Biotech Values

[DewDiligence]

MDCO Loses Attempt to Extend Angiomax Patent

[This is a devastating blow because Angiomax, MDCO’s only marketed drug, will now lose U.S. patent protection in 2010 instead of 2015, unless the new Congress intervenes. The US PTO refused to grant the Hatch-Waxman 5-year extension to the patent term because MDCO filed its application for extension after the statutory deadline.]

http://biz.yahoo.com/e/061211/mdco8-k.html

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11-Dec-2006
Item 8.01 Other Events

The principal U.S. patent that covers The Medicines Company's (the "Company") product, Angiomax® (bivalirudin), expires in 2010. The United States Patent and Trademark Office (the "PTO") has rejected the Company's 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 December 6, 2006, 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. On December 9, 2006, the United States Senate adjourned without considering this bill. The Company is hopeful that the new Congress will consider similar legislation in the next session. The Company can provide no assurance that a bill will be introduced or enacted or that, if it is enacted, the PTO will consider the Company's application or that the Company will be successful in extending the term of the patent.
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