This excerpt taken from the MDCO 8-K filed Aug 4, 2008.
Item 8.01. Other Events.
On August 4, 2008, The Medicines Company (the Company) announced that the U.S. Food and Drug Administration (FDA) has approved the intravenous (IV) therapy CleviprexTM (clevidipine butyrate) injectable emulsion for the reduction of blood pressure when oral therapy is not feasible or not desirable. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
This excerpt taken from the MDCO 8-K filed Jun 24, 2008.
Item 8.01 Other Events
The principal U.S. patent that covers The Medicines Companys (the Company) product, Angiomax® (bivalirudin), expires in 2010. The United States Patent and Trademark Office (the PTO) rejected the Companys application under the Hatch Waxman Act for an extension of the term of the patent beyond 2010 because the application was not filed on time by our counsel.
On June 23, 2008, the United States House of Representatives passed a bill that, if enacted, would provide the PTO with discretion to consider patent extension applications filed late unintentionally under the Hatch Waxman Act. While the Company is hopeful that the United States Senate will consider this legislation, the Company can provide no assurance that a bill will be enacted or that, if it is enacted, the PTO will consider the Companys application or that the Company will be successful in extending the term of the patent.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.