GlaxoSmithKline and Genentech have settled a U.S. lawsuit related to Genentech’s Cabilly II (US 6,331,415) and Cabilly III (US 7,923,221) patents. In the lawsuit, started in October 2009, GSK had sought a declaration that the Cabilly II / III patents were invalid, unenforceable and not infringed by the manufacture, use, sale, offer to sell or importation of GSK’s ofatumumab (ARZERRA) antibody product. GSK is the development and commercial collaborator of the biotechnology company Genmab A/S.
No further terms of the settlement were disclosed.
The Cabilly family of patents generally relate to methods of recombinant antibody production. The Cabilly II application was filed on June 10, 1988, issued in 2001 and survived an ex parte re-examination by the USPTO in 2009. Claim 1 of the Cabilly II patent reads as follows:
1. 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 III application was filed on April 13, 1995 and issued on April 12, 2011. Claim 1 of the Cabilly III patent reads as follows:
1. A method for making an antibody heavy chain or fragment thereof and an antibody light chain or fragment thereof each having specificity for a desired antigen, wherein the heavy chain or fragment thereof comprises a human constant region sequence and a variable region comprising non human mammalian variable region sequences, the method comprising culturing a recombinant host cell comprising DNA encoding the heavy chain or fragment thereof and the light chain or fragment thereof and recovering the heavy chain or fragment thereof and light chain or fragment thereof from the host cell culture.
The Cabilly II / III patents are set to expire in December 2018.
Genmab’s press releases announcing the settlement may be found here.