In their complaint, Repligen and The Massachusetts Institute of Technology (MIT) allege that ImClone’s production of Erbitux infringes a US patent that covers certain genetic elements that increase protein production in a mammalian cell. This patent is assigned to MIT and exclusively licensed to Repligen.
Repligen and MIT allege that the cell line ImClone uses to produce Erbitux employs key technology that is claimed in the patent-in-suit. Repligen and MIT also allege that the cell line was created under contract for the US National Cancer Institute (NCI) by a predecessor to Repligen and subsequently transferred from the NCI to ImClone for use in R&D only.
In its ruling, the court found that neither the transfer to the NCI by Repligen’s predecessor nor the subsequent transfer to ImClone by the NCI exhausted the proprietary rights of Repligen and MIT. The court’s ruling has eliminated these arguments as a potential defense for ImClone at trial.
Repligen and MIT said that they intend to seek damages adequate to compensate them for ImClone’s unlicensed use of the patented technology and will also seek a multiplier of any damage award based on ImClone’s infringement.
The news sent shares of Repligen shooting skyward, at an increase of 25%, while ImClone saw its stock fall by around 4%.
Erbitux was approved by the FDA in February 2004 for certain types of colon cancer. In May 2004, Repligen and MIT filed an action against ImClone for infringement of the patent. Repligen has filed an application with the US Patent and Trademark Office to extend the term of the patent-in-suit until 2009.