Medicines Co. (MDCO) Settles Generic Angiomax Lawsuit w/ APP Pharma
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The Medicines Company (NASDAQ: MDCO) today announced that it has settled the lawsuits filed by MDCO in the U.S. District Court for the District of Delaware relating to the Abbreviated New Drug Application (ANDA) filed by APP Pharmaceuticals, LLC (APP) for a generic version of Angiomax (bivalirudin for injection). The settlement also includes APP's agreement to dismiss its appeal of the August 2010 federal district court decision holding that MDCO's application for Hatch Waxman patent term extension of the Angiomax composition of matter patent, U.S. Patent No. 5,196,404, was timely filed. Upon dismissal of the appeal, all pending litigation regarding the Angiomax composition of matter patent will have been resolved.
As part of the settlement, APP admits that the two patents asserted in the lawsuits related to APP's ANDA, U.S. Patent No. 7,582,727 and U.S. Patent No. 7,598,343, are valid and enforceable against, and would be infringed by, APP's proposed generic bivalirudin product. These patents are listed in the Orange Book and expire on July 27, 2028.
MDCO and APP also agreed to the following arrangements in connection with the settlement:
License by MDCO The settlement agreement includes a license by MDCO to APP and an affiliate of APP under which APP may launch a generic bivalirudin product in the U.S. on May 1, 2019. In certain limited circumstances, this license to APP could become effective prior to May 1, 2019 and could include an authorized generic bivalirudin product supplied by MDCO.
Finished Product Manufacturing for MDCO MDCO entered into an agreement with APP under which APP has agreed to manufacture and supply Angiomax finished product to MDCO. This manufacturing arrangement provides MDCO with an additional source of finished product supply capacity to support anticipated growth of product use, and replaces capacity recently lost when one of MDCO's fill and finish manufacturers announced that it would cease contract manufacturing operations.
Acute Care Generic Products Portfolio Licensed by MDCO MDCO and APP entered into an agreement under which APP has agreed to license and supply to MDCO a portfolio of generic products which are used in therapeutic areas in which MDCO focuses or plans to focus, including treatment of acute cardiovascular, neurological and infectious diseases in hospital.
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As part of the settlement, APP admits that the two patents asserted in the lawsuits related to APP's ANDA, U.S. Patent No. 7,582,727 and U.S. Patent No. 7,598,343, are valid and enforceable against, and would be infringed by, APP's proposed generic bivalirudin product. These patents are listed in the Orange Book and expire on July 27, 2028.
MDCO and APP also agreed to the following arrangements in connection with the settlement:
License by MDCO The settlement agreement includes a license by MDCO to APP and an affiliate of APP under which APP may launch a generic bivalirudin product in the U.S. on May 1, 2019. In certain limited circumstances, this license to APP could become effective prior to May 1, 2019 and could include an authorized generic bivalirudin product supplied by MDCO.
Finished Product Manufacturing for MDCO MDCO entered into an agreement with APP under which APP has agreed to manufacture and supply Angiomax finished product to MDCO. This manufacturing arrangement provides MDCO with an additional source of finished product supply capacity to support anticipated growth of product use, and replaces capacity recently lost when one of MDCO's fill and finish manufacturers announced that it would cease contract manufacturing operations.
Acute Care Generic Products Portfolio Licensed by MDCO MDCO and APP entered into an agreement under which APP has agreed to license and supply to MDCO a portfolio of generic products which are used in therapeutic areas in which MDCO focuses or plans to focus, including treatment of acute cardiovascular, neurological and infectious diseases in hospital.
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