Protein expression patent fight

Repligen and MIT sue ImClone over 1987 Tonegawa mammalian cell protein production patent

Jeffrey Perkel(jperkel@the-scientist.com)
May 13, 2004

A fundamental U.S. biotech patent expired last week (May 5), accompanied by a flurry of legal activity. The patent holder and its licensee filed a patent-infringement lawsuit the day before the patent's expiration. They also asked the US Patent and Trade Office (USPTO) to extend the life of the patent.

Massachusetts biotech firm Repligen and the Massachusetts Institute of Technology (MIT) filed suit May 4 in US District Court, Boston, in which they allege patent infringement by ImClone Systems Inc., in the development and manufacturing processes of its anti-cancer drug, Erbitux (Cetuximab). Erbitux is a chimeric (human/mouse) monoclonal antibody directed against the epidermal growth factor receptor (EGFR). The US Food and Drug Administration (FDA) on February 12, 2004, approved the drug for use in the treatment of EGFR-expressing, metastatic colorectal cancer.

ImClone has not yet formally responded to the allegations, but David Pitts, ImClone's assistant vice president of corporate...