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  • davey_douchberg davey_douchberg Aug 30, 2011 2:15 PM Flag

    Genentech Announces Victory in Cabilly Re-examination

    Genentech Announces Victory in Cabilly Re-examination

    Genentech announced last week that the U.S. Patent and Trademark Office had determined it would issue a re-examination certificate in Re-examination Control No. 90/007,542 involving U.S. Patent No. 6,331,415 ("the Cabilly II patent"). While a major victory for Genentech, it represents a bitter defeat for Medimmune, Genentech's licensee, as well as other biotechnology companies affected by Genentech's exclusive rights to basic recombinant DNA technology.

    The Cabilly II patent claims fundamental methods for making recombinant cells expressing both an immunoglobulin light chain and heavy chain; these methods are useful for making any of several genetically-engineered antibody molecules. Claim 1 of the patent, which will issue in the re-examination certificate unchanged from the claim in the '415 patent, reads as follows:

    A process for producing an immunoglobulin molecule or an immunologically functional immunoglobulin fragment comprising at least the variable domains of the immunoglobulin heavy and light chains, in a single host cell, comprising the steps of:
    (i) transforming said single host cell with a first DNA sequence encoding at least the variable domain of the immunoglobulin heavy chain and a second DNA sequence encoding at least the variable domain of the immunoglobulin light chain, and
    (ii) independently expressing said first DNA sequence and said second DNA sequence so that said immunoglobulin heavy and light chains are produced as separate molecules in said transformed single host cell.
    The Cabilly II patent issued on December 18, 2001, on a application filed June 10, 1988. That application claimed priority as a continuation from U.S. Application No. 06/483,457, filed April 8, 1983, and issued as U.S. Patent No. 4,816,567 on March 28, 1989.

    Prosecution of the Cabilly II patent was delayed by an interference declared between the Cabilly II application and U.S. Patent No. 4,816,397 to Boss. The Board entered judgment against Cabilly on August 13, 1998. Genentech filed suit under 35 U.S.C. § 146 that was not resolved in its favor until March 18, 2001. The first of two ex parte re-examination requests (which were merged) was filed (by counsel for Medimmune) on May 13, 2005, and the re-examination ordered on July 7, 2005. This re-examination was merged with re-examination Control No. 90/007,859 on June 6, 2006.

    The following is a timeline of the procedural history of this patent:


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