Repligen Corporation has reached a settlement with Bristol-Myers Squibb Company in its lawsuit alleging infringement of US Patent No. 6,685,941 ("the '941 patent"), based on Bristol-Myers Squibb's sale of Orencia for the treatment of rheumatoid arthritis.
The settlement provides for Bristol-Myers Squibb to make an initial payment of $5,000,000 and to pay royalties on the US net sales of Orencia for any clinical indication at a rate of 1.8 per cent for the first $500,000,000 of annual sales, 2.0 per cent for the next $500,000,000 of annual sales and 4 per cent 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 University of Michigan to Bristol-Myers Squibb of an exclusive worldwide license under certain patent rights of Repligen and the University of Michigan. The settlement serves as the basis for Repligen and co-plaintiff the University of Michigan to dismiss the lawsuit against Bristol-Myers Squibb.
"We are very pleased by the settlement of this case which will provide us a substantial new source of revenue," stated Walter C. Herlihy, president and chief executive officer, Repligen Corporation. "Based on analysts' estimates of US sales of Orencia, we expect total cash receipts from our Protein A business, Orencia royalties, research and development and other income of greater than $30 million for fiscal year 2009, beginning April 1, 2008."
In January 2006, Repligen and the University of Michigan 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. The claims of the '941 patent relate to the use of CTLA4-Ig (Orencia) for the treatment of specific auto-immune diseases, including rheumatoid arthritis. The '941 patent is owned by the University of Michigan and the United States Department of the Navy and is exclusively licensed to Repligen.