bezug auf +acc 
 Protein Design's antibody humanization Humanization
Fusing the constant and variable framework region of one or more human immunoglobulins with the binding region of an animal immunoglobulin, done to reduce human reaction against the fusion antibody.

Mentioned in: Alemtuzumab
 patents and certain of Genentech's humanized antibodies Humanized antibodies or chimeric antibodies are a type of monoclonal antibody that have been synthesized using recombinant DNA technology to circumvent the clinical problem of immune response to foreign antigens. .

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 See page description language.

1. PDL - Page Description Language.
2. PDL - Program Design Language.
3. PDL - Push Down List.
4. PDL - Dave Lebling, one of the co-authors of Zork.
 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 Adj. 1. contingent upon - determined by conditions or circumstances that follow; "arms sales contingent on the approval of congress"
contingent on, dependant on, dependant upon, dependent on, dependent upon, depending on, contingent
 approval of that product by the United States Food and Drug Administration United States Food and Drug Administration (FDA), a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics.
. 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 not covered Health care adjective Referring to a procedure, test or other health service to which a policy holder or insurance beneficiary is not entitled under the terms of the policy or payment system–eg, Medicare. Cf 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. .

Protein Design is a recognized leader in the discovery and development of humanized monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of 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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