Federal Circuit Rules for The Medicines Company in Angiomax® (bivalirudin) Patent Litigation
The Medicines Company announced that the U.S. 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, Inc., finding that the Company's Orange Book patents covering Angiomax® 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, MD, PhD, Chief Executive Officer, The Medicines Company, 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."
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The Company operates in the Americas, Europe and the Middle East and Asia Pacific regions with global centers today in Parsippany, N.J. and Zurich.
Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "expects," "hopes," and "potential" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether our product candidates, including CARBAVANCE, will advance in the clinical trials process on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, whether the Company will make regulatory submissions for its product candidates on a timely basis or at all, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis, or at all, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's quarterly report on Form 10-Q filed with the SEC on May 9, 2016, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
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Christopher Visioli, 973-290-6013
Christopher.Visioli@themedco.com
Krishna Gorti, M.D., 973-290-6122
Krishna.Gorti@themedco.com