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May 24, 2010
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The order was passed related to a lawsuit filed by the Medicines Company against the PTO, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services.
The Medicines Company has applied to the court to set aside the PTO’s latest denial of the company’s patent extension application for Angiomax. The PTO had denied The Medicines Co.’s application and granted an interim extension of the patent until May 23, 2010 (excluding 6-months pediatric exclusivity). The Medicines Company is asking the court to ignore this denial and direct the PTO to accept its patent term extension application as having been filed on a timely basis. Moreover, the company wants the court to order the PTO to extend the term of the patent under the Hatch-Waxman Act.
Angiomax (bivalirudin), The Medicines Company’s lead product, is a specific and reversible direct thrombin inhibitor that was launched in early 2001.
The Medicines Co. had filed for Hatch-Watchman exclusivity way back in 2001. However, the patent extension request was filed a day late due to confusion related to the approval date for Angiomax. Since then, The Medicines Company has been petitioning the PTO to accept the late filing which was due to "unintentional circumstances." The PTO has already rejected the company’s petition earlier.
With Angiomax accounting for almost 95% of total sales in 2009, the entry of generic competition would be devastating for the company. Generic player Teva Pharmaceutical Laboratories Inc. (TEVA) is looking to sell generic versions of Angiomax.
As such, the company is vigorously working on getting its patent extended. We expect investor focus to remain on the resolution of the Angiomax patent issues. We currently have a Neutral recommendation on The Medicines Company.
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