Repligen Corporation settle patent dispute on Abatacept (Orencia)

Repligen Corporation announced that it has reached a settlement with Bristol-Myers Squibb (BMS) in its lawsuit alleging infringement of US6685941 (claims a method of treating a patient having multiple sclerosis comprising administering to the patient CTLA-4Ig in an amount effective to suppress the patient's immune response) , based on BMS's sale of Abatacept (Orencia) for the treatment of rheumatoid arthritis.
Abatacept (marketed as Orencia) is a fusion protein composed of an immunoglobulin fused to the extracellular domain of CTLA-4, a molecule capable of binding B7. Abatacept is a selective costimulation modulator as it inhibits the costimulation of T cells. It was developed by BMS and is licensed in the United States for the treatment of rheumatoid arthritis in the case of inadequate response to anti-TNFα therapy.The settlement provides for Bristol-Myers Squibb to make an initial payment of $5,000,000 and to pay royalties on the U.S. net sales of Orencia for any clinical indication at a rate of 1.8% for the first $500,000,000 of annual sales, 2.0% for the next $500,000,000 of annual sales and 4% of U.S. annual sales in excess of $1 billion for each year from January 1, 2008 until December 31, 2013. The settlement also provides for the grant by Repligen and co-plaintiff the to Bristol-Myers Squibb of an exclusive worldwide license under certain patent rights of Repligen and the . The settlement serves as the basis for Repligen and co-plaintiff the to dismiss the lawsuit against Bristol-Myers Squibb. In January 2006, Repligen and the filed a complaint in the United States District Court for the Eastern District of Texas against Bristol-Myers Squibb alleging infringement of the '941 patent based on its sale of Orencia(R).