By Suresh Pillai —

Last month, Morphotek, Inc., a subsidiary of Eisai Co., Ltd. based in Exton, Pennsylvania, announced that it had been granted U.S. Patent No. 7,235,643 ("Antibodies and methods for generating genetically altered antibodies with high affinity," issued June 26, 2007).  This is the eleventh U.S. Patent awarded to Morphotek, Inc.

Prior to cell division, gene duplication is accomplished by the parent cell’s replication of the cell’s genetic material.  Errors in replication can lead to mutations among the duplicated genes; however, DNA repair mechanisms, such as mismatch repair (MMR), normally repair such mutations prior to cell division.  MMR is a proofreading mechanism by which the cell checks the genetic coding between the two copies of the genetic material to ensure that the genes are, in fact, copies of one another.  Normally, cell division occurs only upon completion of MMR.  In cells where MMR is dysfunctional, mutations accumulate through the genome to the point where sibling cells have traits different from the parents.  Morphogenics is a technology whereby the MMR process is selectively regulated within a living host.  Through the regulation of morphogenics and targeted mutation, scientists can accelerate cellular evolution, thereby creating unique organisms ideal for the study of disease pathogenesis or other commercial applications.

The ‘643 patent covers both Morphotek’s proprietary human MORPHODOMA® technology, which combines an ex vivo immunization with morphogenics.  The resultant antibodies naturally target specific disease-associated antigens.

The ‘643 patent issued from U.S. Application No. 10/243,130 which was filed on September 13, 2002 and which was a continuation-in-part of U.S. Application No. 09/707,468, filed November 7, 2000, which is now U.S. Patent No. 6,808,894.  Independent claim 1 recites:

1.  A method for producing a monoclonal antibody having an increased affinity for the antigen to which it binds relative to a monoclonal antibody comprising a heavy chain variable region comprising SEQ ID NO: 18, the method comprising substituting Alanine at the sixth position of SEQ ID NO:18 with Proline, whereby the affinity of the produced monoclonal antibody for said antigen is increased.

Suresh Pillai, Ph.D., is a molecular biologist and a third-year law
student at DePaul University College of Law.  Dr. Pillai
was a member of MBHB’s 2007 class of summer associates, and is currently working as a law clerk at MBHB.