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April 1, 2014
05:38 EDTHSP, MDCOThe Medicines Co. provides update on Angiomax patent litigation
On March 31, Judge Andrews in the U.S. District Court of Delaware issued his Trial Opinion in The Medicines Company v. Hospira, Inc. The case involves Hospira's (HSP) Abbreviated New Drug Applications, or ANDAs, seeking approval to commercially manufacture, use or sell a generic version of The Medicines Company's (MDCO) Angiomax bivalirudin drug product before the expiration of the patents covering this product. The Delaware Decision follows a September 23-25, 2013 bench trial. With respect to patent validity, the Court held that the two patents in the case, U.S. Patent Nos. 7,582,727 and 7,598,343 were valid on all grounds. Specifically, the Court found that Hospira had failed to prove that the patents were either anticipated and/or obvious. The Court further held that the patents satisfied the written description requirement, were enabled and were not indefinite. With respect to infringement, based on its July 2013 Markman Decision, the Court found that Hospira's ANDAs did not meet the "efficient mixing" claim limitation and thus did not infringe the asserted claims of the '727 and '343 patents. The Court found that the other claim limitations in dispute were present in Hospira's ANDA products. The Court has not yet entered a final judgment. Any appeal to the Court of Appeals for the Federal Circuit would need to be filed within 30 days of such entry. The '727 and '343 patents expire in 2028.
News For MDCO;HSP From The Last 14 Days
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November 20, 2015
12:02 EDTMDCOThe Medicines Co. receives EC approval for IONSYS
The Medicines Company announced that the European Commission has granted marketing authorization for IONSYS(40 micrograms per dose transdermal system), with active ingredient fentanyl, for the management of acute moderate-to-severe, post-operative pain in adult patients for use in the hospital. IONSYS will be the only needle-free, patient-controlled, pre-programmed iontophoretic transdermal delivery system for use in adult patients requiring opioid analgesia in EU hospital settings. The marketing authorization follows the issuance of a positive opinion in September by the Committee for Medicinal Products for Human Use of the European Medicines Agency and is now valid in the 31 countries of the European Economic Area, which includes all 28 European Union Member States, plus Norway, Iceland and Liechtenstein. A supplemental new drug application for IONSYS was approved by the U.S. FDA in April 2015 with an approved IONSYS Risk Evaluation Mitigation Strategy program. The product is commercially available in the U.S. as of July 2015.
November 13, 2015
14:52 EDTMDCOFederal Circuit overturns District Court decision on Angiomax patents
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13:57 EDTMDCOAppeals court vacates decision invalidating Medicines Co. Angiomax patents
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13:38 EDTMDCOThe Medicines Co. jumps 9% following reports of court decision
Shares of The Medicines Co. jumped after reports surfaced that an appeals court vacated the decision invalidating Angiomax patents.

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