The US Court of Appeals for the Federal Circuit Court, in an en banc review, unanimously affirmed the earlier district court ruling in The Medicines Company v Hospira, finding that the company's Orange Book patents covering Angiomax (bivalirudin) that expire in 2028 (pediatric exclusivity expiring in 2029) were not invalid under the "on sale" bar.
The Federal Circuit also remanded the remainder of the issues on appeal and cross-appeal to the original Federal Circuit panel.
Clive Meanwell, chief executive of The Medicines Company (Nasdaq: MDCO), said: “We are pleased that the district court decision on invalidity has been upheld. 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.”
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