The Medicines Company Settles Angiomax® (Bivalirudin) Patent Litigation With Sun
The Medicines Company (NASDAQ:MDCO) today announced that it has settled its litigation with Sun Pharmaceutical Industries Ltd. (Sun Pharma) and certain of its subsidiaries relating to MDCO’s U.S. Patent No. 7,582,727 and U.S. Patent No. 7,598,343 covering Angiomax® (bivalirudin). The patents are listed in the Orange Book and expire on July 27, 2028.
As a result of the settlement, MDCO will permit a Sun Pharma subsidiary to market a generic bivalirudin product in the United States on June 30, 2019, or earlier in certain limited circumstances. This settlement validates MDCO’s patents while allowing a Sun Pharma subsidiary to enter the market with its generic product.
Glenn Sblendorio, President and Chief Financial Officer of The Medicines Company stated, “This settlement further confirms the strength of our Angiomax patents and, we believe, is a common sense approach to resolving this litigation.”
The other terms of the agreement are confidential. The agreement will be submitted to the applicable governmental agencies for review.
Background on the litigation
In October 2011, MDCO received a Paragraph IV Certification Notice Letter from a subsidiary of Sun Pharma notifying MDCO that the subsidiary had submitted an ANDA to the U.S. Food and Drug Administration for approval to market a generic version of Angiomax®. In November 2011, MDCO filed a patent infringement lawsuit against Sun. The complaint, filed in the U.S. District Court for the District of New Jersey, alleged infringement of U.S. Patent Nos. 7,582,727 and 7,598,343.
MDCO remains in infringement litigation involving U.S. Patent Nos. 7,582,727 and 7,598,343 with Hospira, Inc., Mylan Pharmaceuticals, Dr. Reddy’s Laboratories, Apotex Inc., Accord Healthcare Inc. USA, Aurobindo Pharma Ltd. and Exela Pharma Sciences, LLC.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 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, NJ, USA and Zurich, Switzerland.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements 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" and "expects" 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 the extent of the commercial success of Angiomax and the Company’s other products; whether the Company is able to maintain market exclusivity for Angiomax; whether the Company is able to obtain or maintain patent protection for the intellectual property relating to the Company's products; whether the Company's products and product candidates will advance in the clinical trials process on a timely basis or at all; whether the Company will make regulatory submissions for product candidates on a timely basis; whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all ; risks related to the Company’s dependence on third parties to manufacture and supply its products; 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 Annual Report on Form 10-K filed on March 2, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The Medicines Company
Neera Dahiya Ravindran, MD, +1 973-290-6044
Vice President, Investor Relations & Strategic Planning
Bob Laverty, +1 973-290-6162
Mobile +1 609-558-5570
Vice President, Global Communications