November 24, 2015 —The U.S. Court of Appeals has overturned a federal circuit court’s decision in The Medicines Company v. Hospira Inc., supporting the patents claims for bivalirudin (Angiomax). This vacates the court’s earlier decision invalidating the Orange Book patents covering bivalirudin that expire in 2028 (pediatric exclusivity expiring in 2029).
The court requested briefing concerning the commercial on-sale bar issue. It has requested the views of the United States Department of Justice, and will also allow other amicus curiae to submit their views. An amicus curiae is someone who is not a party to a case and offers information that bears on the case, but who has not been solicited by any of the parties to assist a court.
“We are extremely pleased that the invalidity decision has been vacated, and that the entire Appeals Court will now review the issue anew,” said Clive Meanwell, M.D., Ph.D., chief executive officer, The Medicines Company. “We continue to believe that our patents are valid and infringed by the ANDA filers, and are now considering all of our options with respect to Hospira, Mylan and other generics.”
For more information: themedco.com